%0 Journal Article %@ 1929-0748 %I JMIR Publications %V 15 %N %P e85469 %T Motor Imagery and Action Observation in Breast Cancer Survivors: Protocol for a Randomized Controlled Trial %A Arnal-Vallés,María Pilar %A Soto-Ruiz,Nelia %A Bays-Moneo,Ana Beatriz %A García-Vivar,Cristina %A Escalada-Hernández,Paula %K breast cancer %K survivors %K survivorship %K rehabilitation %K motor imagery %K action observation %K lymphedema %K pain %K mobility %K functionality %K strength %K upper limb %K kinesiophobia %K range of motion %K imagery ability %K randomized %K trial %K protocol %K exercises %K oncology %D 2026 %7 30.3.2026 %9 %J JMIR Res Protoc %G English %X Background: Breast cancer is the most common type of cancer in women worldwide, and its incidence is increasing. Although breast cancer survival is slowly increasing, related sequelae can persist after the disease has been treated. The main physical symptoms associated with breast cancer survival include pain, lymphedema, and associated functional limitations. Although multiple treatments are available for alleviating symptoms in breast cancer survivors, their effectiveness remains limited. Motor imagery (MI) and action observation (AO) therapies, which are based on the theory of motor simulation and are used in multiple fields with satisfactory results, have been proposed as alternatives for treating pain and improving mobility and strength. Objective: This study aims to design, implement, and evaluate the effectiveness of a program combining MI and AO therapies to improve functionality and mobility and alleviate pain and lymphedema of the affected upper limb in women who have survived breast cancer. Methods: A randomized controlled clinical study will be conducted in a sample of 108 participants who have experienced breast cancer and, as a result, have pain in the affected extremity, lymphedema, or loss of strength and/or mobility. The intervention group will include 54 participants managed with the MI and AO program (a combination of MI, AO, and mobility exercises), while the control group will consist of 54 women performing mobility exercises alone. Pain intensity, muscle strength, joint range, limb diameter, fear of movement, and imagery capability will be evaluated. Results: The intervention is expected to yield improvements in pain intensity, joint range, muscle strength, and symptoms associated with lymphedema, among other outcomes. The study was funded in December 2023. The number of participants recruited as of manuscript submission is approximately 80, and data analysis has not yet started. These results will be published in 2026. Conclusions: The implementation of an intervention based on MI and AO has the potential to positively impact female breast cancer survivors who face physical and psychological sequelae that interfere with their daily lives. Trial Registration: ClinicalTrials.gov NCT07067710; https://clinicaltrials.gov/study/NCT07067710 International Registered Report Identifier (IRRID): DERR1-10.2196/85469 %R 10.2196/85469 %U https://www.researchprotocols.org/2026/1/e85469 %U https://doi.org/10.2196/85469 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 15 %N %P e85956 %T Spinal Manipulative Therapy on a Healthy Population: Protocol for a Randomized Blinding Feasibility Trial %A Sliwka,Margaret %A Perez,Tyson %A Qazi,Ahmed %A Sullivan,Stephanie %K double-blind %K chiropractic %K manual therapy %K randomized controlled trial %K gait analyses %D 2026 %7 27.3.2026 %9 %J JMIR Res Protoc %G English %X Background: Few manual chiropractic high velocity, low amplitude (HVLA) type shams have been validated in research. The proposed project is a randomized controlled trial (RCT) designed to assess a novel, full-spine, manual sham chiropractic maneuver and its blinding success. Objective: This study aims to evaluate the blinding integrity of participants receiving a genuine or sham chiropractic maneuver. We will also be evaluating the effects of genuine chiropractic treatments relative to sham chiropractic treatments by measuring several neurophysiological mechanisms. Methods: Participants (N=60) will be recruited from in and around Marietta, Georgia, United States. They will undergo a chiropractic physical exam and health history review with a licensed chiropractor and be randomized to either a sham or genuine chiropractic group (1:1 ratio). Participants, outcome assessors, and data analysts will be blinded to group allocation. The genuine group will receive diversified HVLA chiropractic spinal manipulative therapy (SMT), while the sham group will receive a novel chiropractic HVLA-emulating therapy. Each participant will attend 2 sessions spaced 1 week apart. Assessments will consist of blinding surveys postsessions (both visits) and presession (second visit). Additionally, we will measure gait parameters. The primary outcome of interest is blinding measured via the Bang Blinding Index (Bang BI). Secondary aims include measuring blinding via the James Blinding Index (James BI) and exploring the potential differential effects of genuine versus sham SMT on gait parameters. Results: This study is being supported and internally funded by the Dr. Sid E. Williams Center for Chiropractic Research at Life University in Marietta, Georgia, United States. Our study was prospectively registered on clinicaltrials.gov (NCT06931600) on March 28, 2025, and the first participant was enrolled on May 5, 2025. As of December 10, 2025, 18 participants have completed the trial. Projections for completing data collection, data analysis, and manuscript submission are Summer 2026, Fall 2026, and Winter 2027, respectively. Conclusions: The significance of the current RCT will be in its ability to inform whether our novel, full-spine, manual sham SMT protocol successfully blinds participants, suggesting feasibility for future clinical trials, as well as assessing for secondary outcome measures between groups. Trial Registration: ClinicalTrials.gov NCT06931600; https://clinicaltrials.gov/study/NCT06931600 and Universal Trial Number (UTN) U1111-1321-6250; https://trialsearch.who.int/Trial2.aspx?TrialID=NCT06931600 International Registered Report Identifier (IRRID): DERR1-10.2196/85956 %R 10.2196/85956 %U https://www.researchprotocols.org/2026/1/e85956 %U https://doi.org/10.2196/85956 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 15 %N %P e82712 %T Tunnel Anastomosis vs Double-Tract Jejunal Interposition Reconstruction After Proximal Gastrectomy: Protocol for a Multicenter Prospective Randomized Controlled Trial %A Xie,Qingyu %A Peng,Rui %A Yue,Chao %A Wei,Wei %A Huang,Lingli %A Wang,Xiaoxiao %A Wang,Haitian %A Chen,Liang %A Gu,Rongmin %A Chen,Huanqiu %A Ming,Xuezhi %A Wen,Xu %A Xu,Weiguo %A Sun,Guangli %A Fan,Hao %A Wang,Zhe %A Yang,Longhao %A Zhou,Xiaohua %A Wu,Xiaoyu %A Zhou,Jin %A Wang,Meng %A Xu,Hao %A Li,Gang %K gastric cancer %K proximal gastrectomy %K tunnel anastomosis %K double-tract jejunal interposition reconstruction %K antireflux %D 2026 %7 27.3.2026 %9 %J JMIR Res Protoc %G English %X Background: Tunnel anastomosis is a novel anastomotic technique for digestive tract reconstruction following proximal gastrectomy. A previous retrospective study by our team demonstrated its favorable antireflux effect; therefore, we hypothesize that tunnel anastomosis is noninferior to double-tract jejunal interposition reconstruction in preventing postoperative reflux esophagitis, and we will conduct this prospective study to further validate this assumption. Objective: In this study, we will prospectively compare tunnel anastomosis with the currently more prevalent double-tract jejunal interposition reconstruction technique to further validate its safety and efficacy. Methods: This is a multicenter prospective randomized controlled study that will enroll 240 patients who will undergo proximal gastrectomy. The study will be divided into 2 groups: the tunnel anastomosis group and the double-tract jejunal interposition reconstruction group, with 120 patients in each group. Patients will undergo clinical assessments and complete questionnaires preoperatively, as well as at the 3rd, 6th, and 12th months postoperatively. The primary end point is the incidence of reflux esophagitis within 1 year. The secondary end points include perioperative safety, postoperative quality of life, and postoperative nutritional status. Results: Recruitment of patients commenced in March 2022 and is scheduled to conclude in February 2027. The follow-up for all enrolled patients will be completed by February 2028. Conclusions: To our knowledge, this is the first prospective study on this technique, aiming to provide novel insights into the methods of digestive reconstruction following proximal gastrectomy. Trial Registration: Chinese Clinical Trial Registry ChiCTR2200057397; https://www.chictr.org.cn/showprojEN.html?proj=154418 International Registered Report Identifier (IRRID): DERR1-10.2196/82712 %R 10.2196/82712 %U https://www.researchprotocols.org/2026/1/e82712 %U https://doi.org/10.2196/82712 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 15 %N %P e86508 %T Impact of Enhanced Family Education on BMI Changes in Children and Adolescents With Overweight or Obesity: Study Protocol for a City-Wide Cluster Randomized Controlled Trial %A Zhang,Rui Hang %A Lu,Ting Yu %A Hou,Si Han %A Qu,Ya Bin %A Chen,Qiu Xia %A Li,Meng %A Wang,Jiao %A Xu,Lin %K enhanced family education %K obesity %K school %K China %K randomized controlled trial %D 2026 %7 26.3.2026 %9 %J JMIR Res Protoc %G English %X Background: The prevalence of obesity among children and adolescents has become a critical global public health issue, particularly in China, with significant increases observed over the past few decades. Despite regular surveillance for overweight and obesity in the past decades, there have been no annual reports provided to parents, resulting in a significant underrecognition of this issue. Early intervention and enhanced family-based educational intervention are necessary to address this growing problem. Objective: This protocol aims to evaluate the effectiveness of an enhanced family-based educational intervention in reducing overweight and obesity among school-age children and adolescents. Methods: This study uses a stratified cluster randomized controlled trial design involving 40 schools from 4 cities in Guangdong Province, selected based on economic levels and overweight and obesity prevalence. Schools will be randomly assigned to intervention or control groups. The intervention group receives an enhanced family-based educational intervention on obesity prevention, including health reports and educational materials. The control group continues with regular practices, including routine physical examinations, general health education activities, and school-based physical activity programs. The intervention spans 9 months, followed by a 3-month follow-up. Data on BMI, waist circumference, and waist-to-height ratio are collected at baseline and after 12 months to assess the potential effectiveness of the intervention. Results: This trial was funded in January 2024 and registered in the Chinese Clinical Trial Registry on November 5, 2024. Recruitment was completed in December 2024, with 20 schools enrolled in each of the intervention and control groups. Baseline data collection was completed during the 2024 fall semester, and follow-up data collection continued through December 2025. Data analysis will start after completion of the 12-month assessments. The study findings are expected to be published in 2026. Conclusions: This study protocol addresses the urgent need for effective interventions to combat the increasing prevalence of childhood and adolescent obesity in Guangdong Province. Given the significant underrecognition of the need for consistent reporting to parents, the proposed enhanced family-based educational intervention aims to fill this gap by raising parental awareness and promoting healthier lifestyles among children and adolescents. If successful, this approach could significantly reduce the risk of overweight and obesity in Chinese populations, which account for approximately one-fifth of the world’s population. The findings will provide insights into the efficacy of family-centered interventions and underscore the importance of integrating routine parental reporting into existing surveillance programs. Trial Registration: Chinese Clinical Trial Registry ChiCTR2400091909; https://www.chictr.org.cn/showprojEN.html?proj=239755 International Registered Report Identifier (IRRID): DERR1-10.2196/86508 %R 10.2196/86508 %U https://www.researchprotocols.org/2026/1/e86508 %U https://doi.org/10.2196/86508 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 15 %N %P e79721 %T Comparison of Uncemented and Hybrid Hip Arthroplasty: Protocol for a Brazilian Randomized Controlled Trial %A Souza,Bruno Gonçalves Schroder e %A Lacerda,Isabella Dias %A Vasconcelos,Matheus Malta %A Furtado,Nathália Lacerda %A Vieira,Julia Machado %A Souza,Iasmim Sand Ferreira de %A Magalhães,Marco Antônio Perígolo %A Amaral,Leonã Aparecido Homem do %A Assad,Luiz Guilherme Vidal %A Silva,Carlos Henrique Cavaglieri Silveira %A Tsen,Carolina %A Oliveira,Valdeci Manoel de %K hip %K osteoarthritis %K surgical procedures %K operative %K arthroplasty %K replacement %K randomized controlled trial %D 2026 %7 16.3.2026 %9 %J JMIR Res Protoc %G English %X Background: Total hip arthroplasty is a highly successful procedure for treating hip arthritis, improving patients’ pain, function, and quality of life (QoL). Scarce publications on total hip arthroplasty performance using Brazilian-manufactured materials report results comparable to those from other countries. Objective: The aim of this study is to compare the clinical, radiographic, functional, pain, and QoL outcomes of patients who underwent surgery with a national hybrid prosthesis (with femoral cementation) versus patients who underwent surgery with a national uncemented prosthesis. Methods: This study is a single-center, single-surgeon, single-approach, pragmatic, double-blinded, and prospective randomized trial. A total of 120 patients will be enrolled and randomly allocated in a 1:1 ratio to 2 groups: the hybrid group and the uncemented group. The incidence of complications (during and after surgery) and the restoration of normal anatomical parameters on postoperative radiographs will be assessed using radiographic parameters. Participants’ QoL, joint mobility, function, and satisfaction will be evaluated using the 12-Item Short Form Health Survey version 2 questionnaire, hip range of motion, the Harris Hip Score, and a numeric rating scale. Prosthesis survival will be analyzed using the annual revision surgery rate from 1 to 5 years, and up to 10 years. Results: The project did not receive external funding. Data collection began in October 2024 and is ongoing, with completion expected in December 2029. As of April 2025, 72 participants have been enrolled. Preliminary data analysis has been initiated and is ongoing. The first results are expected to be published in the first half of 2026. Conclusions: This study is a pragmatic clinical trial that uses blinding to evaluate national implants for both hybrid and uncemented hip arthroplasty. Successful completion of this study may provide clinical evidence on the performance of national implants and identify a preferred implant construct (hybrid or uncemented), if any, for hip replacement in Brazil. Trial Registration: Brazilian Registry of Clinical Trials RBR-263nf22; https://ensaiosclinicos.gov.br/rg/RBR-263nf22 International Registered Report Identifier (IRRID): DERR1-10.2196/79721 %R 10.2196/79721 %U https://www.researchprotocols.org/2026/1/e79721 %U https://doi.org/10.2196/79721 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 15 %N %P e81887 %T Clinical Efficacy Evaluation of Tuina Combined Medicated Oil in the Treatment of Nonspecific Low Back Pain: Protocol for a Randomized Controlled Trial %A Yuan,Man %A Guo,Guangxin %A Wang,Siyu %A Yao,Fei %A Wang,Guimao %A Xu,Hongxi %K Tuina %K medicated oil %K non-specific low back pain %K clinical effect %K randomized controlled trial %D 2026 %7 11.3.2026 %9 %J JMIR Res Protoc %G English %X Background: Nonspecific low back pain (NSLBP) is a significant global public health concern that affects the health and well-being of individuals across different age groups, limiting their daily activities and reducing their quality of life. As Tuina (Chinese therapeutic massage) therapy and medicated oil are widely used in China, it is necessary to design a randomized clinical trial to assess the effectiveness of Tuina combined medicated oil (TNO) in treating NSLBP. Objective: This study aims to evaluate the efficacy and safety of Tuina therapy combined with medicated oil in treating NSLBP. Methods: One hundred participants will be enrolled and randomly allocated to either a TNO group (n=50) or a Tuina combined water group (n=50). Treatment will last for 4 weeks, with sessions 3 times a week, followed by a 4-week follow-up. The visual analog scale score is the primary outcome; secondary outcomes include the evaluation of treatment Japanese Orthopaedic Association scores, infrared thermography, muscle tension tests, and tenderness scores. All adverse reactions will be recorded. Results: The trial commenced in June 2023 and is expected to conclude in September 2025. In June 2025, key preliminary steps were completed, and the ethical review and clinical trial registration were concluded. Recruitment is proceeding as planned, with 100 participants enrolled to date. Data collection is underway, while formal data analysis has not yet commenced. Conclusions: The project’s purpose is to evaluate the effectiveness of TNO in alleviating pain and improving lumbar function in patients with NSLBP. Trial Registration: ChiCTR ChiCTR2300076144; https://www.chictr.org.cn/hvshowproject.html?id=247247 International Registered Report Identifier (IRRID): DERR1-10.2196/81887 %R 10.2196/81887 %U https://www.researchprotocols.org/2026/1/e81887 %U https://doi.org/10.2196/81887 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 15 %N %P e86322 %T Kidney-Tonifying, Phlegm-Resolving, and Blood Stasis–Removing Therapy for Multiple Myeloma: Protocol for a Randomized Controlled Trial on Epigenetic and Immune Modulation %A Sun,Xiaoqi %A Zhou,Yongming %A Wang,Yujue %A Dai,Youya %A Zhu,Wenwei %A Chen,Hailin %K myeloma %K herbal medicine %K randomized controlled trial %K epigenetic regulation %K tumor immune microenvironment %D 2026 %7 5.3.2026 %9 %J JMIR Res Protoc %G English %X Background: Multiple myeloma (MM) is characterized by kidney deficiency, phlegm, and blood stasis as core findings, specifically in Traditional Chinese Medicine (TCM), and the kidney-tonifying, phlegm-resolving, and blood stasis–removing (KPR) method is a fundamental therapeutic approach for MM in TCM. Western medicine primarily focuses on targeted immunotherapy or chemotherapy for MM treatment, whereas TCM characterizes MM through distinct pathological patterns that directly correspond to immune microenvironment dysregulation. Emerging evidence implicates the PHD finger protein 19 (PHF19)/enhancer of zeste homolog 2 (EZH2)/trimethylated histone H3 at lysine 27 (H3K27me3) epigenetic axis in immune microenvironment dysregulation and MM progression. Notably, TCM “blood stasis” correlates with hypoxia-induced immune gene silencing in MM bone marrow, and KPR (a clinically validated TCM decoction with 16 herbs) acts on this axis via its active components that regulate EZH2 and epigenetic function, merging TCM syndrome differentiation with modern epigenetics. We have designed a randomized controlled trial (RCT) to investigate the mechanism of action and safety of the KPR method in MM. Objective: This RCT aims to assess whether a KPR herbal formula combined with standard bortezomib-based therapy improves the immune microenvironment via the PHF19-EZH2-H3K27me3 epigenetic axis to restore immune function in MM, providing a mechanistic basis for integrating TCM into evidence-based oncology care in relapsed or refractory patients. Methods: This is a single-center, prospective RCT involving patients with MM. It has been designed to test the hypothesis that the KPR formula epigenetically regulates the PHF19-EZH2-H3K27me3 axis to improve the immune microenvironment. Patients are randomly assigned in a 1:1:1 ratio to 3 groups (blank control group, Western medicine control group, and integrated TCM and Western medicine treatment group). All patients undergo 12 weeks of treatment and a 6-month follow-up. The primary outcome is the CD3+ T-cell ratio in bone marrow/peripheral blood, which is detected by flow cytometry. The secondary outcomes include quantified TCM syndrome scores, Western medicine efficacy evaluation criteria, complete blood count, bone marrow morphology, blood and urine immunoglobulin levels, quantitative M protein levels, free light chain levels, β2-microglobulin levels, and whole-body imaging findings. Statistical analysis involves linear mixed models for longitudinal data and Bonferroni correction to verify KPR’s immunomodulatory effects via the targeted epigenetic axis. Results: This study was funded in November 2023. Recruitment was initiated in March 2025 and is expected to be completed in February 2026. As of October 2025, 41 patients have been enrolled. Data collection is projected to end in October 2026. Data analysis has not yet been initiated, and the results are expected to be published in 2027. Conclusions: This unique mechanistic RCT evaluating a TCM formula targeting the PHF19-EZH2-H3K27me3 axis in patients with MM will establish a biomarker-driven framework for integrating TCM with immunotherapy, offering novel strategies for treatment-refractory patients. Trial Registration: International Traditional Medicine Clinical Trial Registry ITMCTR2025000671; https://itmctr.ccebtcm.org.cn/mgt/project/view/4375050683463103813 and ITMCTR2025000449; https://itmctr.ccebtcm.org.cn/mgt/project/view/4779140633660123982 International Registered Report Identifier (IRRID): DERR1-10.2196/86322 %R 10.2196/86322 %U https://www.researchprotocols.org/2026/1/e86322 %U https://doi.org/10.2196/86322 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 15 %N %P e77571 %T Validating a Multibiomarker Panel for the Assessment of Quantity and Quality of Plant Foods in the Diet (PLAENTI): Protocol for a Parallel Group–Designed Randomized Controlled Trial %A Schmalle,Victor %A Renz,Julia %A Ferrario,Paola G %A Seifert,Stephanie %A Engelbert,Ann Katrin %A Wittek,Oliver %A Merz,Benedikt %A Brennan,Lorraine %A Manach,Claudine %A Rist,Manuela J %A Bub,Achim %K biomarkers of food intake %K dietary assessment %K multibiomarker panel %K plant-based diet %K randomized controlled trial %K targeted metabolomics %K standardized diet %D 2026 %7 27.2.2026 %9 %J JMIR Res Protoc %G English %X Background: Although a high intake of plant foods is often considered healthy, some plant foods can be detrimental to health. Reliable dietary assessment is crucial to examine the relationship between diet and disease. Current dietary assessment methods rely on self-reported intake data, which are subject to bias. Objective measurement using biomarkers of food intake could mitigate this problem. However, single biomarkers of food intake have limitations as well. Combining several biomarkers of food intake into a multibiomarker panel could attenuate these limitations and allow for an accurate, objective dietary assessment. Objective: The PLAENTI study aims to validate a multibiomarker panel for the assessment of quantity and quality of plant foods in the diet. Methods: PLAENTI is a randomized controlled trial with 4 arms in a parallel design. Metabolically healthy adults (≥18 years old) were enrolled in the study. The study consisted of 1 week of run-in, with a standardized diet low in healthful plant foods for all participants; 2 weeks of a dietary intervention according to the assigned arm; and 1 week of washout, during which participants returned to their habitual diet. During the intervention, the participants’ diet consisted of either a low, medium, or high proportion of healthful plant foods or a high proportion of unhealthful plant foods in the diet according to the assigned arm. The arm that received a high proportion of healthful plant foods served as the control. All food was provided based on energy-adjusted menu plans. During the visits, anthropometry and body composition were assessed, and blood samples were collected. Throughout the study, participants collected multiple urine samples (24-hour urine, evening and morning spot urine) and stool samples. Blood and urine samples will be analyzed by liquid chromatography-mass spectrometry to determine biomarker levels for the validation of a multibiomarker panel. Results: After receiving approval from the ethics committee, recruitment began, and the first screening visit took place in November 2023. Between January and August 2024, of the 66 enrolled participants, 59 (31 female, 28 male) successfully completed the study, and their urine, blood, and stool samples are available for analysis. PLAENTI was conducted in 5 waves with a maximum of 16 participants enrolled in each wave. The mean age of the study population was 45.5 (SD 18.4) years, the mean BMI was 24.8 (SD-3.9) kg/m², and the mean total energy expenditure was 2464 (SD 440) kcal. Conclusions: PLAENTI was conducted in a highly controlled and standardized manner, yielding samples and data that will be used to examine whether the quantity and quality of plant foods in the diet can be assessed using a multibiomarker panel. Successful validation of the multibiomarker panel would enable its application for objective dietary assessment. Trial Registration: German Clinical Trials Register DRKS00032738; https://drks.de/search/en/trial/DRKS00032738 International Registered Report Identifier (IRRID): DERR1-10.2196/77571 %R 10.2196/77571 %U https://www.researchprotocols.org/2026/1/e77571 %U https://doi.org/10.2196/77571 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 15 %N %P e75029 %T Effects of Elastic Tape Associated With Pulmonary Rehabilitation in Male Individuals With Chronic Obstructive Pulmonary Disease: Protocol for a 2-Arm, Assessor-Blinded Randomized Controlled Trial %A Pinto,Thiago Fernandes %A dos Santos,Juliana de Melo Batista %A Reis,Estéfane Caroline Monteiro %A Marques da Silva,Cibele C Berto %A de Lima,Fabiano Francisco %A Carvalho-Pinto,Regina Maria %A Carvalho,Celso Ricardo Fernandes %K chronic obstructive pulmonary disease %K COPD %K adhesive elastic tape %K pulmonary rehabilitation %K dyspnea %K exercise capacity %K physical capacity %D 2026 %7 27.2.2026 %9 %J JMIR Res Protoc %G English %X Background: Individuals with severe chronic obstructive pulmonary disease (COPD) may exhibit thoracoabdominal asynchrony, which reduces ventilatory efficiency. A novel intervention using elastic tape (ET) applied to the chest wall has been shown to acutely reduce thoracoabdominal asynchrony and dyspnea during exercise among individuals with COPD. We hypothesize that using ET in pulmonary rehabilitation (PR) may increase the benefits of PR in this population. Objective: This study aims to evaluate the additional effects of ET on exercise capacity, symptoms of anxiety and depression, health-related quality of life, and physical activity in daily life among male individuals with moderate to very severe COPD who are undergoing PR. Methods: This is a protocol for a randomized, controlled, 2-arm, parallel, blinded assessor clinical trial. Individuals will be followed for 8 weeks, twice a week, with PR sessions lasting approximately 1 hour. Health status (COPD Assessment Test), health-related quality of life (Chronic Respiratory Questionnaire), and psychological distress (Hospital Anxiety and Depression Scale) will be assessed before and after the intervention. Then, exercise capacity will be assessed via the incremental shuttle walking test and endurance shuttle walking test, and participants will use a triaxial accelerometer (ActiGraph) for 7 days to assess physical activity in daily life. Subsequently, individuals will be randomized into ET or sham groups; both groups will complete a PR program (2 times per week for 8 weeks). The ET group will receive applications of ET, whereas the sham group will receive a nonelastic tape. Data will be presented as means and SDs or medians and IQRs. Intergroup comparisons will be performed using a 2-way ANOVA, followed by the Bonferroni post hoc correction test, or the Kruskal-Wallis test, followed by the Dunn post hoc test. The threshold for statistical significance will be set at 5%. Results: The clinical trial registration was approved in June 2023. Recruitment and data collection for the trial are ongoing; as of November 2025, a total of 10 individuals have been recruited, and the results are expected to be available by the end of November 2026. Conclusions: We hypothesize that the use of ET can enhance the benefits of PR in individuals with moderate to very severe COPD and increase exercise capacity and quality of life, as well as reduce symptoms of anxiety and depression. Trial Registration: ClinicalTrials.gov NCT05939999; https://clinicaltrials.gov/study/NCT05939999 International Registered Report Identifier (IRRID): DERR1-10.2196/75029 %R 10.2196/75029 %U https://www.researchprotocols.org/2026/1/e75029 %U https://doi.org/10.2196/75029 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 15 %N %P e89004 %T Determining the Impact of a Physiotherapist-Led Primary Care Model for Low Back Pain: Protocol and Analysis Plan for a Cluster Randomized Controlled Trial and Embedded Process Evaluation %A Miller,Jordan %A Donnelly,Catherine %A McClintock,Chad %A Varette,Kevin %A Camargo,Yeimi %A Marsh,Jacquelyn %A Taljaard,Monica %A Mamun,Mir Sanim Al %A Bacchus,Geneviève %A Barber,David %A Cooper,Lynn %A French,Simon %A Hill,Jonathan %A Green,Michael %A MacDermid,Joy %A Norman,Kathleen %A Richardson,Julie %A Tranmer,Joan %A Wideman,Timothy %+ School of Rehabilitation Therapy, Faculty of Health Sciences, Queen's University, 31 George Street, Kingston, ON, K7L3N6, Canada, 1 (613) 533 6103, jordan.miller@queensu.ca %K primary health care %K clinical trial %K health services %K cluster randomized controlled trial %K physiotherapy %D 2026 %7 26.2.2026 %9 Protocol %J JMIR Res Protoc %G English %X Background: Low back pain (LBP) is a common and disabling condition that is costly for health systems and society. Interprofessional primary care models may improve care quality and reduce this burden. Objective: This protocol and analysis plan communicates the methods for a cluster randomized trial with the following objectives: (1) evaluate the effectiveness of a physiotherapist-led (PT-led) primary care model for LBP at improving disability (primary outcome), pain intensity, quality of life, global rating of change, patient satisfaction, and adverse events compared with usual physician-led primary care; and (2) determine the impact of the PT-led primary care model for LBP on the health care system and society (health care access, health care use, missed work, cost-effectiveness). Both objectives are evaluated over a 1-year period. A multimethod process evaluation is embedded to assess model implementation, mechanisms, perspectives of patients and providers, and contextual influences. Methods: This study is a cluster randomized controlled trial with 20 primary care practices (clusters) in Canada, randomized 1:1 to a PT-led or usual physician-led primary care model for LBP. Adults seeking care from their primary care team for LBP are recruited over 1 year. Data collection occurs at baseline, 6 weeks, and 3, 6, 9, and 12 months. Effectiveness will be analyzed using linear mixed regression. The process evaluation analysis will include: descriptive and comparative analyses to assess implementation; descriptive and mediation analyses to assess potential mechanisms; qualitative interpretive description to understand experiences and perspectives of patients, PTs, and other health professionals; and mixed methods to determine contextual influences on implementation. Results: Recruitment of primary care sites (clusters) was completed in June 2023, following delays related to the COVID-19 pandemic. Cluster randomization occurred in July 2023. Recruitment of patient participants began in October 2023 and concluded in November 2024 (n=739). The final self-reported patient data was collected on November 25, 2025. Extraction of electronic health record data is scheduled for completion on December 19, 2025. Data analysis will be conducted in accordance with the study protocol and analysis plan and will begin once all data collection activities are complete. No interim analyses have been performed. Conclusions: The results of this trial will provide evidence for knowledge users to determine whether a PT-led primary care model for LBP is effective and should be adopted more widely. Knowledge users have identified the impact of the new model of care on disability, quality of life, and cost-effectiveness as key evidence needed to inform key decision-making. The multimethod process evaluation will provide critical evidence to interpret trial results and inform future scale and spread of this model of care if effective. Trial Registration: ClinicalTrials.gov NCT04287413; https://clinicaltrials.gov/study/NCT04287413 International Registered Report Identifier (IRRID): DERR1-10.2196/89004 %M 41747241 %R 10.2196/89004 %U https://www.researchprotocols.org/2026/1/e89004 %U https://doi.org/10.2196/89004 %U http://www.ncbi.nlm.nih.gov/pubmed/41747241 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 15 %N %P e78864 %T Impact of Ocular Massage on Intraocular Pressure and Schlemm Canal Dimensions in Healthy Adults: Protocol for a Randomized Controlled Trial %A Zhang,Mingxuan %A Qin,Luning %A Tan,Liangzhang %A Li,Yongtao %A Zhang,Qing %A Wang,Shuhan %A Zhang,Zhihui %A Pazo,Emmanuel Eric %A Ren,Xinjun %+ Department of Ocular Trauma, Tianjin Key Laboratory of Retinal Functions and Diseases, Tianjin Branch of National Clinical Research Center for Ocular Disease, Eye Institute and School of Optometry, Tianjin Medical University Eye Hospital, 251 Fu Kang Road, Tianjin, 300384, China, 1 86 022 86428787, xin2023ren@tmu.edu.cn %K ocular massage %K Schlemm canal %K trabecular meshwork %K intraocular pressure %K aqueous humor %D 2026 %7 26.2.2026 %9 Protocol %J JMIR Res Protoc %G English %X Background: Ocular massage has been reported to lower intraocular pressure (IOP) temporarily. This effect could be related to enhanced aqueous humor outflow; however, the mechanism is unclear. Objective: This study aims to examine the impact of digital and EyePeace ocular massage on IOP fluctuations and investigate whether the observed reduction in IOP is attributable to morphological changes in the Schlemm canal (SC). Methods: Participants were randomly assigned in a 1:1:1 ratio to 1 of 3 groups: digital ocular massage, EyePeace ocular massage, or no ocular massage. The primary outcome measure will be IOP. The secondary outcome measures will include anterior segment optical coherence tomography assessment of the SC and trabecular meshwork. In addition, adverse events in the quality of vision will be monitored and documented using a mobile app–based questionnaire. All assessments will be performed at baseline and 10 minutes after the assigned interventions. Results: Data collection was completed in the summer of 2025. The study results are expected to be published by the end of 2025. Conclusions: This study will investigate the impact of ocular massage on IOP and SC dimensions by using a randomized controlled design. As preliminary evidence suggests that ocular massage may transiently reduce IOP by enhancing aqueous humor outflow, this study will aim to clarify the underlying mechanism. By comparing digital ocular massage, EyePeace ocular massage, and no ocular massage, the study will assess changes in IOP and SC morphology. The findings are expected to provide insights into the role of mechanical manipulation in modulating aqueous humor outflow, potentially informing nonpharmacological strategies for possible glaucoma management. Trial Registration: Chinese Clinical Trial Registry ChiCTR2400093512; https://www.chictr.org.cn/showproj.html?proj=250459 International Registered Report Identifier (IRRID): DERR1-10.2196/78864 %M 41747246 %R 10.2196/78864 %U https://www.researchprotocols.org/2026/1/e78864 %U https://doi.org/10.2196/78864 %U http://www.ncbi.nlm.nih.gov/pubmed/41747246 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 15 %N %P e78584 %T Urban Care Farming to Enhance Quality of Life Among Older Adults: Protocol for a Waitlist Randomized Trial %A Chen,Cynthia %A Lam,Jocelin %A Shi,Zhenye %A Akksilp,Katika %A Aw,Su %A Chong,Mary Foong-Fong %A Ong,Choon Nam %A Sia,Angelia %A Thang,Leng Leng %A Tham,Xin Kai %A Pong,JunXiang %A Omar,Kartini %A Hung,Joan %A Kukumberg,Marek %A Ho,Roger %A Diehl,Elizabeth %K biopsychosocial health %K complex intervention %K healthy and active aging %K quality of life %K urban care farming %D 2026 %7 25.2.2026 %9 %J JMIR Res Protoc %G English %X Background: Population aging poses challenges to health systems and costs, and evidence shows that older adults spend a long time in ill health. Improving healthspan, time spent in good health, allows older adults to contribute and improve in their quality of life. Active and healthy aging are crucial to improving healthspan. Urban care farming (UCF) is a behavioral intervention that is purported to enhance active and healthy aging. Objective: This trial evaluates the effectiveness of a care farming intervention in improving the quality of life and biopsychosocial health outcomes of older participants. Methods: We conducted a parallel group, 2-arm pragmatic waitlist randomized trial with a 1:1 allocation, in which participants were randomized into either the intervention or waitlist control arm. Community-dwelling participants aged 50-85 years, without any mobility issues, were recruited. Participants in the intervention arm commenced the 24-week UCF program, while waitlist control participants received no intervention during this period. The primary (World Health Organization Quality of Life−brief version) and secondary outcomes were collected at baseline, 6th month, and 12th month after the intervention group completed the trial. Secondary outcomes include objectively measured physiological outcomes, cognition, frailty, and self-reported psychosocial outcomes. Intervention effects were estimated using mixed-effects difference-in-differences regression to account for repeated measurements. Results: The randomized controlled trial commenced in April 2024, with the intervention group starting first. By April 2024, we had enrolled 137 participants at commencement, with 67 participants randomized to the intervention group and 70 to the control group. The intervention arm started in April 2024 and concluded in September 2024. Baseline data were collected in March 2024, and 6-month follow-up data were collected in September 2024. The waitlist control participants began the UCF intervention at the end of September 2024 and concluded in April 2025. Data collection for the 12-month follow-up concluded in May 2025. Analysis of the baseline and 6-month follow-up data is still ongoing. Conclusions: The outcomes of this study will contribute to the understanding of UCF on quality of life and health. This trial has potential positive implications for public health, as it utilizes a robust research design and methods to provide empirical insights into the multifaceted health benefits of the multicomponent UCF intervention. This trial could also serve as a model for future intervention research on scalable, community-based programs. Taken together, the UCF content and the outcomes, process, and economic evaluations completed through this study could inform scalable models of the UCF intervention, with potential implications for public health strategies to address health issues related to population aging. Trial Registration: ClinicalTrials.gov NCT06277583; https://clinicaltrials.gov/study/NCT06277583 International Registered Report Identifier (IRRID): DERR1-10.2196/78584 %R 10.2196/78584 %U https://www.researchprotocols.org/2026/1/e78584 %U https://doi.org/10.2196/78584 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 15 %N %P e83449 %T Diffusion Tensor Imaging in the Diagnosis of Perianal Abscess: Protocol for a Single-Blind Randomized Controlled Trial %A Ma,Yuting %A Mei,Pingping %A Guo,Xiutian %A Chen,Yan %K diffusion tensor imaging %K magnetic resonance imaging %K perianal abscess %K single-blind method %K pelvic floor %D 2026 %7 25.2.2026 %9 %J JMIR Res Protoc %G English %X Background: Perianal abscesses are common anorectal conditions that often necessitate surgical intervention. Accurate preoperative assessment is crucial for effective treatment and reducing recurrence rates. Diffusion tensor imaging (DTI) is a valuable method for visualizing the degree of infection and infiltration, the extent of abscess formation, and the relationship between perianal abscess erosion. However, there is currently a lack of specific studies focusing on perianal abscesses. Objective: The objective of this study is to investigate the diagnostic utility of DTI in the preoperative assessment of perianal abscesses. By enhancing the precision of preoperative evaluation, we aim to minimize damage to the anal sphincter, reduce the recurrence rate, and improve the prognosis and quality of life for patients. Methods: This study adopts a randomized, prospective, single-blind design. Ninety participants are being randomized into 2 groups: a DTI group and a conventional magnetic resonance imaging group. A structured report is being completed based on imaging of the perianal abscesses in terms of location, number, specific pus cavity alignment, thickness, and relationship to the surrounding muscles. In addition, the patient condition is being assessed, and corresponding surgical treatment is being performed. If the patient’s blood routine shows infection, cefuroxime sodium combined with metronidazole is being administered intravenously as an anti-infective therapy. Postoperatively, the primary variable is being assessed for recurrence rate at 6 months, and the secondary variables, including postoperative pain scores on days 3 and 7, peripheral blood inflammatory factors, and assessment of anal function, are being evaluated. Normally distributed continuous data will be presented as mean (SD) and analyzed using independent or paired t tests. Non-normally continuous data will be analyzed with rank-sum tests. Categorical data will be expressed as frequency (%) and compared using a chi-square test or appropriate nonparametric tests. Ordinal data will be analyzed using the Ridit test. A P value <.05 will be considered statistically significant. Results: This study is funded by Science and Technology Commission of Shanghai Municipality Science and Technology Program (grant 23Y11920800). Patient recruitment was initiated in April 2025. As of January 2026, 37 participants have been enrolled, and data collection is scheduled to be completed in October 2026. Conclusions: DTI technique can be used to gain a deeper understanding of the relationship between internal orifice, the degree of infected infiltration, the extent of the abscess, and the involvement of the perianal tissues and muscles in patients with perianal abscess. Deep pelvic floor DTI reveals the complex 3D structure of the pelvic floor in perianal abscesses through structured reports, which may provide new insights into the diagnosis of perianal abscesses. Trial Registration: Itmctr.ccebtcm.org.cn ITMCTR2025000068; https://itmctr.ccebtcm.org.cn/mgt/project/view/6847137108505689154 International Registered Report Identifier (IRRID): DERR1-10.2196/83449 %R 10.2196/83449 %U https://www.researchprotocols.org/2026/1/e83449 %U https://doi.org/10.2196/83449 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 15 %N %P e73155 %T Online Personalized Normative Feedback to Foster Intention to Change and Help Seeking in Young Adults With Disordered Gambling and Trading Behaviors: Protocol for a Randomized Controlled Trial %A Coloma-Carmona,Ainhoa %A Carballo,José Luis %A Miró-Llinares,Fernando %A Pérez-Jover,Virtudes %K young adults %K gambling %K trading %K gambling disorder %K trading disorder %K brief intervention %K normative feedback %K clinical trial %K study protocol %D 2026 %7 23.2.2026 %9 %J JMIR Res Protoc %G English %X Background: Despite the availability of treatment options, help-seeking rates among individuals with gambling problems remain low. To reach a broader population of those affected by disordered gambling, online and self-guided interventions have been developed. Personalized normative feedback (PNF) is one of the most widely used strategies for preventing gambling issues among young adults. However, most studies on PNF efficacy focus solely on its impact on the intensity and severity of gambling behavior, without exploring its potential to increase intention to change and help-seeking behaviors. Furthermore, there is a lack of studies assessing the efficacy of PNF in addressing emerging online gambling-like behaviors, such as betting within video games or excessive financial trading of high-risk assets (eg, cryptocurrencies), which have been linked to gambling disorder. Objective: This study aims to (1) quantify intention to change and the prevalence of help-seeking behaviors in young adults in Spain with disordered gambling or trading behaviors and (2) assess the efficacy of online PNF in increasing these behaviors. Methods: A randomized controlled trial using a Solomon 3-group design was conducted with a sample of emerging adults aged 18 to 34 years. The study included 3 assessments: a pretest, an immediate posttest, and a 12-week follow-up assessment. Participants were randomized into 1 of 3 conditions, with the intervention group receiving online PNF. The primary outcomes were intention to change and help-seeking behaviors. Secondary outcomes included gambling and trading behaviors (intensity, frequency, and severity) and their longitudinal trajectories. Individual, interpersonal, and contextual factors will be assessed to identify the profile of individuals most likely to benefit from this intervention. Results: The study was funded in December 2023 by the Spanish Ministry of Social Rights, Consumer Affairs and 2030 Agenda (SUBV23/00004) and approved by the Ethics Committee of the Miguel Hernández University. The first study assessment was conducted between December 2024 and January 2025. A total of 1889 people completed the eligibility assessment, of whom 1112 (58.9%) met the inclusion criteria (gambling or trading within the past 60 days) and were enrolled in the trial. The 12-week follow-up was finalized in March 2025, with 666 completing the final assessment (59.9% retention). Data collection has been completed, statistical analyses are ongoing, and primary results are expected to be published in March 2026. Conclusions: By examining motivational outcomes rather than behavioral change alone, this trial addresses a key gap in the literature on digital interventions for gambling-related harm. Findings are expected to inform the development of scalable prevention and early intervention strategies targeting gambling and gambling-like behaviors in young adults. Trial Registration: ClinicalTrials.gov NCT06681103; https://clinicaltrials.gov/study/NCT06681103 International Registered Report Identifier (IRRID): DERR1-10.2196/73155 %R 10.2196/73155 %U https://www.researchprotocols.org/2026/1/e73155 %U https://doi.org/10.2196/73155 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 15 %N %P e81857 %T Effects of Allulose vs Aspartame Consumption on Postprandial Glucagon-Like Peptide-1 Profiles and Metabolic Health: Protocol for a Randomized, Crossover, Double-Blind, Placebo-Controlled Trial %A Busch,Selina %A Ferrario,Paola G %A Henk,Ann-Kathrin %A Engelbert,Ann Katrin %A Wittek,Oliver %A Seifert,Stephanie %A Bub,Achim %A Mack,Carina I %A Hieronimus,Bettina %+ Department of Physiology and Biochemistry of Nutrition, Max Rubner-Institut, Haid-und-Neu-Str. 9, Karlsruhe, 76131, Germany, 49 721 6625 ext 349, bettina.hieronimus@mri.bund.de %K allulose %K aspartame %K gut hormones %K insulin sensitivity %K randomized controlled study %K satiety %D 2026 %7 19.2.2026 %9 Protocol %J JMIR Res Protoc %G English %X Background: Excessive sugar consumption is a public health concern. Allulose, a low-calorie sugar with similar functional properties to sucrose, offers potential metabolic benefits. Animal and limited human studies suggest it may stimulate glucagon-like peptide-1 (GLP-1) secretion, improve glucose regulation, and support weight management. However, evidence to substantiate these effects in humans remains scarce. Objective: The primary aim of this study, the low-calorie sweetener intervention study allulose (LisA), was to assess differences in the postprandial GLP-1 profile (primary outcome) between an acute intake of allulose and aspartame interventions in healthy adults. Secondary goals included exploratively assessing potential subacute adaptation effects over a 4-week consumption period and evaluating a comprehensive set of parameters as hypothesis-generating findings for future large-scale research. Methods: We conducted a randomized, double-blind, placebo-controlled, crossover trial in healthy adults. Participants daily consumed either 3 allulose-sweetened or aspartame-sweetened beverages for 4 weeks in crossover, with a washout in between. Standardized inpatient procedures were conducted at the study baseline and at the beginning and end of each intervention phase. The primary outcome is the postprandial profile of GLP-1. Secondary outcomes include further parameters of gut hormone secretion, insulin sensitivity (Matsuda Index), body composition (body impedance analysis), subjective satiety (visual analog scales), and gastrointestinal tolerance. We also assess multiomic endpoints, including sugaromics and gut microbiome composition. The primary outcome will be analyzed using the incremental area under the curve with a 2-tailed paired t test. All further outcomes (including peak and total area under the curve for GLP-1) will be assessed using linear mixed models. Results: A total of 10 participants (4 female and 6 male; mean age 31.2, SD 6.8 years; BMI 25.1, SD 2.6 kg/m2) completed all study procedures. The sample collection phase was successfully concluded in November 2023. Data processing and statistical analysis for the primary outcome are expected to be completed by June 2026. Conclusions: The comprehensive study protocol, integrating a rigorous crossover design with multiomic analysis, is poised to provide confirmatory evidence for the acute GLP-1 effects of allulose and generate valuable mechanistic hypotheses regarding its subacute metabolic and gut health effects. The findings will contribute to the evidence base required for evaluating allulose’s potential role in public health sugar reduction strategies. Trial Registration: German Clinical Trials Register DRKS00028521; https://drks.de/search/en/trial/DRKS00028521 International Registered Report Identifier (IRRID): DERR1-10.2196/81857 %M 41713874 %R 10.2196/81857 %U https://www.researchprotocols.org/2026/1/e81857 %U https://doi.org/10.2196/81857 %U http://www.ncbi.nlm.nih.gov/pubmed/41713874 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 15 %N %P e83266 %T Immediate and Sustained Effects of Intensive Equine-Assisted Physiotherapy Based on Neuroproprioceptive “Facilitation and Inhibition” on Psychomotor Development, Clinical Functions, Quality of Life, and Molecular Biological Indicators in Children With Spinal Muscular Atrophy: Protocol for a Crossover Randomized Controlled Trial %A Marikova,Katerina %A Reissigova,Jindra %A Vilimek,Miloslav %A Cerna,Marie %A Pokorna,Marketa %A Rasova,Kamila %K spinal muscular atrophy %K genetic therapy %K equine-assisted therapy %K child %K pediatrics %K physical therapy modalities %K long noncoding RNA %K neuroproprioceptive facilitation %K neuroproprioceptive inhibition %K The Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorders %D 2026 %7 19.2.2026 %9 %J JMIR Res Protoc %G English %X Background: Spinal muscular atrophy (SMA) is a rare neuromuscular disease and the most common genetic cause of infant death. Although pharmacological treatment improves survival rates and functional capacity, physiotherapy remains a key component of care. A newly developed innovative equine-assisted physiotherapy method based on neuroproprioceptive “facilitation and inhibition” principles (NEUROEQUIP-SMA) is hypothesized to improve the quality and extent of motor development in children with SMA. Objective: The aim of this study is to assess the efficacy of NEUROEQUIP-SMA compared with standard individual outpatient physiotherapy based on the same neuroproprioceptive “facilitation and inhibition” principles (SMA-SOC-N) and to evaluate its effects on functional outcomes and quality of life (QoL). In addition, the response of molecular biomarkers to treatment will be assessed. Methods: In this crossover randomized controlled trial, 20 children with SMA types I-III, aged 2‐9 years, will participate in two 6-day therapy programs (A and B) of equal duration (50 min per day) and separated by a 10-week washout period. Each child will be randomly assigned to receive the therapies in either the AB or BA sequence. Therapy A consists of a newly developed NEUROEQUIP-SMA (15 min twice daily), whereas therapy B involves SMA-SOC-N (30 min once daily). Both programs include therapeutic horse grooming (20 min a day). The Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP INTEND) was selected as the primary outcome measure. Secondary outcomes included motor coordination assessed through 3D motion analysis, muscle fatigue, spirometry, and standardized clinical tests and rating scales, as well as monitoring of psychomotor development (via home-video analysis) and QoL (via questionnaires). Molecular biomarkers will be analyzed from blood samples. The immediate effect of the intervention will be evaluated for most outcomes, while psychomotor development and QoL will be monitored 28 days after therapy as longer-term outcomes. Treatment effect sizes will be reported alongside P values to illustrate the magnitude of changes in the outcomes. The study was approved by the Ethics Committee of the Third Faculty of Medicine, Charles University, under the number UK3LF/658559/12025. Results: The study is designed for 20 participants. Data collection will begin in February 2026 and will be completed in May 2026. Data analyses are planned for autumn 2026, and study results are expected to be available in 2027. A paired t test comparing the primary outcome (CHOP INTEND) between treatments NEUROEQUIP-SMA and SMA-SOC-N in 20 children will have 80% power to detect moderate-to-large effect size (Cohen d=0.66) at a 5% significance level. Conclusions: This trial will be the first study to evaluate the effects of NEUROEQUIP-SMA in children with SMA. If preliminary findings confirm a benefit, this physiotherapy approach may represent a promising adjunct to care for the generation of children undergoing gene therapy. Trial Registration: ClinicalTrials.gov NCT07336602; https://clinicaltrials.gov/study/NCT07336602 International Registered Report Identifier (IRRID): PRR1-10.2196/83266 %R 10.2196/83266 %U https://www.researchprotocols.org/2026/1/e83266 %U https://doi.org/10.2196/83266 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 15 %N %P e81032 %T Evaluation of the Effectiveness of Injectable Platelet-Rich Fibrin as an Adjuvant to One-Stage Full-Mouth Disinfection in Patients with Stage II and III Periodontitis: Protocol for a Randomized Clinical Trial %A Kothekar,Mahima %A Bajaj,Pavan %A Dare,Sneha %A Thakre,Shivani %K one-stage full-mouth disinfection %K OS-FMD %K full mouth disinfection %K FMD %K injectable platelet rich fibrin %K i-PRF %K adjuvant %D 2026 %7 19.2.2026 %9 %J JMIR Res Protoc %G English %X Background: Periodontitis is a chronic inflammatory disease that leads to the progressive destruction of the tooth-supporting structures, including the periodontal ligament, alveolar bone, and gingival tissues, leading to tooth mobility, ultimately resulting in potential tooth loss if left untreated. The new classification of periodontitis helps in establishing an appropriate diagnosis and planning treatment according to disease severity. One-stage full-mouth disinfection (OS-FMD), using chlorhexidine, has shown better outcomes than traditional quadrant-wise therapy. Platelet-Rich Fibrin offers enhancement in healing outcomes and regeneration due to sustained release of growth factors. Injectable platelet-rich fibrin (i-PRF) shows promising results in promoting tissue regeneration, reducing inflammation, and improving periodontal therapy outcomes. To date, no clinical study has been carried out for the assessment of the efficacy of i-PRF as an adjuvant in OS-FMD. Objective: This study aims to assess the efficacy of i-PRF as an adjuvant in OS-FMD therapy based on its clinical outcomes in terms of plaque index (PI), papillary bleeding index (PBI), probing depth (PD), and clinical attachment loss (CAL) in patients with stage II and stage III periodontitis. Methods: This randomized clinical trial will include 26 systemically healthy patients diagnosed with stage II and III periodontitis, selected from the Outpatient Department of Periodontics at Sharad Pawar Dental College, Sawangi (Meghe), Wardha. Participants will be randomly assigned to one of 2 groups using a parallel-arm design to ensure unbiased allocation. The control group will undergo OS-FMD therapy involving subgingival scaling and root planing for the entire dentition, which will be performed within 24 hours, supplemented by application of chlorhexidine intraorally, including mouth rinsing, pocket irrigation, and tongue cleansing. The test group will receive the same OS-FMD protocol as the control group, in addition to subgingival delivery of i-PRF in all periodontal pockets 1 week post therapy. Assessment of clinical parameters, including PI, PBI, PD, and CAL, will be done at baseline, 3 months, and 6 months. To evaluate intragroup and intergroup differences, statistical analysis will be conducted using appropriate methods, including the Wilcoxon signed-rank test. A P value <.05 will be considered statistically significant. Results: The study was enrolled in June 2025 and is scheduled to conclude post assessments and analyses by the end of 2026. The accessibility of the study results is anticipated in early 2027. Conclusions: This study underscores the effectiveness of i-PRF as an adjuvant in OS-FMD therapy on the basis of assessment of clinical parameters. We hypothesize that the use of i-PRF as an adjuvant to OS-FMD will result in superior clinical outcomes beyond the antimicrobial benefits achieved with chlorhexidine in standard OS-FMD, as evidenced by CAL gain, reduction in PD, and reduction in the scores of PI and PBI, due to regenerative and anti-inflammatory properties of i-PRF along with enhanced healing potential. Trial Registration: Clinical Trials Registry India CTRI/2025/06/088718; https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTMzNTAy&Enc=&userName= International Registered Report Identifier (IRRID): DERR1-10.2196/81032 %R 10.2196/81032 %U https://www.researchprotocols.org/2026/1/e81032 %U https://doi.org/10.2196/81032 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 15 %N %P e85597 %T Impact of the Population Medicine Multimorbidity Intervention in Xishui County (POPMIX) on People at High Risk for Chronic Obstructive Pulmonary Disease: Protocol for the POPMIX-COPD Cluster Randomized Controlled Trial %A Wang,Chen %A Liu,Yuhao %A Huang,Ke %A Zheng,Zhoutao %A Zhang,Shiyu %A Chen,Wenjin %A Tang,Xingyao %A Cao,Zhong %A Tong,Xunliang %A Tang,Lei %A Zhao,Jinghan %A He,Liu %A Jiao,Lirui %A Wang,Yingping %A Zhao,Tianying %A Luo,Yingchi %A Lai,Qiande %A Lyu,Xiangqin %A Chen,Qiushi %A Bunker,Aditi %A Vollmer,Sebastian %A Geldsetzer,Pascal %A Jamison,Dean %A Bärnighausen,Till %A Yang,Ting %A Chen,Simiao %A , %+ , School of Population Medicine and Public Health, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijige Santiao 31, Dongcheng District, Beijing, 100730, China, 49 6221565948, simiao.chen@uni-heidelberg.de %K population medicine %K multimorbidity %K tobacco-related NCDs %K high-COPD-risk population %K cRCT %D 2026 %7 18.2.2026 %9 Protocol %J JMIR Res Protoc %G English %X Background: Tobacco-related noncommunicable diseases (NCDs) present a major public health challenge in China, requiring population-level management. Chronic obstructive pulmonary disease (COPD) is the most common and prevalent chronic respiratory disease associated with tobacco use. In addition, COPD shares risk factors with other NCDs that frequently co-occur, leading to multimorbidity. This study focuses on the early detection and integrated management of COPD and related multimorbidity among high-risk populations. Population medicine, an emerging and evolving concept aimed at maximizing population health and well-being, provides a promising framework for shifting interventions against COPD from an individual patient focus to a population-level approach. Objective: This study aims to evaluate the effectiveness of a population medicine–based multimorbidity intervention package among individuals at high risk for COPD. Methods: We are conducting a 2-arm, population-based, stratified cluster randomized controlled trial (cRCT). The intervention integrates community screening, chronic disease management, patient education, digital follow-up, and team-based care. The trial is being implemented in Xishui County, Guizhou Province, a low-resource county in Southwestern China. Each of the 26 townships in Xishui County was considered a cluster and stratified into large and small townships based on population size. An equal number of residents from each township stratum (large and small) were randomized to undergo the COPD Screening Questionnaire. Individuals identified as being at high risk for COPD were considered study participants and were subsequently enrolled in either the intervention or control arm. The target sample size was approximately 2850 individuals. Results: Data collection for the POPMIX-COPD trial began in June 2024. Baseline, 3-month, and 6-month assessments have been completed, and 12-month follow-up assessments are planned to be completed in March 2026. All participants in the intervention arm are being followed for 1 year, with 1 telephone follow-up at month 3 and in-person follow-ups at months 6 and 12. Primary outcomes for each participant include the number of chronic conditions controlled, receipt of lung function testing, and forced expiratory volume in 1 second. In addition, secondary outcomes were health-related quality of life, mental and behavioral health status, health care utilization, knowledge of COPD and asthma, and care cascade indicators for chronic conditions. Conclusions: This cRCT is the first multimorbidity intervention study designed within the population medicine framework to target populations at high risk for COPD. It was featured as a case study in the report of the Lancet Commission on Investing in Health. The results of the trial are expected to inform the next generation of multimorbidity management and population medicine practices among global health authorities and practitioners. Trial Registration: ClinicalTrials.gov NCT06456996; https://clinicaltrials.gov/ct2/show/NCT06456996 International Registered Report Identifier (IRRID): DERR1-10.2196/85597 %M 41706509 %R 10.2196/85597 %U https://www.researchprotocols.org/2026/1/e85597 %U https://doi.org/10.2196/85597 %U http://www.ncbi.nlm.nih.gov/pubmed/41706509 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 15 %N %P e79324 %T Efficacy of Tuina for Myopia in Children: Protocol for a Randomized Controlled Trial %A Zhang,Shouyao %A Han,Yanju %A Zhang,Lijuan %A Tan,Fang %A Huang,Xueping %A Zhang,Can %A Yao,Zheng %A Xiong,Lei %A Tai,Xiantao %K myopia %K pediatric tuina therapy %K adolescents %K randomized controlled trials %K protocol %K tuina %K Tui Na %D 2026 %7 12.2.2026 %9 %J JMIR Res Protoc %G English %X Background: Myopia has emerged as a major threat to the visual health of adolescents worldwide. Early intervention can effectively slow down the progression of myopia in adolescents. Tuina (also known as Tui Na), a significant therapeutic method in traditional Chinese medicine, has shown promising clinical efficacy in delaying the progression of myopia; however, it lacks robust, large-scale, and standardized randomized controlled trials. Objective: This study aims to explore the efficacy and safety of tuina therapy in managing myopia in adolescents, thereby providing solid evidence for the application of tuina in the clinical treatment of myopia. Methods: This study is a multicenter randomized controlled clinical trial. A total of 62 children with myopia will be recruited from 4 hospitals and randomly assigned in a 1:1 ratio to a tuina experimental group and a drug-positive control group (tropicamide eye drops). Treatments in each group will be administered 3 times per week for a total of 8 weeks. The tuina experimental group will receive 20 minutes of tuina therapy per session, while the drug-positive control group will receive tropicamide eye drops administered every other day, with 2 drops per session. The primary outcome measures include uncorrected visual acuity and axial length, while secondary outcome measures include refractive power and accommodative amplitude. Data will be collected at baseline (week 0), on the day of completion of weeks 4 and 8 of treatment, and at the end of the 10-week follow-up period. Adverse events will be monitored and recorded throughout the study. Statisticians will be blinded. Data will be analyzed using SPSS version 28.0. Results: This study has been funded, and recruitment began in June 2025. As of December 2025, 29 participants have been enrolled, with 16 allocated to the tuina group and 13 to the drug-positive control group. Recruitment is expected to continue until October 2026. Final manuscript submission is anticipated by December 2026. Conclusions: This study aims to evaluate the efficacy and safety of tuina therapy in the treatment of adolescents with myopia. We hypothesize that the therapeutic effect of tuina therapy is noninferior to that of tropicamide eye drops, with the additional advantages of fewer side effects and stable long-term efficacy, thereby providing reliable evidence and support for the application of tuina therapy in the management of myopia in adolescents. Trial Registration: Chinese Clinical Trial Registry ChiCTR2600116606; https://www.chictr.org.cn/bin/project/edit?pid=263583 International Registered Report Identifier (IRRID): DERR1-10.2196/79324 %R 10.2196/79324 %U https://www.researchprotocols.org/2026/1/e79324 %U https://doi.org/10.2196/79324 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 15 %N %P e82683 %T Effect of Du-Moxibustion Combined With Spine-Pinching Therapy on Cognitive Frailty in Older Adults With Prefrailty: Protocol for a Randomized Controlled Trial %A Liu,Suzhen %A Qi,Mengxia %A Li,Hua-Fang %A Ye,Ziqiu %A Xu,Yu %A Yang,Xiangying %K cognitive frailty %K Du-moxibustion %K older adults %K prefrailty %K randomized controlled trial %K RCT %K spine-pinching therapy %D 2026 %7 10.2.2026 %9 %J JMIR Res Protoc %G English %X Background: Cognitive frailty (CF), characterized by the coexistence of mild cognitive impairment and physical frailty in the absence of dementia or other neurodegenerative diseases, is a significant risk factor for dementia and functional decline in older adults. Although Du-moxibustion has shown potential benefits in improving CF, the effect of spine-pinching therapy remains underexplored. Objective: This study aims to evaluate, for the first time, the efficacy and safety of Du-moxibustion combined with spine-pinching therapy in older adults with prefrailty and CF. Methods: This is a prospective, single-center, randomized, single-blind, 4-arm parallel controlled trial. A total of 156 older adults with prefrailty and CF will be recruited and randomly assigned to 1 of 4 groups: routine care group, Du-moxibustion group, spine-pinching group, or combined intervention group. The intervention will last for 8 weeks. The primary outcome is the change in Montreal Cognitive Assessment score. Secondary outcomes include the Fried frailty phenotype, Barthel Index (activities of daily living), 15-item Geriatric Depression Scale, 36-item Short Form Health Survey, global frailty status, and traditional Chinese medicine syndrome scores. Outcome assessments will be performed at baseline (wk 0), midintervention (wk 6), postintervention (wk 8), and follow-up (wk 12). Results: Recruitment for this study is scheduled to commence in March 2026 and will end in June 2027 (recruitment and intervention). All follow-up and data collection activities will be finalized by October 2027. Results are anticipated to be completed in the first quarter of 2028. Conclusions: This study is expected to provide high-quality evidence for the clinical efficacy of Du-moxibustion combined with spine-pinching therapy in managing CF and contribute to the integration of traditional Chinese medicine external therapies in the promotion of healthy aging. Although the single-blind design may introduce expectancy bias, strict randomization procedures and standardized interventions will enhance the reliability and scientific rigor of the results. Trial Registration: International Traditional Medicine Clinical Trial Registry ITMCTR2025001589; https://itmctr.ccebtcm.org.cn/mgt/project/view/1957679735857348608 International Registered Report Identifier (IRRID): PRR1-10.2196/82683 %R 10.2196/82683 %U https://www.researchprotocols.org/2026/1/e82683 %U https://doi.org/10.2196/82683 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 15 %N %P e84082 %T Effects of Acupuncture-Combined Tuina on Patients With Knee Osteoarthritis: Protocol for a Randomized Controlled Trial %A Gu,Chendong %A Wei,Dong %A Zhang,Kaiyue %A Ren,Jinxi %A Qiao,Yihui %A Zhang,Fengyu %A Zhu,Yiting %A Xu,Zhixian %A Cao,Yinlong %A Yao,Shuyi %A Guo,Hanrui %A Wang,Yihang %A Wang,Huan %A Wang,Lin %A Wang,Quanliang %A Guo,Guangxin %K knee osteoarthritis %K Tuina %K acupuncture %K pain %K stiffness %K multimodal magnetic resonance imaging %D 2026 %7 5.2.2026 %9 %J JMIR Res Protoc %G English %X Background: Knee osteoarthritis (KOA) is a prevalent degenerative joint disease that is characterized by joint pain, stiffness, and dysfunctional impairment, imposing a substantial medical burden annually. Tuina, a widely used noninvasive traditional Chinese medicine therapy commonly used for KOA, has been used for the management of this condition; however, its additive benefit to acupuncture remains unclear. Objective: The objective of the study is to assess whether the effectiveness of acupuncture-combined Tuina is superior to that of acupuncture in the management of KOA. Methods: This single-center, parallel-group, randomized controlled trial aims to enroll 60 patients with KOA, who will be randomly assigned to either a Tuina group (acupuncture-combined Tuina) or an acupuncture group (30 patients per group). Baseline assessments will include demographic and clinical evaluations: the visual analog scale from the short-form McGill Pain Questionnaire, pain threshold, muscle tension, 10-meter walking test, Western Ontario and McMaster Universities Osteoarthritis Index, and multimodal magnetic resonance imaging. Over a 6-week intervention, the Tuina group will receive Tuina on the basis of acupuncture, that is, acupuncture-combined Tuina, while the acupuncture group will undergo just acupuncture, with both groups continuing standard care as prescribed. Posttreatment, clinical outcomes and safety will be reassessed using baseline indicators. A 12-week follow-up will include all clinical evaluations. Assessments will be conducted by blinded assessors, and statistical analyses will be conducted by independent, blinded analysts. Outcomes will evaluate clinical pain and functional differences between groups and will elucidate the underlying cerebral mechanisms. Results: This study was funded in August 2024. The experimental plan will begin on December 31, 2025, and end on May 4, 2027. Conclusions: This trial aims to verify whether acupuncture-combined Tuina receives better efficacy than single acupuncture, as well as to explore the neuroimaging mechanisms that are clinically affected, thus providing scientific evidence for the treatment of clinical patients with KOA. Trial Registration: International Traditional Medicine Clinical Trial Registry ITMCTR2024000635; https://itmctr.ccebtcm.org.cn/mgt/project/view/8026608627430517572 International Registered Report Identifier (IRRID): PRR1-10.2196/84082 %R 10.2196/84082 %U https://www.researchprotocols.org/2026/1/e84082 %U https://doi.org/10.2196/84082 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 15 %N %P e84601 %T Enhancing Upper Secondary Students’ Situational Engagement and Cognitive Prerequisites of Learning Through the Physically Active Academic Lessons Intervention: Protocol for a Mixed Methods Cluster Randomized Individual Crossover Trial %A Syväoja,Heidi J %A Takalo,Susanna %A Kukko,Tuomas %A Salmela,Nina %A Hakonen,Harto %A Kulmala,Janne %A Lindfors,Heidi %A Oksanen,Hermanni %A Räsänen,Pekka %A Mäkitalo,Kati %A Tammelin,Tuija H %K physically active learning %K physically active break %K student engagement %K executive functions %K acute effects %K experience %K cluster randomized individual crossover trial %D 2026 %7 3.2.2026 %9 %J JMIR Res Protoc %G English %X Background: Internationally, physical activity is successfully integrated into academic lessons in primary schools, showing promising results on cognition and student engagement. However, there is a lack of knowledge about its effects and feasibility for individual situated learning processes in upper secondary school. Objective: This protocol describes the design and methods of the Physically Active Academic Lessons (PAAL) study, a mixed methods, cluster randomized, individual crossover trial. The PAAL study aims to examine the acute effects of physically active academic lessons on cognitive prerequisites of learning (alertness and executive functions) and situational engagement (behavioral, cognitive, and emotional engagement; disaffection; competence experiences; and help seeking), as well as factors modifying these effects (physical and mental load and perceived physical and academic competence). Further, subject teachers’ and students’ experiences and perceptions of physically active academic lessons in general upper secondary school will be explored. Methods: The first part of the PAAL study involves exploring subject teachers’ experiences of facilitators, barriers, usefulness, and the meaning of physically active academic lessons for the situational learning process through semistructured interviews with 14 teachers. The second part consists of a cluster‑randomized individual crossover trial including 168 students in mathematics and foreign language lessons, followed by interviews with 30 students. Results: Funding for the study was obtained in May 2023. Ethical approval for the teacher interviews was granted in September 2023, and for the student trial in December 2023. Data collection was completed between October 2023 and November 2024. Data analysis is ongoing. The findings of the study will provide essential evidence-based information on physically active classroom practices that support teachers and schools in implementing pedagogical methods that enhance student learning and well-being in upper secondary schools. Conclusions: The background, design, content of the intervention, and methods of the PAAL study are presented. This study aims to address a gap in the literature regarding the feasibility and effectiveness of physically active methods during academic lessons in upper secondary school. Trial Registration: ISRCTN 63809854; http://www.controlled-trials.com/ISRCTN63809854/63809854 International Registered Report Identifier (IRRID): RR1-10.2196/84601 %R 10.2196/84601 %U https://www.researchprotocols.org/2026/1/e84601 %U https://doi.org/10.2196/84601 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 15 %N %P e79327 %T Efficacy of Acupuncture for Mild to Moderate Depression in Older People: Protocol for a Randomized Controlled Trial %A Fu,Qingnan %A Xiao,Kaihui %A Zhang,Jie %A Li,Yang %A Wang,Yuxian %A Jiang,Molin %A Man,Zengqi %A Yang,Jing %A Lu,Wei %K depression %K mild to moderate depression in older people %K acupuncture %K randomized controlled trial %K protocol %D 2026 %7 30.1.2026 %9 %J JMIR Res Protoc %G English %X Background: Selective serotonin reuptake inhibitors are first-line antidepressants; however, only approximately 60% of patients can benefit from them. There is insufficient evidence for using acupuncture for symptom relief or for improving tolerance to selective serotonin reuptake inhibitors. Objective: This randomized controlled trial aims to assess the effects of acupuncture combined with citalopram hydrobromide on mild to moderate depression in older people. Methods: This study is a 2-arm, parallel, randomized controlled trial. A total of 132 participants aged 60 to 80 years diagnosed with major depressive disorder were divided into an acupuncture and medication group or a medication group. Participants in both groups take citalopram hydrobromide at a dose of up to 20 mg daily for 12 weeks. The acupuncture and medication group additionally receives 36 sessions of acupuncture treatment over 12 weeks. The primary outcome is the response rate of the 17-item Hamilton Depression Scale at the twelfth week. The secondary outcomes include changes in scores on the 17-item Hamilton Depression Scale and Mini-Mental State Examination at various time points. Adverse events will be recorded in detail. Results: The study commenced on June 30, 2023, and as of October 17, 2024, a total of 132 participants had been enrolled. Data collection has been completed. Currently, data analysis is in progress, with preliminary findings anticipated to be available by October 2025. The findings of this study are expected to be submitted for publication in 2026. Conclusions: This pilot study is expected to provide critical insights into the feasibility of integrating acupuncture with standard medication for managing mild to moderate depression in older people. By generating preliminary evidence on its potential benefits, the study aims to inform the design and sample size estimation of future multicenter trials, potentially advancing nonpharmacological treatment options for depression. Trial Registration: Chinese Clinical Trial Registry ChiCTR2300072740; https://www.chictr.org.cn/showproj.html?proj=198821 International Registered Report Identifier (IRRID): DERR1-10.2196/79327 %R 10.2196/79327 %U https://www.researchprotocols.org/2026/1/e79327 %U https://doi.org/10.2196/79327 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 15 %N %P e75670 %T Brief Intervention for Discontinuing Inappropriate Z-Hypnotic Use Among Older Patients in Primary Care: Protocol for a Cluster Randomized Controlled Trial With a Single Crossover %A Siddiqui,Tahreem Ghazal %A Bjelkarøy,Maria Torheim %A Simonsen,Tone Breines %A Selle,Maria Lie %A Lundqvist,Christofer %+ Department of Health Services Research, Institute of Clinical Medicine, Campus Akershus University Hospital, University of Oslo, PO Box 1000, Lørenskog, 1478, Norway, 47 47278881, a.c.lundqvist@medisin.uio.no %K Z-hypnotics %K inappropriate prescription medication %K older people %K general practice %D 2026 %7 30.1.2026 %9 Protocol %J JMIR Res Protoc %G English %X Background: Older patients are frequent users of Z-hypnotics despite consensus recommendations against extended use. Inappropriate Z-hypnotic use among older patients is frequently reported, posing risks of side effects and dependence. Interventions have been mainly at the population level and through prescription regulations. There are few instruments helping general practitioners (GPs) deal with inappropriate use among individual patients. Objective: Through a randomized controlled trial (RCT), we aim to test the effectiveness of a behavioral brief intervention (BI) method used by trained GPs for reducing inappropriate Z-hypnotic use among their patients. Methods: We will conduct a double-blind RCT with a single crossover. Patients (aged >60 years) on participating GPs’ lists who are using Z-hypnotics inappropriately, do not have serious mental or physical disorders, and can provide valid informed consent are eligible. GPs randomized to the BI arm will be trained to administer the BI, and those randomized to business as usual (BAU) will not receive training. GPs’ patient lists will be screened for inappropriate Z-hypnotic users through an electronic questionnaire. The GP will be informed of patients who should be given an appointment and administered the BI. Untrained GPs will continue BAU. Randomization-blinded outcome evaluation will be conducted at 6 weeks, 6 months, and 1 year in both the study groups. Results: The main outcome is the proportion of patients with inappropriate Z-hypnotic use, comparing BI versus BAU, after 6 weeks. Secondary outcomes are cognitive function, pain, self-reported sleep evaluation, sleep efficiency (actigraphy) and quality of life, and change compared to baseline. We will also report on the characteristics of the screened GP patient population. Other variables are other medication use or polypharmacy, anxiety and depression, severity of dependence, and mortality. Conclusions: If RCT-level evidence demonstrates the effectiveness of the BI for reducing inappropriate Z-hypnotic use among older patients without worsening of secondary outcomes, this could be a simple, transferable intervention to implement on a larger scale among GPs, other physicians, and health workers. International Registered Report Identifier (IRRID): DERR1-10.2196/75670 %M 41616300 %R 10.2196/75670 %U https://www.researchprotocols.org/2026/1/e75670 %U https://doi.org/10.2196/75670 %U http://www.ncbi.nlm.nih.gov/pubmed/41616300 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 15 %N %P e84864 %T Implementation of a Participatory Ergonomics Intervention to Reduce Musculoskeletal and Stress-Related Mental Health Risks in Australian Retail Workers: Protocol for a Randomized Controlled Trial %A Condie,Elise %A Weale,Victoria %A Lambert,Katrina A %A Oakman,Jodi %+ Centre for Ergonomics and Human Factors, Department of Public Health, La Trobe University, Kingsbury Drive, Bundoora, Victoria, 3083, Australia, 61 3 9479 3235, e.condie@latrobe.edu.au %K ergonomics %K implementation science %K musculoskeletal diseases %K occupational stress %K randomized controlled trial %D 2026 %7 29.1.2026 %9 Protocol %J JMIR Res Protoc %G English %X Background: Worker participation has been identified as important for managing the risks of work-related musculoskeletal disorders (WMSDs) and stress-related mental health problems (MHPs). Previously identified barriers include securing long-term management support to implement risk reduction measures. Few studies evaluate how a manager or decision maker’s readiness to act influences the outcomes of a participatory ergonomics program. The Stages of Change (SoC) framework has been suggested for tailoring ergonomics interventions to managers’ receptiveness in a workplace setting. Objective: The main aim is to evaluate the implementation of the “A Participatory Hazard Identification and Risk Management” (APHIRM) toolkit in the online order fulfillment department for a sample of stores in a large retail organization, compared to usual risk management practice. Methods: This study is a cluster quasi–randomized controlled trial, comparing implementation of the APHIRM toolkit with usual safety risk management practice. As is typical for workplaces, the intervention is facilitated by the organization’s safety team. We recruited 9 control and 9 intervention stores to the study through random selection of eligible stores. Quantitative data are collected at baseline and 12-month follow-up. Qualitative data to enable a process evaluation are collected over the duration of the study. Primary outcome measures are physical and psychosocial hazard severity scores. Secondary outcomes are self-rated pain and discomfort scores and action plan implementation measures. Managers’ progression through SoC is an additional outcome measure. The primary outcome measures (physical and psychosocial hazard severity ratings) will be analyzed by variance-weighted cluster-level ANCOVA. Ethics approval was granted by the La Trobe University Human Research Ethics Committee (HEC25088). Results: Funding was provided in June 2025. Recruitment and randomization concluded in early August 2025. The intervention, including data collection, commenced in late August 2025 and is expected to conclude in September 2026. A total of 332 participants have been recruited to the study. Response rates have averaged 46% across control and intervention groups. As of January 2026, no data analyses have been conducted. Primary findings are anticipated to be published in Spring 2028. Conclusions: This study evaluates the implementation of the APHIRM toolkit survey in a multisite, large retail organization in Australia and describes the use of toolkit resources. It evaluates managers’ SoC regarding WMSD and MHP prevention and how this may influence outcomes. Findings from this study should provide additional insight on how to implement the toolkit in large organizations to reduce WMSD and stress-related MHP risk and inform future development of the content of the APHIRM toolkit. This study is anticipated to further inform tailoring of interventions to managers’ and decision-makers’ SoC. Trial Registration: OSF Registries 10.17605/OSF.IO/82R9G; https://osf.io/82r9g International Registered Report Identifier (IRRID): DERR1-10.2196/84864 %M 41611220 %R 10.2196/84864 %U https://www.researchprotocols.org/2026/1/e84864 %U https://doi.org/10.2196/84864 %U http://www.ncbi.nlm.nih.gov/pubmed/41611220 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 15 %N %P e84593 %T Clinical Efficacy and Safety Assessment of Specific-Mode Electroacupuncture Stimulation Combined With Paclitaxel for Recurrent Malignant Gliomas: Study Protocol for a Single-Arm Trial %A Jia,Zhaoxing %A Jiang,Tianxiang %A Zhang,Yiqing %A Chen,Qianyue %A Di,Zhong %A Yuan,Qi %A Qian,Kecheng %A Gan,Lin %A Ma,Congcong %A Lin,Xianming %K ABX %K albumin-bound paclitaxel %K BBB %K blood-brain barrier %K glioma %K recurrent %K single-arm trial %K SMES %K specific-mode electrical stimulation %D 2026 %7 29.1.2026 %9 %J JMIR Res Protoc %G English %X Background: Despite advances in surgical resection, radiotherapy, and chemotherapy, the prognosis of recurrent malignant gliomas (rMG) remains poor, with limited efficacy of conventional treatments due to the blood-brain barrier (BBB) hindering drug delivery to the tumor site. Studies have demonstrated that albumin-bound paclitaxel (ABX), while potent in vitro, is restricted in its intravenous use due to BBB limitations. To overcome this, specific-mode electrical stimulation (SMES) has shown promise in transiently opening the BBB, enhancing the accumulation of ABX in glioma tumors. Therefore, this protocol designs a single-center, single-arm, prospective phase II clinical trial aiming to evaluate the safety and clinical efficacy of SMES combined with ABX (SMES+ABX) for treating rMG. Objective: This study primarily evaluates the safety of SMES+ABX therapy in treating patients with rMG and assesses whether it can improve the 4-month progression-free survival (4m-PFS) rate, while providing data support for future large-scale clinical trials. Methods: In this study, 20 eligible patients will receive intravenous ABX (135‐175 mg/m²) per 21-day cycle for 6 cycles, combined with SMES for BBB modulation. A Simon 2-stage design will be employed, with the primary end point being the 4m-PFS. Secondary end points include adverse events, disease control rate, objective response rate, duration of disease control, duration of response, Neurological Assessment in Neuro-Oncology score, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, progression-free survival, and overall survival. Results: The results will determine the 4m-PFS rate, overall safety profile, secondary efficacy outcomes, and patient-reported quality of life measures. The data will be analyzed upon trial completion. Patient enrollment is scheduled to begin in May 2025. The treatment and primary efficacy assessment phases are anticipated to be completed by January 2027 (allowing for staggered enrollment and a 4-month treatment period for the last enrolled patient). The final survival follow-up for all patients is anticipated to be completed by January 2028 (ie, 1 year after the last patient completes treatment). Data management is currently ongoing, and formal statistical analyses have not yet been performed. Conclusions: This study aims to evaluate the efficacy and safety of SMES combined with ABX in the treatment of rMG. If successful, the combination could offer a promising therapeutic strategy for this challenging patient population. Trial Registration: ClinicalTrials.gov NCT06818331; https://clinicaltrials.gov/study/NCT06818331 International Registered Report Identifier (IRRID): DERR1-10.2196/84593 %R 10.2196/84593 %U https://www.researchprotocols.org/2026/1/e84593 %U https://doi.org/10.2196/84593 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 15 %N %P e75621 %T A Home-Based Intervention to Improve Adherence to the 24-Hour Movement Guidelines in Young Children: Protocol for a Mobile App–Based Randomized Control Trial %A Kracht,Chelsea L %A Berge,Jerica M %A LeBlanc,Monique %A Newton Jr,Robert L %A Rhodes,Ryan E %A Bolamperti,Grace %A Snodgrass,Madigan %A Redman,Leanne M %+ Department of Internal Medicine, University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS, 66160, United States, 1 9135881655, ckracht@kumc.edu %K screen time %K sitting time %K movement behavior %K sleep %K physical activity %K adherence %D 2026 %7 29.1.2026 %9 Protocol %J JMIR Res Protoc %G English %X Background: One in 10 preschoolers (aged 3-4 y) meet the three 24-hour Movement Guidelines, that is, (1) physical activity, (2) sedentary screen time, and (3) sleep. Objective: The overarching aim of this study is to evaluate the effectiveness and feasibility of a 12-week mobile health home-based intervention on 24-hour movement behaviors in preschoolers who meet few guidelines (zero or 1 guideline). Methods: We will conduct a 12-week randomized controlled trial with a wait-list control in 80 families (40 per arm). Preliminary studies in this population informed intervention app content, features, and app development. Behavior change theories, including transfer theory and the multi-process action control framework, helped inform content presentation and topics. Primary outcomes include device-based and parent-report measures of 24-hour movement behaviors, and the secondary outcome is the feasibility and acceptability of the app. Exploratory outcomes include preschoolers’ cognitive and motor skills, changes within the home environment, and behavioral control processes. Results: This 2-phase study (K99/R00) received initial funding in March 2022, and preliminary studies were concluded in December 2023. The main grant received institutional review board approval in April 2024, and the grant funding began in May 2024. The study was registered in Clinical Trials in October 2024 and enrolled its first participant in January 2025. As of October 2025, the study has enrolled 39 families. We anticipate the trial will be completed in late 2026. Conclusions: This research is designed to test a novel approach to improve all three 24-hour movement behaviors in preschoolers in home settings by using a mobile app. Results from this study will have implications for future 24-hour movement interventions, our understanding of improving all 3 behaviors, and ultimately, improvements in preschoolers’ health. Trial Registration: Clinicaltrials.gov NCT06667661; https://clinicaltrials.gov/study/NCT06667661 International Registered Report Identifier (IRRID): DERR1-10.2196/75621 %M 41610419 %R 10.2196/75621 %U https://www.researchprotocols.org/2026/1/e75621 %U https://doi.org/10.2196/75621 %U http://www.ncbi.nlm.nih.gov/pubmed/41610419 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 15 %N %P e81837 %T Acupuncture Prescription Based on Thermal-Sensitized Acupoints for the Treatment of Knee Osteoarthritis: Protocol for a Randomized Controlled Pilot Trial %A Wang,Xue-Zhou %A Lv,Tao-Tao %A Zhang,Kua-Yue %A Chen,Zhuo-Ya %A Qin,Li-Na %A Gang,Wei-Juan %A Chen,Wei-Heng %A Mi,Bao-Hong %+ The Third Affiliated Hospital of Beijing University of Chinese Medicine, 51 Xiaoguan Street, Andingmenwai, Chaoyang District, Beijing, 100029, China, 86 17703359107, mibaohong12587@163.com %K knee osteoarthritis %K acupuncture %K infrared thermography %K acupoint %K pilot %D 2026 %7 28.1.2026 %9 Protocol %J JMIR Res Protoc %G English %X Background: Treatment options for knee osteoarthritis (KOA) remain limited. Although previous studies suggest that acupuncture can alleviate pain and functional impairment associated with KOA, there is significant variation in acupoint selection across studies and a lack of objective criteria to guide this choice. Infrared thermography (IRT) is recognized as a reliable method for identifying inflammatory regions in KOA. Our previous research revealed abnormal skin temperature at specific acupoints and surrounding areas in the lower limbs of patients with KOA, indicating potential treatment targets. However, there is still insufficient evidence to support their clinical application. Objective: This pilot trial aims to assess the feasibility of conducting large-scale studies in the future and to provide preliminary evidence of the effects of acupuncture applied at IRT-guided thermal-sensitized acupoints (TAs) for the treatment of KOA. Methods: This will be a randomized, controlled pilot trial with participant blinding. A total of 60 patients with KOA will be randomly allocated in a 1:1 ratio to either the TA group or the conventional acupoint group. Both groups will receive 3 acupuncture sessions per week for 4 weeks. In the TA group, acupoint selection will be based on points with abnormal skin temperature identified by IRT using real-time surface projection technology. In the conventional acupoint group, acupoint selection will follow the established prescription validated in previous studies. The primary outcome will be feasibility, assessed using a traffic light system to evaluate recruitment, retention, intervention completion, and completion of other outcome measures. Secondary outcomes will include the visual analog scale for pain, the Western Ontario and McMaster Universities Osteoarthritis Index function subscale, the credibility and expectancy questionnaire, skin temperature, and safety. Results: The study has been approved by the ethics committee of the Third Affiliated Hospital of Beijing University of Chinese Medicine (BZYSY-2024KYKTPJ-44) and registered in the International Traditional Medicine Clinical Trial Registry. The first participant was enrolled on February 25, 2025, and a total of 30 participants had been enrolled by January 1, 2026. All enrollment and follow-up are expected to be completed by June 2026. Conclusions: The findings of this study will provide evidence on the feasibility and preliminary clinical effects to support the future adoption of acupuncture prescriptions based on TAs for the treatment of KOA. Trial Registration: International Traditional Medicine Clinical Trial Registry ITMCTR2025000019; https://itmctr.ccebtcm.org.cn/mgt/project/view/-5870917416012215224 International Registered Report Identifier (IRRID): DERR1-10.2196/81837 %M 41605504 %R 10.2196/81837 %U https://www.researchprotocols.org/2026/1/e81837 %U https://doi.org/10.2196/81837 %U http://www.ncbi.nlm.nih.gov/pubmed/41605504 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 15 %N %P e80858 %T Real-World Effectiveness and Noninferiority Evaluation and Comparison of Messenger RNA–Based and Protein-Based COVID-19 Vaccines: Protocol for the BEEHIVE Randomized Study With a Hybrid Effectiveness Design %A Yoon,Sarang K %A Ellsworth,German L %A Battan-Wraith,Steph %A Phillips,Andrew L %A Fink,Rebecca V %A Griffin,Joshua %A Rowley,Elizabeth A K %A McKell,Jacob %A Smith,Ashley S %A Campbell,Riley %A Williams,Jesse %A Ball,Sarah W %A Zhao,Hongwei %A Warren,Brandy %A Rousculp,Matthew D %A Thiese,Matthew S %+ Division of Occupational and Environmental Health, School of Medicine, University of Utah, 50 North Medical Drive, Salt Lake City, UT, 84132, United States, 1 801 213 4500, sarang.yoon@hsc.utah.edu %K protein %K COVID-19 %K SARS-CoV-2 %K omicron %K surveillance %K vaccine effectiveness %K clinical trial %D 2026 %7 27.1.2026 %9 Protocol %J JMIR Res Protoc %G English %X Background: Surveillance of COVID-19 vaccine effectiveness (VE) was extensive upon vaccine introduction; however, it declined after the withdrawal of pandemic status in May 2023. Continued monitoring of updated vaccine formulations is needed to ensure the maintenance of VE in the face of evolving viral strains. Objective: The Booster Epidemiological Evaluation of Health, Illness and Vaccine Efficacy (BEEHIVE) study (NCT06065176), a randomized trial with a hybrid design, was developed to assess the real-world VE of the 2023-2024 Pfizer–BioNTech and Novavax COVID-19 vaccine formulations targeting the XBB.1.5 SARS-CoV-2 variant. Methods: This study was designed to enroll approximately 1500 participants aged ≥18 years from the Salt Lake City, Utah, area who had previously received ≥2 doses of an authorized messenger RNA (mRNA)–based COVID-19 vaccine but had not received a dose of the 2023-2024 formulation. The study used a randomized, hybrid design comprising 2 blinded groups assigned to receive the 2023-2024 formula of either the Novavax COVID-19 vaccine or the Pfizer–BioNTech COVID-19 vaccine and a nonrandomized, observational control group of volunteers who chose not to receive a 2023-2024 vaccine dose during the study. Follow-up lasted 24 weeks and included symptom surveys and self-administered COVID-19 antigen testing, both occurring weekly. The primary aim was to compare VE (defined as prevention of symptomatic SARS-CoV-2 infection) between study-vaccinated participants and the control group. The secondary aim was to determine the relative VE of the Pfizer–BioNTech mRNA and Novavax 2023-2024 COVID-19 vaccines. Secondary objectives included assessing how the number of previous COVID-19 vaccinations impacted VE of the 2023-2024 COVID-19 vaccines; identifying predictors and associated factors for asymptomatic versus symptomatic infection and/or prolonged or severe illness; examining factors associated with post–COVID-19 conditions; and evaluating participants’ knowledge, attitudes, and practices related to COVID-19 vaccination. Participant engagement was maintained via online and text-based reminders and surveys, as well as researcher follow-up. Results: Participants were recruited from November 2023 through March 2024, with 452 and 457 participants randomized to the Novavax and Pfizer–BioNTech vaccine groups, respectively, and 279 participants enrolled in the control group. SARS-CoV-2 variants from the XBB, JN.1, KP.2, and KP.3 lineages were in circulation in the United States and the Utah region during data collection. The study ended on September 9, 2024, with results expected to be published in 2026. Conclusions: Data from this study will provide valuable real-world VE data for a dose of the Novavax COVID-19 vaccine or the Pfizer–BioNTech COVID-19 vaccine after an mRNA-based COVID-19 primary series. Trial Registration: ClinicalTrials.gov NCT06065176; https://www.clinicaltrials.gov/study/NCT06065176 International Registered Report Identifier (IRRID): RR1-10.2196/80858 %M 41592795 %R 10.2196/80858 %U https://www.researchprotocols.org/2026/1/e80858 %U https://doi.org/10.2196/80858 %U http://www.ncbi.nlm.nih.gov/pubmed/41592795 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 15 %N %P e80993 %T Effectiveness and Safety of Kangjia Decoction Granules for the Treatment of Hashimoto Thyroiditis: Protocol for a Randomized, Double-Blinded, Placebo-Controlled, Multicenter Clinical Trial %A Zhang,Duanchun %A Zhang,Dan %A Qu,Xiaoxiao %A Cao,Huihong %A He,Yanming %+ Department of Endocrinology, Shanghai Minhang of Integrated Traditional Chinese and Western Medicine, Number 155 Jianchuan Road, Minhang District, Shanghai, 200437, China, 86 18017595587, rosyfry@126.com %K kangjia decoction granules %K Hashimoto thyroiditis %K evidence-based clinical trial %K randomized controlled trial %K protocol %D 2026 %7 26.1.2026 %9 Protocol %J JMIR Res Protoc %G English %X Background: Hashimoto thyroiditis (HT) is a chronic inflammation of the thyroid gland mediated by autoimmune disorders, often leading to hypothyroidism and a significant reduction in a patient’s quality of life. At the time of this writing, there is a lack of effective clinical treatments for early-stage HT. Kangjia decoction granules (KDGs) were developed based on clinical experience and results analysis, showing promising outcomes in improving antibody levels and quality of life in patients with HT. However, there is a lack of further evaluation of the efficacy and safety of KDGs. Objective: This pilot study aims to further understand and validate the efficacy and safety of KDGs for treating HT through clinical research and comprehensively assess the benefits of this intervention for patients. Methods: This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial. Participants meeting the HT diagnostic criteria will be randomly allocated to the intervention and control groups (n1=n2=70). The intervention group will receive KDG treatment, whereas the control group will receive a placebo treatment. All participants will undergo treatment for 3 months. Changes in antithyroid peroxidase antibody (TPOAb) levels will be the primary outcome. Secondary outcomes include antithyroglobulin antibodies (TGAb), thyrotropin, also known as thyroid stimulating hormone (TSH), triiodothyronine (T3), thyroid hormone (T4), serum free triiodothyronine (FT3), serum free thyroxine (FT4), thyroid ultrasonography, IL17 mRNA and FOXP3 mRNA, traditional Chinese medicine (TCM) syndrome efficacy scores, and quality of life scale scores. Throughout the treatment and follow-up periods, safety indicators, such as routine blood and urine tests, hepatic and renal function, electrocardiography, and major adverse reactions, will be monitored. Results: The research protocol and informed consent form received approval from the Clinical Research Ethics Committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, affiliated with Shanghai University of Traditional Chinese Medicine, on December 14, 2022 (Approval No. 2022-123). Participant recruitment commenced in June 2023. All intervention and concurrent data collection activities were scheduled for completion by October 2025. Data management is still ongoing; therefore, data analysis has not yet been performed. Conclusions: This study’s findings will offer initial clinical evidence regarding the efficacy of the TCM compound KDGs in modulating peripheral immunity in patients with HT, decreasing autoimmune antibody levels, ameliorating TCM syndromes, and enhancing quality of life. These results will serve as a basis for future large-scale trial designs. Trial Registration: China Clinical Trials Registry ChiCTR2300070184; https://www.chictr.org.cn/showprojEN.html?proj=189169 International Registered Report Identifier (IRRID): DERR1-10.2196/80993 %M 41587451 %R 10.2196/80993 %U https://www.researchprotocols.org/2026/1/e80993 %U https://doi.org/10.2196/80993 %U http://www.ncbi.nlm.nih.gov/pubmed/41587451 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 15 %N %P e76815 %T Efficacy, Safety, and Economic Impact of Cytisinicline Maintenance Therapy in Patients Who Are Candidates for Smoking Cessation: Protocol for a Phase IV, Multicenter, Randomized, Open-Label, Controlled, Parallel Clinical Trial (CITISILONG Trial) %A Rabade Castedo,Carlos %A Estany-Gestal,Ana %A Jiménez Ruiz,Carlos A %A de Granda-Orive,José Ignacio %A Riesco-Miranda,Juan Antonio %A Cristóbal Fernández,María Isabel %A Ramos-Pinedo,Angela %A Signes-Costa Miñana,Jaime %A Gorordo-Unzueta,María Inmaculada %A Valido-Morales,Agustin %A Sellarés -Torres,Jacobo %A Cabrera-César,Eva %A Frino-García,Alejandro %A Valdés Cuadrado,Luis %+ Department of Pulmonology, Complejo Hospitalario Universitario de Santiago, Travesía da Choupana S/N, Santiago de Compostela, 15706, Spain, 34 981950000 ext 250000, crabcas1@gmail.com %K cytisinicline %K smoking cessation %K maintenance therapy %K efficacy %K safety %D 2026 %7 23.1.2026 %9 Protocol %J JMIR Res Protoc %G English %X Background: Cytisinicline has proven to be an effective, efficient, and safe molecule in smoking cessation. However, the established 25-day regimen could be insufficient in a high percentage of smokers, so it is necessary to study maintained therapies of this drug. Objective: This study aims to compare the efficacy of the cytisinicline regimen used in routine clinical practice versus 2 maintained regimens of 50 and 75 days, respectively. In addition, the safety and economic impact of each regime will be determined. Methods: A prospective, multicenter, open-label, controlled, parallel, phase IV clinical trial of 402 smoker patients prepared to quit smoking. The study was conducted in 10 hospitals in Spain. A control group is compared to 2 intervention groups in which the duration of the drug is increased without increasing its dose, administering half and all, respectively, of an additional marketed container that includes 100 tablets. Thus, participants will be randomized to three groups in a 1:1:1 ratio to receive cytisinicline: (1) a control group treated with cytisinicline according to the usual clinical guidelines and product information (25 days); (2) a group with a 50-day cytisinicline regimen (an additional 25 days at a dose of 1.5 mg every 12 hours), seeking to increase its efficacy while minimally impacting adherence; and (3) a group with a 75-day regimen (an additional 50 days at a dose of 1.5 mg every 12 hours), attempting to increase its efficacy, although the longer duration of the drug may threaten adherence. Efficacy in the 3 arms will be analyzed through sustained abstinence at 6 and 12 months, point abstinence rate assessed every 7 days, and abstinence rate from Day 25 to Day 50 and from Day 25 to Day 75 in the 3 study arms. (1) The variation in withdrawal and craving symptoms in the 3 groups, (2) safety through the percentage of adverse events in the 3 treatment arms, and (3) economic impact by evaluating the cost-effectiveness and cost-utility ratios of the 2 prolonged regimens versus the usual clinical cytisinicline regimen. To calculate the differences between the 3 groups for each outcome variable, a univariate analysis will be performed. Statistically significant variables will be included in a multivariate model. Results: Recruitment for the trial and patient enrollment were completed in November 2026. Follow-up of all participants will extend to December 2027. Conclusions: In conclusion, this study evaluates the optimization of cytisinicline in daily clinical practice, increasing the benefits of its pharmaceutical properties without affecting patient safety. All of this will improve the effectiveness of smoking cessation by reducing the number of smokers, which implies lower morbidity and mortality and lower costs associated with smoking. Trial Registration: European Clinical Trials Register 2024-518936-36-00; https://euclinicaltrials.eu/ctis-public/view/2024-518936-36-00 International Registered Report Identifier (IRRID): PRR1-10.2196/76815 %M 41576369 %R 10.2196/76815 %U https://www.researchprotocols.org/2026/1/e76815 %U https://doi.org/10.2196/76815 %U http://www.ncbi.nlm.nih.gov/pubmed/41576369 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 15 %N %P e84122 %T Curative Effect and Autonomic Nerve Function of Patients With Primary Insomnia of Liver Depression and Spleen Deficiency Type Based on the Acupoint Selection of Meridian Theory: Protocol for a Randomized Controlled Trial %A Fu,Su %A He,Kang %A Zhou,Chuanlong %K liver stagnation and spleen deficiency insomnia %K acupuncture %K randomized controlled trial %K autonomic nerve function %K Jing Bie theory %K traditional Chinese medicine %D 2026 %7 22.1.2026 %9 %J JMIR Res Protoc %G English %X Background: Primary insomnia often corresponds to the syndrome of liver depression and spleen deficiency in traditional Chinese medicine. This study evaluates a new acupuncture protocol derived from the “Jing Bie” theory. Tianrong (TE16) and Tianyou (SI17) were selected to regulate the Shaoyang meridian, soothe the liver, regulate qi (the basic life energy or life force to maintain the physiological function of the body according to traditional Chinese medicine), strengthen the spleen, and tranquilize the mind, so as to restore sleep. Objective: The objective of this study is to evaluate the clinical efficacy of this regimen and to explore its effects on autonomic nervous system function and central nervous system chemistry. Methods: This is a single-blind randomized controlled trial. A total of 96 patients with primary insomnia (liver depression and spleen deficiency pattern) will be recruited and randomly assigned to the treatment group or the control group. At the same time, 48 healthy volunteers will be recruited as the healthy control group. Results: This study was funded in November 2023. Recruitment and data collection began in January 2024 and are currently underway. As of December 2025, a total of 40 participants have been enrolled, of whom 4 have withdrawn. Recruitment is projected to conclude by December 2026. Data analysis will be performed after the completion of recruitment. The results are expected to be published in summer 2027. Conclusions: This study integrates a traditional Chinese medicine framework with modern physiological measurements. The aim is to provide evidence for targeted acupuncture strategies by linking clinical improvement to autonomic nervous system balance and neurochemical changes and to elucidate potential mechanisms to provide a nondrug treatment option for insomnia. Trial Registration: ClinicalTrials.gov NCT06782815; https://clinicaltrials.gov/study/NCT06782815 International Registered Report Identifier (IRRID): DERR1-10.2196/84122 %R 10.2196/84122 %U https://www.researchprotocols.org/2026/1/e84122 %U https://doi.org/10.2196/84122 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 15 %N %P e79579 %T Jiedu Xiaozhen Granules for Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor–Mediated Skin Toxicity: Protocol for a Randomized Controlled Trial %A Hao,Shoujiang %A Li,Xiaoli %A Hao,Shulan %A Zhang,Xiaoying %A Qi,Xiaojun %A Jin,Gang %A Shen,Fangfang %A Liu,Likun %K traditional Chinese medicine %K non–small cell lung cancer %K targeted drugs %K jiedu xiaozhen granules %K skin toxicity %D 2026 %7 22.1.2026 %9 %J JMIR Res Protoc %G English %X Background: Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) are widely used in the treatment of non–small cell lung cancer due to their precision, efficiency, and ease of use. However, skin rashes induced by EGFR-TKIs are the most common and earliest form of skin toxicity, often affecting the quality of life and treatment compliance of patients and leading to early discontinuation of therapy. These skin reactions may even impact cancer outcomes. In clinical practice, traditional Chinese medicine detoxification granules have shown effectiveness in relieving skin discomforts such as itching, pain, and burning caused by EGFR-TKI therapy. A prior single-arm trial investigating the treatment of targeted drug–induced rashes demonstrated a sustained improvement in rash symptoms with an effectiveness rate of 80.77% and was well tolerated by patients. Objective: As an exploratory clinical study, this randomized controlled trial will preliminarily evaluate the potential efficacy and safety of jiedu xiaozhen (JDXZ) granules in managing EGFR-TKI–related skin toxicities. Methods: This randomized controlled trial will be conducted at Shanxi Provincial Hospital of Traditional Chinese Medicine. A total of 94 patients with confirmed epidermal growth factor receptor gene–mutated non–small cell lung cancer who developed rashes after EGFR-TKI treatment will be enrolled. Patients will be randomly assigned to either a JDXZ traditional Chinese medicine group (group J) or a urea ointment group (group U). The primary outcome will be the severity of the rash as assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events grading. Secondary outcomes will include the WoMo (Wollenberg and Moosmann) score, numerical rating scale, Dermatology Life Quality Index scale, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 score, median progression-free survival, and changes in the levels of fibroblast growth factor 7 and hepatocyte growth factor in the blood. Adverse reactions will be recorded throughout the study. Data will be analyzed using SPSS. Results: The clinical trial registration was completed in October 2024. This study is currently underway. As of December 1, 2025, a total of 81 eligible participants had been enrolled, all of whom were assigned to groups following the randomization principle. Among them, 42 participants were allocated to the JDXZ group (with an additional 2 participants pending enrollment), and 39 to the control group. Based on the current progress, the estimated trial completion date has been extended to January 31, 2026. Conclusions: The results of this study may help develop an effective treatment for EGFR-TKI–mediated rashes. The findings will be published in academic journals upon the completion of the trial. Trial Registration: Chinese Clinical Trial Registry ChiCTR2400086657; https://www.chictr.org.cn/showprojEN.html?proj=234631 International Registered Report Identifier (IRRID): DERR1-10.2196/79579 %R 10.2196/79579 %U https://www.researchprotocols.org/2026/1/e79579 %U https://doi.org/10.2196/79579 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 15 %N %P e75286 %T Normalization of Gastrointestinal Symptoms in Adults With Constipation With Daily Green Kiwifruit Consumption: Protocol for an Open-Label Intervention Study %A Maggo,Jasjot %A Ng,Hwei Min %A Bayer,Simone Birgit %A Wall,Catherine L %A Hoad,Caroline L %A Marciani,Luca %A Mullaney,Jane %A Cabrera,Diana %A Fraser,Karl %A Cooney,Janine M %A Günther,Catrin S %A Trower,Tania %A Tang,Jeffery %A Gasser,Olivier %A Milan,Amber %A McNabb,Warren C %A Spiller,Robin %A Conner,Tamlin %A Frampton,Chris %A Foster,Meika %A Roy,Nicole C %A Gearry,Richard B %K functional constipation %K constipation-predominant irritable bowel syndrome %K green kiwifruit %K abdominal pain %K colonic volume %K gut microbiome %K metabolites %K randomized control trial %K mobile phone %D 2026 %7 13.1.2026 %9 %J JMIR Res Protoc %G English %X Background: Irritable bowel syndrome with constipation (IBS-C) and functional constipation (FC) have significant personal, health care, and social impacts, affecting patients’ quality of life. Treatment of these conditions is challenging. While green kiwifruit is a promising natural alternative to laxatives, its effectiveness in managing abdominal pain and the underlying mechanism of action is yet to be substantiated. Objective: This study investigates the effect of consuming 2 green kiwifruit daily for 4 weeks (the habitual serving) on abdominal pain and discomfort in individuals with IBS-C and FC. Methods: This study is a 2-arm parallel, open-label, placebo-controlled randomized study. This study’s duration was 9 weeks, with a 3-week lead-in phase, a 4-week intervention phase, and a 2-week follow-up phase. A total of 60 participants with IBS-C and FC were randomized to consume either 2 Zespri green kiwifruit (Actinidia deliciosa “Hayward,” ~150 g per serving, ~90 kcal) or maltodextrin (calorie-matched to the fruit, ~25 g per serving, ~90 kcal) per day for 4 weeks. The participants completed validated questionnaires assessing digestive and general health and well-being parameters, underwent magnetic resonance imaging to determine colon physiological measures, ingested a blue food dye, provided blood and fecal samples to measure microbial, immunological, and biochemical parameters, and ingested wireless motility devices (selected participants only) to assess physiological processes. Results: Recruitment for this study began in May 2021 and was completed in May 2022. A total of 63 participants were randomized, and 57 were analyzed using intention-to-treat analysis. Data analysis is complete, and full results are expected to be published in a peer-reviewed journal by April 2026. Conclusions: This study aims to evaluate the effectiveness of green kiwifruit consumption in managing abdominal pain in individuals with IBS-C and FC. It will provide new insights into the mechanisms behind the habitual consumption of green kiwifruit for digestive comfort in this population. Trial Registration: Australian New Zealand Clinical Trial Registry ACTRN12621000621819; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=381723 International Registered Report Identifier (IRRID): RR1-10.2196/75286 %R 10.2196/75286 %U https://www.researchprotocols.org/2026/1/e75286 %U https://doi.org/10.2196/75286 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 15 %N %P e82043 %T Virtual Mentored Implementation to Improve Care Transitions in Chronic Obstructive Pulmonary Disease: Protocol for a Pragmatic Implementation Study %A Lee,Cathryn T %A Traeger,Leah %A Akula,Mahima %A Fegley,April E %A Goldstein,Jenna %A Erwin,Kim %A Damschroder,Laura J %A Rommes,Jean %A Pick,Hannah %A Auerbach,Andrew %A Lindenauer,Peter %A Wan,Wen %A Jackson Sagredo,Andrea %A Press,Valerie G %+ Section of Pulmonary and Critical Care Medicine, Department of Medicine, University of Chicago, 5841 S Maryland Ave, Chicago, IL, 60637, United States, 1 773 702 5170, vpress@bsd.uchicago.edu %K COPD %K chronic obstructive pulmonary disease %K hospital readmissions %K transitions of care %K COPD exacerbation %K hybrid effectiveness-implementation design %D 2026 %7 13.1.2026 %9 Protocol %J JMIR Res Protoc %G English %X Background: Chronic obstructive pulmonary disease (COPD) is a leading cause of mortality and morbidity among US adults, including recurrent emergency department (ED) visits and unplanned hospital admissions. Despite this, the transition of care (TOC) from the inpatient to outpatient setting remains under-studied. Objective: The objectives of the Reduce Respiratory Emergent Visits using Implementation Science Interventions Tailored to Setting (Reduce REVISITS) study are to conduct contextual assessments to inform implementation plans for COPD TOC interventions, conduct a cluster randomized trial evaluating implementation over 1 year of COPD TOC bundles, and monitor sustainment of implementation over a 2-year period across 20 sites. Methods: This pragmatic, multisite study uses a hybrid type II effectiveness-implementation design to evaluate clinical and implementation outcomes of COPD TOC programs across 20 sites. Sites are cluster-randomized to 1 of 4 intervention groups, varying by program delivery method (in-person vs virtual) and implementation strategy (mentored implementation with or without co-design). Sites select evidence-based interventions they wish to incorporate into their COPD TOC program and are randomized to in-person or virtual delivery. During the 1-year active implementation period of the study, assigned mentors will meet monthly with sites (for a total of 12 sessions) to enable on-the-ground troubleshooting of site-specific difficulties with TOC interventions. The primary effectiveness outcome for this study will be COPD-specific acute health care use, defined as a composite of all ED visits and hospitalizations within 30 days of index hospitalization for a COPD exacerbation. The primary implementation outcome will be reach, defined as the proportion of patients receiving their assigned TOC interventions (the whole bundle). Results: As of August 2025, 21 sites completed the contextual assessments and developed site-specific implementation plans. Publication of the qualitative data from this pre-implementation phase is anticipated in December 2025. Site randomization is complete; sites randomized to co-design have completed 3 sessions. Baseline data collection on use is complete. Implementation-year data collection on use is nearly complete. Year 1 and 2 post-implementation-phase data collection on use is ongoing. Quantitative data analyses of the baseline and implementation-phase reports are nearly complete. Manuscript submission for the primary implementation-phase manuscript is anticipated for December 2025. Manuscript submission for the implementation-sustainment analyses are anticipated for September 2026. Qualitative data collection for year 1 of the post-implementation phase is complete, and analysis is under way. Qualitative data collection for year 2 began in August 2025. Conclusions: The Reduce REVISITS study will use novel integrated implementation science and human-centered design methodology to investigate bundles of effective COPD TOC interventions with the goal of reducing COPD hospital revisits. The study will evaluate evidence-based programs for effectiveness and implementation across a wide variety of health care sites to ultimately improve outcomes in this high-risk patient population. Trial Registration: ClinicalTrials.gov NCT05568043; https://clinicaltrials.gov/study/NCT05568043 International Registered Report Identifier (IRRID): DERR1-10.2196/82043 %M 41529255 %R 10.2196/82043 %U https://www.researchprotocols.org/2026/1/e82043 %U https://doi.org/10.2196/82043 %U http://www.ncbi.nlm.nih.gov/pubmed/41529255 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 15 %N %P e71381 %T Cluster Randomized Controlled Trial to Promote Physical Activity Among Low-Resourced Mothers in New York City: Protocol for the Free Time for Wellness Effectiveness Trial %A Watterson,Jessica %A Magsamen-Conrad,Kate %A Gokal,Kajal %A Oakley-Girvan,Ingrid %A Hirsch,Jennifer S %A Qian,Min %A Buchsbaum,Richard %A Niles,Charlene %A Van Horn,Kendra %A Moshier,Stephanie %A Martinez,Andreina %A Garcia Flores,Avery %A Laine,Sherece %A Vega,Marilisa %A Houghton,Lauren C %+ Department of Epidemiology, Mailman School of Public Health, Columbia University, 722 West 168th Street, New York, NY, 10032, United States, 1 212 342 0246, lh2746@cumc.columbia.edu %K public health %K physical activity %K low-resourced %K mothers %K chronic disease epidemiology %K low income %K chronic disease %K childcare %D 2026 %7 13.1.2026 %9 Protocol %J JMIR Res Protoc %G English %X Background: Physical inactivity is pervasive and prevalent in the United States, particularly among women of low socioeconomic position and women with children. Structural and social barriers make active leisure time a rare commodity, creating a pressing health issue because physical inactivity increases the risk of chronic diseases and poor health. Objective: The broad objective of this study is to test the effectiveness of Free Time for Wellness, a multilevel intervention to increase physical activity among low-resourced mothers. Methods: This study comprises a 3-arm parallel cluster randomized controlled trial (RCT) with low-resourced mothers living in New York City. We will randomize fitness class sites (clusters) into arm A (contact control), receipt of free weekly fitness classes; arm B, receipt of free childcare combined with free weekly fitness classes; and arm C, receipt of free childcare combined with free weekly fitness classes and peer support activities. Over 2 years, we will recruit a pilot wave followed by 7 additional waves, totaling 720 participants into 24 fitness classes. Physical activity is the primary outcome, measured using accelerometers, but secondary outcomes also include physical activity assessed using a self-reported questionnaire and attendance data. We will assess additional secondary outcomes (eg, health status, depression, and anxiety) and mediators or moderators (eg, social support and cohesion) with a baseline and follow-up questionnaire. The intention-to-treat analysis will use linear mixed-effects models to assess the main intervention effects on physical activity outcomes and other secondary outcomes. Ethnographic methods will examine how intersecting forms of social identity shape women’s experiences of physical activity and understand how real-world conditions shape the intervention implementation. Results: The study received funding from the US National Institute of Health, covering the period of time from April 1, 2023, through March 31, 2028. We received initial institutional review board approval in August 2023. The study is active and recruiting participants. As of the day of manuscript submission, we have enrolled 471 participants. Data collection is anticipated to occur until September 2026 for primary completion. The estimated study completion date is December 2026. Dissemination of the results will take place with participants, community members, partners, and researchers through methods such as reports, websites, events, and academic publications and conferences. Conclusions: This cluster RCT tests whether access to childcare (an understudied structural barrier) and social support can increase physical activity. The study design and outcomes integrate ethnographic methods with a cluster RCT to better understand mechanisms and the impact of intersecting factors such as race or ethnicity, culture, gender, and socioeconomic position. The study leverages widely accessible, existing resources to promote physical activity and foster social support with the ultimate goal of assessing the effect of childcare access on parental health. Trial Registration: ClinicalTrials.gov NCT06654843; https://clinicaltrials.gov/study/NCT06654843 International Registered Report Identifier (IRRID): DERR1-10.2196/71381 %M 41529256 %R 10.2196/71381 %U https://www.researchprotocols.org/2026/1/e71381 %U https://doi.org/10.2196/71381 %U http://www.ncbi.nlm.nih.gov/pubmed/41529256 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 15 %N %P e83336 %T Ayurvedic Therapeutic Regimen as an Add-On to Optimized Conventional Management of Parkinson Disease: Protocol for an Exploratory Randomized Controlled Trial Evaluating Clinical, Cortical Excitability, Neuroimmune, and Autonomic Function Parameters %A Chikkanna,Umesh %A Pal,Pramod Kumar %A Jameela,Sophia %A Mahale,Rohan R %A Kamble,Nitish %A Shivakumar,Venkataram %A Holla,Bharath %A Yadav,Ravi %A Holla,Vikram V %A Sathyaprabha,Talakad Narasappa %A Udupa,Kaviraja %A Sahoo,Srinibash %A Venkataswamy,Manjunath M %A Ganapathy,Selva %A Rao,Chandra Shekara %A Yadav,Babita %A M,Sreenithya %A Varambally,Shivarama %A Bhat,Sulochana %A Srikanth,Narayanam %A Ramakrishna,Kishore Kumar %K Ayurveda %K Parkinson disease %K transcranial magnetic stimulation %K autonomic function test %K immunoparameters %D 2026 %7 9.1.2026 %9 %J JMIR Res Protoc %G English %X Background: Parkinson disease (PD), a progressive neurodegenerative disorder, lacks disease-modifying treatments. Current therapies focus on symptomatic relief, highlighting the need for adjunctive neuroprotective strategies. Ayurveda, a holistic system, shows promise in improving PD clinical outcomes. Objective: This assessor-blinded randomized controlled study aims to systematically evaluate the efficacy of an add-on Ayurveda therapeutic regimen compared to conventional treatment as usual (TAU) in improving the clinical outcomes of PD. Methods: A total of 80 patients with PD, diagnosed according to UK Parkinson’s Disease Society Brain Bank criteria, will be randomized into two groups: TAU and add-on Ayurveda. The intervention group will receive Ayurvedic therapy alongside conventional treatment for 180 days, whereas the control group will continue TAU. Assessments will occur at baseline and at 60-, 120-, and 180-day follow-ups, evaluating motor and nonmotor symptoms. Transcranial magnetic stimulation, heart rate variability, and pulmonary function tests will assess cortical excitability, autonomic function, and pulmonary function, respectively. Immunological parameters, including cytokine levels and telomere length, will be analyzed at baseline and at 180 days to explore disease-modifying effects. Liver and renal function tests will monitor safety. Results: As of 2025, a total of 259 patients with PD have been screened for eligibility, of whom 58 participants have been successfully enrolled in the trial. Among these, 33 participants have completed the intervention and follow-up assessments, 14 have discontinued participation, and 11 are currently continuing participation in the study. Recruitment and follow-up are ongoing, and the trial is scheduled for completion in September 2026. Conclusions: This study aims to address the lack of mechanistic evidence and robust data on Ayurveda in PD. By systematically evaluating clinical efficacy and potential biomechanisms, the findings will provide preliminary evidence for Ayurvedic interventions, potentially paving the way for their integration into comprehensive PD management. Trial Registration: Clinical Trial Registry of India CTRI/2022/01/039803; https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=NjQ4MTU=&Enc=&userName= International Registered Report Identifier (IRRID): DERR1-10.2196/83336 %R 10.2196/83336 %U https://www.researchprotocols.org/2026/1/e83336 %U https://doi.org/10.2196/83336 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 15 %N %P e81284 %T The Effects of Multi-Theory Model–Based Behavior Change Intervention with Staircase Approach on Sedentary Lifestyle Among Community-Dwelling Older Adults: Study Protocol for a Randomized Controlled Trial %A Tuerdi,Subinuer %A Yang,HuiLing %A He,Li %A Yan,Rong %A Cui,YaoYi %A Wang,XingHui %A Dong,ShanShan %A Yang,JiaYu %A Zhang,KeQiang %A Li,Feng %A Li,YueWei %K sedentary behavior %K sedentary lifestyle %K physical activity %K older adults %K behavior change %K MTM %K lifestyle intervention %K multi-theory model %D 2026 %7 6.1.2026 %9 %J JMIR Res Protoc %G English %X Background: Sedentary lifestyles, as a nursing diagnosis, are prevalent in the life patterns of community-dwelling older adults, who have been shown to be the most sedentary and physically inactive subgroup. Prolonged low energy expenditure during waking hours leads to an increased risk of noncommunicable diseases and impairs physical functioning in older adults, negatively impacting their health outcomes. Therefore, interventions targeting changes in sedentary lifestyles are necessary to improve health behaviors in older adults. Objective: This study aimed to investigate the effect of the multi-theory model–based stepped behavior change intervention on sedentary lifestyle among community-dwelling older adults. Methods: This study is designed as a community-based, parallel-arm, assessor-blinded randomized controlled trial. Sixty participants were enrolled in this study and randomly assigned to the intervention group (received theory-based sedentary lifestyle change intervention) and the control group (received conventional behavioral change advice). End points were collected at baseline, immediately after the end of the intervention, week 12, and week 18. The primary endpoint is the change in self-reported sedentary time. Secondary endpoints include the changes in step count, time spent in light-intensity physical activity and moderate-to-vigorous-intensity physical activity, Measuring Change in Physical Activity Questionnaire score, Short Physical Performance Battery score, BMI, waist circumference, blood pressure, and Short-Form Health Survey-12-Version 2 score. Results: The study was initiated in May 2024. As of May 2025, the project had completed participant recruitment and data collection. The final manuscript with findings is expected to be submitted for publication in September 2025. Conclusions: This study uses a multi-theory model as its theoretical framework and adopts stepped sedentary lifestyle change as the intensity gradient of exercise behavior, creating a behavioral change pattern from sitting to standing and movement to light-intensity physical activity, to moderate-to-vigorous-intensity physical activity, and ultimately improving the sedentary lifestyle and obtaining health benefits, to provide community-dwelling older adults with individualized behavior change programs that are easy to adhere to and more applicable to daily activity patterns. Trial Registration: China Clinical Trial Registry ChiCTR2400082225; https://www.chictr.org.cn/showproj.html?proj=223351 International Registered Report Identifier (IRRID): DERR1-10.2196/81284 %R 10.2196/81284 %U https://www.researchprotocols.org/2026/1/e81284 %U https://doi.org/10.2196/81284 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 15 %N %P e72854 %T The Effect of Virtual Reality–Based Social Cognitive Training for Autistic Adults: Protocol for STEPS (Social Cognitive Training Enhancing Pro-Functional Skills) Randomized Clinical Trial %A Andresen,Johannes %A Jeppesen,Alberte C E %A Due,Anne Sofie %A Mariegaard,Lise Sandvig %A Parvaiz,Rizwan %A Hjorthøj,Carsten %A Pinkham,Amy Elizabeth %A Nordentoft,Merete %A Letnar,Gasper %A Jepsen,Jens Richardt Møllegaard %A Glenthøj,Louise Birkedal %K autism spectrum disorder %K virtual reality %K psychosocial functioning %K social skills %K social cognitive training %K emotion recognition %K theory of mind %D 2026 %7 5.1.2026 %9 %J JMIR Res Protoc %G English %X Background: Autistic adults constitute a growing and largely overlooked population with limited clinical and research resources. Social cognitive impairments are key deficits faced by this population, significantly impacting social interactions, educational and vocational functioning, and quality of life. Interventions targeting social cognition in autistic adults have shown promising results. Recent studies investigating the effect of virtual reality (VR)–based interventions for autistic adults have provided preliminary evidence supporting the feasibility and effectiveness of using this innovative technology. These studies indicate that VR interventions can enhance functional and social skills and improve specific neurocognitive and social cognitive functions. However, large-scale randomized clinical trials are urgently needed to fully assess the effectiveness of VR-based interventions for autistic adults. Objective: This protocol aims to provide a comprehensive description of the design and methodology of the STEPS (Social Cognitive Training Enhancing Pro-Functional Skills) trial. Methods: STEPS is a clinical, randomized, assessor-blinded, parallel-group superiority trial. A total of 140 participants will be allocated to receive either virtual reality–based social cognitive training (VRSCT) + treatment as usual (TAU) or TAU alone. The experimental group will receive 12 weekly 1-hour sessions of VRSCT, aiming at improving psychosocial functioning and social cognition through exposure to virtual social environments. The intervention comprises 3 core modules, namely emotions, social understanding, and complex social interactions. The exact content and duration of TAU received by each participant will be mapped and documented upon trial completion. Assessments will be conducted at baseline, at cessation of the intervention (3 months post baseline), and at 6 months post baseline. Results: Participant enrollment began in May 2024. As of February 2025 (initial manuscript submission), 34 participants had been enrolled, increasing to 97 participants as of December 2025. Completion of enrollment is expected in April 2026. Data analysis is expected to begin in October 2026 following the final 6-month follow-up assessment. Results are anticipated in December 2026 and will be disseminated through peer-reviewed publications. Conclusions: To our knowledge, STEPS is the hitherto largest randomized clinical trial globally investigating the effect of VRSCT for autistic adults. The results of this innovative intervention approach may significantly advance research in the field of autism. VRSCT holds potential to improve psychosocial functioning, quality of life, and co-occurring clinical symptoms, and to reduce social cognitive deficits in autistic adults. Establishing evidence-based interventions is crucial for addressing the debilitating psychosocial challenges faced by this population, especially considering the absence of established gold-standard treatments. Trial Registration: ClinicalTrials.gov NCT06438536; https://clinicaltrials.gov/study/NCT06438536 International Registered Report Identifier (IRRID): DERR1-10.2196/72854 %R 10.2196/72854 %U https://www.researchprotocols.org/2026/1/e72854 %U https://doi.org/10.2196/72854 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 15 %N %P e84521 %T Effects of Oliceridine Versus Sufentanil on Postoperative Recovery Quality During Hysteroscopy Under Laryngeal Mask Airway Anesthesia: Protocol for a Single-Blind and Randomized Controlled Trial %A Shou,YuHang %A Luo,JianSheng %A Zhang,XianJie %A Zhai,WenHu %A Han,Jia %+ Department of Anesthesiology, Deyang People’s Hospital, No 173, Section 1, Taishan North Road, Jingyang District, Sichuan, Deyang, 618000, China, 86 13518278867, will418@126.com %K oliceridine %K hysteroscopy %K quality of recovery %K opioid-related adverse events %K sufentanil %K general anesthesia %D 2026 %7 2.1.2026 %9 Protocol %J JMIR Res Protoc %G English %X Background: Hysteroscopy, the gold standard for diagnosing and treating intrauterine pathologies, has shown substantial increase in its adoption in clinical practice. Nevertheless, early postoperative pain and opioid-related adverse effects remain critical determinants of recovery quality. Oliceridine—a novel G protein-biased μ-opioid receptor agonist—demonstrates an improved therapeutic range over conventional opioids in preliminary studies. Objective: This study aims to evaluate whether oliceridine enhances recovery quality while reducing opioid-related complications compared to sufentanil in patients undergoing hysteroscopy under general anesthesia. Methods: This single-center randomized controlled trial will enroll 120 patients undergoing hysteroscopy under general anesthesia with 1:1 randomization to sufentanil- or oliceridine-based analgesia. The primary outcome is early recovery quality assessed by the 15-item Quality of Recovery scale at 24 hours after the surgery, while secondary outcomes include hemodynamic fluctuations during induction, total intraoperative opioid consumption and supplemental bolus frequency, proportion requiring vasoactive agents, incidence of respiratory depression in postanesthesia care unit, postoperative extubation time, opioid-related adverse events within 24 hours, and Visual Analog Scale pain scores at 30 minutes, 4 hours, 8 hours, and 24 hours postextubation. Results: This study received approval from the Medical Ethics Committee of Deyang People’s Hospital, Deyang, China, on April 16, 2025 (approval 2025-03-009-K01). Participant recruitment is anticipated to be completed by December 2025. Data analysis, manuscript preparation, and submission for publication are expected to be completed by February 2026. Conclusions: The successful completion of this trial will generate evidence regarding whether oliceridine enhances recovery quality while reducing opioid-related complications compared to sufentanil in patients undergoing hysteroscopy under general anesthesia. Trial Registration: Chinese Clinical Trial Registry ChiCTR2500104024; https://www.chictr.org.cn/showproj.html?proj=275501 International Registered Report Identifier (IRRID): DERR1-10.2196/84521 %M 41481911 %R 10.2196/84521 %U https://www.researchprotocols.org/2026/1/e84521 %U https://doi.org/10.2196/84521 %U http://www.ncbi.nlm.nih.gov/pubmed/41481911 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e76576 %T Efficacy of an Ayurvedic Intervention as an Adjunct to Standard Care in Preventing Acute Pain Crises in Sickle Cell Anemia: Protocol for a Randomized Controlled Trial %A Namburi,U R Sekhar %A Thakare,Priya %A Kuchewar,Vaishali %A Deshmukh,Manish %A Kachare,Kalpana %A Tikas,Madhukar %A Makhija,Deepa %A Rao,Bhogavalli Chandra Sekhara %A Suryawanshi,MN %A Mahajan,Satish %A Sharma,Abha %A Srikanth,N %A Acharya,Ravinarayana %K hemoglobin %K raktavaha srotas dushti %K dadimadi ghrita %K Ayush-RP %K pandu %D 2025 %7 31.12.2025 %9 %J JMIR Res Protoc %G English %X Background: Sickle cell anemia (SCA) represents a major health concern among the tribal population of India, with frequent acute pain crises significantly compromising the quality of life of the affected individuals. As an inherited disorder, there is no definitive cure for the condition. Hydroxyurea remains the primary therapeutic option and is typically used for lifelong management, although it may be associated with certain side effects. In light of the pressing need for a safe, accessible, and effective alternative for long-term care, this study is planned to explore the potential of Ayurveda in managing pain crises alongside conventional standard care. Objective: This study aims to evaluate the efficacy of Ayurvedic intervention in preventing acute pain crises in individuals with SCA and improving their quality of life. Methods: This study is designed as a randomized, active-controlled, open-label clinical trial. Participants diagnosed with SCA are enrolled in the study according to the selection criteria. The intervention group receives Ayurvedic interventions, namely dadimadi ghrita and Ayush-RP, along with standard care, whereas the control group receives standard care only. The intervention is administered over a period of 8 months. Participants are evaluated on the 30th, 60th, 105th, 150th, 195th, and 240th days to assess changes in the frequency of pain crises and quality of life. Results: This study was initiated on September 5, 2023. Total enrollment of 1510 participants has been completed by screening 1644 participants. As of August 14, 2025, a total of 1137 participants have successfully completed the study, 280 (24.62%) are continuing, and 93 (8.18%) have dropped out. Conclusions: This study aims to establish the efficacy and safety of Ayurvedic interventions as part of an integrated approach to managing SCA, with a focus on reducing the frequency of pain crises and improving patients’ overall quality of life. Trial Registration: Clinical Trials Registry- India Ctri/2023/04/052141; https://tinyurl.com/yzfb62xb International Registered Report Identifier (IRRID): DERR1-10.2196/76576 %R 10.2196/76576 %U https://www.researchprotocols.org/2025/1/e76576 %U https://doi.org/10.2196/76576 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e83401 %T Hidden Workers in Aging Australia: Protocol of Intersectionality-Informed Mixed Methods Study %A Lee,Sora %A Kang,Woojin %A Yang,Lu %A Batra,Mehak %+ Department of Public Health, School of Psychology and Public Health, La Trobe Univeristy, HS2 Building 5.45 Bundoora VIC, Melbourne, 3086, Australia, 61 3 94791773, sora.lee@latrobe.edu.au %K employment %K unemployment %K aging workers %K aging workers %K hidden workers %K intersectionality %K health status disparities %K mixed methods %D 2025 %7 31.12.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Australians are living longer and are expected to remain in the workforce for longer; yet, many older adults struggle to secure employment despite being willing and able to work. A growing share of these individuals are “hidden workers,” those underused in the labor market due to missed hours, long-term unemployment, or withdrawal from job seeking despite the capacity to work. This group reflects a global trend of aging yet underused workforces, and in Australia, they represent a significant proportion of the working-age population. Addressing the challenges of hidden workers is crucial, as their inclusion could help meet labor market demands, alleviate fiscal pressures of aging, and promote healthier, more equitable aging trajectories. Objective: This intersectional mixed methods study has 3 overarching aims. First, to investigate how intersecting social identities (eg, age, gender, cultural background, health status, and caregiving responsibilities) shape hidden workforce participation and associated health outcomes among aging Australians. Second, to compare hidden workers with currently employed populations in order to identify health discrepancies between the 2 groups. Third, to explore the lived experiences of hidden workers, focusing on how intersecting and multiply disadvantaged identities impose additional burdens on employment outcomes and health status. Together, these aims will generate an integrated understanding of both structural and lived dimensions of hidden work, providing evidence to inform more equitable labor market and health policies. Methods: This study uses an explanatory sequential mixed methods design to investigate the health, resources, and employment experiences of aging hidden workers in Australia. In phase 1, an online cross-sectional survey was administered to 1166 participants (696 hidden workers aged more than 45 years and 470 current workers), capturing variables on employment history, health, discrimination, workplace social capital, caregiving, and socioeconomic status. Validated instruments, including the Workplace Age Discrimination Scale, Intersectional Anticipated Discrimination Scale, and Workplace Social Capital Index, were incorporated to ensure reliability. Phase 2 will involve semistructured interviews with a purposive subsample (30 participants) identified from survey results, focusing on lived experiences of workforce exclusion and intersecting barriers. In phase 3, quantitative and qualitative findings will be integrated through triangulation and complementarity to provide a comprehensive understanding of hidden workers’ challenges and assets, generating evidence to inform policy and stakeholder recommendations. Results: As of September 2025, the online survey has been completed, phase 2 interviews are underway, and phase 3 integration is scheduled for completion by mid-2026. Conclusions: This study will generate the first intersectional evidence on the health and employment challenges of hidden aging workers in Australia. These insights will inform tailored policy interventions that can support re-engagement, reduce inequities in health and well-being, and strengthen workforce participation. Ultimately, the findings will contribute to addressing skills shortages while promoting social and economic inclusion of aging Australians. International Registered Report Identifier (IRRID): DERR1-10.2196/83401 %M 41474975 %R 10.2196/83401 %U https://www.researchprotocols.org/2025/1/e83401 %U https://doi.org/10.2196/83401 %U http://www.ncbi.nlm.nih.gov/pubmed/41474975 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e79158 %T Cardio-Cerebral Protective Effect of Moxibustion on Phlegm-Dampness Type Hypertension: Protocol for a Randomized Controlled Trial %A Cheng,Ling %A Bai,Ning %A Zheng,Liang %A Cao,Lulu %A Wu,Huangan %A Wang,Ruiping %A Zhao,Chen %A Shen,Yunli %A Zhao,Haiyin %A Li,Gang %A Yang,Bing %A Yang,Qinghui %A Xing,Yan %A Cao,Jianhong %A Wang,Yixing %A Xu,Ling %A Yan,Junjie %A Cao,Jie %A Guo,Yiyang %+ Acupuncture and Moxibustion Department of East Hospital Affiliated to Tongji University, No.150, Jimo Road, Shanghai, 200120, China, 86 13701854848, chlrosy.east@sina.com %K hypertension %K blood pressure %K moxibustion %K acupoint specificity %K cardioprotection %K moxibustion %K treatment %K patients %K trials %D 2025 %7 29.12.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Hypertension is associated with a high rate of disability and mortality and leads to a substantial socioeconomic burden. Moxibustion is an external treatment in traditional Chinese medicine that has been used to treat mild to moderate hypertension in individuals with phlegm-dampness constitution and has demonstrated acupoint specificity. However, a standard large-scale randomized controlled trial is still needed to verify its effectiveness. This study is proposed to examine the clinical effectiveness and potential cardioprotective benefits of moxibustion performed at home as a treatment for individuals with phlegm-dampness hypertension. Objective: The objective of this trial is to evaluate the cardio-cerebral protective clinical efficacy of moxibustion for phlegm-dampness type hypertension and to explore its acupoint specific effects. Methods: This study is a multicenter, randomized controlled trial. A total of 120 patients with mild to moderate hypertension and phlegm-dampness constitution will be recruited and randomly assigned in a 1:1 ratio to the treatment group (acupoint: Zusanli, ST36) or the control group (acupoint: Xuanzhong, GB39). All patients will receive 12 weeks of treatment and a 12-week follow-up period. The primary outcome measure is the change in morning systolic blood pressure from baseline to week 12. The secondary outcome measures include blood pressure–related indicators (morning diastolic blood pressure, average systolic blood pressure, average diastolic blood pressure, nighttime systolic blood pressure, nighttime diastolic blood pressure, and blood pressure circadian rhythm) and short-term blood pressure variability coefficient, all of which will be measured by 24-hour ambulatory blood pressure monitoring. Additionally, cardiac-related indicators measured by 24-hour Holter monitoring, metabolic disorder-related indicators, liver and kidney function indicators, transformed scores of the traditional Chinese medicine phlegm-dampness constitution scale, and the Montreal Cognitive Assessment will also be evaluated. Results: This study was registered on July 5, 2024, with the Chinese Clinical Trial Registry. Data collection began in June 2023 and ended in February 2025. Currently, data from this trial are in the collection phase, and no data analysis has been performed. As of January 2025, we have collected data from 118 patients. The results of this trial are expected to be submitted for publication in May 2026. Conclusions: This multicenter, randomized, controlled clinical trial will provide evidence on the clinical effectiveness and potential cardioprotective benefits of moxibustion performed at home as a treatment for individuals with phlegm-dampness type of hypertension. Trial Registration: Chinese Clinical Trial Registry ChiCTR2400086582; https://www.chictr.org.cn/showproj.html?proj=211688 International Registered Report Identifier (IRRID): DERR1-10.2196/79158 %M 41251199 %R 10.2196/79158 %U https://www.researchprotocols.org/2025/1/e79158 %U https://doi.org/10.2196/79158 %U http://www.ncbi.nlm.nih.gov/pubmed/41251199 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e79855 %T Effectiveness of Metformin Prolonged-Release Formulation on Achievement of Optimal Glycemic Control in Gestational Diabetes Mellitus: Protocol for a Pilot, Randomized, Double-Blind, Clinical Trial %A Boriboonhirunsarn,Dittakarn %A Sunsaneevithayakul,Prasert %+ Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Wanglang Road, Siriraj, Bangkoknoi, Bangkok, 10700, Thailand, 66 0818085718, dittakarn.bor@mahidol.ac.th %K gestational diabetes mellitus %K metformin %K prolonged-release formulation %K glycemic control %K effectiveness %D 2025 %7 19.12.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Gestational diabetes mellitus (GDM) is one of the most common complications in pregnancy. Optimal glycemic control is key to reducing the risk of adverse pregnancy outcomes. If glycemic control is inadequate, additional medications are needed. A large body of evidence has shown that metformin is an effective medication for GDM. Compared to the immediate-release formulation, the prolonged-release (PR) formulation of metformin offers some advantages with a single daily dose and has less frequent side effects, leading to better compliance. To date, no study has specifically reported the effectiveness of metformin PR in the treatment of GDM or the time required to achieve glycemic control after treatment. The results will help clinicians plan a better choice of treatment and follow-up for women with GDM and inadequate glycemic control. Objective: This study aims to evaluate the effectiveness of metformin PR in the treatment of GDM in terms of achieving glycemic control within 6 weeks, time to achieve glycemic control, and associated factors. Methods: A randomized, double-blind, placebo-controlled clinical trial will be conducted among 80 pregnant women diagnosed with GDM who had inadequate glycemic control at a university hospital in Thailand. The women will be randomized into 2 equal groups, receiving either metformin PR or a placebo in addition to nutritional therapy and behavioral modification. Dosage adjustment will be made every 2 weeks. If the glycemic target is not achieved within 6 weeks, insulin therapy will be initiated. All the participants and the investigators are blinded to the treatment provided. The primary outcome is the rate of achievement of glycemic control, and secondary outcomes are time to achieve glycemic control, rate of insulin therapy, and factors associated with the success of metformin PR use. Results: The study was funded in May 2025 when recruitment started. The study is projected to be completed in October 2026. Women with GDM who experienced inadequate glycemic control by nutritional therapy were assessed for eligibility. As of October 2025, 24 women with GDM agreed to participate and follow-ups were scheduled. The results are expected to be published in 2027. Conclusions: The results of this study will provide additional information on the use of metformin in the treatment of GDM, including the use of different formulations, rate of glycemic control, time to achieve glycemic control, and associated factors. This will help physicians better plan care for pregnant women with GDM, especially when glycemic control is inadequate, including choices of metformin formulation and dosage, follow-up schedule, and identification of women at risk of treatment failure. Trial Registration: Thai Clinical Trial Registry TCTR20250525007; https://www.thaiclinicaltrials.org/show/TCTR20250525007 International Registered Report Identifier (IRRID): DERR1-10.2196/79855 %M 41367107 %R 10.2196/79855 %U https://www.researchprotocols.org/2025/1/e79855 %U https://doi.org/10.2196/79855 %U http://www.ncbi.nlm.nih.gov/pubmed/41367107 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e77956 %T The 5 R’s of Indigenous Research as a Framework to Co-Design and Evaluate an Outdoor Play Program in Early Learning and Child Care Centers: Protocol for the Promoting Early Childhood Outside (PRO-ECO) 2.0 Wait-List Control Cluster Randomized Trial %A Brussoni,Mariana %A Ramsden,Rachel %A Grieve,Sheila %A Mount,Dawn %A Fox,Emily %A Herrington,Susan %A Lin,Yingyi %A Johnson,Stella Erasmus %A Lloyd,Jean %A Elliot,Enid %A Mlieczko,Emily %A Lemire,Andrea %A Scott,Laranna %A Barrett,Ashley %A Cottier,Emma %A Rice,Ally %+ Department of Pediatrics, University of British Columbia, F513, 4480 Oak Street, Vancouver, BC, V6H 3V4, Canada, 1 6048753712, mbrussoni@bcchr.ubc.ca %K early childhood education and care %K indigenous data sovereignty %K risky play %K community-based research %K methodology %D 2025 %7 12.12.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Outdoor play is a fundamental part of childhood. Children’s participation in outdoor play connects them to nature and the land, and supports their role in the natural world. Early learning and child care (ELCC) centers provide opportunities for outdoor play; however, barriers toward the provision of outdoor play exist, including educator attitudes, policies and procedures, outdoor space limitations, and adverse weather conditions. Objective: The Promoting Early Childhood Outside (PRO-ECO) 2.0 study is a community-based research partnership with Indigenous Knowledge Keepers and Elders, Indigenous and early childhood organizations, early childhood education faculty, ELCC centers, and families, aiming to expand outdoor play in ELCC centers. This paper provides an overview of the community-based design process, guided by the 5 R’s—Respect, Relevance, Responsibility, Reciprocity, and Relationship—and the resulting study protocol for the mixed methods waitlist control cluster randomized trial. Methods: This study considered a 5 R’s research approach from its inception, beginning with the formation of a Steering Committee and over a year of relationship building before formal study activities commenced. A key early focus was collaboratively identifying project values through an iterative process. Collectively, we worked to promote equity, disrupt power dynamics, and embed Indigenous data sovereignty principles into research agreements, marking a significant departure from traditional Western research processes. The PRO-ECO program and study protocol are implemented in partnership with 10 ELCC centers delivering licensed full-day, year-round care to children aged 2.5-6 years in rural and urban areas of British Columbia, Canada. The PRO-ECO program includes 4 components to address common barriers to outdoor play in ELCC settings. Primary outcome measures include the proportion and diversity of observed nature play behavior during dedicated outdoor times at ELCC centers as measured through observational behavior mapping. Secondary outcomes include changes in educator attitudes, quality of ELCC outdoor play space, and children’s perspectives of their experiences at ELCC centers. Outcome data are collected at baseline, and 6 months and 12 months post baseline. The community’s perspectives (educators, children, and families) on the project are assessed qualitatively to understand the acceptability of the PRO-ECO program. Mixed-effect models will test the effect of the PRO-ECO program on quantitative outcomes. Qualitative data will support the interpretation of quantitative findings and provide evidence on project acceptability. Results: Participant recruitment for this study began in August 2023, and data collection was completed in March 2025. A total of 229 children, 91 staff and early childhood educators, and 40 family members were recruited to participate in this study. Conclusions: The PRO-ECO 2.0 study uses a rigorous experimental design within a community-based research project. The 5 R’s approach grounded our work in shared values, disrupting traditional academic power relations and weaving together Indigenous and Western worldviews in the context of academic research. Trial Registration: ClinicalTrials.gov NCT05626595; https://clinicaltrials.gov/study/NCT05626595 International Registered Report Identifier (IRRID): DERR1-10.2196/77956 %M 41385788 %R 10.2196/77956 %U https://www.researchprotocols.org/2025/1/e77956 %U https://doi.org/10.2196/77956 %U http://www.ncbi.nlm.nih.gov/pubmed/41385788 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e70649 %T Comparative Evaluation of the Effectiveness of Demineralized Freeze-Dried Bone Allografts With Titanium Platelet-Rich Fibrin and Autologous Dentin Graft With Titanium Platelet-Rich Fibrin for Alveolar Socket Preservation: Protocol for a Randomized Controlled Trial %A Thakre,Shivani %A Bajaj,Pavan %+ Department of Periodontology, Sharad Pawar Dental College, Datta Meghe Institute of Medical Sciences, Sawangi-Meghe, Wardha, Maharashtra, 442001, India, 91 8788271171, thakareshivani21@gmail.com %K demineralized freeze-dried bone allograft %K DFDBA %K autologous dentin graft %K ADG %K titanium platelet-rich fibrin %K T-PRF %K socket preservation %K cone beam computed tomography %K CBCT %K histomorphometric analysis %D 2025 %7 10.12.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Postextraction ridge resorption compromises the aesthetics and function of the subsequent implant therapy or prosthetic rehabilitation. Several techniques are employed to reduce ridge resorption, ranging from basic socket fillers such as blood clot preservation to more advanced techniques using barrier membranes and bone grafts such as autografts, allografts, xenografts, and synthetic materials. Objective: The aim of this study is to evaluate and compare the effectiveness of alveolar socket preservation by using demineralized freeze-dried bone allograft (DFDBA) with titanium platelet-rich fibrin (T-PRF) and autologous dentin graft (ADG) with T-PRF. This assessment will be performed through comprehensive clinical, radiographic, and histomorphometric analyses. The primary objective of this study is to histologically evaluate the new bone formation in the extraction sockets preserved using either DFDBA with T-PRF or ADG with T-PRF. The secondary objective is to evaluate the dimensional changes, including ridge width and height at these healing points, as measured by clinical and radiographic methods. We will evaluate and compare the clinical, radiographic, and histomorphometric outcomes of using DFDBA with T-PRF versus ADG with T-PRF for maintaining socket integrity after tooth extraction. We will also ascertain which grafting technique facilitates the production of new bone during the healing phase and preserves alveolar ridge dimensions. Methods: This randomized controlled trial will involve 16 patients aged 22-60 years requiring tooth extractions and subsequent implant placement. Participants will be randomly assigned to one of the 2 groups: (1) socket preservation using DFDBA in combination with T-PRF or (2) socket preservation using ADG with T-PRF. At baseline, all the clinical variables will be assessed using UNC-15 probe and cone beam computed tomography radiographs. Extraction will be done atraumatically with minimal flap reflection by using periotomes. Postextraction sockets will be preserved using DFDBA+T-PRF or ADG+T-PRF. At 4 months, clinical and radiographic evaluations will be done, and the implant will be placed using a 2-stage protocol. Histomorphometric analysis will be performed after receiving bone samples during implant placement. At 3 months after implant placement, the second-stage surgery will be done. Results: Participant enrollment commenced in March 2024, and the study is scheduled to conclude postassessments and analyses by the end of 2025. The results of this study are anticipated to be accessible in late 2025. This study is not funded, and the results are expected to be published by 2026. Conclusions: This study represents valuable insights into the clinical effectiveness of 2 biologically driven socket preservation techniques. We hypothesize that the use of ADG combined with T-PRF will show similar or more effective outcomes in alveolar socket preservation demonstrated by enhanced bone formation and better maintenance of socket dimensions compared to DFDBA combined with T-PRF without increased morbidity. Trial Registration: Clinical Trials Registry – India CTRI/2024/05/068192; https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTI1NzIz&Enc=&userName= International Registered Report Identifier (IRRID): DERR1-10.2196/70649 %M 41371622 %R 10.2196/70649 %U https://www.researchprotocols.org/2025/1/e70649 %U https://doi.org/10.2196/70649 %U http://www.ncbi.nlm.nih.gov/pubmed/41371622 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e85154 %T Effectiveness of Different Methods of Interdental Hygiene in Daily Practice Among Young Adults: Protocol for a Randomized, Single-Blind Controlled Trial %A Carrouel,Florence %A Lan,Romain %A Saliasi,Ina %A Bourgeois,Denis %A Benech,Nicolas %A Murat-Ringot,Audrey %A Viennot,Stéphane %K prophylaxis %K oral hygiene %K periodontitis %K gingival inflammation %K microbiota %K biofilm %K toothbrush %D 2025 %7 4.12.2025 %9 %J JMIR Res Protoc %G English %X Background: Interdental spaces are particularly susceptible to biofilm accumulation and gingival inflammation, which contribute to periodontal diseases and their systemic associations. While interdental brushes (IDBs) are recognized as the most effective method of interdental cleaning, their efficacy depends on proper adaptation to the interdental space. Calibration with a colorimetric probe may enhance their effectiveness and comfort. However, evidence directly comparing calibrated and noncalibrated IDBs, especially in young adults, a key target group for preventive strategies, remains limited. The Hygiene of Interdental Junctions in Adults (HIJA) trial was designed to address this gap. Objective: This protocol aims to compare the clinical, microbiological, and acceptability outcomes associated with calibrated versus noncalibrated IDBs in young adults, focusing on interdental inflammation, periodontal indices, and microbiota composition. Methods: The HIJA trial is a monocentric, randomized, controlled, single-blind, and parallel-arm study. Overall, 50 healthy, nonsmoking adults aged 18‐30 years will be randomized (1:1) to receive either calibrated or noncalibrated IDBs. Participants will perform daily interdental cleaning in addition to conventional toothbrushing for 3 months. The primary outcome will be the reduction in interdental inflammation, expressed as the change in bleeding on probing at 3 months. Secondary outcomes will assess differences in interdental microbiota composition (16S ribosomal RNA sequencing), periodontal indices (plaque index, gingival index, probing depth, and clinical attachment loss), and user acceptability measured through the Theoretical Framework of Acceptability questionnaire at 1, 2, and 3 months. Results: The HIJA trial will generate evidence on whether calibrated IDBs provide additional benefits over noncalibrated brushes in reducing interdental inflammation and improving oral health in young adults. Conclusions: HIJA findings could contribute to the implementation of clinical guidelines and preventive strategies for interdental hygiene in daily practice. Trial Registration: ClinicalTrials.gov NCT06848790; https://clinicaltrials.gov/study/NCT06848790 International Registered Report Identifier (IRRID): PRR1-10.2196/85154 %R 10.2196/85154 %U https://www.researchprotocols.org/2025/1/e85154 %U https://doi.org/10.2196/85154 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e72715 %T Quality of Life and Metabolomics Analysis in Response to Meal Kit Intervention During Perioperative Chemotherapy in Patients with Early-Stage Breast Cancer: Protocol for a Single-Center Phase Ⅱ Randomized Crossover Trial %A Fushimi,Atsushi %A Taguchi,Eriko %A Kamio,Makiko %A Kazama,Takashi %A Fuke,Azusa %A Nogi,Hiroko %K nutritional intervention %K perioperative treatment %K patient-reported outcomes %K metabolic profiling %K supportive care %D 2025 %7 4.12.2025 %9 %J JMIR Res Protoc %G English %X Background: Patients with breast cancer undergoing chemotherapy experience significant adverse effects, including fatigue, nausea, and taste alterations, leading to malnutrition in 40% of patients. Traditional nutritional counseling has shown limited effectiveness in addressing these challenges during treatment. Objective: This study aimed to evaluate the impact of a structured meal kit intervention on quality of life and metabolomic profiles in patients with breast cancer during perioperative anthracycline and taxane-based chemotherapy. Methods: This single-center phase 2 randomized crossover trial will enroll 20 patients with breast cancer scheduled for perioperative chemotherapy at Jikei University Hospital between October 2024 and October 2025. Patients will be randomized 1:1 to receive a meal kit intervention either during the first or second 3-month period of chemotherapy. The intervention consists of weekly deliveries of preportioned ingredients with dietitian-designed recipes (one 2-serving meal kit during chemotherapy weeks, two during nonchemotherapy weeks). The primary endpoint is the change in the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30) “appetite loss” domain score. Secondary endpoints include changes in total EORTC QLQ-C30 score, plasma metabolome profiles, body composition, nutritional status, and chemotherapy completion rate. Data will be collected at baseline, crossover (12 wk), and study completion (24 wk). Results: The study was funded in March 2024. Data collection began on March 26, 2025, and as of manuscript submission, 11 participants have been recruited out of the planned 20 participants. Data analysis has not yet commenced, and results are expected to be published in Spring 2026. Conclusions: This trial will provide evidence for the effectiveness of a meal kit intervention in supporting patients with breast cancer during chemotherapy. The findings may help establish evidence-based standards for nutritional support in oncology care. Trial Registration: Japan Registry of Clinical Trials jRCT1033240599; https://jrct.mhlw.go.jp/latest-detail/jRCT1033240599 International Registered Report Identifier (IRRID): DERR1-10.2196/72715 %R 10.2196/72715 %U https://www.researchprotocols.org/2025/1/e72715 %U https://doi.org/10.2196/72715 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e72018 %T A Primary Care Program Based on Behavioral Reeducation and Abdominal Massage for Improving the Symptoms of Chronic Constipation: Protocol for a Randomized Controlled Trial %A Segura-Bayona,Cristina %A Vidal-Alaball,Josep %A Ramírez-Morros,Anna %A Miró-Catalina,Queralt %A Ruiz-Comellas,Anna %K primary health care %K proctologic disease %K pelvic floor disorders %K physical therapy %K health education %D 2025 %7 4.12.2025 %9 %J JMIR Res Protoc %G English %X Background: Chronic constipation is a prevalent and often underestimated gastrointestinal disorder that significantly affects quality of life, particularly among women and older adults. In Spain, it is estimated to affect between 12% and 20% of the population, contributing to increased health care visits, economic costs, and medication dependency. Although pharmacological treatments such as laxatives are widely used, they often offer only temporary relief and may lead to adverse effects or dependency. There is growing interest in nonpharmacological interventions that address the root behavioral and functional causes of constipation, such as dietary habits, physical inactivity, and impaired defecation techniques. However, evidence regarding the effectiveness of such approaches, especially within a primary care setting, remains limited. Objective: This study aims to evaluate the effectiveness of a primary care–based structured rehabilitation program that combines behavioral reeducation and abdominal massage therapy in reducing the severity of chronic constipation and use of laxatives. A secondary aim is to assess improvements in quality of life and sustainability of effects over time. Methods: This is a randomized controlled trial involving adults aged 18 to 75 years from the counties of l’Anoia and Bages (Catalonia, Spain) who meet the Rome IV diagnostic criteria for chronic constipation. A total of 45 participants will be randomly assigned in a 1:1:1 ratio (approximately 22‐23 per center, with 15 per group overall) into 3 groups: a control group, behavioral intervention (BI) group, and behavioral intervention and massage (BIM) group. All participants will complete baseline assessments that include the Rome IV criteria, the Bristol Stool Form Scale, the CVE-20 quality of life questionnaire, and the International Physical Activity Questionnaire. The BI group will receive 2 group education sessions, focused on healthy bowel habits, diet, hydration, physical activity, stress management, and medication use, delivered by a multidisciplinary team. The BIM group will receive the same intervention as the BI group, plus two 30-minute sessions with a physiotherapist to learn abdominal self-massage techniques. The control group will receive usual care. Follow-up assessments will occur at 3 and 6 months after the intervention using the same instruments and a self-recorded calendar of laxative use and massage application. Data will be analyzed using appropriate statistical tests, including the χ2 test, a 2-tailed t test, and ANOVA/Kruskal-Wallis tests, depending on variable type. Results: Participant enrollment concluded in August 2025, and data collection is ongoing and expected to continue until April 2026. Conclusions: This trial will provide evidence on the efficacy of conservative, low-risk interventions for managing chronic constipation in primary care. The findings may support broader implementation of integrative approaches that reduce pharmacological dependence and enhance patient empowerment, with potential public health and economic benefits. Trial Registration: ClinicalTrials.gov NCT06359249; https://clinicaltrials.gov/study/NCT06359249 International Registered Report Identifier (IRRID): DERR1-10.2196/72018 %R 10.2196/72018 %U https://www.researchprotocols.org/2025/1/e72018 %U https://doi.org/10.2196/72018 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e77574 %T Effectiveness and Cost-Effectiveness of a Stepped Model of Care for Musculoskeletal Disorders: Protocol for a Multiarm Randomized Controlled Trial (Edu-First Trial) %A Roy,Jean-Sébastien %A Massé-Alarie,Hugo %A Dubé,Marc-Olivier %A Pinard,Anne Marie %A Lamontagne,Martin %A Sole,Gisela %A Tittley,Jean %A Laberge,Maude %A Dupuis,Frédérique %A Fiset,Félix %A Nduwimana,Ildephonse %A McArthur,Eric %A Desmeules,François %+ , Centre for Interdisciplinary Research in Rehabilitation and Social Integration (Cirris), CIUSSS de la Capitale-Nationale, 525, Boulevard Wilfrid-Hamel, Quebec City, QC, G1M 2S8, Canada, 1 4185299141 ext 46005, Jean-Sebastien.Roy@fmed.ulaval.ca %K education %K cost-effectiveness %K rehabilitation %K shoulder pain %K low back pain %K anterior knee pain %K neck pain. %D 2025 %7 19.11.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Musculoskeletal disorders (MSKDs) are a leading cause of pain and disability, placing a substantial burden on health care systems. Optimizing resource use through innovative interventions is essential. Evidence from randomized controlled trials suggests that not all individuals with MSKDs require ongoing follow-up with a health care provider; for many, education alone is sufficient for symptom resolution. A stepped care model, which prioritizes patient education as a first-line intervention and reserves usual care for those with persistent symptoms, may enhance health care efficiency and reduce costs. Objective: The primary objective of this randomized controlled trial is to evaluate the effectiveness of a stepped care model compared to the 2 most common approaches for managing MSKDs: usual medical care and usual rehabilitation care. A secondary objective is to assess cost-effectiveness. Methods: This pragmatic, noninferiority, multiarm, parallel-group randomized controlled trial will enroll 369 adults with MSKDs, randomly assigned to one of three 12-week intervention groups: stepped care, usual medical care (physician-led), or usual rehabilitation care (physiotherapist-led). Participants in the stepped care group will first complete a 6-week education program. Those with persistent symptoms after 6 weeks will receive rehabilitation interventions, while participants whose symptoms have resolved will receive no further intervention. The primary outcome is functional limitations at 24 weeks. Secondary outcomes include pain severity, health-related quality of life, pain-related fear, and pain self-efficacy, assessed at baseline and at 6, 12, and 24 weeks. Linear mixed models will be used for group comparisons, and incremental cost-effectiveness analyses will evaluate cost-effectiveness. The ethics committee of the CIUSSS-CN approved the project (#2024-2982). Findings will be shared through clinical and community platforms, peer-reviewed publications, and conference presentations. Results: The Edu-First trial is funded by a project grant from the Canadian Institutes of Health Research (grant #495615). Recruitment began on January 31, 2025. As of September 2025, a total of 65 participants have been enrolled. Recruitment is expected to continue for up to 3 years, targeting approximately 10 new participants per month, and is anticipated to be completed by Winter 2028. Conclusions: We anticipate that the stepped care model will be noninferior to usual medical care and usual rehabilitation care in terms of treatment effectiveness. Furthermore, it is expected to be cost-effective by reducing reliance on expensive resources, such as provider consultations and medical investigations. By emphasizing education and self-management as the initial approach, the stepped care model may enhance access to care without compromising quality, while empowering patients to actively manage their condition. Findings from this study could inform systemic changes in MSKD care delivery, improving treatment accessibility and reducing the average cost per care episode. Trial Registration: ClinicalTrial.gov NCT06832852; https://clinicaltrials.gov/ct2/show/NCT06832852 International Registered Report Identifier (IRRID): DERR1-10.2196/77574 %M 41258669 %R 10.2196/77574 %U https://www.researchprotocols.org/2025/1/e77574 %U https://doi.org/10.2196/77574 %U http://www.ncbi.nlm.nih.gov/pubmed/41258669 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e73896 %T Exploring Subjective Well-Being in Human-Machine Interaction: Protocol for a Mixed Methods, Cross-Sectional Analysis in Manufacturing 5.0 %A Bassi,Giulia %A Orso,Valeria %A Salcuni,Silvia %A Gamberini,Luciano %+ Department of General Psychology, University of Padova, Via Venezia 8, Padova, Italy, 39 349 285 350, valeria.orso@unipd.it %K subjective well-being %K operators %K manufacturing 5.0 %K human-machine interaction %K protocol study %D 2025 %7 14.11.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Human-machine interaction (HMI) has gained significant attention in the context of advanced production technologies, especially concerning trust and acceptance. However, the investigation of the subjective well-being of operators working with these technologies in manufacturing companies has been largely overlooked. Moreover, previous research mostly relied on a single data-collection method, either quantitative or qualitative, thereby failing to capture a rich picture of their cognitive and affective states. Objective: This cross-sectional study protocol aimed to fill that gap by examining operators’ subjective well-being and workplace dynamics, including fluency in HMI, negative attitudes toward technologies, and social relationships among coworkers in manufacturing companies. Methods: We adopt a mixed methods approach, incorporating both quantitative and qualitative data collection techniques. Quantitative data will be gathered via a digital survey containing self-report questionnaires. A path analysis will be performed to explore the multiple mediating roles of fluency in HMI and negative attitudes toward such technologies between cognitive and affective well-being. We further qualitatively investigate the operators’ lived experience in HMI using semistructured audio-recorded interviews. A thematic analysis relying on text-mining techniques will then be conducted to explore operators’ textual data. Results: We quantitatively expect that fluency in HMI may act as a protective factor for operators’ affective well-being, while negative attitudes toward advanced production technologies may contribute to the development or worsening of operators’ psychological distress. From a qualitative perspective, we intend to seamlessly merge quantitative insights to create a more comprehensive and well-grounded analysis. Moreover, the integrated interpretation of both the quantitative and qualitative data collected will generate a consensus report, which will aim to serve as a practical framework for guiding workplace policies and training programs meant to foster subjective well-being and effective HMI. At the time of publication, we have collected data from 12 participants and scheduled a further data collection session. Conclusions: Embracing one of the fundamental pillars of Industry 5.0, human-centricity, by detecting potential psychological issues early, organizations can create a workplace that prioritizes the well-being of operators. Early recognition and prevention are crucial to promoting operators’ mental well-being involved in HMI. International Registered Report Identifier (IRRID): DERR1-10.2196/73896 %M 41236791 %R 10.2196/73896 %U https://www.researchprotocols.org/2025/1/e73896 %U https://doi.org/10.2196/73896 %U http://www.ncbi.nlm.nih.gov/pubmed/41236791 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e76501 %T Effects of Shallow Needling for Chronic Primary Insomnia: Protocol for a Randomized Controlled Trial %A Lin,Wanqing %A Wang,Chenlin %A Ye,Jiajia %A Ye,Yingling %A Tang,Min %A Hu,Qianqian %A Chen,Bin %K shallow needling %K chronic insomnia %K acupuncture %K study protocol %K randomized controlled trial %D 2025 %7 11.11.2025 %9 %J JMIR Res Protoc %G English %X Background: Primary insomnia (PI), commonly identified by difficulties in initiating and maintaining sleep, negatively impacts both physical and mental health and increases the risk of occupational and vehicular accidents. Previous research has indicated that shallow needling, a form of acupuncture, may ameliorate the symptoms of PI. Nevertheless, the scientific evidence regarding its efficacy in enhancing sleep quality remains limited. Objective: This trial aims to assess the therapeutic efficacy of shallow needling in the treatment of chronic PI in adults. Methods: A single-center, prospective, assessor-blinded randomized controlled clinical trial retrospectively registered with the International Traditional Medicine Clinical Trial Registry (ITMCTR2024000409). With 2 parallel arms, the trial will be conducted at the Affiliated People’s Hospital of Fujian University of Traditional Chinese Medicine. A total of 124 participants with PI will be randomly divided into the control group and the treatment group in a ratio of 1:1 (n=62 for each group). The control group will receive 1 mg eszopiclone orally, once a day for 4 weeks. In addition to taking eszopiclone, the treatment group will receive shallow needling therapy once daily, 5 times a week, for 4 weeks. Data will be collected at 3 time slots—before treatment, after treatment, and 4 weeks after treatment—and will be analyzed using SPSS (version 23.0). The primary outcome measure is the Pittsburgh Sleep Quality Index. The secondary outcome measures include the Hamilton Anxiety Scale, Insomnia Severity Index, serum neurotransmitter detection (including dopamine, norepinephrine, and melatonin), sleep parameters, and magnetic resonance spectroscopy of the thalamus. Results: Participant recruitment for this study is currently in progress. The first participant was enrolled in August 2023, marking the official commencement of the trial. Following the completion of recruitment, data processing and statistical analysis will be initiated. The final results of this study are expected to be prepared and submitted for publication in January 2026. Conclusions: This study will evaluate the therapeutic effectiveness and safety of shallow needling in the treatment of chronic insomnia to provide the necessary scientific basis for the clinical application and promotion of shallow needling. The findings of this study may provide a scientific and standardized treatment protocol for shallow needling in adults with chronic insomnia. Trial Registration: International Traditional Medicine Clinical Trial Registry ITMCTR2024000409; https://itmctr.ccebtcm.org.cn/mgt/project/view/3352938396834771013 International Registered Report Identifier (IRRID): DERR1-10.2196/76501 %R 10.2196/76501 %U https://www.researchprotocols.org/2025/1/e76501 %U https://doi.org/10.2196/76501 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e66489 %T Efficacy of a Ready-to-Feed Starter Liquid Infant Formula Containing 2-Fucosyllactose and Lacto-N-Neotetraose in Chinese Infants: Protocol for a Double Blind, Randomized Controlled Trial %A Wang,Ying %A Le Roy,Caroline Ivanne %A Li,Jing %A Han,Shuping %A Liu,Zhiwei %A Lahiry,Anirban %A Sahu,Himanshu %A Li,Qiaoji %A Dong,Jie %A Mondragon,Alric %A Samuel,Tinu Mary %A Cai,Wei %+ Shanghai Institute for Pediatric Research, 1665 Kongjiang Road, Shanghai, China, 86 13817667935, caiw1978@163.com %K Bifidobacteria %K gut microbiome %K gastrointestinal tolerance %K growth %K immune health %K human milk oligosaccharides %K infant nutrition %D 2025 %7 31.10.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Bioactive compounds, such as human milk oligosaccharides (HMOs), impact the development of the intestinal microbiome and immune maturation in early life. They have been shown to result in positive benefits, including improved gut health, reduced frequency of infections, and age-appropriate growth when added to infant formula. However, data supporting the added value of including these HMOs in early-stage infant formula is currently lacking among Chinese infants. Objective: In this double-blind randomized controlled trial including a nonrandomized reference breastfed group, we will test the efficacy of ready-to-feed infant formula containing 2 HMOs (2-fucosyllactose and lacto-N-neotetraose) on Bifidobacteria abundance, gut microbiome, gut and immune health, growth, and quality of life. Methods: Healthy infants will be enrolled between 3 and 14 days after birth at 5 sites in China and randomized to either the experimental group (fed ready-to-feed infant formula containing 2 HMOs) or the control group (fed the same ready-to-feed infant formula without the 2 HMOs), using a dynamic allocation algorithm with double blinding. Infants will receive trial formula until age 6 months and will be followed up until age 12 months. The breastfed group will serve as a reference. The primary end point will be Bifidobacteria abundance in fecal samples at 3 months, measured via quantitative polymerase chain reaction. Secondary end points will include fecal microbiome (including taxonomy, diversity, functionality, and metabolites), fecal markers of immune health, gastrointestinal tolerance, stooling patterns, immune competence (overall state of the immune system), sleep quality, growth, quality of life, medication use, and physician-reported adverse events. A 2-sided test at the 5% significance level will be used for statistical testing. Results: The study received ethical approval in March 2024 and will be completed by the end of 2026, which will be followed by a publication in a peer-reviewed journal. Conclusions: The Starter Liquid Infant Formula Trial (STARLIT) will be one of the first to assess the efficacy of these 2 HMOs among Chinese infants on gut and immune health, in addition to clinically relevant outcomes such as quality of life, growth, and adverse events. This study should help to demonstrate that an increase in the growth of beneficial Bifidobacteria in response to intake of 2-fucosyllactose and lacto-N-neotetraose may have a broader impact on overall gut microbiome composition and infant gut and immune health. Trial Registration: ClinicalTrials.gov NCT06361719; https://clinicaltrials.gov/study/NCT06361719 International Registered Report Identifier (IRRID): PRR1-10.2196/66489 %M 41172301 %R 10.2196/66489 %U https://www.researchprotocols.org/2025/1/e66489 %U https://doi.org/10.2196/66489 %U http://www.ncbi.nlm.nih.gov/pubmed/41172301 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e80010 %T Moderating Role of State and Trait Positive Affect in Virtual Reality Exposure for Public Speaking Anxiety: Protocol for a Multisite Experimental Study %A Otto,Michael W %A Long,Laura J %A Papini,Santiago %A Culver,Tara %A Taylor,Charles T %A Rubin,Mikael %A Fitzgerald,Hayley E %A Liu,Qimin %A Smits,Jasper A J %A Anderson,Rebecca A %A Aslanidou,Asimina %A Benke,Christoph %A Cox,Wouter R %A Engelhard,Iris M %A Friedman,Sydney E %A Goodman,Rachel R %A Graham,Bronwyn M %A Hearon,Bridget A %A Howard,Houston W %A Jacquart,Jolene %A Johnson,Hannah M %A Kredlow,M Alexandra %A Lam,Charlene L M %A Lee,Eric B %A McClure,Grace Vogelzang %A McEvoy,Peter M %A Melzig,Christiane A %A Moore,Tara M %A Moses,Karen %A Nagy,Samantha M %A Newby,Jill M %A Pfaff,Paul F R %A Regan,Amy %A Rief,Winfried %A Rudaizky,Daniel %A Smith,Logan H %A Sung,Sharon C %A Wieser,Matthias J %A Wong,Alex H K %A Wong,Quincy J J %A Zainal,Nur Hani %A Zhang,Zhiqi %K team science %K exposure therapy %K moderators %K state affect %K trait positive affect %K speech anxiety %K virtual reality %D 2025 %7 30.10.2025 %9 %J JMIR Res Protoc %G English %X Background: The identification of moderators of exposure-based cognitive behavioral therapy (EXCBT) outcomes has the potential to (1) guide the judicious application of the limited resource that is EXCBT and (2) identify additional treatment targets for ameliorating the deleterious effects of an identified moderator, thereby enhancing clinical response. Experimental and clinical studies have yielded intriguing findings for the moderating influence of positive affect on EXCBT outcomes. Mixed findings for state positive affect (at the time of extinction or exposure trials) as a predictor of EXCBT outcomes stand in contrast to evidence that baseline levels of trait positive affect may be a more effective predictor. As such, questions remain about the best way to assess positive affect as a potential treatment moderator. Objective: This study was designed to investigate (1) the relative value of state and trait positive affect for predicting the outcome of a single-session virtual reality exposure intervention for public speaking anxiety in adults attending college and (2) the role of 3 related constructs—optimism, hopefulness, and mental health self-efficacy—that may explain the predictive significance of trait positive affect. Methods: State affect will be manipulated at an experimental level using affect induction procedures; trait positive affect will be measured at baseline. Three dependent measures—a primary outcome of public speaking anxiety and secondary outcomes of social phobia and self-reported valence—will be examined. This study relies on a team science approach and is being conducted across 12 collaborating sites through the Exposure Therapy Consortium, allowing for replication of all findings across diverse study sites worldwide. Results: Data collection for this study began in October 2024 and ended in August 2025. We expect to complete data analysis and submit results for publication in approximately November 2025. Conclusions: This study will help clarify the relationship among positive affect (state and trait), exposure learning, and 3 related constructs (optimism, hopefulness, and mental health self-efficacy). These findings will illuminate strategies for future treatment improvement and enhanced efficacy. Trial Registration: ClinicalTrials.gov NCT06593847; https://clinicaltrials.gov/study/NCT06593847 International Registered Report Identifier (IRRID): DERR1-10.2196/80010 %R 10.2196/80010 %U https://www.researchprotocols.org/2025/1/e80010 %U https://doi.org/10.2196/80010 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e77022 %T Effectiveness of an Education Toolkit Delivered by Soap Operas Among Communities Living in Extreme Poverty in Improving Vaccination Confidence in the Philippines: Protocol for a Cluster Randomized Controlled Trial %A Wu,Shishi %A Dong,Quanfang %A Zhang,Zhitong %A Pang,Sharon %A Thorpe,Kevin %A Kelly,Melinda %A Haldane,Victoria %A Lau,Lincoln %A Wei,Xiaolin %+ Dalla Lana School of Public Health, University of Toronto, 582-155 College Street, Toronto, M5T 3M7, Canada, 1 416 978 2020, xiaolin.wei@utoronto.ca %K measles %K polio %K vaccination %K education intervention %K randomized controlled trial %D 2025 %7 30.10.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Measles and polio pose significant public health challenges globally, particularly in low-resource settings such as the Philippines, where vaccine coverage falls short of the World Health Organization’s (WHO’s) targets, with hard-to-reach populations contributing to the “last mile.” This research addresses the “last mile” challenge in routine immunization efforts by bridging the vaccination gap in marginalized populations. Objective: We describe the implementation of a cluster randomized controlled trial to evaluate the impact of an education toolkit aimed at improving confidence in measles and polio vaccines among communities living in extreme poverty in the Philippines. Methods: Developed with local stakeholders, our intervention consists of a 10-minute video and vaccination reminders delivered by health trainers. It is embedded within the Soap Opera Trial, a large cluster randomized controlled trial conducted by the International Care Ministries that evaluates a 15-episode soap opera series combining drama with aspirational messages on hope, self-worth, and education, aimed at improving participants’ knowledge and practices in health, hygiene, nutrition, and livelihood. A total of 180 communities with 5400 participants will be randomly assigned to the intervention and control arms. By leveraging an existing community-based education program on health and livelihood run by our local partner, the proposed intervention will be delivered to participants in the intervention arm of the existing program, while those in the control arm will receive standard participatory adult learning sessions on health education. The primary outcome is the first-dose measles-containing vaccine coverage among participants’ children aged 1 year. Secondary outcomes include the 2-dose measles-containing vaccine coverage among children aged 2 to 6 years, polio vaccination coverage among children aged 1 year, and participants’ knowledge of measles and polio vaccines. The absolute differences in these outcomes between the intervention and control arms will be estimated using generalized estimating equations while adjusting for baseline levels and covariates. In addition, we will conduct a process evaluation. Results: Between January 31 and February 29, 2024, we recruited 66.9% (3613/5400) of the participants for the trial. Data collection is ongoing at the time of manuscript submission. Conclusions: Findings from this trial will provide critical insights into effective strategies for enhancing vaccine confidence and uptake in marginalized populations. By leveraging community-based approaches and local partnerships, this study aims to improve public health responses to vaccine-preventable diseases and contribute to global efforts to eradicate measles and polio. Furthermore, the findings will inform scalable interventions that can be adapted to similar contexts, potentially reducing health disparities and advancing global health equity. Trial Registration: ClinicalTrials.gov NCT06218368; https://clinicaltrials.gov/study/NCT06218368 International Registered Report Identifier (IRRID): DERR1-10.2196/77022 %M 41166704 %R 10.2196/77022 %U https://www.researchprotocols.org/2025/1/e77022 %U https://doi.org/10.2196/77022 %U http://www.ncbi.nlm.nih.gov/pubmed/41166704 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e73366 %T Boosting Human Papillomavirus Vaccination Rates: Protocol for a Randomized Controlled Trial of Awareness Interventions in Réunion Island %A Duclaud,Julie %A Bertolotti,Antoine %A Chirpaz,Emmanuel %A Sambourg,Jessica %A Diallo,Kevin %A Balaya,Vincent %A Tran,Phuong Lien %+ Department of gynecology and obstetrics, Centre Hospitalier Universitaire de La Réunion, Avenue du Président Mitterrand, Saint Pierre, 97448, France, 262 262359098, phuong_lien_tran@yahoo.com %K human papillomavirus %K HPV vaccine %K primary prevention %K middle school %K serious game %K peer learning %D 2025 %7 27.10.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Human papillomavirus (HPV) is the most common sexually transmitted infection worldwide and imposes a significant public health burden. In 2019, HPV was responsible for approximately 620,000 cancer cases in women, 70,000 in men, and more than 300,000 deaths globally. Despite the proven efficacy of the vaccine, vaccination rates remain alarmingly low in certain regions of France. In Réunion Island, only 16% of girls and 9% of boys under 16 years old were fully vaccinated in 2024. This underscores the need for increased awareness, education, and outreach programs. Peer learning is well-established in health education, whereas serious game–style card games are newer and require further research. Both methods have been shown to improve knowledge on specific topics. Objective: The main objective of this study is to assess the impact of 2 awareness-raising strategies on increasing HPV vaccination rates among middle school students by actively involving them in the process. Methods: This protocol describes the design of a randomized, open-label, controlled trial aimed at evaluating the effectiveness of 2 awareness-raising interventions—peer learning and a card-based serious game—in improving HPV vaccination rates among middle school students in Réunion Island. The study will span an entire school year, beginning in August. Approximately 3600 students from 24 middle schools in Réunion Island will be included, with schools randomized into 3 groups of 8 each: (1) a control group receiving the existing national vaccination campaign initiated by the French public health institute; (2) ambassador classes, whose students will receive education about the HPV vaccine and later educate other students in the same school; and (3) serious game card group, where students can play and learn about HPV during a science class. The primary outcome will be the proportion of teenagers who initiate the vaccination process, compared across the 3 groups using appropriate statistical methods. Anonymized data will be collected at the end of the school year using social security records. Teenagers’ knowledge of HPV will be assessed both before and 3 months after each intervention, and satisfaction will also be evaluated after the intervention in each group. Results: As of May 2025, a preliminary result enrolling 124 students showed an increase in vaccination coverage after students played a serious game. We expect higher vaccination rates in the intervention groups compared with the control group, although it is difficult to predict which strategy will be more effective. The estimated target vaccination coverage for groups b and c is 45%. Conclusions: This study aims to improve HPV vaccination rates among teenagers in Réunion Island by evaluating the impact of 2 awareness-raising strategies using innovative and engaging tools. If successful, this approach could be adapted and implemented in other regions of France or internationally. International Registered Report Identifier (IRRID): PRR1-10.2196/73366 %M 41143859 %R 10.2196/73366 %U https://www.researchprotocols.org/2025/1/e73366 %U https://doi.org/10.2196/73366 %U http://www.ncbi.nlm.nih.gov/pubmed/41143859 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e66342 %T Efficacy of Fuzheng Quxie Formula Against Postoperative Metastasis of Lung Cancer in Stage IIA-IIIA With Negative Driver Genes: Protocol for a Multicenter, Double-Blind, Randomized Controlled Trial %A Xu,Fan %A Yang,Yun %A Luo,Yinbin %A Luo,Bin %A Yao,Jialiang %A Zhou,Yiyang %A Li,Minghua %A Wu,Jianchun %A Shi,Wenfei %A Jiang,Lei %A Huang,Qian %A Fang,Wentao %A Fang,Zhihong %A Li,Yan %A Tian,Jianhui %+ Clinical Oncology Center, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, 274 Zhijiang Middle Road Jing'an District, Shanghai, 200071, China, 86 13761351319, tjhhawk@shutcm.edu.cn %K traditional Chinese medicine %K Fuzheng Quxie Formula %K lung cancer metastasis %K negative driver genes expression %K efficacy %K safety %D 2025 %7 24.10.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Metastasis is the primary cause of poor prognosis and high mortality in lung cancer. Surgery with postoperative adjuvant chemotherapy is the standard treatment for patients with stage IIA-IIIA lung cancer with negative driver genes. However, recurrence rates remain significant. In China, traditional Chinese medicine shows potential as an adjuvant therapy to reduce treatment toxicity and improve clinical efficacy. Objective: This study aimed to evaluate its efficacy and safety in preventing postoperative metastasis in driver gene-negative stage IIA-IIIA lung cancer, based on the promising preclinical results of Fuzheng Quxie Formula against lung cancer metastasis. In this trial, we hypothesize that the treatment group will have better efficacy and safety than the control group. Methods: A multicenter, double-blind, randomized, placebo-controlled parallel group trial will be conducted. Eligible patients will be randomized into a treatment group (daily Fuzheng Quxie Formula granules+regular chemotherapy) and a control group (daily Chinese medicine placebo granules+regular chemotherapy) in a ratio of 1:1. Fuzheng Quxie Formula will be administered orally, twice a day, in the morning and evening, for 6 months. Patients will be followed up after the end of treatment for 18 months. After the end of the program, follow-up will be continued for 5 years or until the patient dies (or progressed). The primary efficacy endpoint is disease-free survival, and the secondary efficacy endpoints are overall survival, minimal residual disease, circulating tumor cells, Chinese medicine symptom score, quality-of-life assessment, immune indicators, tumor markers, peripheral blood systemic immune-inflammation index, and prognostic nutritional index. We will conduct per-protocol analyses on these outcomes. In addition, we will also evaluate the safety of the Fuzheng Quxie Formula. Results: This study began screening and recruitment in March 2023. Recruitment is ongoing; by the end of 2024, a total of 180 eligible participants will be enrolled. Recruitment will continue until the end of June 2025 or until the target sample is reached. We estimate that the results will be published by March 2026. Conclusions: This study is a high-quality, large-scale, multicenter, double-blind, randomized controlled trial. This will be the first trial to evaluate the efficacy and safety of Fuzheng Quxie Formula in inhibiting metastasis after surgery in stage IIA-IIIA lung cancer with negative driver genes. Provide a basis for the clinical application of Fuzheng Quxie Formula. Trial Registration: ClinicalTrials.gov NCT06381960; https://clinicaltrials.gov/study/NCT06381960 International Registered Report Identifier (IRRID): DERR1-10.2196/66342 %M 41135941 %R 10.2196/66342 %U https://www.researchprotocols.org/2025/1/e66342 %U https://doi.org/10.2196/66342 %U http://www.ncbi.nlm.nih.gov/pubmed/41135941 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e75877 %T Evaluation of the Comparative Efficacy of Aquatherapy Versus Conventional Physiotherapy on Motor Function and Psychosocial Well-Being in Children With Acute Lymphoblastic Leukemia: Protocol for a Randomized Controlled Trial %A Khairnar,Shrutika Sharad %A Hullumani,Sharath %A Umale,Neha %+ Faculty of Paedaitrics and Neonatal Physiotherapy, Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha, 442107, India, 91 9964066927, sharathhullumani@gmail.com %K acute lymphoblastic leukemia %K aqua therapy %K rehabilitation %K conventional physiotherapy %K motor functions %K psychosocial well-being %K chemotherapy %D 2025 %7 23.10.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Children with acute lymphoblastic leukemia (ALL) undergoing chemotherapy have limited access to rehabilitation support. While rehabilitation on the basis of physiotherapy has been found to enhance psychosocial well-being and motor performance, a viable substitute for this can be aquatherapy. However, no trials have currently evaluated the effectiveness of aquatherapy in this population. Objective: We aim to evaluate the comparative efficacy of aquatherapy versus conventional physiotherapy on the motor function and psychosocial well-being of children with ALL. Methods: We will conduct a parallel, single-blinded (participant-blinded), randomized controlled trial with embedded quantitative analysis. In total, 54 survivors of ALL undergoing chemotherapy will be recruited from the Acharya Vinoba Bhave Rural Hospital in Sawangi (Meghe), Wardha, Maharashtra, India. The experimental group will attend a 4-week, thrice-weekly, 45-minute aquatherapy session focusing on exercise-based rehabilitation. The comparison group will receive conventional physiotherapy including standardized exercises. Assessments will be completed at weeks 0 (baseline), 4 (postintervention), and 12 (follow-up). The primary outcome related to motor function will be measured using the timed up and go test and the Pediatric Balance Scale at week 4. Secondary outcomes will include psychosocial well-being measured with the Hospital Anxiety and Depression Scale and functional abilities measured with the Functional Independence Measure for Children (WeeFIM). Health service data, including length of stay in the hospital, hospital readmissions, and emergency department presentations, will be recorded. Semistructured interviews will be completed within an interpretive description framework to explore participant descriptions. The primary outcome will be analyzed using linear mixed effects models. Results: The trial is scheduled to commence in October 2025. Conclusions: The trial will inform future implementation of rehabilitation for children with ALL by providing important data regarding the efficacy of aquatherapy compared with conventional physiotherapy as well as patient experience. Trial Registration: Clinical Trials Registry - India CTRI/2025/03/083036; https://tinyurl.com/v446cd6z International Registered Report Identifier (IRRID): PRR1-10.2196/75877 %M 41129816 %R 10.2196/75877 %U https://www.researchprotocols.org/2025/1/e75877 %U https://doi.org/10.2196/75877 %U http://www.ncbi.nlm.nih.gov/pubmed/41129816 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e75453 %T Tailoring Antibiotic Duration for Respiratory Tract Infections in Primary Care: Protocol for a Pragmatic Randomized Controlled Trial Study (STORM) %A Morros,Rosa %A Moragas,Ana %A García-Sangenís,Ana %A Monfà,Ramon %A Miravitlles,Marc %A Vallejo-Torres,Laura %A Jarca,Carmen I %A Llor,Carl %+ Institut Universitari d'Investigació en Atenció Primària Jordi Gol, Gran Via de les Corts Catalanes, 587, àtic, Barcelona, 08007, Spain, 1 34 0644673590, carles.llor@gmail.com %K respiratory tract infections %K anti-bacterial agents %K drug resistance, microbial %K patient-centered care %K deprescriptions %K duration %K drug-related side effects and adverse reactions %K randomized clinical trial %D 2025 %7 20.10.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Combating the rise of drug-resistant organisms and minimizing side effects requires a shift in how we approach the duration of antibiotic therapy. A promising strategy involves tailoring the length of antibiotic therapy to patients’ needs, allowing discontinuation once patients feel better. Objective: This study aims to assess whether shortening antibiotic therapy based on patients’ recovery time is as effective as completing the full course in treating acute respiratory tract infections (RTIs). Methods: We plan to enroll a minimum of 474 outpatients ranging from 18 to 75 years of age with clinical features of acute RTIs across Spanish health centers. Patients diagnosed with acute lower RTIs or acute rhinosinusitis, deemed by clinicians to require a β-lactam course, will be randomized to either usual care, involving a full-course antibiotic therapy based on current guidelines, or a tailored approach. In the intervention group, patients will be advised to visit the center as soon as they feel better and are afebrile for a clinical assessment and C-reactive protein rapid testing. Treatment will be discontinued if these clinical results are normal. The primary outcome will be assessment of clinical resolution at day 14, while secondary outcomes include antibiotics given and duration; adherence to the prescribed antibiotic; other therapies given; early clinical assessment at day 7; days of severe, moderate, and any symptom, complications and reattendance within the first month; drug-related adverse events; absenteeism; and health-related quality of life. All participants will be given a symptom diary, recording their symptoms each evening. Additionally, a cost-effectiveness study and qualitative studies involving clinicians and patients aimed at exploring the strategy’s pros, cons, uptake, and satisfaction levels will be carried out. Results: The final results will be published by the end of 2027. Conclusions: We will examine whether adults who present with symptoms of RTI who are treated with antibiotic courses until they feel better are as effective as longer standard courses. It is highly important that a possible reduction in the antibiotic course as soon as the patient feels better does not compromise patients’ recovery. This comprehensive approach aims to shed light on the practicality and impact of tailoring antibiotic duration in RTIs. Trial Registration: ClinicalTrials.gov NCT06581367; https://clinicaltrials.gov/study/NCT06581367 International Registered Report Identifier (IRRID): PRR1-10.2196/75453 %R 10.2196/75453 %U https://www.researchprotocols.org/2025/1/e75453 %U https://doi.org/10.2196/75453 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e69814 %T The Effects of a Multidomain Lifestyle Intervention on Brain Function and Its Relation With Immunometabolic Markers and Intestinal Health in Older Adults at Risk of Cognitive Decline: Study Design and Baseline Characteristics of the HELI Randomized Controlled Trial %A van Loenen,Mark R %A Remie,Lianne B %A van Trijp,Mara PH %A Jansen,Michelle G %A Marques,José P %A Claassen,Jurgen AHR %A van de Rest,Ondine %A Vermeiren,Yannick %A Smidt,Nynke %A Sikkes,Sietske AM %A Deckers,Kay %A Zwan,Marissa D %A van der Flier,Wiesje M %A Köhler,Sebastian %A Steegenga,Wilma T %A Oosterman,Joukje M %A Aarts,Esther %K lifestyle %K cognitive ageing %K risk factors %K risk reduction %K multidomain %K intervention %K randomized controlled trial %K brain %K gut-brain %K magnetic resonance imaging %D 2025 %7 15.10.2025 %9 %J JMIR Res Protoc %G English %X Background: Studies of multidomain lifestyle interventions show mixed results on preventing or delaying cognitive decline in aging. A better understanding of central and peripheral mechanisms underlying these interventions could help explain these mixed findings. Objective: The HELI (Hersenfuncties na LeefstijlInterventie) study aims to investigate the brain and peripheral mechanisms of a multidomain lifestyle intervention in older adults at risk of cognitive decline. Methods: The HELI study is a 6-month multicenter, randomized, controlled multidomain lifestyle intervention trial powered to include 104 Dutch older adults at risk of cognitive decline. Individuals were deemed at risk when scoring ≥2 points on a lifestyle-modifiable risk factor scale (eg, overweight, physical inactivity, hypertension, and hypercholesterolemia). The intervention consisted of 5 domains (diet, physical activity, stress management and mindfulness, cognitive training, and sleep) and participants were randomized to one of two groups: (1) a high-intensity coaching group with weekly supervised online and on-site group meetings, exercises, and lifestyle-specific course materials, and (2) a low-intensity coaching group receiving general lifestyle health information sent through email every 2 weeks. The primary study outcomes are changes between baseline and 6-month follow-up in (1) brain activation in dorsolateral prefrontal cortex (dlPFC) and hippocampus and task accuracy during a functional magnetic resonance imaging (fMRI) working memory task, (2) arterial spin labeling-quantified cerebral blood flow in dlPFC and hippocampus, (3) systemic inflammation from blood plasma (interleukin-6, tumor necrosis factor-α, high-sensitivity C-reactive protein) and (4) microbiota profile from feces (gut microbiome diversity [Shannon and phylogenetic diversity] and richness [Chao1]). In addition, we will investigate intervention-induced gut-immune-brain links by assessing relations between effects in primary brain and gut outcomes. Secondary study outcomes include (1) structural and neurochemical magnetic resonance imaging (MRI), (2) anthropometric measurements, (3) neuropsychological test battery scores, (4) lifestyle-related questionnaire and smartwatch measures, and peripheral measures from (5) fecal, (6) blood, and (7) breath analyses. Results: This work was supported by a Crossover grant (Maintaining Optimal Cognitive Functioning In Aging [MOCIA] 17611) of the Dutch Research Council (NWO), granted in December 2019. The MOCIA program is a public-private partnership. Between April 2022 and October 2023, we successfully included 102 older Dutch adults (mean age 66.6, SD 4.3 years; 67/102, 65.7% female) with ≥2 lifestyle-modifiable risk factors of cognitive aging (median risk 3, IQR 2-3). The most common self-reported lifestyle-modifiable risk factors at baseline were overweight or obesity (76/102, 74.5%), followed by hypertension (58/102, 56.9%), hypercholesterolemia (57/102, 55.9%), and physical inactivity (57/102, 55.9%). Conclusions: The HELI study aims to enhance our understanding of the working mechanisms of multidomain lifestyle interventions through its comprehensive characterization of central and peripheral markers. We intend to achieve this aim by assessing lifestyle intervention-induced changes in functional and structural MRI brain measures, as well as peripheral measures of the gut-immune–brain axis involved in cognitive aging. Trial Registration: ClinicalTrials.gov NCT05777863; https://clinicaltrials.gov/study/NCT05777863 International Registered Report Identifier (IRRID): DERR1-10.2196/69814 %R 10.2196/69814 %U https://www.researchprotocols.org/2025/1/e69814 %U https://doi.org/10.2196/69814 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e75060 %T At-Home Morning Bright Light Treatment for Chronic Nociplastic Pain: Protocol for a Randomized Clinical Trial %A Burgess,Helen J %A Rodgers,Allie A %A McNeil,Kiley A %A Mott,Jackson %A Fejer,Agnes %A Dereski,Tori %A Rizvydeen,Muneer %A Sibille,Kimberly T %A Kim,Hyungjin Myra %A Cofield,Cherie %A Burns,John W %A Shaikh,Sana %A Hassett,Afton L %+ Sleep and Circadian Research Laboratory, Department of Psychiatry, University of Michigan, Rachel Upjohn Building, 4250 Plymouth Rd, Ann Arbor, MI, 48109, United States, 1 734 615 8303, bhelen@med.umich.edu %K fibromyalgia %K light %K mood %K nociplastic %K pain %K sleep %D 2025 %7 13.10.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Fibromyalgia, the quintessential nociplastic pain condition, affects more than 20 million Americans and results in significant disability, lost productivity, and poor quality of life, with profound individual and societal cost. As pharmacological treatment approaches offer only modest benefits and result in a high rate of discontinuation due to adverse effects, nonpharmacological interventions such as physical therapy, exercise, and cognitive behavioral therapy are recommended. However, cost and access to these treatments can create barriers to care, and engagement can be problematic. Morning bright light treatment is a promising option for improving fibromyalgia symptoms, with early studies indicating clinically meaningful improvements in fibromyalgia symptoms. Objective: This study aims to prospectively examine the potential benefits and active elements of morning bright light treatment and sleep timing stabilization for individuals with fibromyalgia in the largest randomized controlled trial to date. Methods: We will recruit 390 adults who meet diagnostic criteria for fibromyalgia and report at least mild symptoms. Participants will be randomized to one of three groups: 4 weeks of morning bright light treatment (1 hour per day, using a commercially available Re-timer device), 4 weeks of sleep timing stabilization alone (a component of morning bright light treatment, some benefit anticipated), or 4 weeks of treatment as usual, with equivalent study contact. Patient-reported outcomes of function and pain will be assessed before and after treatment, with mood, sleep quality, and morningness-eveningness examined as potential mediators of treatment effects. Social determinants of health risk will be examined as a potential moderator influencing baseline symptoms, treatment engagement, and treatment response. Results: Data collection began in September 2024 and is projected to end in March 2029. Conclusions: Morning bright light treatment is well-positioned to be an effective nonpharmacological treatment for fibromyalgia with minimal side effects. The study findings will provide important insights relevant to the development of morning bright light treatment as an accessible treatment for chronic nociplastic pain. Trial Registration: ClinicalTrials.gov NCT06567886; https://clinicaltrials.gov/study/NCT06567886 International Registered Report Identifier (IRRID): DERR1-10.2196/75060 %M 40880266 %R 10.2196/75060 %U https://www.researchprotocols.org/2025/1/e75060 %U https://doi.org/10.2196/75060 %U http://www.ncbi.nlm.nih.gov/pubmed/40880266 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e64066 %T Evaluation of the Comparative Efficacy of Honey Thermal Microcautery, Standard Physiotherapy, and Sida cordifolia Oil via Nasal Administration in the Management of Frozen Shoulder: Protocol for a Randomized Controlled Trial %A Pathania,Shalini %A Parwe,Shweta %A Sawarkar,Punam %A Nisargandha,Milind %K frozen shoulder %K range of motion %K placebo %K Sida cordifolia %K physiotherapy %K thermal microcautery %D 2025 %7 10.10.2025 %9 %J JMIR Res Protoc %G English %X Background: Frozen shoulder is an ailment that denotes dysfunction in the arm characterized by limited range of motion accompanied by pain. The prevalence of adhesive capsulitis is 3% to 5% in the general population and up to 20% in those with diabetes. Physiotherapy, analgesics, corticosteroids, and surgical capsulotomy are common forms of treatment. Administering oil through the nasal route (or nasya karma) is mentioned in the Ayurvedic scriptures for managing neck and clavicle disorders. Thermal microcautery (or agni karma) is a parasurgical procedure for treating related pathologies of bodily humors (vata and kapha). This study will aim to compare the efficacy of honey thermal microcautery, standard physiotherapy, and Sida cordifolia oil via nasal administration in the treatment of frozen shoulder to determine which provided the most relief. Objective: The primary aim is to evaluate the efficacy of honey thermal microcautery, standard physiotherapy, and S cordifolia oil via nasal administration using the visual analogue scale, range of motion, the Shoulder Pain and Disability Index, and the McGill Pain Questionnaire and compare these interventions. The secondary objective is to assess sustained relief in all 3 groups. Methods: We will enroll 60 patients, 20 in each group, for this single-blind assessor-controlled study. Group A will receive Ayurvedic treatment, that is, thermal microcautery using honey for 2 days (the first and seventh) and placebo capsules (twice per day) for 7 days, group B will receive standard physiotherapy and placebo capsules (twice per day) for 7 days, and group C will be given S cordifolia oil via nasal administration with 8 drops in each nostril and placebo capsules (twice per day) for 7 days. The evaluation parameters are pain (visual analogue scale), range of motion measured using a goniometer, the Shoulder Pain and Disability Index, and the McGill Pain Questionnaire. On September 18, 2023, approval was received from the Institutional Ethics Committee of Mahatma Gandhi Ayurved College Hospital and Research Centre (MGACHRC/IEC/Sep-2023/740). Results: The results will be subjected to statistical analysis using appropriate methods such as ANOVA. If the ANOVA shows significance, post hoc tests (eg, the Tukey honestly significant difference test) will identify group differences, with P<.05 considered significant. As of January 2025, a total of 16 patients have been recruited, divided into 3 groups, and the final results are expected to be published in November 2025. Conclusions: This comparative study seeks to establish the most effective treatment among honey thermal microcautery, standard physiotherapy, and S cordifolia oil nasya for managing frozen shoulder, potentially offering new integrative approaches to treating this condition. Trial Registration: Clinical Trials Registry India CTRI/2023/11/059594; https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=OTQyNjc=&Enc=&userName= International Registered Report Identifier (IRRID): PRR1-10.2196/64066 %R 10.2196/64066 %U https://www.researchprotocols.org/2025/1/e64066 %U https://doi.org/10.2196/64066 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e73618 %T Promoting Healthier Meal Selection and Intake Among Children in Restaurants: Protocol for a Cluster-Randomized Trial %A Anzman-Frasca,Stephanie %A Tauriello,Sara %A Epstein,Leonard %A Ferrante,Mackenzie J %A Gampp,April %A Goldsmith,Juliana %A Haines,Jess %A Leone,Lucia A %A Paluch,Rocco %+ Department of Pediatrics, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, State University of New York, G56 Farber Hall, South Campus, Buffalo, NY, 14214, United States, 1 7168296692, safrasca@buffalo.edu %K restaurant %K choice architecture %K repeated exposure %K menu %K child %K diet %K health %D 2025 %7 10.10.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: US children’s diets are high in calories and are of poor nutritional quality, and a likely contributing factor is the consumption of food from restaurants. While children readily accept the sweet and salty foods that characterize restaurant children’s menus, research shows that their taste preferences are malleable, and regular exposure to healthier foods can promote their acceptance. Objective: We describe a cluster-randomized controlled trial testing the effects of behavioral intervention strategies (choice architecture and repeated exposure) on ordering and dietary intake among children in restaurants and present baseline demographic data for the study cohort. Methods: Six locations of a regional quick-service restaurant chain were randomized to the intervention or control group in pairs based on income in surrounding census tracts. Families with children aged 4 to 8 years were recruited and asked to complete 8 visits to the study restaurant, including a baseline assessment completed at the time of enrollment, followed by 6 visits during a designated 2-month exposure period and a final posttest assessment. Intervention content provided to intervention group families after baseline assessments includes placemats promoting 2 healthier kids’ meals and the opportunity to redeem their kids’ meal “cone token” for a toy instead of a dessert (choice architecture strategies). In addition, participating families receive frequent diner cards, which can be used to earn a free kids’ meal after purchasing a promoted kids’ meal 6 times (repeated exposure strategy). Families in control restaurants receive generic versions of these materials (eg, frequent diner cards that can be redeemed for a free kids’ meal after purchasing any 6 kids’ meals). The primary outcome is the meal ordered for the child at a posttest restaurant visit following the exposure period (ie, whether or not a promoted meal was ordered). Additional order data will include calories, saturated fat, sodium, and sugar content of children’s orders at posttest. Other outcomes include children’s in-restaurant and daily consumption of calories, saturated fat, sodium, and sugar. Results: This study was funded in 2019, with preregistration completed in 2020, data collection occurring from June 2021 to November 2024, and data processing, analysis, and primary outcome manuscript preparation in 2025-2026. A total of 236 families provided baseline data on children’s orders and comprise the study cohort; 234 of these families provided demographic data (n=184, 78.3% female parents; n=133, 56.8% female children; child mean age 6.5, SD 1.3 years). Conclusions: Given that restaurants are normative eating contexts for many children, this intervention has the potential to impact children’s dietary intake and health. If found to be successful, future directions could include scaling the current intervention approach and conducting further effectiveness, implementation, and dissemination research to understand its applicability and impact across different types of restaurants and sociodemographic contexts. Trial Registration: ClinicalTrials.gov NCT04334525; https://clinicaltrials.gov/study/NCT04334525 International Registered Report Identifier (IRRID): DERR1-10.2196/73618 %M 41072006 %R 10.2196/73618 %U https://www.researchprotocols.org/2025/1/e73618 %U https://doi.org/10.2196/73618 %U http://www.ncbi.nlm.nih.gov/pubmed/41072006 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e73718 %T Implementation Mapping to Identify Best Practices for Implementing Population-Wide Genomic Screening Programs: Protocol for the FOCUS (Facilitating the Implementation of Population-Wide Genomic Screening) Study %A Roberts,Megan %A Marable,Jarrod %A Foss,Kimberly %A Whitcomb,Cason %A Cragun,Deborah %A Buchanan,Adam %A Hallquist,Miranda %A Baker,Nathaniel %A Bosch,Rebecca %A Craig,Derek W %A Wagner,Ingrid %A Fernandez,Maria %A Hughes-Halbert,Chanita %A Allen,Caitlin %K protocol %K learning health system %K population genomic screening %K health equity %K implementation science %D 2025 %7 7.10.2025 %9 %J JMIR Res Protoc %G English %X Background: Population-wide genomic screening (PGS) for genetic conditions such as hereditary breast and ovarian cancer syndrome, Lynch syndrome, and familial hypercholesterolemia presents opportunities to reduce morbidity and mortality among the 1%‐2% of the population at elevated risk for these serious, preventable diseases. With decreasing sequencing costs and growing support from national bodies, there are increasing numbers of PGS programs in the United States. However, guidelines and strategies to support implementation are limited, especially regarding equitable access to PGS. Contextual factors, such as organizational structures and processes, impact PGS implementation, often failing to benefit underrepresented populations. To address these challenges, we are completing the Facilitating the Implementation of Population-wide Genomic Screening (FOCUS) project, which will develop and test a freely available, web-based implementation toolkit to guide best practices for implementing PGS. Objective: The FOCUS project aims to (1) examine barriers and facilitators of PGS implementation at diverse health systems, (2) develop implementation strategies with input from an advisory panel and package them into the FOCUS toolkit, and (3) evaluate the toolkit’s impact on improving PGS reach, effectiveness, adoption, and maintenance using a hybrid stepped-wedge cluster randomized trial design. Methods: We will complete implementation mapping, guided by the Consolidated Framework for Implementation Research integrated with health equity, and the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework for Health Equity to develop and evaluate an equity-focused PGS implementation toolkit. The study will involve 10 design sites to identify implementation barriers and facilitators and 12 Test Sites to assess the toolkit’s effectiveness. Both design and test sites will be representative of the following 4 stages of implementation: exploration or emerging, planning, implementation, and sustainment. Results: The FOCUS project was funded in September 2024 and will conclude in June 2029. The project was funded through the Advancing Genomic Medicine Research Program at the National Human Genome Research Institute (R01HG013851-01). Data collection for aim 1 (qualitative interviews with implementation team members, patients, and laboratory vendors) began January 2024. At the time of reporting, 33 interviews have been completed with implementation team members, 8 with patients, and two with laboratory vendors. Qualitative analyses for aim 1 are underway at the time of reporting. Conclusions: The FOCUS toolkit will establish a standardized approach to scaling PGS programs across diverse populations and settings, ensuring genomics benefits are accessible to all. International Registered Report Identifier (IRRID): DERR1-10.2196/73718 %R 10.2196/73718 %U https://www.researchprotocols.org/2025/1/e73718 %U https://doi.org/10.2196/73718 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e68600 %T Identifying Optimal Testing Modalities to Increase COVID-19 Testing Access in Baltimore, Maryland: Protocol for a Household Randomized Controlled Trial %A Duchen,Jessica %A Mueller,Alexandra K %A Ahmed,Saifuddin %A Perin,Jamie %A Borsuk,Courtney %A Trowell,Joshua %A Lowensen,Kelly %A Huettner,Steven %A Peytchev,Andy %A Farley,Jason E %A Mehta,Shruti H %A Jennings,Jacky M %+ Center for Child and Community Research, Department of Pediatrics, Johns Hopkins School of Medicine, 5200 Eastern Ave, Baltimore, MD, 06511, United States, 1 6318289238, jennings@jhmi.edu %K infectious disease %K SARS-CoV-2 %K mobile %K disease control %K health equity %K urban health %K health disparities %K healthcare access %K %D 2025 %7 2.10.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: The COVID-19 pandemic disproportionately affected low-income and racial and ethnic minority populations. Testing plays a critical role in disrupting disease transmission, but complex barriers prevent optimal testing access, particularly for Black and Latinx communities. There is limited evidence regarding the optimal testing modalities to increase testing access for these populations. Objective: This study aimed to define the optimal COVID-19 testing modalities for maximizing testing acceptance, uptake, and timeliness of receipt of results. Methods: The Community Collaboration to Combat COVID-19 (C-FORWARD) trial was a household randomized comparative effectiveness trial conducted in a representative sample of an urban population. Households across 653 census block groups were sampled using a probability proportional to size approach. The primary outcome was the completion of SARS-CoV-2 or COVID-19 testing within 30 days of randomization. Results: Between February 2021 and December 2022, a total of 1083 individuals were enrolled, including 881 (81.35%) index participants and 202 (18.65%) household members. The mean age of participants was 51 (SD 18) years.Of the total sample, 43% (n=460) of participants identified as Black or African American, 48.6% (n=526) as White, and 9% (n=91) as other, including Asian, American Indian, Native Hawaiian or Pacific Islander, and multiple races; 4.8% (n=48) of participants identified as Hispanic or Latino. At the time of enrollment, 51.1% (n=553) were currently working either full time or part time, and 32.9% (n=342) of participants had an advanced degree. In total, 80% (n=809) of participants had been tested for COVID-19 previously, with 22.3% (n=179) reporting a prior positive test for COVID-19, and 86.8% (n=890) reporting receiving at least one COVID-19 vaccination before enrollment. Conclusions: Data from the C-FORWARD trial will be used to address important questions regarding COVID-19 testing acceptance and uptake in an urban population. International Registered Report Identifier (IRRID): RR1-10.2196/68600 %M 41037805 %R 10.2196/68600 %U https://www.researchprotocols.org/2025/1/e68600 %U https://doi.org/10.2196/68600 %U http://www.ncbi.nlm.nih.gov/pubmed/41037805 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e73926 %T Feasibility, Safety, and Impact of the Probiotics Lactiplantibacillus plantarum and Bifidobacterium longum subspecies infantis in Papua New Guinean Infants: Protocol for a Randomized Controlled Trial %A Ford,Rebecca L %A Greenhill,Andrew R %A Sapura,Joycelyn %A Koata,Amelia %A Dreyam,Mary %A Orami,Tilda %A Jude,Joe %A Ong,Madeline %A Kirarock,Wendy %A Joseph,Dorcas %A Masiria,Geraldine %A Aho,Celestine %A Pomat,William S %A van den Biggelaar,Anita H J %A Richmond,Peter C %+ Papua New Guinea Institute of Medical Research, PO Box 60, , Goroka, EHP 441, Papua New Guinea, 675 532 2800, rebecca.ford.imr@gmail.com %K probiotics %K synbiotics %K Bifidobacterium longum subspecies infantis %K Lactiplantibacillus plantarum %K infant health %K neonatal infections %K gut microbiota %K colonization %D 2025 %7 2.10.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Childhood mortality in low- or middle-income countries (LMICs) remains a major public health concern, with infections being a leading cause of infant death. Probiotics have shown promise in reducing infection-related morbidity and mortality in preterm infants, but their use in newborns born at or near term in LMICs requires further investigation. Objective: This study aims to assess the feasibility, safety, and initial outcomes of administering 1 of 2 synbiotic formulations or a placebo to newborns in the Eastern Highlands Province of Papua New Guinea. Methods: Following ethics approvals in 2018 and 2019, and receipt of the synbiotic preparations in September 2020, healthy neonates (<72 h old; n=244) were recruited between October 2020 and June 2023 and randomly assigned in a double-blind manner (1:1:1) to receive an oral preparation containing Lactiplantibacillus plantarum, Bifidobacterium longum subspecies infantis, or placebo for 7 consecutive days. Follow-up continued for 6 months, with rectal swabs, stool, blood, saliva, and nasopharyngeal swabs collected before the intervention; on day 7; at age 2 weeks; and at ages 1, 3, 4, and 6 months. Ongoing analyses will assess probiotic gut colonization, bacterial nasopharyngeal carriage, and antibody responses to routine childhood vaccines (Hemophilus influenzae type b; hepatitis B; 13-valent pneumococcal conjugate vaccine; and diphtheria, tetanus, and whole-cell pertussis) as well as hospitalization and infection rates among the intervention groups compared to the placebo group. Results: Recruitment began in October 2020, with the target sample size expanded from 195 to 240 in March 2023 owing to higher-than-anticipated loss to follow-up during the COVID-19 pandemic. Of the 244 enrolled infants, 218 (89.3%) completed the full 7-day synbiotic or placebo course, and 169 (69.3%) completed the study. All follow-up visits concluded in December 2023. Disruptions due to the COVID-19 pandemic led to family relocations outside the study area, preventing some infants (75/244, 30.7%) from completing the study. High rates of sample collection were achieved, with rectal swabs (1452/1474, 98.1%), nasopharyngeal swabs (1255/1262, 99.44%), saliva samples (881/882, 99.9%), and blood samples (876/882, 99.3%) successfully obtained at multiple time points. Data analysis is ongoing and expected to be completed by the end of 2025. Conclusions: This study demonstrates that probiotic supplementation is feasible and safe in healthy infants in an LMIC such as Papua New Guinea. The findings from this study will inform the design of larger trials of probiotics and synbiotics to complement existing efforts to reduce infection-related infant mortality in LMICs, while also providing insights into their clinical, immunological, and microbiological impacts in infants. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620001369910; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12620001369910 International Registered Report Identifier (IRRID): DERR1-10.2196/73926 %M 41037809 %R 10.2196/73926 %U https://www.researchprotocols.org/2025/1/e73926 %U https://doi.org/10.2196/73926 %U http://www.ncbi.nlm.nih.gov/pubmed/41037809 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e67168 %T Comparative Effectiveness of Titanium Platelet-Rich Fibrin and Connective Tissue Graft Harvested from the Tuberosity Area Via Modified Vestibular Incision Supraperiosteal Tunnel Access for Managing Gingival Recession: Protocol for a Randomized Controlled Trial %A Punse,Sanehi %A Dhadse,Prasad %+ , Department of Periodontics and Implantology, Datta Meghe Institute of Higher Education and Research (DU), Sawangi (M), Wardha, Maharashtra, 442001, India, 91 9284717880, punsesanehi@gmail.com %K modified vestibular incision supraperiosteal tunnel access %K M-VISTA %K titanium-prepared platelet-rich fibrin %K T-PRF %K gingival recession %K maxillary tuberosity %K connective tissue graft %K periodontal surgery %K periodontist %K periodontology %K dentistry %K gum %K gingivitis %K gingival recession %K graft %K gum graft %K randomized controlled trial %K RCT %K protocol %D 2025 %7 2.10.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Periodontal surgery has traditionally relied on connective tissue grafts (CTGs) obtained from the tuberosity site to correct gingival recession abnormalities. However, there are challenges to be addressed, including insufficient graft quantity and patient susceptibility. Consequently, titanium-prepared platelet-rich fibrin, or T-PRF, has emerged as a competitive alternative. By combining T-PRF with the modified vestibular incision supraperiosteal tunnel access (M-VISTA) approach, a more conservative way is provided, which may improve the course of treatment. Objective: The objective of this study is to compare the effectiveness of T-PRF and CTGs from the tuberosity area in managing gingival recession defects using the M-VISTA technique. The study aims to evaluate improvements in clinical outcomes, including pocket probing depth (PPD), clinical attachment level (CAL), relative gingival margin level (RGML), recession depth (RD), and width of keratinized gingiva (WKG), as well as plaque and bleeding indices. Methods: The proposed methodology entails conducting a randomized clinical trial over 2 years with 24 participants, each presenting with multiple gingival recessions (>2 mm, Miller’s Class I or II) on the buccal or labial aspects of teeth in the maxilla or mandible. Participants will be randomly allocated into 2 groups: the test group and the control group. The M-VISTA technique will be used for root coverage using T-PRF in the test group and tuberosity CTG in the control group as regenerative materials. Their effectiveness will be compared by evaluating PPD, CAL, RGML, RD, and WKG. Additionally, the plaque index will be calculated by dividing the total plaque index score of all teeth by the number of teeth examined, and the papillary bleeding index will be assessed using a periodontal probe with scores evaluated on a scale of 0-4 based on bleeding potential. Data will be analyzed using Student paired and unpaired t tests to compare results from baseline to 3 and 6 months for each group. Results: Recruitment, participant selection, baseline data collection, and randomization of groups concluded in September 2024, and the intervention phase is scheduled to end in December 2025. The study is expected to be completed by July 2026, with final evaluation, data analysis, and publication preparation taking place between June and July 2026. Conclusions: Based on existing evidence, we anticipate that the M-VISTA technique with T-PRF will provide superior root coverage compared to tuberosity CTG because no second surgical site is involved. Evidence suggests that T-PRF may offer comparable clinical benefits to CTG, particularly in clinical attachment gain, RD reduction, and gingival thickness, supporting the advancement of minimally invasive periodontal plastic surgery. Trial Registration: Clinical Trials Registry of India CTRI/2024/07/071619; https://tinyurl.com/ypfe34b5 International Registered Report Identifier (IRRID): DERR1-10.2196/67168 %M 41037807 %R 10.2196/67168 %U https://www.researchprotocols.org/2025/1/e67168 %U https://doi.org/10.2196/67168 %U http://www.ncbi.nlm.nih.gov/pubmed/41037807 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e70293 %T A Stage of Change Theory–Based, Stage-Matched Intervention for Healthy Dietary Intake Among Office Workers in a Low- to Middle-Income Country: Protocol for a Cluster Randomized Trial %A Godevithana,Janaka %A Wijesinghe,Champa Jayalakshmie %A Wijesinghe,Millawage Supun Dilara %+ Department of Community Medicine, Faculty of Medicine, University of Ruhuna, PO Box 70, Labuduwa Road, Karapitiya, Galle, 80000, Sri Lanka, 94 912234801 ext 221, janakagode@gmail.com %K dietary intake %K office workers %K stage-matched interventions %K stage of change theory %K behavior change %D 2025 %7 30.9.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: An unhealthy diet is a well-established risk factor for the development of noncommunicable diseases, and office workers are at a higher risk of noncommunicable diseases due to their sedentary work style. Stage of change (SOC) theory–based and stage-matched interventions effectively influence dietary and behavior changes. The effectiveness of such interventions in the context of low- and middle-income countries is yet to be assessed. Objective: This protocol describes a cluster randomized trial planned to evaluate the effectiveness of an intervention for changing dietary behavior among government office workers in the Galle district in Sri Lanka. Methods: A cluster randomized trial was conducted in 20 clusters divided into intervention and control arms. A cluster was an office with 30 clerical-type workers who were sedentary at work. A stage-matched intervention based on behavior change processes was implemented in the intervention clusters for 3 months. Participants were provided with an intervention matched to their SOC at baseline. Precontemplators and contemplators received awareness-raising and emotional arousal interventions. Others received goal setting and self-monitoring interventions. The SOC and dietary intake were assessed at baseline and the postintervention stage through a staging algorithm, and 24-hour dietary recall was supplemented with a picture guide and computer software. Adherence to the intervention was assessed monthly. We hypothesized that participants would achieve a progressive change in the SOC and healthy dietary intake in the intervention clusters compared to the control clusters. Results: By December 2024, the planned intervention was completed. Data analysis on the effectiveness of the intervention is to be completed and published in 2025. Conclusions: This protocol reports a stage-matched intervention based on SOC theory, enriching the current knowledge base with new evidence from office workers in a low- to middle-income country. Trial Registration: Sri Lanka Clinical Trials Registry SLCTR/2020/025; https://slctr.lk/trials/slctr-2020-025 International Registered Report Identifier (IRRID): DERR1-10.2196/70293 %M 41027024 %R 10.2196/70293 %U https://www.researchprotocols.org/2025/1/e70293 %U https://doi.org/10.2196/70293 %U http://www.ncbi.nlm.nih.gov/pubmed/41027024 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e76555 %T Efficacy and Safety of Runzaozhiyang Lotion for Chronic Hand Eczema: Protocol for a Randomized Controlled Trial %A Zang,Rui %A Xu,Chen-Chen %A Cui,Bing-Nan %A Bi,Jia-Ning %A Song,Ao-Lin %A Wei,Fan %A Yang,Jiao %K runzaozhiyang lotion %K chronic hand eczema %K clinical trial %K traditional Chinese medicine %K topical medication %D 2025 %7 24.9.2025 %9 %J JMIR Res Protoc %G English %X Background: Chronic hand eczema (CHE) is a prevalent inflammatory skin disease in clinical practice. Guidelines recommend the use of topical medications, including corticosteroids and calcineurin inhibitors; however, prolonged use of these drugs may result in adverse effects, such as skin atrophy, drug tolerance, and rebound phenomena. Moreover, these medications exhibit limited efficacy in managing chronic hypertrophic hand eczema. Traditional Chinese medicine (TCM) has a long history of treating patients. The Runzaozhiyang lotion (RZZYL) is often used in the Department of Dermatology of Guang'anmen Hospital, China Academy of Chinese Medical Sciences, for these patients, with marked efficacy on symptoms, keratinization, hypertrophy, and pruritus improvements. Nonetheless, there is still no high-quality evidence from evidence-based medicine to prove the effectiveness and safety of CHE treatment. Objective: This study aimed to examine the efficacy and safety of a classic Chinese herbal prescription, RZZYL, for CHE and to provide a different treatment option for patients with hand eczema who are resistant to conventional Western pharmaceutical treatments. Methods: This study is a clinical trial characterized as randomized, double-blind, double-dummy, and positive drug-controlled. A total of 122 patients diagnosed with CHE have been randomized and allocated in a 1:1 ratio into 2 distinct groups, with one receiving the intervention and the other serving as the control. Participants in the intervention group will receive RZZYL granules along with a placebo cream of mometasone furoate, whereas the control group will get mometasone furoate cream in combination with a placebo for RZZYL granule. Both groups will be treated with either the active drug or a placebo for 4 weeks. The primary outcome metrics are the Hand Eczema Severity Index (HECSI) and the Numerical Rating Scales (NRS). Secondary outcome metrics consist of the target lesion area score, the Patient-Oriented Eczema Measure (POEM), the Dermatology Life Quality Index (DLQI), and the Investigator Global Assessment (IGA). The outcomes will be assessed at the start of the study and again at 2 and 4 weeks after the treatment period. Results: The study will be conducted according to the guidelines and regulations approved by the participating institutions. Recruitment is expected to commence in March 2025 and conclude in March 2026. Data collection is anticipated to be completed by June 2026, with the study expected to conclude in August 2026. Conclusions: This protocol addresses the limitations of previous research and aims to explore the efficacy and safety of RZZYL in treating CHE through a higher-quality clinical study. It seeks to provide additional treatment options for patients with CHE who are resistant to or have poor responses to current therapies. Trial Registration: International Traditional Medicine Clinical Trial Registry ITMCTR2025000287; https://itmctr.ccebtcm.org.cn/mgt/project/view/698241578753484879 International Registered Report Identifier (IRRID): PRR1-10.2196/76555 %R 10.2196/76555 %U https://www.researchprotocols.org/2025/1/e76555 %U https://doi.org/10.2196/76555 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e73039 %T Effectiveness of Tocotrienol-Rich Fraction in Older Adults: Protocol for a Randomized, Double-Blind, Placebo-Controlled Trial %A Amir Razak,Nor Amira Nabila %A Goon,Jo Aan %A Wan Ngah,Wan Zurinah %A Makpol,Suzana %A Ahmad Damanhuri,Mohd Hanafi %A Ibrahim,Nor Faeizah %A Abdul Sani,Nur Fathiah %A Mohd Murshid,Nuraqila %A Mohd Azizan,Anis Faqihah %A Chin,Kok Yong %A Aminuddin,Amilia %A Mohd Yunus,Mohd Heikal %A Md Mansor,Munirah %A Neo,Juvenia Rui En %A Yap,Wei Ney %A Loong,Hsieu Yen %A Ung,Yee Wei %+ Department of Biochemistry, Faculty of Medicine, Universiti Kebangsaan Malaysia, Jalan Yaacob Latif, Kuala Lumpur, 56000, Malaysia, 60 16 5329035, joaan@ukm.edu.my %K tocotrienol %K skin %K cognition %K brain %K weight %K satiety %K aging %K oxidative stress %K immune %K inflammation %D 2025 %7 23.9.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Tocotrienol, a naturally occurring form of vitamin E, has been extensively studied for its potent antioxidant, anti-inflammatory, and immune-stimulating properties. However, the clinical impact of tocotrienol supplementation on older adults’ overall health and well-being remains relatively unexplored. This research aims to investigate the efficacy of tocotrienol-rich fraction (TRF) on various health parameters associated with general well-being in individuals aged between 50 years and 75 years. Objective: It is hypothesized that TRF supplementation may exhibit positive outcomes on blood biochemistry and several physiological aspects, including lowered levels of oxidative stress and inflammation biomarkers; improvement in vascular age; and enhancement of skin condition, bone mineral density, and cognitive function. Methods: This randomized, double-blind, placebo-controlled trial was designed to investigate the effectiveness of TRF supplementation on overall health in healthy older adults. The study aims to assess the impact of a daily dosage of 200 mg of TRF over a period of 6 months. A total of 220 participants is enrolled in the study, with one-half receiving the placebo and the other one-half receiving TRF supplementation. The study comprises 3 time points: baseline, 3 months, and 6 months. At each time point, various measurements are taken to evaluate different aspects of health. The primary outcome measurements include blood biochemistry assessments, such as liver function tests, renal profile, lipid profile, and full blood count. Oxidative stress markers, including malondialdehyde, advanced glycation end products, protein carbonyl, and isoprostane, are also evaluated. Immune response markers such as interleukin-6 and tumor necrosis factor-α are assessed. Satiety regulation is examined through measurements of leptin and ghrelin. Body composition and skin health parameters, including wrinkling, pigmentation, elasticity, hydration, and sebum secretion, are evaluated. Additionally, arterial stiffness is assessed using arteriography at baseline and 6 months. For secondary outcome measures, bone mineral density is measured using dual x-ray absorptiometry, and cognitive function is assessed using the Montreal Cognitive Assessment, Rey Auditory Verbal Learning Test, and digital span test. Both bone mineral density and cognitive function are also measured at baseline and 6 months. Results: The study is progressing as planned, with 209 participants recruited as of April 2025. The research was funded in 2019, and data collection started in December 2020. Preliminary data analysis has been completed for the first 120 participants, and final results are expected upon completion of data collection and unblinding in 2026. Conclusions: By comprehensively evaluating these health aspects, this study seeks to provide valuable insights into the potential benefits of tocotrienol supplementation for promoting the overall health and well-being of the aging population. Trial Registration: National Medical Research Register (NMRR) NMRR-19-2972-51179; https://tinyurl.com/yy9yueer International Registered Report Identifier (IRRID): DERR1-10.2196/73039 %M 40986853 %R 10.2196/73039 %U https://www.researchprotocols.org/2025/1/e73039 %U https://doi.org/10.2196/73039 %U http://www.ncbi.nlm.nih.gov/pubmed/40986853 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e72670 %T A Triple Perspective on the Triple Visit: Protocol for a Mixed Methods Evaluation of the Implementation of a Pediatric Multidisciplinary Clinic Model for Inflammatory Bowel Disease %A Curtin Wach,Aisling %A Lalani,Yasmin %A Christofides,Alexandra %A Wegier,Pete %A Hart,Lara %+ Humber River Health Research Institute, 1235 Wilson Avenue, Toronto, ON, M3M 0B2, Canada, 1 4162421000 ext 21203, acurtinwach@hrh.ca %K child-centered methods %K Crohn disease %K health maintenance %K mental health %K multidisciplinary care model %K pediatric inflammatory bowel disease %K patient perspectives %K parent perspectives %K rapid access clinic %K ulcerative colitis %D 2025 %7 12.9.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Given the impact of inflammatory bowel disease (IBD) on both physical health and psychosocial functioning, the management of pediatric IBD requires a multidisciplinary approach that provides holistic care, rapid access, and health education to young patients with IBD. Yet despite recommendations, a formalized clinic model for holistic pediatric IBD care remains an unmet need for this population. Objective: The objective of this study is to comprehensively evaluate the implementation of a new clinic model aimed at providing holistic care, rapid access, and health education for pediatric patients with IBD. Methods: This study uses a multiperspective mixed methods design, incorporating both qualitative and quantitative data collected simultaneously from clinicians, parents or guardians, and pediatric patients. The quantitative component includes a pre-post implementation chart review, structured observations of clinical practices, and surveys tailored to pediatric patients and their parents or guardians. The qualitative aspect encompasses semistructured interviews with clinicians and parents or guardians as well as play-based interviews with patients. Triangulation will be used to converge these different methodologies and to produce a holistic evaluation of the IBD clinic. Results: This study was approved by the Humber River Health Research Ethics Board on December 23, 2024. Recruitment for this study began on January 30, 2025, and we anticipate a data collection end date of December 2025. Conclusions: Given that this clinic model is relatively new, this protocol will provide sound methodological direction for other studies that aim to evaluate or implement this type of model in their setting. The evaluation itself will provide comprehensive insights into both the successes and challenges of implementing a multidisciplinary approach that provides a holistic model of care for pediatric patients with IBD. As such, this evaluation will be foundational in providing an applied understanding of the impact and effectiveness of this holistic approach in pediatric patients with IBD. International Registered Report Identifier (IRRID): PRR1-10.2196/72670 %M 40939171 %R 10.2196/72670 %U https://www.researchprotocols.org/2025/1/e72670 %U https://doi.org/10.2196/72670 %U http://www.ncbi.nlm.nih.gov/pubmed/40939171 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e74981 %T Acupuncture for Poststroke Cognitive Impairment Based on Default Mode Network Analysis: Protocol for a Randomized Controlled Trial %A Cheng,Wangxinjun %A Wang,Moyu %A Li,Moyi %+ Department of Rehabilitation Medicine, First Affiliated Hospital, Jiangxi Medical College, Nanchang University, Yong wai zheng street, Nanchang, 330006, China, 86 15806031050, limoyi123@aliyun.com %K cognitive function %K traditional Chinese medicine %K functional magnetic resonance imaging %K fMRI %K randomized controlled trial %K poststroke cognitive impairment %K PSCI %D 2025 %7 12.9.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Poststroke cognitive impairment (PSCI) is a prevalent and disabling complication following stroke, affecting critical functions such as memory, attention, language, and executive abilities. Despite the growing clinical burden, standardized and effective treatment strategies for PSCI remain limited. Acupuncture, a key modality in traditional Chinese medicine, has shown promise in improving cognitive outcomes among survivors of stroke. However, the neural mechanisms underlying its efficacy are not well understood. The default mode network (DMN), a brain network implicated in cognition and memory, has been shown to exhibit altered functional and structural connectivity in patients with PSCI. Investigating whether acupuncture modulates DMN activity may provide critical insights into its therapeutic potential. Objective: This study aims to evaluate the efficacy of acupuncture in improving cognitive function in patients with PSCI and explore its potential neurobiological mechanisms, particularly those involving changes in the DMN, using multimodal neuroimaging techniques. Methods: We will conduct a single-blind, randomized controlled trial involving 54 eligible patients with PSCI who will be randomly assigned to either an acupuncture group or a sham acupuncture control group. Both groups will receive conventional rehabilitation therapies. The intervention group will undergo standardized scalp acupuncture targeting Baihui (GV20), Shenting (GV24), and Sishencong (EX-HN1) for 8 weeks. The control group will receive sham acupuncture at nonacupoint locations using placebo needles. Cognitive function will be assessed at baseline and 4 and 8 weeks using the Montreal Cognitive Assessment and Mini-Mental State Examination. Secondary outcomes include activities of daily living, quality of life, and neuroimaging data acquired through resting-state functional magnetic resonance imaging and diffusion tensor imaging. Results: This study is currently in the recruitment phase. All results, including clinical and imaging data, will be reported upon trial completion and publication. Conclusions: This protocol is designed to investigate the efficacy of acupuncture and its underlying mechanisms in treating PSCI, with a particular focus on functional brain networks. By integrating clinical cognitive assessments and neuroimaging analysis of DMN connectivity, this study seeks to establish objective correlates of cognitive improvement. Findings from this research may advance the understanding of how acupuncture modulates large-scale brain networks and contribute to the development of imaging-based biomarkers for treatment evaluation. If successful, this approach could support the inclusion of acupuncture as a personalized nonpharmacological strategy in the neurorehabilitation of cognitive deficits following stroke. International Registered Report Identifier (IRRID): PRR1-10.2196/74981 %M 40939166 %R 10.2196/74981 %U https://www.researchprotocols.org/2025/1/e74981 %U https://doi.org/10.2196/74981 %U http://www.ncbi.nlm.nih.gov/pubmed/40939166 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e73923 %T Strong Families Start at Home/Familias Fuertes Comienzan en Casa—Improving Child Diet Quality and Parental Feeding Practices: Protocol for a Randomized Controlled Trial %A Tovar,Alison %A Bouchard,Kelly Lynn %A Moore,Amy M %A Perry,Michelle %A Lurssen,Ivone %A Arriola Carnicelli,Leonardo %A Sanchez Contreras,Alexia %A Risica,Patricia %A von Ash,Tayla %A Savage,Jennifer S %A Dunsiger,Shira %A Gans,Kim %+ Department of Behavioral and Social Sciences, School of Public Health, Brown University, 121 S Main Street, Providence, RI, 02912, United States, 1 4014872981, kelly_bouchard@brown.edu %K Hispanic or Latino %K child %K diet quality %K feeding practices %K feeding behavior %K randomized controlled trial %K motivational interviewing %D 2025 %7 10.9.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Children in the United States have poor diet quality, increasing their risk for chronic disease burden later in life. Caregivers’ feeding behaviors are a critical factor in shaping lifelong dietary habits. The Strong Families Start at Home/Familias Fuertes Comienzan en Casa (SFSH) was a 6-month, home-based, pilot randomized-controlled feasibility trial that aimed to improve the diet quality of 2-5-year-old children and promote positive parental feeding practices among a predominantly Hispanic/Latine sample. The pilot saw significant improvements in children’s Healthy Eating Index-2015 total and whole fruit scores, as well as multiple food parenting practices, and it was received well by participants. Objective: Building on the success of the pilot study, this protocol paper describes the modifications, study design, and procedures for a fully powered randomized controlled trial. Methods: Caregiver-child dyads are randomized to a “healthy eating” intervention group or a “reading readiness” attention control group. In the intervention group, a trained community health worker conducts monthly home visits or phone calls for 6 months that focus on age-appropriate nutrition recommendations and food parenting practices. There are three home visits that include tailored nutrition education materials that address their child’s appetitive traits and eating habits, an interactive cooking activity, and a review of a family meal video with feedback. Community health workers use motivational interviewing and goal setting, which are key components of the program. The control group is similarly structured, with content focusing on reading and language development. Caregivers complete in-person and over-the-phone baseline and 6-month follow-up measurements to capture diet quality (primary outcomes: Healthy Eating Index-2015 scores via two 24-h dietary recalls and dermal carotenoids) and selected parental feeding practices and availability of healthy foods in the home (secondary outcomes). Results: This protocol was approved by the Brown University institutional review board (protocol number 2022003389). As of March 2025, a total of 81 participants were randomized. Of these, 29 participants completed the study, and 8 participants withdrew. Recruitment will continue until 257 participants have been randomized. Data analysis is expected to conclude in 2028. Conclusions: Findings will determine the efficacy of the intervention to improve child diet quality and parental feeding practices, which will ultimately inform future effectiveness and the real-world of home-based food parenting programs. Trial Registration: ClinicalTrials.gov NCT06099288; https://clinicaltrials.gov/study/NCT06099288 International Registered Report Identifier (IRRID): DERR1-10.2196/73923 %M 40929716 %R 10.2196/73923 %U https://www.researchprotocols.org/2025/1/e73923 %U https://doi.org/10.2196/73923 %U http://www.ncbi.nlm.nih.gov/pubmed/40929716 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e72842 %T Evaluating the Effect of a Molecular Point-of-Care Test on Acute Respiratory Infections in General Practice: Protocol for a Cluster Randomized Trial %A Balasubramaniam,Kirubakaran %A Simonsen,Line Maria %A Kongstad,Line Planck %A Thilsing,Trine %A Wehberg,Sonja %A Hallas,Jesper %A Sopina,Liza %A Nielsen,Jesper Bo %A Overbeck,Gritt %A Hvidt,Elisabeth Assing %A Jarbøl,Dorte Ejg %A Rasmussen,Tina Lein %A Søndergaard,Jens %+ Research Unit of General Practice, Department of Public Health, University of Southern Denmark, Campusvej 55, Odense M, 5230, Denmark, 45 65503739, kiruba@health.sdu.dk %K point-of-care %K acute respiratory infections %K general practice %D 2025 %7 8.9.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Acute respiratory infections (ARIs) are frequent reasons for medical consultations in general practice and can lead to unnecessary recontacts. Introducing new point-of-care (POC) polymerase chain reaction (PCR) diagnostic equipment may offer an attractive and efficient way of providing a more precise and exact microbial diagnosis. Successful uptake of POC PCR equipment could potentially lead to a reduction in recontacts with benefits for both staff and patients. However, introducing new diagnostic technology is a complex intervention and several contextual factors may impact the implementation. Objective: This study aims to evaluate the effect of POC PCR test availability in general practice on the subsequent (1) number of recontacts to the general practitioner (GP) for patients with symptoms of ARIs (primary outcome) and (2) hospital admissions, deaths, antibiotic prescriptions, health-related quality of life, GP and patient satisfaction, costs, cost-effectiveness, and contextual facilitators and barriers conditioning the implementation process (secondary outcomes). Methods: This study is a cluster-randomized, crossover, nonblinded superiority trial with a 1:1 allocation ratio between usual care (control) and POC PCR test availability (intervention). Questionnaire data are collected at day 0, 7, 14, and 28 after the initial contact (health-related quality of life, absenteeism and presentism among patients, and patient satisfaction) and after finalization of the study period (GP satisfaction). Data on recontacts, hospital admissions, redeemed antibiotic prescriptions, costs, and deaths will be retrieved from the Danish national registries. The implementation process will be evaluated based on data from interviews with users of POC PCR tests (i.e., GPs, staff, and patients) and from observations in the clinics in line with Medical Research Council guidelines. Results: As per the randomized crossover design carried out during September 2023 to March 2024 investigating a sample of 100 GP clinics, we expect to obtain an in-depth and multifaceted understanding of the effects of the availability of the POC PCR test equipment in general practice. Conclusions: This study will provide valuable information about the diagnostic conditions and possibilities in general practice and provide insights into the organization of primary health care. Trial Registration: ClinicalTrials.gov NCT06120153; https://clinicaltrials.gov/study/NCT06120153 International Registered Report Identifier (IRRID): DERR1-10.2196/72842 %M 40921063 %R 10.2196/72842 %U https://www.researchprotocols.org/2025/1/e72842 %U https://doi.org/10.2196/72842 %U http://www.ncbi.nlm.nih.gov/pubmed/40921063 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e70246 %T Pay-It-Forward 23-Valent Pneumococcal Polysaccharide Vaccination Among Older Adults: Protocol for a Randomized Controlled Trial %A Qin,Jiao %A Wei,Liangjia %A Tao,Chunxing %A He,Jinfeng %A Wu,Dan %A Lin,Zhifeng %A Huang,Ting %A Qin,Shiyu %A Su,Qiuqian %A Gao,Yanxiao %A Chen,Shuiming %A Wang,Ganqin %A Tang,Xianyan %A Ye,Li %A Liang,Hao %A Ning,Chuanyi %A Tang,Weiming %A Tucker,Joseph D %A Liang,Bingyu %+ Guangxi Key Laboratory of AIDS Prevention and Treatment, School of Public Health & Life Science Institute, Guangxi Medical University, No.22, Shuangyou Road, Qingxiu District, Nanning, 530021, China, 86 1 807 481 4940, liangbingyu@gxmu.edu.cn %K randomized controlled trial %K 23-valent pneumococcal polysaccharide vaccine %K pay-it-forward %K older adults %K China %D 2025 %7 8.9.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: The 23-valent pneumococcal polysaccharide vaccine reduces the risk of pneumonia among adults by 38% to 46%. However, only a few older adults in resource-limited areas of China have received the pneumococcal vaccination. Pay-it-forward is a social innovation that offers participants free or subsidized health services and a community-engaged message, with an opportunity to donate to support subsequent recipients. Objective: This study aims to assess the effectiveness and cost-effectiveness of the pay-it-forward intervention in encouraging the uptake of the 23-valent pneumococcal polysaccharide vaccine in adults aged ≥60 years. Methods: A 2-arm, parallel randomized controlled trial will be conducted in 4 community health centers in Nanning city, Guangxi province, China. We will use a block randomization design. A total of 204 older adults will be randomly allocated in a 1:1 ratio to either the pay-it-forward group or the standard-of-care group. Each participant will complete a web-based questionnaire. The standard-of-care group will be required to pay for the vaccine themselves. In contrast, the pay-it-forward group will receive a 150 RMB (US $20.7) vaccination subsidy, postcards, and the opportunity to donate. The participants in both groups will be followed up in the second and fourth weeks after enrollment. The primary outcome will be uptake of the 23-valent pneumococcal polysaccharide vaccine, as determined by administrative data. Secondary outcomes include costs, pneumococcal vaccination knowledge, attitudes toward the vaccine, perceptions of gratitude, incidence of adverse reactions and adverse events, and the likelihood of recommending pneumococcal vaccination to others. Results: Participant recruitment and follow-up were conducted from January 2024 to September 2024. A total of 220 participants were enrolled. Finalized results are expected in June 2026. Conclusions: This study will provide evidence on the effectiveness and economic costs of the pay-it-forward strategy for pneumonia vaccination among older adults. The findings could have implications for vaccination policy and offer a new approach for increasing vaccination in resource-limited areas. Trial Registration: Chinese Clinical Trial Registry ChiCTR2400079410; https://www.chictr.org.cn/showprojEN.html?proj=213999 International Registered Report Identifier (IRRID): DERR1-10.2196/70246 %M 40921060 %R 10.2196/70246 %U https://www.researchprotocols.org/2025/1/e70246 %U https://doi.org/10.2196/70246 %U http://www.ncbi.nlm.nih.gov/pubmed/40921060 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e68758 %T Effects of a Dialogic Book-sharing Intervention for Female Caregivers in Rural Tanzania (EDBiT): Protocol for a Randomized Controlled Trial %A Schlossarek,Martin %A Šerá Komlossyová,Eva %A Murray,Lynne %A Cooper,Peter J %A Vencálek,Ondřej %A Dušková,Lenka %A Machumu,Maregesi %A Šafaříková,Simona %A Harmáček,Jaromír %A Syrovátka,Miroslav %+ , Department of Development & Environmental Studies, Palacký University Olomouc, 17. listopadu 12, Olomouc, 77900, Czech Republic, 420 585634980, eva.serakomlossyova@upol.cz %K dialogic book-sharing %K cognitive development %K child language %K parenting %K Tanzania %K study protocol %D 2025 %7 8.9.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Children in low- and middle-income countries face obstacles to optimal language and cognitive development due to a variety of factors related to adverse socioeconomic conditions. One of these factors is compromised caregiver-child interactions and associated pressures on parenting. Early development interventions, such as dialogic book-sharing (DBS), address this variable, with evidence from both high-income countries and urban areas of low- and middle-income countries showing that such interventions enhance caregiver-child interaction and the associated benefits for child cognitive and socioemotional development. Yet, evidence for DBS effects is lacking from poor rural communities where the need for such early development intervention may be greatest. Objective: The objective of this study is to assess the effects of a DBS intervention, a parenting program for female caregivers of children aged between 15 and 45 months, implemented in rural Tanzania. We aim to assess the impact of the intervention on the following domains: child cognitive and socioemotional skills, parenting and parental stress, and child health. Methods: The study is a 3-arm cluster randomized controlled trial. In total, 443 female caregivers participated in the study. Clusters of caregivers were randomized to either (1) an index DBS intervention group, (2) a playful activity active control group, or (3) a waitlist control group. The active control group was designed to control for any attention effects, ensuring that observed improvement in the index group can be attributed to the DBS intervention’s content. The primary outcomes were child language, parental sensitivity, and parent-child interaction. The secondary outcomes concerned child attention and behavior, parenting practices, and parental stress. A combination of questionnaires and direct observations was applied. Qualitative methods were also used, primarily to capture caregivers’ experiences and subjective perspectives on intervention-induced changes. Results: Data collection for the study was completed in September 2024. The study results are expected to be published by late 2025. Conclusions: This randomized controlled trial of a DBS intervention implemented in rural Tanzania adds to a growing body of international literature exploring the impact and limitations of a simple and scalable early development intervention to enhance child outcomes. Trial Registration: International Standard Registered Clinical/Social Study Number (ISRCTN) ISRCTN12613329; https://www.isrctn.com/ISRCTN12613329 International Registered Report Identifier (IRRID): DERR1-10.2196/68758 %M 40920460 %R 10.2196/68758 %U https://www.researchprotocols.org/2025/1/e68758 %U https://doi.org/10.2196/68758 %U http://www.ncbi.nlm.nih.gov/pubmed/40920460 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e68871 %T Platelet-Rich Plasma Versus Saline for the Treatment of Vulvar Lichen Sclerosus: Protocol for a Randomized Controlled Trial %A Nguyen,Tran %A Beljic,Milica %A Willison,Nadia %A Taheri,Mahshid %A Aryan,Pouria %A Abbott,Derek %A Behnia-Willison,Fariba %+ Discipline of Biomedical Engineering, School of Electrical and Mechanical Engineering, University of Adelaide, 46 Marleston Avenue, Ashford, Adelaide, 5035, Australia, 61 431757799, tran.nguyen@adelaide.edu.au %K regenerative medicine %K vulvar dermatoses %K female sexual health %K autologous therapies %K clinical trial protocols %K women’s health research %D 2025 %7 3.9.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Vulvar lichen sclerosus (LS) is a chronic relapsing dermatosis commonly affecting the anogenital region in postmenopausal women, though it can affect people of any age and sex. The current gold standard treatment is lifelong topical steroid application to reduce symptoms and prevent the progression of disease, causing irreversible architectural change to the vulval tissue. LS is associated with decreased quality of life and increased risk of vulvar neoplasia. Alternatives to current treatments are highly desired by both clinicians and patients. Platelet-rich plasma (PRP) is an autologous blood product containing high concentrations of platelets and growth factors and is hypothesized to promote wound healing. PRP has been reported to improve symptoms of LS in several case reports and uncontrolled trials. Objective: This study aims to evaluate the efficacy of PRP versus saline injections to improve the clinical signs and symptoms of LS. Methods: This is a protocol for a 12-month, single-center, parallel-group, double-blind, randomized controlled trial evaluating the efficacy of PRP for LS compared to saline. Adult female patients with biopsy-proven LS who are otherwise in good health but are nonresponders to topical steroid treatment prior to inclusion are eligible for the trial. A total of 68 participants will be randomly allocated via a random number generator to receive either PRP or saline injections to areas of the vulva with LS. All participants will be blinded to the intervention received. Participants will be followed up with assessments of clinical LS signs, subjective symptom scores, and quality of life questionnaires by blinded assessors at 4 timepoints: baseline, 6 weeks, 6 months, and 12 months. The primary outcome is the clinical scoring system for LS—the total LS score. Results: Recruitment commenced in May 2020 and concluded in November 2023. This study closed in September 2024 due to slow recruitment. Data are being analyzed in 2025, and results are expected to be published in late 2025. Conclusions: This study will evaluate the safety and efficacy of PRP injections compared to those of saline injections for the treatment of vulvar LS, potentially providing a novel therapeutic option for patients who do not respond to topical steroids. Trial Registration: Australia and New Zealand Clinical Trials Registry ACTRN12618001321235p; Universal Trial Number: U1111-1207-4893; anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375536 International Registered Report Identifier (IRRID): DERR1-10.2196/68871 %M 40902148 %R 10.2196/68871 %U https://www.researchprotocols.org/2025/1/e68871 %U https://doi.org/10.2196/68871 %U http://www.ncbi.nlm.nih.gov/pubmed/40902148 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e68306 %T Efficacy of a Multimodal Ayurveda Regimen in the Management of Primary Knee Osteoarthritis: Protocol for an Open-Label Randomized Controlled Trial %A Rai,Amit Kumar %A Yadav,Babita %A Kumar,Uma %A Gupta,Bharti %A Patel,Kishore %A Khanduri,Shruti %A Sharma,Bhagwan S %A Singhal,Richa %A Chandrasekhararao,Bhogavalli %A Srikanth,Narayanam %A Acharya,Rabinarayan %+ Department of Rheumatology, All India Institute of Medical Sciences, Room No 4076 , 4th Floor, Teaching Block, New Delhi, 110029, India, 91 11 26594467, umaakumar@yahoo.co.in %K Janu Basti %K Laksha Guggulu %K Matra Basti %K osteoarthritis %K WOMAC %K Western Ontario and McMaster Universities Osteoarthritis Index %D 2025 %7 3.9.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Ayurveda recommends a comprehensive therapeutic approach for osteoarthritis management. However, most of the published clinical studies on Ayurveda interventions for osteoarthritis management have addressed selected modalities of Ayurveda treatment rather than the holistic therapeutic regimen. Objective: This study aimed to assess the efficacy and safety of a multimodal Ayurveda treatment protocol in the long-term management of primary osteoarthritis of the knee compared with standard care. Methods: The proposed open-label, parallel-group randomized controlled trial was conducted in individuals of any gender aged 40 to 70 years and diagnosed with primary osteoarthritis of the knee as per the American College of Rheumatology criteria. Individuals with grade 4 radiographic changes in the affected knee (based on the Kellgren-Lawrence classification) and with comorbidities were not considered. The study was conducted at the All India Institute of Medical Sciences, New Delhi, India. A total of 150 participants underwent random assignment in a 1:1 ratio to receive either the Ayurveda treatment protocol or conventional standard care for 180 days. The primary outcome was the change in the Western Ontario and McMaster Universities Osteoarthritis Index score from baseline. The secondary outcome measures included the change in the score for pain, stiffness, and physical function from baseline; change in the range of motion of the knee joint; change in the score of the numeric pain rating scale, Pain Disability Index, and 12-item short-form survey questionnaire (to assess health-related quality of life); change in highly sensitive C-reactive protein levels, interleukin-6 levels, magnetic resonance imaging scan findings, and dual-energy X-ray absorptiometry scan findings; and change in the need for rescue analgesic medication from baseline. Safety was evaluated by recording the incidence of adverse events and changes in liver and kidney function tests from baseline. Results: Recruitment of study participants commenced on October 11, 2022. Currently, all the participants completed the study and the analysis of the study outcomes is ongoing. Conclusions: This randomized controlled trial will be the first study to explore the potential benefits of a multimodal Ayurveda regimen (based on Ayurveda principles and scientific evidence) in the long-term management of osteoarthritis of the knee through validated subjective, laboratory, and imaging parameters. The outcomes of this study may address the needs and challenges associated with osteoarthritis management. Trial Registration: Clinical Trial Registry of India CTRI/2022/05/042792; https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=Njk0MTM=&Enc=&userName= International Registered Report Identifier (IRRID): DERR1-10.2196/68306 %M 40900633 %R 10.2196/68306 %U https://www.researchprotocols.org/2025/1/e68306 %U https://doi.org/10.2196/68306 %U http://www.ncbi.nlm.nih.gov/pubmed/40900633 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e68340 %T Constraint-Induced Movement Therapy With or Without Neuromuscular Electrical Stimulation Versus Conventional Therapy for Upper Extremity Function in Chronic Stroke Survivors: Protocol for a Cluster Randomized Controlled Trial %A Dboba,Mahmoud M %A Mohd Nordin,Nor Azlin %A Manaf,Haidzir %A Mohd Rasdi,Hanif Farhan %A Abdul Aziz,Aznida Firzah %+ Department of Family Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia, Jalan Yaacob Latif, Kuala Lumpur, 56000, Malaysia, 60 0391456117, draznida@hctm.ukm.edu.my %K stroke %K upper extremity %K constraint-induced movement therapy %K neuromuscular electrical stimulation %K Post-stroke %K stroke rehabilitation %D 2025 %7 28.8.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Motor impairment is a common consequence of stroke, significantly impacting patients’ daily functioning and quality of life. More than 80% of stroke survivors experience upper extremity (UE) motor impairments, which severely impact their ability to carry out daily living activities. Combining motor rehabilitation techniques, such as constraint-induced movement therapy (CIMT), with sensorimotor stimulation methods, such as neuromuscular electrical stimulation (NMES), may be beneficial in enhancing UE functional recovery after a stroke. This combined approach could activate a broader range of brain regions, improving motor control. However, evidence for the effectiveness of these interventions when combined is still lacking. Objective: In this randomized controlled trial, we aim to determine the effectiveness of CIMT combined with NMES, CIMT alone, and conventional therapy in rehabilitating UE function in chronic stroke survivors. Methods: We will compare 3 intervention groups, 2 experimental groups (CIMT combined with NMES group and CIMT group) and 1 control group (conventional therapy), in this assessor-blinded, cluster randomized controlled trial. A total of 42 participants will be recruited and randomly assigned to 1 of the 3 groups. Participants in the CIMT group will undergo 6 shaping practice tasks (50 repetitions for each task, totaling 300 repetitions per session). The combined CIMT/NMES group will perform tasks similar to those carried out by the CIMT-only group, and a biofeedback electrical stimulator for NMES will also be provided. The control group will receive conventional neurodevelopmental therapy. All groups will receive 1 session per day of treatment for 3 consecutive days a week for 4 weeks. A blinded assessor will measure the interventions’ outcomes using standardized tests, including UE motor function, motor impairment, perceived motor function, and upper limb self-efficacy. All data will be analyzed descriptively, presenting the means and SDs. We will conduct inferential tests using a 2-way mixed ANOVA to evaluate the effects of the interventions and compare them between and within groups. Results: Funding for this study was provided by the Research and Ethics Committee of the Universiti Kebangsaan Malaysia (the National University of Malaysia) starting in November 2023. Between January 2023 and May 2023, we developed the initial ethics proposal and recruited research staff. Research ethics applications were submitted to the Research and Ethics Committee of the Universiti Kebangsaan Malaysia from May 2023 to November 2023. We anticipate publishing the study results in September 2025. Conclusions: This trial will provide insights into the effectiveness of CIMT combined with NMES, CIMT alone, and conventional therapy for UE rehabilitation in stroke survivors. Findings will be published in a peer-reviewed journal, and any updates based on emerging evidence will be provided. Any changes to the study methods will be documented in the final publication. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12624000564550; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=387308 %M 40874667 %R 10.2196/68340 %U https://www.researchprotocols.org/2025/1/e68340 %U https://doi.org/10.2196/68340 %U http://www.ncbi.nlm.nih.gov/pubmed/40874667 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e63528 %T Efficacy of Tuina Versus the Proprioceptive Neuromuscular Facilitation (PNF) Technique in Patients With Nonspecific Chronic Neck Pain: Protocol for a Randomized Controlled Trial %A Fan,Kaiqi %A Wang,Aicheng %A Gao,Hainan %A Yu,Ting %A Zhu,Xiangyu %+ Beijing University of Chinese Medicine, No 51 Xiaoguan Street, Andingmenwai, Chaoyang District, Beijing, 100029, China, 86 18810361589, 116491992@qq.com %K nonspecific neck pain %K nonspecific chronic neck pain %K efficacy %K randomized controlled trial %K tuina %K proprioceptive neuromuscular facilitation %K combined therapy %K neck pain %K chronic neck pain %K evidence %K support %K effectiveness %K therapy %K China %K manipulation %K traction %K cervical traction %D 2025 %7 14.8.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Nonspecific chronic neck pain (NCNP), characterized by a long course, a high recurrence rate, and a young age of onset, causes a huge economic burden. Scientific evidence supports the efficacy of tuina, a manual traditional Chinese medicine (TCM) therapy involving manipulation of soft tissues and joints, for NCNP. However, there is little evidence of the effectiveness of proprioceptive neuromuscular facilitation (PNF), a rehabilitative method involving specific patterns of muscle contraction and stretching, in treating NCNP, either alone or in combination with tuina. Objective: This study aims to compare the effects of the PNF technique, tuina, and their combination on patients with NCNP and assess whether combined therapy outperforms monotherapies. Methods: The parallel, double-blind, three-arm clinical randomized controlled trial (RCT) is being conducted at the Beijing University of Chinese Medicine and its affiliated hospitals. Patients will be recruited and randomly assigned to a PNF group, a tuina group, and a combined (PNF+tuina) group in a 1:1:1 ratio. The PNF intervention (PNF stretching and PNF plyometrics) will last for 30 minutes each session. Tuina therapy will also last for 30 minutes each session. The combined group will receive 30 minutes of PNF, followed by 30 minutes of tuina therapy. Participants will receive 4 weeks of treatment, thrice a week, for a total of 12 treatments. Visual Analogue Scale (VAS) and Neck Disability Index (NDI) scores will be used as primary outcome measures. Cervical active joint mobility measured with the MicroFET3 Portable Muscle Strength Test and Joint Mobility Meter and muscle physical properties tested with the Myoton Muscle Tester will be used as secondary outcome measures. Data will be analyzed at baseline, at the end of the intervention, and during the 4 weeks of follow-up using repeated measures ANOVA. The significance level will be 5%. Results: As of May 26, 2025, 43 participants were already recruited and randomly assigned to the three treatment groups (PNF: n=14, 32.6%; tuina: n=15, 34.9%; combined: n=14, 32.5%). All enrolled participants have initiated treatment, with an average adherence rate of 92% and no withdrawals due to adverse events (AEs) or treatment dissatisfaction. The short-term follow-up (end of intervention) for the first cohort was completed on July 30, 2025, with long-term follow-up (1 month postintervention) to be completed by August 31, 2025. The final analysis is projected to include data of all 69 participants by October 2025, with primary results expected to be submitted for publication in December 2025. Conclusions: Our findings will provide a solid evidence base for clinical approaches to managing NCNP. Moreover, our results will offer valuable insights into the relative efficacy of tuina, PNF, and their combination, shedding light on their potential benefits and helping identify the most effective treatment strategies for NCNP. Trial Registration: International Traditional Medicine Clinical Trial Registry ITMCTR2023000061; https://itmctr.ccebtcm.org.cn/mgt/project/view/346154483678331720/false International Registered Report Identifier (IRRID): PRR1-10.2196/63528 %M 40812738 %R 10.2196/63528 %U https://www.researchprotocols.org/2025/1/e63528 %U https://doi.org/10.2196/63528 %U http://www.ncbi.nlm.nih.gov/pubmed/40812738 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e75475 %T Honey as a Wound Care Modality in Treating Deep Neck Space Abscesses: Protocol for a Randomized Controlled Trial %A Wulandari,Dian Paramita %A Subronto,Yanri Wijayanti %A Surono,Agus %+ Department of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada, Senolowo, Jl. Farmako, Sekip Utara, Depok, Sleman, 55281, Indonesia, 62 811259775, dian.paramita.w@ugm.ac.id %K natural dressing %K cytokines %K growth factor %K Bates-Jensen Wound Assessment tool %K clinical trial protocol %K honey %D 2025 %7 14.8.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Deep neck abscesses are a disease in the field of otorhinolaryngology-head and neck surgery that causes significant morbidity, death, and expenditures. Treatment length, whether inpatient or outpatient, is also prolonged. Deep neck abscesses are managed with incision and drainage, abscess exploration, systemic broad-spectrum antibiotic treatment, comorbidity control, and postoperative wound care through recovery. Standard dressings for wound treatment have proven time-consuming and expensive. Honey is one type of dressing that has long been used in wound treatment for a number of body areas and disorders. Objective: The purpose of this study is to investigate the use of honey as a potential substitute for standard dressings for deep neck abscesses. Methods: This is a single-blind randomized controlled trial. Randomization will be done through simple random sampling. The population and sample of the study include all patients with deep neck abscesses treated at Dr Sardjito General Hospital, which is equipped with board-certified otorhinolaryngologists. Patients with deep neck abscesses who were given ethical clearance and meet the inclusion criteria were recruited as study participants until the sample size was reached. There are 18 participants in each group. Participants in the intervention group received standard dressings in addition to honey dressings, whereas those in the control group received standard dressings alone. Proinflammatory cytokines and growth factors, wound size, Bates-Jensen Wound Assessment Tools scoring, and quantitative bacterial colony identification will be all evaluated and assessed. The gathered data will be documented and subjected to statistical analysis. Results: This manuscript presents a study protocol for a randomized controlled trial investigating honey as a wound care modality in patients with deep neck space abscesses. Ethical approval and partial funding for the study were obtained in May 2024. Recruitment and data collection commenced in June 2024 and were successfully completed as of June 2025. Conclusions: We hypothesize that honey may serve as a safe, effective, and affordable alternative wound dressing for the management of deep neck abscesses, with potential benefits in both clinical and health care system outcomes. Trial Registration: ClinicalTrials.gov NCT06562257; https://clinicaltrials.gov/study/NCT06562257. International Registered Report Identifier (IRRID): DERR1-10.2196/75475 %M 40810438 %R 10.2196/75475 %U https://www.researchprotocols.org/2025/1/e75475 %U https://doi.org/10.2196/75475 %U http://www.ncbi.nlm.nih.gov/pubmed/40810438 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e75982 %T Qizhi Jieyu Pill for the Treatment of Cerebral Infarction During the Recovery Phase: Protocol for a Randomized Controlled Clinical Trial %A An,Xuedong %A Yu,Liangqing %A Ma,Yuqin %A Zhang,Junwei %A Guo,Shiping %A Xu,Jilong %A Zhao,Ping %A Xu,Hongyan %A Gao,Feng %A Wu,Xueqin %A Gao,Yanlan %A Jiang,Yao %A Liu,Yali %+ Guang'anmen Hospital of China Academy of Chinese Medical Sciences, No. 5 North Line Pavilion, Xicheng District, Beijing, 100053, China, 86 19801207372, doctor_anxd@163.com %K cerebral infarction %K recovery phase %K Qizhi Jieyu pill %K clinical research %K study protocol %D 2025 %7 13.8.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Cerebral infarction, a life-threatening neurodegenerative disease, is one of the leading causes of disability and death. The recovery phase is a critical period for patients to regain cognitive ability, memory, and motor functions and to improve their ability to perform daily activities. Over the past 10 years, we have applied Qizhi Jieyu pill in the treatment of patients in the recovery phase of cerebral infarction. We retrospectively analyzed clinical data from 152 patients and found preliminary results suggesting that Qizhi Jieyu pill may help alleviate clinical symptoms, improve quality of life, and reduce the recurrence of cerebral infarction. However, the lack of high-quality clinical evidence supporting its efficacy and safety has limited its widespread clinical application. Objective: This protocol describes a randomized controlled trial aiming to evaluate the efficacy and safety of Qizhi Jieyu pill in patients during the recovery phase of cerebral infarction. Methods: This study adopts a multicenter, randomized controlled clinical trial design. A total of 126 patients aged 30-70 years in the recovery phase of cerebral infarction will be recruited and randomly assigned in a 1:1 ratio to either the study group (n=63, receiving conventional treatment plus Qizhi Jieyu pill) or the control group (n=63, receiving conventional treatment alone). The intervention period will last 12 weeks, and the total follow-up period will be 48 weeks. The primary outcome is the change in the National Institutes of Health Stroke Scale score at week 48. Secondary outcomes include changes in traditional Chinese medicine syndrome scores, the recurrence rate of cerebral infarction, and modified Rankin Scale scores. Adverse events will be recorded and used to assess the safety profile. All data analyses will be performed according to a prespecified statistical analysis plan. Results: The study received ethics approval on March 3, 2025, from the Ethics Committee of Guang’anmen Hospital, China Academy of Chinese Medical Sciences (2025-025-KY-01) and was registered on April 6, 2025. Participant recruitment began on April 10, 2025, and is expected to be completed by December 31, 2025. Final results will be published by December 31, 2026. Conclusions: This study is the first randomized controlled clinical trial to evaluate the efficacy and safety of Qizhi Jieyu pill in the treatment of patients during the recovery phase of cerebral infarction. It will contribute to the development of integrated treatment strategies, potentially leading to broader clinical adoption, by providing a high-quality, evidence-based treatment option for clinical practice. Trial Registration: International Traditional Medicine Clinical Trial Registry ITMCTR2025000653; https://itmctr.ccebtcm.org.cn/mgt/project/view/2028021950497347405/false International Registered Report Identifier (IRRID): PRR1-10.2196/75982 %M 40802347 %R 10.2196/75982 %U https://www.researchprotocols.org/2025/1/e75982 %U https://doi.org/10.2196/75982 %U http://www.ncbi.nlm.nih.gov/pubmed/40802347 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e68582 %T Effect of Dual Bronchodilation on the Exercise Capacity of Individuals With Non-Cystic Fibrosis Bronchiectasis: Protocol for a Randomized Controlled Double-Blind Crossover Study %A Marques da Silva,Cibele Cristine Berto %A Dal Corso,Simone %A Lunardi,Adriana Claudia %A Fonseca,Alfredo José %A Rached,Samia Zahi %A Athanazio,Rodrigo Abensur %A Carvalho,Celso Ricardo Fernandes %+ , Department of Physical Therapy, University of São Paulo, Rua Cipotânea, 51, São Paulo, 05360-160, Brazil, 55 11984153234, cscarval@usp.br %K bronchiectasis %K bronchodilator agents %K exercise test %K exercise %K non-cystic fibrosis bronchiectasis %K exercise capacity %K thoracoabdominal kinematics %D 2025 %7 28.7.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Bronchodilators (BDs) have been used therapeutically to improve exercise capacity in patients with other chronic respiratory diseases. However, the effect of BDs on the exercise capacity of individuals with non-cystic fibrosis bronchiectasis (NCFB) is poorly understood. Objective: The aim of this study was to evaluate the effects of BDs on exercise capacity and thoracoabdominal kinematics in patients with NCFB. Methods: This crossover randomized controlled trial will involve 45 outpatients with NCFB aged 18 to 59 years. They will be evaluated in 3 visits. On day 1, the maximal exercise capacity (cardiopulmonary exercise test; peak work rate [Wpeak]) will be assessed. On day 2, individuals will be randomized to receive either BD (ipratropium bromide 160 µg and fenoterol hydrobromide 400 µg) or a placebo and then undergo simultaneous endurance exercise capacity (constant work-rate exercise test) and thoracoabdominal kinematics (optoelectronic plethysmography) assessments. After at least 1-week washout (day 3), the individuals will repeat the same assessments as on day 2 in the reverse order. The time to the limit of tolerance will be obtained in both groups (BD and placebo groups) as the primary outcome. Thoracoabdominal kinematics will be assessed at 3 time points: at rest, during unloaded exercise, and at 75% Wpeak. The total chest wall and compartmental volumes as well as thoracoabdominal asynchrony will be assessed. The assessors and patients will be blinded to the interventions (BDs or placebo). Data will be compared using 1-sided t tests or Wilcoxon tests and repeated-measures analysis of variance or Friedman tests. Categorical data will be analyzed using the chi-square test or Fisher test. The associations among variables will be analyzed using Pearson or Spearman correlation. The significance level will be set at 5% (P<.05). Results: The ethics approval was granted in November 2018, and a pilot study was commenced in April 2019 but was interrupted due to the COVID-19 pandemic. The study restarted in April 2022, and data collection is anticipated to continue until November 2025. The publication of the results is anticipated to be in 2025 or 2026. Conclusions: There is no evidence that BDs can improve the exercise capacity of patients with NCFB. This trial will compare the endurance exercise capacity of the same individual with and without dual bronchodilation. If successful, this study will demonstrate that exercise capacity can be improved with the use of BDs in adults with NCFB. Trial Registration: ClinicalTrials.gov NCT05183841; https://clinicaltrials.gov/study/NCT05183841 International Registered Report Identifier (IRRID): DERR1-10.2196/68582 %M 40720815 %R 10.2196/68582 %U https://www.researchprotocols.org/2025/1/e68582 %U https://doi.org/10.2196/68582 %U http://www.ncbi.nlm.nih.gov/pubmed/40720815 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e69744 %T Hydrogen-Rich Water Consumption for Acute and Residual Fatigue After Simulated Football Matches: Protocol for a Randomized, Double-Blinded, Placebo-Controlled, Parallel Trial %A Hruby,Michal %A Hulka,Karel %A Bernatik,David %+ Department of Sport, Faculty of Physical Culture Olomouc, Palacký University Olomouc, Hynaisova 9, Olomouc, 77900, Czech Republic, 420 777320009, karel.hulka@upol.cz %K molecular hydrogen %K oxidative stress %K recovery %K repeated sprint ability %K antifatigue effect %K readiness to play %D 2025 %7 22.7.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Football matches induce acute and residual fatigue, impairing neuromuscular, metabolic, and perceptual performance. Hydrogen-rich water (HRW) is a novel intervention with antifatigue and antioxidative properties. The intermittent high-intensity nature of football, which includes frequent accelerations, decelerations, sprints, changes of direction, and physical contacts, imposes substantial demands on both central and peripheral physiological systems. This results in acute fatigue, observable during or immediately after a match, and residual fatigue, which can persist for 24-72 hours post match, depending on the intensity, match context, and recovery strategies. Objective: This study will investigate the effects of pre-exercise HRW administration versus a placebo on neuromuscular performance, biochemical markers, and perceptual measures of fatigue during a 72-hour recovery after a simulated football match. Methods: Using a randomized, double-blinded, placebo-controlled, parallel design, elite junior football players will undergo neuromuscular performance assessments (repeated sprint ability and countermovement jump test). Metabolic fatigue will be measured by creatine kinase level and muscle soreness, rated using a visual analog scale. These assessments will occur at critical time points: immediately post warm-up; directly following the simulated football match to detect acute fatigue; and 24, 48, and 72 hours after training sessions to detect residual fatigue. Results: Data collection has been scheduled with the clubs to coincide with the beginning of the players’ transition period (ie, at the start of August 2025). The expected duration of data collection, including the initial medical examination, is planned to be 1 month. We anticipate publishing the results in late 2025 or during the first half of 2026. Conclusions: This study will assess the influence of molecular hydrogen on acute fatigue manifestation and recovery quality during a 72-hour period after a simulated football match. The potential positive effects of molecular hydrogen, such as attenuation of oxidative stress, reduction in muscle damage markers, and accelerated neuromuscular recovery, may contribute to faster restoration of functional capacities. If confirmed, these effects could enhance players’ readiness to return to high-intensity training and optimize the structure of microcycles in competitive periods. Additionally, understanding the recovery dynamics facilitated by HRW may inform evidence-based recovery strategies and support individualized player monitoring frameworks. The possible positive effect of molecular hydrogen would speed up the players’ readiness to train after the match and help protect players against illness and noncontact injuries. %M 40694834 %R 10.2196/69744 %U https://www.researchprotocols.org/2025/1/e69744 %U https://doi.org/10.2196/69744 %U http://www.ncbi.nlm.nih.gov/pubmed/40694834 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e68166 %T Efficacy and Safety of Electroacupuncture Through Nerve Stimulation in Patients With Anxiety Disorders: Protocol for a Randomized, Assessor-Blind, Three-Arm, Parallel-Group Clinical Trial %A Jung,In Chul %A Kang,Dong-Hoon %A Choi,Sunyoung %A Choi,Yujin %A Kwon,Ojin %A Kook,Hye Jeong %A Lee,Daeun %A Park,Yang-Chun %A Kim,Jieun %+ , KM Science Research Division, Korea Institute of Oriental Medicine, 1672 Yuseong-daero, Yuseong-gu, Daejeon, 34054, Republic of Korea, 82 10 7113 9407, jieunkim@kiom.re.kr %K anxiety disorders %K electroacupuncture %K nerve stimulation %K vagus nerve %K median nerve %D 2025 %7 21.7.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Anxiety disorders are among the most common mental health disorders, affecting a significant portion of the population. However, conventional treatments, such as pharmacotherapy and psychotherapy, often have limited effectiveness and may lead to undesirable side effects. Consequently, there is a growing demand for new alternative treatments for anxiety disorders. Recent studies suggest that electroacupuncture may demonstrate therapeutic effects in managing anxiety by mediating nerve stimulation. Objective: This study is designed to assess the efficacy and safety of electroacupuncture in treating anxiety disorders through nerve stimulation. Specifically, it will involve stimulating the median nerve at the PC6 acupoint (Neiguan) and the vagus nerve at the TF4 acupoint (Shenmen of ear acupuncture). Methods: This study is a randomized, assessor-blind, three-arm, parallel-group clinical trial comprising the PC6 electroacupuncture group, TF4 electroacupuncture group, and a control group. Participants will include patients diagnosed with social anxiety disorder, panic disorder, agoraphobia, and generalized anxiety disorder. Eligible participants will be randomly assigned to one of the 3 groups, with each group containing 20 individuals. The electroacupuncture groups will receive treatments at the designated acupoints twice weekly for 8 weeks, totaling 16 sessions. The control group will receive usual care without any treatment interventions through the end of the study period. The primary outcome is the comparison of Hamilton Anxiety Rating Scale scores between the treatment groups and the control group. Secondary outcomes include scores on the Hamilton Anxiety Rating Scale, Beck Anxiety Inventory, Beck Depression Inventory-II, Patient Health Questionnaire-15, World Health Organization Quality of Life Assessment Instrument abbreviated version, Penn State Worry Questionnaire, Panic Disorder Severity Scale, and Leibowitz Social Anxiety Scale. Safety evaluation variables include the frequency of adverse events, vital signs, and suicide risk assessment. Exploratory variables include performance on the Emotional Reactivity Test, empathy quotient, and heart rate variability. Results: The first participant was enrolled on December 15, 2022. As of October 2024, a total of 60 participants have been fully registered, and the intervention is currently in progress. We expect the completion of this trial to occur within the year 2025. Conclusions: In this study, we will evaluate the safety and efficacy of electroacupuncture for anxiety disorders. By elucidating the therapeutic mechanisms of electroacupuncture through nerve stimulation, this study will provide clinical evidence to support the development of potential interventions for patients with anxiety disorders. Trial Registration: Clinical Research Information Service of the Republic of Korea KCT0008378; https://cris.nih.go.kr/cris/search/detailSearch.do/24503 International Registered Report Identifier (IRRID): DERR1-10.2196/68166 %M 40690751 %R 10.2196/68166 %U https://www.researchprotocols.org/2025/1/e68166 %U https://doi.org/10.2196/68166 %U http://www.ncbi.nlm.nih.gov/pubmed/40690751 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e65253 %T Kissing as a Protective Factor Against Decreased Salivary pH: Protocol for a Randomized Clinical Trial %A Armijos Briones,Marcelo %A Aguila Gaibor,Mariuxi %A Bermúdez Velásquez,Andrea %+ Dental School, Universidad Católica de Santiago de Guayaquil, Av. Carlos Julio Arosemena Km 1 1⁄2, Sauces 1, Guayaquil, 090509, Ecuador, 593 969711767, fernando.armijos@cu.ucsg.edu.ec %K Saliva %K oral health %K sugar-sweetened beverages %K dental caries prevention %K kissing %K protective %K social behavior %K stress %K relationship %K pH %K fermented drinks %K randomized controlled trial %D 2025 %7 17.7.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Kissing is a common social behavior that may influence physiological responses and impact oral health. Prior research has shown that affectionate behaviors like kissing can reduce stress and improve relationship satisfaction. However, the effects of kissing on salivary pH, particularly after consuming sugary or fermented beverages, have not been thoroughly investigated. Objective: This study aims to determine whether kissing accelerates salivary pH recovery following the consumption of sugary or fermented beverages. Methods: A randomized controlled trial will be conducted with 60 couples aged 18-30 years. Participants will be divided into 3 groups: a control group (no kissing), an experimental group where one partner consumes a beverage, and another experimental group where both partners consume a beverage. The study will measure salivary pH at baseline, after beverage consumption, and following a 40-second kiss or control period, with measurements taken every 5 minutes until the pH returns to neutral levels. The data will be analyzed using SPSS software (IBM Corporation). ANOVA will be used to compare salivary pH recovery between groups, and if assumptions of normality or sphericity are not met, alternative models such as generalized linear models or nonparametric tests will be considered. Results: The study is ongoing, with participant recruitment already initiated and preliminary data collection in progress. The study was funded by the Catholic University of Santiago de Guayaquil from June 2024 to June 2025. Ethics approval was obtained in June 2023. The results are expected to be published in the last quarter of 2025. Conclusions: This study will provide insights into the relationship between kissing, salivary pH, and oral health, potentially offering new strategies for the prevention of dental caries. The results may challenge existing assumptions about the role of kissing in oral health. Trial Registration: ClinicalTrials.gov NCT06501729; https://clinicaltrials.gov/study/NCT06501729 International Registered Report Identifier (IRRID): DERR1-10.2196/65253 %M 40674724 %R 10.2196/65253 %U https://www.researchprotocols.org/2025/1/e65253 %U https://doi.org/10.2196/65253 %U http://www.ncbi.nlm.nih.gov/pubmed/40674724 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e73508 %T The Effect of Maternal Choline Intake on Offspring Cognition in Adolescence: Protocol for a 14-year Follow-Up of a Randomized Controlled Feeding Trial %A Roth,Sophie A %A Lam,Angie E %A Strupp,Barbara J %A Canfield,Richard L %A Larson,Elisabeth Anne %+ Division of Nutritional Sciences, Cornell University, 244 Garden Ave, Ithaca, NY, 14853, United States, 1 (607) 255 8001, sar338@cornell.edu %K choline %K pregnancy %K adolescent %K nutrition %K cognition %K mental health %K supplement %K virtual testing %D 2025 %7 11.7.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Choline is an essential micronutrient crucial for fetal neurodevelopment. Numerous rodent studies reveal that compared to maternal consumption of standard chow, maternal prenatal choline deficiency produces lifelong offspring cognitive deficits, and maternal choline supplementation produces lifelong improvements in offspring cognition. Few studies have evaluated this question in humans, with mixed results. Nonetheless, the available data raise concerns about the low choline intakes of pregnant women and highlight the need for knowledge of the functional consequences of various choline intakes during pregnancy. Objective: This study will evaluate the cognitive and affective functioning of adolescents born to women who participated in a randomized controlled trial (RCT) of 2 levels of choline intake during pregnancy, with the primary aim of assessing offspring attention and spatial memory. Methods: In a double-blind, randomized controlled choline feeding trial 26 women beginning their third trimester of pregnancy were randomly assigned to 2 groups: daily choline consumption at 480 or 930 mg/day. In this 14-year follow-up, the offspring (n=21) of these women will complete cognitive tests proctored over videoconferencing software. Cognitive function domains will be assessed using web-based software from the Cambridge Neuropsychological Test Automated Battery (CANTAB Connect). We will also assess facets of mental health using the Achenbach System of Empirically Based Assessment (ASEBA). These assessments will test the hypothesis that third-trimester maternal choline intake exerts lasting effects on offspring attention, memory, executive function, and mental health. Results: Between January 2009 and October 2010, 26 women beginning their third trimester of pregnancy from the Ithaca area were enrolled in the original controlled feeding study. We successfully re-recruited 21 (80%) of the original 26 offspring to this 14-year remote follow-up study. Recruitment started in August 2023 and was concluded in October 2023. Analysis is ongoing, and the first results are expected to be submitted for publication in the fall of 2025. We hypothesize that adolescent offspring born to women in the 930 mg/day group will perform better in domains of attention, memory, executive function, and mental health than offspring of women in the 480 mg/day group. This study is unique because the total maternal choline intake is precisely known, and the offspring are followed into adolescence, a time when group differences are indicative of lifelong effects of prenatal intervention. Conclusions: The findings will provide important new information concerning the lasting functional consequences of maternal choline intake during pregnancy for offspring neurobehavioral health, thereby informing dietary recommendations and supplementation policies for pregnant women. Trial Registration: ClinicalTrials.gov: NCT05859126; https://clinicaltrials.gov/study/NCT05859126 International Registered Report Identifier (IRRID): DERR1-10.2196/73508 %M 40644695 %R 10.2196/73508 %U https://www.researchprotocols.org/2025/1/e73508 %U https://doi.org/10.2196/73508 %U http://www.ncbi.nlm.nih.gov/pubmed/40644695 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e71829 %T Effects of Therapeutic Ultrasound and Aussie Current With High-Intensity Interval Training on Abdominal Adiposity in Young Adults With Overweight and Obesity: Protocol for a Randomized Controlled Trial %A Marcondes-Scalli,Ana Carolina Aparecida %A Rehder-Santos,Patricia %A Signini,Étore De Favari %A Castro,Alex %A Dato,Carla %A Furlan,Leonardo %A Liebano,Richard Eloin %A Catai,Aparecida Maria %+ Cardiovascular Physical Therapy Laboratory, Nucleus of Research in Physical Exercise, Universidade Federal de São Carlos, Via Washington Luiz, km 235, São Carlos, CP: 676, 13565-905, Brazil, 55 996332487, marcondesanacarolina70@gmail.com %K combined therapy %K abdominal subcutaneous fat %K obesity %K lifestyle %K physiotherapy %D 2025 %7 11.7.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: More than half of the world’s population will be overweight or obese by 2035, and it is known that physical exercise, such as high-intensity interval training (HIIT), is a tool for controlling obesity by improving body composition and the metabolic profile. Noninvasive techniques such as therapeutic ultrasound (TUS) and the Aussie current have shown potential in controlling adipose tissue, but their effects combined with HIIT remain unknown. TUS may be combined with the Aussie current to potentiate the specific effects of each intervention, such as lipolysis induced by TUS and lymphatic activation promoted by the Aussie current. The integration of HIIT into this protocol is justified by its ability to stimulate β-oxidation and facilitate the metabolic use of fatty acids mobilized by the electrophysical resources. Furthermore, the use of HIIT as opposed to moderate-intensity continuous training contributes to reducing the total duration of the intervention. Objective: This study aims to evaluate the effects of TUS+Aussie current combined with HIIT on body composition, serum metabolic profile, and cardiovascular autonomic modulation (CAM) in individuals with overweight and obesity. Methods: This is a randomized, double-blind (researcher and outcome assessor) clinical study. The participants will be randomized into 3 groups: active TUS+Aussie current with HIIT group, placebo for TUS+Aussie current with HIIT group, and TUS+Aussie current–only group. All participants will undergo nutritional monitoring 30 days before the proposed interventions to adjust macronutrients, optimize energy intake, and improve diet quality. Primary outcomes include changes in subcutaneous adipose tissue thickness, body composition, and serum metabolic profile. Secondary outcomes assess perceived stress, body image, blood biochemistry, sleep quality, and CAM. Data analysis involves linear mixed models estimated using the maximum likelihood method with an appropriate covariance matrix structure. Results: A total of 60 participants will be recruited and randomized between February 2024 and June 2025. The baseline assessments and intervention are scheduled to be completed in August 2025, and data collection will be completed by the end of September 2025. Data acquisition is still ongoing; therefore, data analysis has not yet been carried out. Conclusions: This is the first study to combine TUS+Aussie current with HIIT, potentially integrating the effects of lipolysis and fat oxidation and possible changes in the serum metabolic profile and CAM. The results could optimize treatment duration, promote changes in lipid profile, and maintain cardiovascular health in people with overweight and obesity. Trial Registration: Brazilian Registry of Clinical Trials RBR-4xh6232, Universal Trial Number: U1111-1287-2345; https://ensaiosclinicos.gov.br/rg/RBR-4xh6232 International Registered Report Identifier (IRRID): DERR1-10.2196/71829 %M 40644684 %R 10.2196/71829 %U https://www.researchprotocols.org/2025/1/e71829 %U https://doi.org/10.2196/71829 %U http://www.ncbi.nlm.nih.gov/pubmed/40644684 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e75547 %T Efficacy of Tuina Therapy Based on Hip-Knee-Ankle Synergy in the Lower Extremity Kinematic Chain in Patients With Knee Osteoarthritis: Protocol for a Randomized Controlled Trial %A Wen,Zonglin %A Lyu,Ruoyun %A Zhang,Shuaipan %A Yu,Yifeng %A Wang,Jianwei %A Kong,Lingjun %A Fang,Min %+ , Department of Tuina, Shuguang Hospital, No 528, Zhangheng Road, Shanghai, 201203, China, 86 18818273239, chunyong01@163.com %K KOA %K knee osteoarthritis %K Tuina %K hip-knee-ankle synergies %K kinematic chain %K clinical trial %D 2025 %7 7.7.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Knee osteoarthritis (KOA) is a progressive degeneration of the knee joint that has the potential to impair the function of the lower extremity. Tuina, as an important component of traditional Chinese medicine (TCM), is a common treatment for KOA. However, the prevailing practice often limits the therapeutic focus to the knee joint, overlooking potential coexisting hip and ankle injuries. Thus, the therapeutic efficacy may not be optimal in these instances. Objective: This study aims to evaluate the clinical efficacy of Tuina therapy based on hip-knee-ankle synergy combined with conventional treatment in patients with KOA. It also seeks to explore the potential effects on the lower extremity kinematic chain and provide clinical practitioners with a potentially valuable therapeutic approach. Methods: This single-blind randomized controlled trial (RCT) will involve a total of 96 participants with KOA from 1 study center (including 2 branches). Participants will be randomly divided into a conventional treatment (control) group and a Tuina+conventional treatment (intervention) group in a 1:1 ratio. Participants in the control group will receive regular health education, self-administered acupressure, and functional exercise. This routine will be completed in 4 weeks, with a total of 5 sessions planned each week. Participants in the intervention group will receive 8 sessions of Tuina therapy based on hip-knee-ankle synergy (twice a week for 4 weeks), combined with conventional treatment. The primary outcome of this study will be improvement in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) scores from baseline to 16 weeks. Among the secondary measures, the Key Symptoms and Signs/TCM Syndrome Classification Quantitative Evaluation of KOA and the 11-item Tampa Scale of Kinesiophobia (TSK-11) score will be evaluated from baseline to 16 weeks. The Functional Movement Screen (FMS), the Timed Up and Go (TUG) test, and the Weight Bearing Lunge Test (WBLT) scores will only be evaluated at baseline and 4 weeks. Results: The trial commenced in September 2024 and is expected to conclude in September 2025. As of April 2025, key preliminary steps have been successfully completed. Specifically, the ethical review and clinical trial registration have been finalized. Participant recruitment is proceeding well, with 69 individuals having been enrolled to date. Data collection is currently ongoing, and formal data analysis has not yet been initiated. Conclusions: This RCT aims to contribute to the growing evidence base supporting the necessity of kinetic chain–based integrative diagnosis and treatment, while also evaluating the feasibility of the study protocol and exploring the benefits of manipulative therapy. Trial Registration: International Traditional Medicine Clinical Trial Registry ITMCTR2024000293; https://tinyurl.com/4tsszfdu International Registered Report Identifier (IRRID): DERR1-10.2196/75547 %M 40623301 %R 10.2196/75547 %U https://www.researchprotocols.org/2025/1/e75547 %U https://doi.org/10.2196/75547 %U http://www.ncbi.nlm.nih.gov/pubmed/40623301 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e69484 %T Salivary MicroRNAs as Potential Noninvasive Biomarkers for the Diagnosis of Nasopharyngeal Carcinoma: Protocol for a Scoping Review %A Wibowo,Anton Sony %A Indrasari,Sagung Rai %A Herdini,Camelia %A Purnomosari,Dewajani %A Ernawati,Sulis %+ Academic Hospital, Universitas Gadjah Mada, Jl Kabupaten, Kronggahan I, Trihanggo, Kec. Gamping, Kabupaten Sleman, Daerah Istimewa, Yogyakarta, 55291, Indonesia, 62 81328084821, antonsonywibowo@ugm.ac.id %K nasopharyngeal carcinoma %K microRNA %K miRNA %K biomarker %K saliva %K diagnosis %D 2025 %7 4.7.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Nasopharyngeal carcinoma (NPC) is the fourth-most-prevalent cancer in both Indonesia and Asia. Globally, an estimated 133,354 cases and 80,008 deaths were attributed to NPC in 2020. Early diagnosis plays a key role in managing NPC. Molecules found in bodily fluids, such as saliva, contain compounds (including microRNAs [miRNAs]) that can aid in detecting diseases like NPC. More studies on the expression, role, use, and accuracy of salivary miRNAs as potential diagnostic biomarkers of NPC are needed. Objective: This protocol provides a framework for conducting a scoping review aimed at mapping the expression, role, use, and diagnostic accuracy of specific salivary miRNAs as potential diagnostic biomarkers of NPC. Methods: The guidelines established by the JBI will be followed, which include defining the research questions, identifying relevant studies, and selecting studies based on titles and abstracts. The process will involve charting the data; collating, summarizing, and reporting the findings; and consultation. The synthesis will specifically examine the expression, role, use and accuracy of salivary miRNAs as potential diagnostic biomarkers of NPC. Both quantitative and qualitative analyses will be performed. Results: The selection of studies based on keywords was completed in August 2024, and the study screening and review processes were finished by November 2024. The drafting of the scoping review manuscript is currently underway. The development of this scoping review protocol was supported by funding from the Centre for Higher Education Funding and the Indonesia Endowment Fund for Education. Conclusions: The findings of this study will offer a comprehensive overview of the expression, role, use, and diagnostic accuracy of salivary miRNAs as potential diagnostic biomarkers of NPC. The findings of this review are expected to serve as a basis for further research. Trial Registration: Open Science Framework k3prh_v1; https://osf.io/preprints/osf/k3prh_v1 International Registered Report Identifier (IRRID): DERR1-10.2196/69484 %M 40614255 %R 10.2196/69484 %U https://www.researchprotocols.org/2025/1/e69484 %U https://doi.org/10.2196/69484 %U http://www.ncbi.nlm.nih.gov/pubmed/40614255 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e77927 %T Efficacy of WuSheZhiYang Pills in Mild-to-Moderate Atopic Dermatitis: Protocol for a Double-Blind, Randomized, Placebo-Controlled Trial %A Gao,Xiangjin %A Ding,Yuning %A Cai,Ruiqi %A Zhang,Xiuqi %A Duan,Zhen %A Xu,Quanruo %A Shen,Fanlingzi %A Li,Siyuan %A Zhang,Rui %A Wang,Ruiping %+ Clinical Research Center, Shanghai Skin Disease Hospital, 1278 Baode Road, Jing’an District, Shanghai, 200443, China, 86 18706521768, w19830901@126.com %K atopic dermatitis %K WSZY pills %K randomized controlled trial %K clinical trial protocol %K skin diseases %D 2025 %7 2.7.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Atopic dermatitis (AD) is a recurrent, inflammatory, and chronic skin disease that influences over 200 million individuals around the world and is viewed as an important health problem due to its elevated prevalence, long course of disease, and heavy disease burden. WuSheZhiYang (WSZY) pills are composed of 11 Chinese herbs and have the effects of nourishing the blood, drying dampness, and relieving itching. In clinical practice, WSZY pills are recommended for itching skin diseases, but high-quality clinical trial evidence is still limited. Objective: In this study, we will implement a double-blind, randomized, placebo-controlled trial to evaluate the efficacy of WSZY pills for mild-to-moderate AD. We hypothesized that WSZY pills can effectively alleviate the disease condition of patients with mild-to-moderate AD. Methods: In this study, we will recruit 60 patients with mild-to-moderate in Shanghai Skin Diseases Hospital from December 2024 through December 2025. In this study, 60 male and female patients with AD aged 18 years to 65 years will be randomly assigned (2:1) to the treatment group (urea ointment and WSZY pills; n=40) or control group (urea ointment and placebo WSZY pills; n=20), and both groups will receive 4 weeks of treatment and 4 weeks of follow-up. The treatment group will receive 3 sessions of urea ointment and 7.5 g of WSZY pills each day for 4 weeks, and the control group will also receive 3 sessions of urea ointment and 7.5 g of placebo WSZY pills each day for 4 weeks. The primary indicator is the change in the objective Scoring Atopic Dermatitis (SCORAD) score between baseline and week 4. The secondary indicators include SCORAD at week 2 and week 8; Peak Pruritus Numerical Rating Scale (PP-NRS), Investigator's Global Assessment (IGA), Patient-Oriented Eczema Measure (POEM), and Dermatology Life Quality Index (DLQI) at week 2, week 4, and week 8; and the proportion of participants receiving remedial treatment, amount of levocetirizine tablets used, and recurrence rate at week 8. In this study, we will analyze the full analysis set and per-protocol set using SAS software version 9.4, and a 2-tailed alpha level of .05 will be viewed as statistically significant. Results: The study received ethics permission in September 2024, and trial registration was completed in October 2024. Recruitment started in December 2024 and is expected to be completed by December 2025. As of June 2025, 30 participants with mild-to-moderate AD were enrolled. Data analysis will begin in January 2026. The main results of the trial are expected to be submitted for publication in peer-reviewed scientific journals in the summer of 2026. Conclusions: This study will evaluate the efficacy of WSZY pills for AD and provide additional evidence, suggest new therapeutic options for patients, and reduce their disease burden. Trial Registration: International Traditional Medicine Clinical Trial Registry ITMCTR2024000724; http://itmctr.ccebtcm.org.cn/zh-CN/Home/ProjectView?pid=bda070f8-a733-4f52-87b0-39e4be57ac00 International Registered Report Identifier (IRRID): DERR1-10.2196/77927 %M 40601920 %R 10.2196/77927 %U https://www.researchprotocols.org/2025/1/e77927 %U https://doi.org/10.2196/77927 %U http://www.ncbi.nlm.nih.gov/pubmed/40601920 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e68761 %T Effect of Whole-Body Electromyostimulation Training on Glycemic Control in People With Prediabetes: Protocol for a Pilot Randomized Controlled Trial Study %A Shojaa,Mahdieh %A Knaub,Katharina %A Schmitz,Norbert %A Nieß,Andreas Michael %A Munz,Barbara %A Rau,Sarah %A Feit,Viktoria %A Mphepo,Wallen %A Dingler,Rahel %A Kemmler,Wolfgang %+ Department of Population-Based Medicine, University Hospital Tübingen, Röntgenweg 9, Tübingen, 72076, Germany, 49 070712988815, mahdieh.shojaa@med.uni-tuebingen.de %K prediabetes %K prevention %K type 2 diabetes mellitus %K whole-body electromyostimulation, lifestyle intervention %K activity tracker %D 2025 %7 24.6.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Diabetes prevention programs focus on people with prediabetes because they have a greater risk of developing type 2 diabetes mellitus than people with normal blood glucose levels. Weight management can reduce this risk. However, in our largely sedentary society, there is less enthusiasm for regular exercise. Whole-body electromyostimulation (WB-EMS) is a training technology that provides exercise-like effects by inducing muscle contractions using electrical currents. There is evidence that local EMS can improve glucose metabolism. Several studies investigated the effect of WB-EMS on cardiometabolic risk factors including blood glucose control in a population of individuals with metabolic syndrome. However, to the best of our knowledge, there is no randomized controlled trial examining the preliminary efficacy of WB-EMS on hemoglobin A1c (HbA1c) levels in individuals with prediabetes. Objective: The objective of this randomized controlled trial is to pilot procedures for a randomized controlled trial testing WB-EMS training on glycemic changes in sedentary adults with prediabetes. Methods: A total of 60 community-dwelling sedentary adults aged 40-65 years with prediabetes will be randomized to one of 3 arms: WB-EMS + an activity tracker and a lifestyle education program (LEP) focusing on diabetes prevention, an activity tracker and LEP, or LEP only, with 20 individuals in each arm. The WB-EMS training will consist of 1.5×20 minutes per week. The intervention will last 16 weeks. As a pilot study, our main outcomes concern the number of participants who will be recruited, and comply with intervention and follow-up. The primary efficacy outcome of interest includes hemoglobin A1c. The intention-to-treat analysis will be conducted with the objective of providing CI estimation of treatment effects. Results: The recruitment of study participants started in February 2024. At the time of submission of this protocol for publication, the recruitment was still ongoing. As of October 2024, a total of 42 participants were allocated to the study groups. The anticipated date of recruitment completion is July 2025. Conclusions: The results of this trial will provide valuable evidence for future investigations comparing the efficacy of the WB-EMS intervention with traditional exercise training to improve glycemic control in this population. Trial Registration: ClinicalTrials.gov NCT06188481; https://clinicaltrials.gov/study/NCT06188481 International Registered Report Identifier (IRRID): DERR1-10.2196/68761 %M 40554784 %R 10.2196/68761 %U https://www.researchprotocols.org/2025/1/e68761 %U https://doi.org/10.2196/68761 %U http://www.ncbi.nlm.nih.gov/pubmed/40554784 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e64405 %T Virtual Diabetes Prevention Program Tailored to Increase Participation of Black and Latino Men: Protocol for a Randomized Controlled Trial %A Chambers,Earle C %A Walker,Elizabeth A %A Schechter,Clyde %A Gil,Eric %A Herbert,Terysia %A Diaz,Katelyn %A Gonzalez,Jeffrey %+ , Albert Einstein College of Medicine, 1300 Morris Park Ave, Block Building Room. 419, Bronx, NY, 10461, United States, 1 7184303057, earle.chambers@einsteinmed.edu %K diabetes prevention %K minority populations %K men's health %K virtual %K diabetes %K prevention %K Black %K Latino %K randomized controlled trial %K RCT %K clinic-based %K standard care %K weight loss %K risks %K effectiveness %K adoption %K hypothesize %K electronic health record %K EHR %K academic medical center %K health system partner %K Power-Up intervention %K mixed-gender %D 2025 %7 24.6.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Black and Latino men are at increased risk for poor diabetes health outcomes but are underrepresented in lifestyle interventions for weight loss and diabetes prevention. Although relatively few men participate in the National Diabetes Prevention Program (NDPP), it remains the most widely available evidence-based approach to type 2 diabetes prevention in the United States. Thus, an NDPP tailored to Black and Latino men has the potential to address prior limitations of NDPP implementation and reduce gender, racial, and ethnic diabetes disparities. It also provides an opportunity to define a population for targeted outreach and evaluate the reach of our recruitment methods and interventions. Objective: We tailored the US Centers for Disease Control and Prevention Prevent T2 curriculum for the NDPP for Black and Latino men, called Power-Up, and will evaluate its effects in comparison to standard mixed-gender NDPP groups via virtual delivery. The primary aim of the project is to assess the effect of Power-Up versus NDPP on weight loss among men with prediabetes. The secondary aim is to compare the engagement and retention of men with prediabetes in Power-Up versus NDPP. We will also examine the reach of our recruitment methods and engagement in our screening, consenting, and assessment procedures prior to the point of randomization. We hypothesized that men randomized to Power-Up would achieve greater percent weight loss from baseline at 16 weeks (end of Core sessions) and 1 year (end of Maintenance sessions) than men randomized to standard, mixed-gender NDPP. Power-Up is also expected to have better engagement and retention. Methods: Using the electronic health record (EHR) systems of a large academic medical center and a network of small to medium independent primary care practices throughout New York City, we identified Black and Latino men who met eligibility criteria for NDPP and enrolled them in a randomized controlled trial in which they were assigned 1:1 to receive Power-Up or the standard, mixed-gender NDPP over 1 year via online videoconferencing. Coaches delivering these interventions were trained according to the standards for the NDPP. Power-Up will be delivered by men coaches. Weight will be collected with home-based electronic scales for primary outcome analyses. Engagement will be assessed by session attendance logs. Results: We identified 11,052 men for outreach based on EHR data, successfully screened 26% of them, consented and enrolled 22% of these, and randomly assigned 48% of consented participants. Primary and secondary outcome analyses will be assessed among randomized men. Conclusions: This study highlights the effort required to reach and engage Black and Latino men for virtually delivered diabetes prevention programs. Forthcoming trial results for weight loss and engagement will further inform efforts to address disparities in diabetes prevention through tailored programming for Black and Latino men. Trial Registration: ClinicalTrials.gov NCT04104243; https://clinicaltrials.gov/study/NCT04104243 International Registered Report Identifier (IRRID): DERR1-10.2196/64405 %M 40554781 %R 10.2196/64405 %U https://www.researchprotocols.org/2025/1/e64405 %U https://doi.org/10.2196/64405 %U http://www.ncbi.nlm.nih.gov/pubmed/40554781 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e65921 %T Acceptance-Based Pre-Exposure Prophylaxis Intervention (ACTPrEP) to Engage Young Black Men Who Have Sex With Men in the Southern United States: Protocol for a Pilot Randomized Controlled Trial %A Arnold,Trisha %A Giorlando,Kayla K %A Barnett,Andrew P %A Gaudiano,Brandon A %A Antonaccio,Cara M %A Elwy,A Rani %A Patrick Edet,Precious %A Ward,Lori M %A Whiteley,Laura %A Bailey,Sarah %A Rogers,Brooke G %A Leigland,Avery %A Rusley,Jack C %A Brown,Larry K %+ Department of Psychiatry, Rhode Island Hospital, 1 Hoppin Street Coro West, Suite 204, Providence, RI, 02903, United States, 1 4017938701, trisha_arnold@brown.edu %K HIV prevention %K pre-exposure prophylaxis %K young Black men who have sex with men %K acceptance and commitment therapy %K protocol %D 2025 %7 20.6.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Given the high rates of HIV infection among young Black men who have sex with men in Jackson, Mississippi, and the underuse of pre-exposure prophylaxis (PrEP) in this population, there is a critical need for innovative interventions to promote PrEP use. Acceptance and commitment therapy (ACT) is a promising intervention for health behavior change. Objective: This study aims to develop and test an intervention, ACTPrEP, to increase PrEP use among young Black men who have sex with men. Methods: We conducted in-depth interviews with 20 young Black men who have sex with men and 10 PrEP staff to inform the development of ACTPrEP, an intervention that uses ACT to improve PrEP use. Specific ACTPrEP adaptations from the qualitative interviews included service settings (interventionists should be PrEP informed and well-integrated), target audiences (provide check-in calls, be caring, and authentically relate), modes of delivery (flexible delivery), and cultural adaptation (normalize PrEP use). A pilot randomized controlled trial will evaluate the feasibility and acceptability of ACTPrEP compared to that of Enhanced Standard of Care in promoting PrEP use among young Black men who have sex with men (N=66). We will specifically evaluate group differences in the proportion of participants who initiate PrEP, PrEP adherence, and PrEP persistence. Measures will be collected at baseline, 6 weeks, and 12 weeks. Results: Research activities began in September 2023 and will be ongoing through June 2026. Preliminary findings are anticipated to be available in late 2026. Conclusions: This study will inform the development of a larger randomized controlled trial to evaluate the efficacy of ACTPrEP for increasing PrEP use among young Black men who have sex with men. Trial Registration: ClinicalTrials.gov NCT05087680; https://clinicaltrials.gov/study/NCT05087680 International Registered Report Identifier (IRRID): DERR1-10.2196/65921 %M 40540736 %R 10.2196/65921 %U https://www.researchprotocols.org/2025/1/e65921 %U https://doi.org/10.2196/65921 %U http://www.ncbi.nlm.nih.gov/pubmed/40540736 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e69131 %T Effect of Live Environmental Music Therapy and Prerecorded Music on State Anxiety, Stress, Pain, and Well-Being Levels of Patients and Caregivers in the Emergency Department Waiting Room: Protocol for a Multicenter Randomized Clinical Trial %A Hernández,Angélica %A Díaz,Ana María %A Moreno,Ornella Fiorillo %A Suárez,Raúl %A Amarillo,Moshé %A Moreno,Ana María %A Ríos Suarez,Bryan Alonso %A Gómez González,Lina Marcela %A Cristancho Olaya,Guiselle Alexandra %A Ettenberger,Mark %+ Clínica Keralty Ibagué, Clínica Colsanitas, Cl. 60 #3-8 no 6, Ibagué, Tolima, 730006, Colombia, 57 3112847635, mark.ettenberger@gmx.at %K anxiety %K emergency department %K mental health %K music therapy %K pain %K stress %K waiting area %D 2025 %7 18.6.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Patients and caregivers attending emergency units often experience elevated levels of stress and anxiety. Music has been used in waiting rooms to reduce stress and anxiety, but existing studies on music therapy in emergency unit waiting areas are scarce and have limitations such as low statistical power and limited music selection. Objective: The aim of this study is to determine the effect of live Environmental Music Therapy and prerecorded music on state anxiety, stress, pain, and well-being levels in patients and caregivers in the emergency unit waiting areas of 2 hospitals in Colombia. Methods: This study is a multicenter randomized clinical trial, with 3 arms: standard care + live Environmental Music Therapy, standard care + prerecorded music, and standard care only. The primary outcome measure is the 6-item State-Trait Anxiety Inventory (STAI-6). Secondary outcome measures are pain and stress levels, both measured with Visual Analogue Scales (VAS), and well-being, measured with the Well-Being Numerical Rating Scales (WB-NRSs). The scales will be applied before and after each intervention. A total of 246 patients (82 in each arm) and 147 caregivers (49 in each arm) will be randomized. Results: Data collection for this study started on September 3, 2024, and as of the submission of the study (November 2024), 216 patients and 134 caregivers have been enrolled. It is expected that the results will be available by May 2025. Conclusions: This study seeks to contribute to improving the mental health, well-being, and quality of care of patients and caregivers in the waiting area of the emergency units. This is the first study in Colombia investigating the effect of live music therapy and prerecorded music interventions in the emergency department. Trial Registration: ClinicalTrials.gov NCT06510153; https://clinicaltrials.gov/study/NCT06510153 International Registered Report Identifier (IRRID): DERR1-10.2196/69131 %R 10.2196/69131 %U https://www.researchprotocols.org/2025/1/e69131 %U https://doi.org/10.2196/69131 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e59682 %T Treatment of Erythematotelangiectatic Rosacea With Collateral Puncture Therapy: Protocol for a Randomized Controlled Trial %A Song,Aolin %A Cui,Bingnan %A Wang,Xuemin %A Bi,Jianing %A Wu,Xiaohong %A Yang,Liu %A Liu,Li %A Qu,Shengyuan %A Fan,Zhu %A Yang,Jiao %A Yan,Yuhe %+ Department of Dermatology, Guang’anmen Hospital, 5 Beixiange St, Xicheng District, Beijing, 100053, China, 86 13521665580, yanyuhe5580@163.com %K erythematotelangiectatic rosacea %K collateral puncture %K intense pulsed light %K randomized controlled trial %K protocol %D 2025 %7 17.6.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Erythematotelangiectatic rosacea (ETR) is the most common subtype of rosacea, characterized by persistent facial erythema and telangiectasia of varying calibers. It causes significant aesthetic impairment and is often accompanied by uncomfortable symptoms, such as burning, stinging, dryness, and itching, profoundly affecting patients’ quality of life. Intense pulsed light (IPL) therapy demonstrates notable improvement in persistent erythema and telangiectasia; however, it is associated with issues such as a prolonged treatment course and high costs. Collateral puncture therapy involves rapid puncturing of specific acupuncture points followed by gentle squeezing around the needle holes to induce minor bleeding. Previous studies have shown that collateral puncture therapy for ETR offers advantages such as rapid onset of effect, a simple procedure, and low cost. Nevertheless, more high-quality clinical research data are needed to confirm these findings. Objective: This study aims to observe the clinical efficacy and safety of collateral puncture therapy in treating ETR. Methods: This study enrolled 60 patients diagnosed with ETR. The patients were randomly divided into 2 groups: one group underwent 4 sessions of collateral puncture therapy with 1-week intervals between treatments, and the other group received a single session of IPL therapy. The primary efficacy end points were the clinician’s erythema assessment and the clinician’s telangiectasia assessment. The secondary efficacy end points included the investigator’s global assessment, patient’s self-assessment, Flushing Assessment Tool results, Dermatology Life Quality Index, and Rosacea-specific Quality-of-Life instrument. The evaluation points were before treatment, immediately after treatment, and during follow-up. The data were statistically analyzed using SPSS (version 25.0; IBM Corp) to compare intragroup and intergroup differences between the 2 sets of data before and after treatment, with a significance level of α=.05 for hypothesis testing. Results: Recruitment began on June 1, 2023. All participants have been recruited. Data analysis will be complete by the end of August 2025, with study findings available by December 2025. Conclusions: This study has the potential to verify the clinical efficacy and safety of collateral puncture therapy in the treatment of ETR, supplement rosacea treatment methods, standardize treatment protocols, and fill a current clinical gap in treating rosacea. Trial Registration: Chinese Clinical Trial Registry ChiCTR2200062639; https://www.chictr.org.cn/showproj.html?proj=177100 International Registered Report Identifier (IRRID): DERR1-10.2196/59682 %M 40527501 %R 10.2196/59682 %U https://www.researchprotocols.org/2025/1/e59682 %U https://doi.org/10.2196/59682 %U http://www.ncbi.nlm.nih.gov/pubmed/40527501 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e68954 %T Effects of Selective Head-and-Neck Cooling on Brain Injury-Related Biomarker Levels and Symptom Rating Following a Boxing Bout: Protocol for an Exploratory Randomized Trial %A Al-Husseini,Ali %A Tegner,Yelverton %A Blennow,Kaj %A Zetterberg,Henrik %A Marklund,Niklas %+ Department of Clinical Sciences Lund, Neurosurgery, Lund University, Klinikgatan 1, EA-blocket plan 4, SUS Lund, Lund, 221 85 Lund, Sweden, 46 (0)46 172145, Ali.al-husseini@med.lu.se %K sports concussion %K biomarker %K boxing %K glial fibrillary acidic protein %K neurofilament-light %D 2025 %7 16.6.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Head impacts are common in contact sports such as boxing and occur at times of elevated core body and brain temperatures induced by the exercise. Following impact, elevated brain temperature may lead to the development of exacerbated brain injury that can be monitored by blood biomarkers. Blood-brain biomarkers S100B and glial fibrillary acidic protein (GFAP) reflect glial injury; neurofilament light (NFL), axonal injury; and Neuron-Specific Enolase (NSE) and Tubulin-associated unit (tau), neuronal injury. Time to peak levels post injury for these biomarkers varies. Levels of S100B l peak early post injury, while NSE, GFAP, and tau are regarded as subacute markers, and NFL shows prolonged increases. We attempt to cover a large spectrum of first week postfight alterations in blood-brain biomarkers and their response to head-neck cooling. Objective: We hypothesized that acute head-and-neck cooling, recently shown to shorten return-to-play in concussed ice hockey players, applied acutely following a boxing bout, is associated with an attenuated concentration of blood biomarkers and improved symptom rating. Methods: The trial is academically driven and funded by external and hospital research funds. Young, healthy elite boxers aged ≥18 years are recruited. Before, and immediately after a competitive boxing bout consisting of 2 or 3 rounds of 2 minutes each, blood samples are drawn. Boxers are randomized to intervention or control management by 1:1 allocation before baseline testing. After the initial postfight blood sample is drawn and symptom rating using the Sports Concussion Assessment Tool-5 (SCAT-5) has been collected, the boxers receive either acute selective head-and-neck cooling for 45 minutes or routine postfight management. The number of head impacts is counted in all boxers on match video recordings. In both groups, blood samples are drawn 45 minutes after the initial postbout blood sample, as well as 3 and 6 days post fight. At all blood sampling time points, the number of symptoms (NOS) and symptom severity score (SSS) are assessed using the symptom rating part of the SCAT-5. The primary endpoint is the difference in biomarker levels (GFAP, NFL, tau, UCH-L1, neuronal-specific enolase) immediately post fight and preintervention, to those obtained at 6 days post fight. The postfight SCAT-5 NOS and SSS are secondary endpoints. Results: Recruitment started in November 2021 and is ongoing. So far, 41 boxers have been included: 20 controls and 21 cooled. Data collection started in October 2024 following the completion of blood sample analysis. We expect to recruit more boxers before the middle of 2025, but challenges with recruitment may limit this. Conclusions: There is no treatment available for boxing-induced brain injury. Biomarkers are surrogate yet objective markers of brain injury, and the head-and-neck cooling treatment may attenuate the concentration of brain injury–related biomarkers as well as reduce symptoms induced by head impacts attained during a boxing fight. Trial Registration: ClinicalTrials.gov NCT06386484; https://clinicaltrials.gov/study/NCT06386484 International Registered Report Identifier (IRRID): DERR1-10.2196/68954 %M 40523276 %R 10.2196/68954 %U https://www.researchprotocols.org/2025/1/e68954 %U https://doi.org/10.2196/68954 %U http://www.ncbi.nlm.nih.gov/pubmed/40523276 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e63586 %T Sexual Health Determinants During the Life Course and Migration of Haitian-Origin People in French Guiana: Protocol for the Parcours d’Haïti Biographical and Transdisciplinary Study %A Alcouffe,Leslie %A Tareau,Marc-Alexandre %A Brun Rambaud,Gabriel %A Lucarelli,Aude %A Boutrou,Mathilde %A Thorey,Camille %A Cantalupi,Greta %A Kpossou,Karl %A Huber,Florence %A Rabier,Sébastien %A Rochemont,Dévi Rita %A Blaise,Théo %A Thomas,Estelle %A Jean,Guerline %A Pierre Louis,Ruth %A Zephirin,Annette %A Basurko,Célia %A Djossou,Félix %A Cissé,Hawa %A Faurous,William %A Drouaud,Quentin %A Mergeay-Fabre,Mayka %A Adenis,Antoine %A Nacher,Mathieu %A Vignier,Nicolas %+ Institut Santé des Populations en Amazonie, Rue des flamboyants, BP6006, Cayenne, 97306, French Guiana, 594 594395050, leslie.alcouffe@inserm.fr %K HIV %K hepatitis B virus %K HBV %K sexual and reproductive health and rights %K transient and migrants %K migrants’ health %K socioeconomic factors %K sexual behavior %K violence %K gender-based violence %K health care quality %K access and evaluation %K health service accessibility %K cultural representations %K French Guiana %K Haiti %D 2025 %7 12.6.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: French Guiana, an overseas territory located in the Guiana Shield in South America, faces unique social and demographic challenges, particularly in relation to migration. Haitians represent 1 of the 3 largest foreign communities in the region and face specific barriers to health care access and prevention. They are also a population exposed to HIV infection. Objective: This Parcours d’Haïti study aims to update knowledge on the health of the Haitian population residing in French Guiana. From a quantitative standpoint, the primary objective of this study was to assess the frequency of sexual behaviors that expose Haitian individuals to HIV risk after arriving in French Guiana and explore the association of this risk with their living conditions. This study adopts a transdisciplinary approach to understand the broader determinants of health and the processes underlying HIV transmission. Methods: This mixed methods study involves a quantitative epidemiological and biographical analysis of Haitian individuals aged 18 to 60 years who have lived in French Guiana for more than 3 months. The biographical component uses a detailed grid that tracks key life events since birth. The qualitative component includes 3 substudies based on semistructured interviews and focus groups with Haitian people and health care professionals. These aim to deepen understanding of health care access, use of traditional and biomedical care, and mental health among Haitians. A phylogenetic component describes the distribution of clades of the Pol gene in the viruses of people living with HIV. The study materials were cocreated with local stakeholders. Recruitment of this partially hidden population used an innovative method involving all local actors and targeting key locations frequented by the Haitian community. Data collection and recruitment were carried out by Haitian Creole–speaking peer investigators (community health mediators). Results: Over 20 months between 2021 and 2023, the Parcours d’Haïti study was implemented in French Guiana. Anticipated results suggest that the main reasons for migration include insecurity and fleeing violence. Upon arrival, Haitian people likely experience significant economic hardship and social isolation. Mental health deterioration is expected, with high rates of posttraumatic stress disorder. People living with HIV are expected to face heightened vulnerability compared to HIV-negative individuals even though they already struggle with precarious living conditions. The qualitative findings regarding health care use indicate that Haitian people encounter numerous barriers to accessing health care, such as administrative complexity, language, and financial and mobility issues. The anthropological results are expected to emphasize the magical-religious origins of HIV and the use of plants and traditional medicine for its treatment. Phylogenetic results are anticipated to show a high prevalence of Caribbean B HIV subtypes. Conclusions: The Parcours d’Haïti study aims to provide valuable insights into the health determinants and HIV-related risks in the Haitian population in French Guiana. These findings should help refine health care policies and practices to better meet the specific needs of this population. Trial Registration: ClinicalTrials.gov NCT05174234; https://clinicaltrials.gov/study/NCT05174234 International Registered Report Identifier (IRRID): DERR1-10.2196/63586 %M 40505127 %R 10.2196/63586 %U https://www.researchprotocols.org/2025/1/e63586 %U https://doi.org/10.2196/63586 %U http://www.ncbi.nlm.nih.gov/pubmed/40505127 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e71255 %T Efficacy and Safety of Haidebao Body Lotion in Patients With Mild Atopic Dermatitis: Protocol for a Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial %A Duan,Zhen %A Ding,Yuning %A Wang,Ruiping %+ Clinical Research Center, Shanghai Skin Diseases Hospital, School of Medicine, Tongji University, 1278 Baode Road, Shanghai, 200443, China, 86 13627971708, w19830901@126.com %K atopic dermatitis %K emollient %K randomized controlled trial %K study protocol %K double blind %K double-blind %D 2025 %7 10.6.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Atopic dermatitis (AD) is a chronic, relapsing skin condition that significantly impacts patients’ quality of life. In clinical practice, AD is commonly managed through the use of emollients and topical corticosteroids. Haidebao Body Lotion (HBL) incorporated with calcium-based antimicrobial peptide compounds (CAPCS) has demonstrated clinical benefits for patients with mild AD, but there is a lack of high-quality clinical trial evidence. Objective: In this study, we will implement a multicenter, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of HBL incorporated with CAPCS as an adjunctive therapy in ameliorating mild AD. Methods: This multicenter, double blind, randomized, placebo-controlled trial will recruit 200 eligible participants from 10 hospitals in China from October 2023 to October 2025. In this study, AD will be confirmed in accordance with Williams diagnostic criteria, and patients with mild AD, aged 18-55 years, who provide signed informed consent will be enrolled. However, patients who are pregnant, have serious underlying diseases, have communication barriers, and violate medication regulations will be excluded. The 200 patients will be randomly assigned (1:1) to a treatment group (HBL with CAPCS; n=100, 50%) and a control group (HBL without CAPCS, placebo; n=100, 50%), and each participant will receive 3 sessions of treatments per day for 4 weeks. The primary outcome is the proportion of patients who achieve at least 60% improvement in the Eczema Area and Severity Index (EASI) score from baseline to week 2. The secondary outcomes include the Numeric Rating Scale (NRS), EASI50, EASI60, and Dermatology Life Quality Index (DLQI) scores at weeks 2 and 4, as well as adherence and adverse events. The full analysis set (FAS) and the per protocol set (PPS) will be analyzed using SAS 9.3 software, and missing data will be processed using the multiple imputation method. In this study, P<.05 is considered statistically significant. Results: Participant recruitment began in January 2024. As of May 2025, we enrolled 180 patients, with 160 (88.9%) completing the 2-week follow-up. Data collection and management are still ongoing, and data analysis has not yet been performed. Conclusions: This study will evaluate the clinical efficacy and safety of HBL incorporated with CAPCS in the treatment of patients with mild AD. If treatment efficacy is proven, HBL incorporated with CAPCS could be clinically used as an adjunctive therapy in ameliorating mild AD. International Registered Report Identifier (IRRID): DERR1-10.2196/71255 %M 40493919 %R 10.2196/71255 %U https://www.researchprotocols.org/2025/1/e71255 %U https://doi.org/10.2196/71255 %U http://www.ncbi.nlm.nih.gov/pubmed/40493919 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e65682 %T Integrated Psychosocial Care in Intensive Care (IPS-Pilot): Protocol for the Systematic, Multimethod Development of a Complex Intervention (Phase A) %A Nickel,Sophie Felicitas %A Korger,Simone %A Schindler,Wencke %A Heytens,Heike %A Krieg,Gironimo %A Drewitz,Karl-Philipp %A Schürmann,Katrin %A Schössow,Leon %A Gehrig,Julianna %A Binneböse,Marius %A Hirning,Christian %A Hönig,Klaus %A Niessen,Rolf Konstantin %A Kirschbaum,Julia %A Erdur,Laurence %A Peter,Sophie %A Junne,Florian %A Rose,Matthias %A Apfelbacher,Christian %A Gündel,Harald %+ Clinic of Psychosomatic Medicine and Psychotherapy, University Hospital Ulm, Albert-Einstein-Allee 23, Ulm, 89081, Germany, 49 73150061801, sophie.nickel@uniklinik-ulm.de %K health services research %K psychosocial intervention %K health personnel %K intensive care units %K critical care %K complex intervention %K feasibility study %D 2025 %7 6.6.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: There is a high, co-dependent strain on health care professionals (HCPs), patients, and their relatives in intensive care units (ICUs), leading to long-term mental, physical, and occupational consequences. To date, there is no systematic intervention to address this growing problem. Objective: The aim of the IPS-Pilot (German: Integrierte Psychosoziale Versorgung; English: “Integrated Psychosocial Care”) project is the development (phase A) and pilot testing (phase B) of an integrated and complex psychosocial care intervention for HCPs, patients, and their relatives in ICUs. This study protocol focuses on phase A. A separate protocol for phase B will be published later. Methods: A structured, multimethod approach was used to gather evidence from the target groups mentioned above on the needs, expected benefits, and necessary conditions for implementation. These methods included (1) a scoping umbrella review conducted by 2 researchers, who independently screened and selected reviews and meta-analyses in the field of needs and demands in the ICU setting, following the Levac framework; (2) web-based and face-to-face interviews and focus group discussions, which were coded independently by 2 researchers and analyzed using qualitative content analysis; the identified categories and codes were then quantified by (3) an online survey conducted with former ICU patients, their relatives, HCPs working in ICUs, and members of the general population. Synthesized results—complemented by the theories of Psychosocial Safety Climate and Conservation of Resources, as well as online and face-to-face stakeholder workshops—were used for intervention development, which was guided by the Intervention Mapping framework. Results: Through the 4 substudies, we aim to gain insights into the psychosocial needs of the aforementioned target groups. Intermediate analyses were conducted to develop both a model of the problem and a model illustrating how these needs can be effectively addressed through a psychosocial intervention that involves integrating a clinically trained psychologist into the HCP team. Data collection and analysis for the intervention development were completed by June 2024, including substudy 1 (n=104 included articles), substudy 2 (n=22 interviews and n=18 participants in focus groups), substudy 3 (n=237 survey participants), and substudy 4 (n=11, n=15, and n=20 participants in 3 consecutive workshops), with further analyses still ongoing beyond the scope of intervention development. The results of the substudies, as well as the final needs-based intervention design, will be published separately. These findings form the basis for the feasibility study (phase B), conducted from July 2024 to July 2025, during which the intervention will be implemented in randomly selected ICU wards and evaluated in terms of feasibility. Conclusions: Phase B will assess the feasibility of the IPS intervention. The findings will be incorporated into the intervention design and serve as the basis for a future randomized controlled trial to evaluate its efficacy. Trial Registration: OSF Registries 10.17605/OSF.IO/VFXJK; https://osf.io/vfxjk International Registered Report Identifier (IRRID): RR1-10.2196/65682 %M 40479723 %R 10.2196/65682 %U https://www.researchprotocols.org/2025/1/e65682 %U https://doi.org/10.2196/65682 %U http://www.ncbi.nlm.nih.gov/pubmed/40479723 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e67319 %T Effectiveness of a Person-Centered and Culturally Sensitive Course of Treatment in Arabic-, Turkish-, and Urdu-Speaking Individuals With Type 2 Diabetes (the ACCT2 Study): Protocol for a Pragmatic Randomized Controlled Trial %A Bjerre,Natasja %A Christensen,Lene %A Hoeiberg,Christina %A Ottosson,Cecilie %A Jensen,Mie Klarskov %A Kildsig,Nanna %A Møller,Trine Kjeldgaard %A Termannsen,Anne-Ditte %A Ewers,Bettina %A Hollender-Schou,Britt %A Grue,Rikke Molin %A Bjerre-Christensen,Ulla %A Jansen,Solveig %A Akram,Kamran %+ Department of Education, Steno Diabetes Center Copenhagen, Copenhagen University Hospital, Borgmester Ib Juuls Vej 83, Herlev, 2730, Denmark, 45 60157718, natasja.bjerre.martinsen@regionh.dk %K immigrants %K migrants %K diabetes management %K ethnic minorities %K trial %K well-being %K public health %K type 2 diabetes %K culturally-sensitive %K randomized controlled trial %D 2025 %7 5.6.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Individuals with non-Western backgrounds consistently exhibit a higher risk of type 2 diabetes (T2D) than ethnic Danes. Factors such as health behaviors, limited health care access, and social determinants of health often contribute to this disparity. Culturally sensitive interventions are crucial; however, effective interventions for managing T2D in non-Western populations remain limited. Objective: This study aims to examine the effect of a 1-year person-centered and culturally sensitive intervention on improving glycemic control (hemoglobin A1c [HbA1c]) in Arabic-, Turkish-, or Urdu-speaking individuals with T2D. The secondary objectives are to improve diabetes management and overall well-being. Methods: This study is designed as a 2-arm randomized controlled trial. A total of 96 women and men with T2D (HbA1c≥53 mmol/mol) speaking either Arabic, Turkish, or Urdu as their native language will be randomized for 1 year to a health care professional–assisted intervention group (person-centered and culturally sensitive course of treatment) or a control group (usual care) in a 1:1 ratio in Denmark. Assessments are scheduled at baseline and 1 year. The primary outcome is HbA1c, while lipids, blood pressure, and patient-reported outcomes, including well-being, diabetes management, health literacy, and use of and adherence to diabetes medication, are secondary outcomes. Feasibility and satisfaction are evaluated through interviews. The study is approved by the Ethics Committee of the Capital Region of Denmark (H-23042245). Results: A 5.0-mmol/mol change in HbA1c is the minimally important difference, requiring 88 participants. To allow for uncertainties and dropouts, the total was increased to 96. As of January 2025, a total of 88 participants have been recruited. Recruitment was completed in March 2025. Data collection will continue until December 2025, with the first results expected by March 2026. Conclusions: This study will contribute to the limited knowledge regarding the effects of person-centered and culturally sensitive treatment approaches for T2D in Arabic-, Turkish-, or Urdu-speaking individuals. The study uses a robust methodological design and will present an alternative avenue for managing T2D and improving overall well-being. The study offers valuable insights into the experiences of participants and health care professionals, including potential obstacles and strategies for implementation in outpatient clinics. Trial Registration: ClinicalTrials.gov NCT06147245; https://clinicaltrials.gov/study/NCT06147245 International Registered Report Identifier (IRRID): DERR1-10.2196/67319 %M 40471662 %R 10.2196/67319 %U https://www.researchprotocols.org/2025/1/e67319 %U https://doi.org/10.2196/67319 %U http://www.ncbi.nlm.nih.gov/pubmed/40471662 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e72672 %T Impact of Virtual Care With Remote Automated Monitoring on the Rate of Acute Hospital Care Post Discharge and Index Length of Hospital Stay: Protocol for the Post Discharge After Surgery Virtual Care With Remote Automated Monitoring Technology 3 (PVC-RAM-3) Trial %A Ofori,Sandra %A McGillion,Michael H %A Borges,Flavia K %A Ouellette,Carley %A Patel,Ameen %A Conen,David %A Marcucci,Maura %A Wang,Michael Ke %A Park,Lily Jaeyoung %A Bell,Conor %A Lounsbury,Jennifer %A Nagatani,Kanae %A Tandon,Vikas %A Wilkieson,Trevor J %A Wyne,Ahraaz %A Harvey,Valerie %A Harrison,Stephanie %A Nenshi,Rahima %A Bogach,Jessica %A Harlock,John %A Cadeddu,Margherita %A Forbes,Shawn %A Haider,Shariq %A Mirza,Reza D %A Narang,Sunita %A Reade,Clare J %A Tushinski,Daniel M %A Raut,Amit %A Raza,Samir %A Scott,Ted %A Adili,Anthony %A Petch,Jeremy %A Devereaux,PJ %+ McMaster University, 1280 Main St W, Hamilton, ON, L8S 4L8, Canada, 1 9055212100 ext 41274, oforis@mcmaster.ca %K elective surgery %K virtual care %K remote automated monitoring %K index length of stay %K acute hospital care %K randomized controlled trial %D 2025 %7 2.6.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: A substantial proportion of patients require acute hospital care after hospital discharge post surgery, and many regions and countries have surgical backlogs. Objective: The Post Discharge After Surgery Virtual Care with Remote Automated Monitoring Technology-3 (PCV-RAM-3) trial tests the hypothesis that informing surgeons and patients of virtual care with remote automated monitoring (VC-RAM) assignment will promote earlier discharge, thereby reducing the index length of hospital stay, and that postdischarge VC-RAM will reduce acute hospital care. Methods: The PVC-RAM-3 trial is a randomized controlled trial that compares VC-RAM to standard postdischarge care among 2500 adults undergoing elective noncardiac surgery in 3 Canadian hospitals. Following the randomization of patients prior to surgery, surgeons and patients are immediately notified whether the patient has been allocated to the VC-RAM or control group. Outcome adjudicators remain blinded to each participant’s group assignment. Patients in the intervention arm learn to use a Health Canada–approved cellular modem–enabled tablet computer and Bluetooth-enabled remote automated monitoring technology from Cloud DX to take daily wound photos for 7 days and measure daily vital signs (ie, blood pressure, heart rate, oxygen saturation, temperature, and weight) three times daily on days 1-7 and twice daily on days 8-14 post discharge, along with completing a brief recovery survey. Nurses review these data and conduct scheduled virtual visits (days 1, 3, 7, and 14). Nurses will escalate care to a preassigned and available perioperative care physician if predetermined vital sign thresholds are exceeded, concerning symptoms arise, or a medication error is detected. These physicians manage the issues and add or modify treatments as needed. The standard care group will receive postdischarge care as per the standard of care at the hospital where they undergo surgery. The coprimary outcomes are acute hospital care and the index hospital length of stay within the first 30 days after randomization. Results: Study recruitment and follow-up are completed, and analysis of the study results is underway. Conclusions: This trial will offer insights into the role of VC-RAM in reducing acute hospital care and index length of hospital stay among adults undergoing elective surgery. Trial Registration: ClinicalTrials.gov NCT05171569; https://clinicaltrials.gov/ct2/show/NCT05171569 International Registered Report Identifier (IRRID): DERR1-10.2196/72672 %R 10.2196/72672 %U https://www.researchprotocols.org/2025/1/e72672 %U https://doi.org/10.2196/72672 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e63050 %T The Effects of Acupoint Stimulation Combined With Transcutaneous Electrical Nerve Stimulation on Labor Pain: Protocol for a Stepped Wedge Cluster Randomized Controlled Trial %A Gu,Yiyun %A Wang,Xiaojiao %A Zhu,Chunxiang %A Min,Hui %A Zhang,Jialu %A Mao,Liping %A Gao,Hua %A Sun,Hangyun %A Zhu,Xinli %A Gu,Chunyi %+ Department of Nursing, Obstetrics and Gynecology Hospital of Fudan University, No. 419, Fangxie Road, Huangpu District, Shanghai, 200011, China, 86 15821932583, guchunyi@fudan.edu.cn %K labor pain %K transcutaneous electric nerve stimulation %K acupressure %K complementary therapies %K pain management %K acupuncture points %K medicine, Chinese traditional %K pulsed electrotherapy %K electrotherapy %K nerve %K pain %K acupuncture %K women %K protocol %K randomized controlled trial %K childbirth %K pregnancy %K pregnant women %K quantitative data %K qualitative data %D 2025 %7 26.5.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Pain experienced during childbirth can significantly impact the progress of labor and the well-being of both the mother and the fetus. Effective management of labor pain is a crucial component of childbirth care. Nonpharmacological methods of pain relief offer notable advantages over pharmacological approaches, including enhanced maternal and fetal safety, equitable access to health care, and greater availability. Among the nonpharmacological options, transcutaneous electrical nerve stimulation (TENS) and acupoint stimulation are two commonly used methods for alleviating pain during labor. However, the clinical efficacy of these methods remains inconsistent, which hinders the generation of high-quality evidence for clinical practice. Objective: This study aims to assess the effects of acupoint stimulation combined with TENS on labor pain, delivery outcomes, and childbirth experience for women undergoing a trial of labor. Methods: This is a 12-month stepped wedge cluster randomized trial to be conducted in 4 labor and delivery units (LDUs) at the Obstetrics and Gynecology Hospital of Fudan University. Each unit will implement 4 types of interventions: TENS, acupoint stimulation, TENS combined with acupoint stimulation, and a control group. We aim to recruit approximately 588 pregnant women. The project will be evaluated using both quantitative and qualitative data. Quantitative data will include visual analog scale (VAS) scores, the nonpharmacological to pharmacological pain management interval (NPI), the rate of epidural analgesia, and childbirth outcomes. Qualitative data will include interviews with the women and midwives. Results: The study commenced on April 1, 2023, and as of March 29, 2024, a total of 600 eligible participants have been enrolled, surpassing the initial target of 588. Data collection has been completed, including quantitative assessments of labor pain intensity, analgesic use, and childbirth outcomes, alongside qualitative interviews with participating women. Currently, data analysis is in progress, with preliminary findings anticipated to be available by March 2025. We hypothesize that TENS combined with acupoint stimulation will demonstrate greater efficacy in managing labor pain compared with standard care. This effect may be observed in key outcome measures, including the VAS score and enhanced maternal childbirth experience. Conclusions: This study protocol details the interventions of acupoint stimulation and TENS for women undergoing a trial of labor. We introduce a novel outcome indicator termed NPI, which monitors whether the application of nonpharmacological pain relief measures can delay or prevent the use of epidural analgesia. The integration of qualitative and quantitative methods will enrich the research on TENS and acupoint stimulation technology within the realm of nonpharmacological labor pain relief, providing high-quality evidence for the future establishment of industry standards and guidelines. Trial Registration: Chinese Clinical Trial Registry ChiCTR2300069705; https://tinyurl.com/2s3mkhr7 International Registered Report Identifier (IRRID): DERR1-10.2196/63050 %M 40418802 %R 10.2196/63050 %U https://www.researchprotocols.org/2025/1/e63050 %U https://doi.org/10.2196/63050 %U http://www.ncbi.nlm.nih.gov/pubmed/40418802 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e71850 %T A Clinical Study on the Efficacy of Acupuncture Treatment in Essential Hypertension: Protocol for Randomized Controlled Trial %A Hao,Xiaomin %A Zhang,Lili %A Gong,Yu %A Wang,Jun %A Qin,Weilan %A Zhang,Xudong %A Guo,Qiulei %A Xu,Meng %A Lv,Taotao %A Guo,Yan %A Liu,Yu %A Liu,Jipeng %A Yue,Bingnan %A Liu,Qingguo %+ School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, No. 11, North Third Ring East Road, Chaoyang District, Beijing., Beijing, 100029, China, 86 18801316550, liuqingguo888@vip.sina.com %K acupuncture %K sham acupuncture %K hypertension %K randomized controlled trial %K study protocol %D 2025 %7 23.5.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Primary hypertension represents a significant global public health issue and is a major risk factor for severe cardiovascular disease complications. Previous research has indicated that acupuncture, as a relatively safe therapeutic approach, effectively reduces blood pressure and alleviates clinical symptoms. Objective: This study aims to assess the clinical efficacy and safety of the “HuoXueSanFeng” acupuncture technique in patients with essential hypertension. Methods: This investigation is designed as a multicenter, randomized, single-blind, sham-controlled clinical trial. A total of 228 participants with essential hypertension will be recruited from 5 tertiary hospitals in China. Participants will be randomly allocated to either the acupuncture group or the sham acupuncture group in a 1:1 ratio. Each participant will undergo treatment 3 times per week over a 6-week period, amounting to 18 sessions in total. Follow-up assessments will be conducted at 1, 2, and 4 weeks post treatment. The primary outcome measures include 24-hour ambulatory blood pressure and immediate in-office blood pressure readings. Secondary outcome measures included the Dizziness Handicap Inventory, the Headache Impact Test-6, and the Pittsburgh Sleep Quality Index. In addition, any adverse events will be documented throughout the study to assess safety. Results: This study was registered with the China Clinical Trial Registration Center on May 23, 2024. Data collection commenced in July 2024 and is anticipated to conclude in June 2025. Currently, the study is in the data collection phase, with 27 participants recruited, and data analysis has yet to be conducted. The findings of this study are expected to be submitted for publication in November 2025. Conclusions: The outcomes of this study are anticipated to further elucidate the benefits of acupuncture in reducing blood pressure and to provide more robust evidence for the treatment of essential hypertension using the “HuoXueSanFeng” acupuncture method. Trial Registration: Chinese Clinical Trial Registry ChiCTR2400084696; https://www.chictr.org.cn/showprojEN.html?proj=229194 International Registered Report Identifier (IRRID): DERR1-10.2196/71850 %M 40409751 %R 10.2196/71850 %U https://www.researchprotocols.org/2025/1/e71850 %U https://doi.org/10.2196/71850 %U http://www.ncbi.nlm.nih.gov/pubmed/40409751 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e66417 %T Impact of Mānuka Honey on Symptoms and Quality of Life in Individuals With Functional Dyspepsia: Protocol for a Feasibility Randomized Controlled Trial %A Ombasa,Laura %A Miller,Jody %A Ware,Lara %A Abbotts-Holmes,Holly %A Tang,Jeffry %A Gasser,Olivier %A Fraser,Karl %A Bayer,Simone %A Kemp,Roslyn %A Costello,Rory %A Highton,Andrew %A Evans,Jackie %A Merry,Troy %A Schultz,Michael %A Frampton,Chris %A Gearry,Richard %A McNabb,Warren %A Roy,Nicole %+ , Department of Human Nutrition, University of Otago, PO Box 56, Dunedin, 9054, New Zealand, 64 3 479 3197, jody.miller@otago.ac.nz %K functional dyspepsia %K quality of life %K mānuka honey %K Lepteridine %K randomised controlled trial %K feasibility protocol %D 2025 %7 21.5.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Functional dyspepsia is a common gastrointestinal condition that reduces the quality of life and increases health care costs. The lack of well-defined causes limits effective treatments. Consumers report using mānuka honey to treat gastrointestinal symptoms, although clinical evidence supporting such use is limited. Preclinical studies suggest its unique bioactive compounds may reduce gastrointestinal inflammation. Recently, 3,6,7-trimethyllumazine (Lepteridine), a natural pteridine in mānuka honey, was shown to inhibit enzymes involved in gastrointestinal inflammation in in vitro studies. Therefore, Lepteridine-standardized mānuka honey may deliver digestive health benefits. Objective: The aim of this feasibility study is to gather the data required to estimate sample size and support study logistics to design future trials. The primary objective will be preliminary assessments of the impact of Lepteridine-standardized mānuka honey on symptom severity and the quality of life in participants with mild-to-moderate functional dyspepsia. Other feasibility objectives include assessing the biological responses to mānuka honey standardized to medium and high levels of Lepteridine and measuring mānuka honey–derived metabolites in blood and urine. Methods: This is a 3-arm, parallel, controlled, double-blind, randomized feasibility study. A total of 75 healthy adults with symptoms of functional dyspepsia (Rome IV criteria) and mild-to-moderate dyspepsia severity (Short Form Leeds Dyspepsia Questionnaire) were recruited between October 2022 and September 2023. Participants were randomized into one of three groups: (1) mānuka honey standardized to contain 10 mg/kg Lepteridine, (2) mānuka honey standardized to contain 40 mg/kg Lepteridine, or (3) honey maple flavored syrup control. After a 2-week lead-in period, participants consumed 10 g of allocated intervention twice daily for 6 weeks. Throughout the study, participants completed daily bowel movement diaries and validated weekly questionnaires about their gastrointestinal symptoms and quality of life. Stool samples and 3-day diet records were collected at baseline and the end of the intervention. Blood samples were collected at baseline, weeks 2 and 4, and at the end of the intervention. In addition, 6 healthy participants without symptoms of functional dyspepsia were recruited to undergo an acute 5-hour assessment for the appearance of Lepteridine and related metabolites in plasma and urine following consumption of Lepteridine-standardized mānuka honey. The study was approved by the Northern B Health and Disability Ethics Committee. Results: Initial analysis includes 68 participants, with laboratory and data analyses being undertaken as of March 2024. The results of the primary and secondary outcomes will be published in peer-reviewed journals. Conclusions: This study will provide essential information on the potential efficacy and suitability of Lepteridine-standardized mānuka honey for designing future clinical trials investigating its effect in treating symptoms of functional dyspepsia. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12622001140741p; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=384094 International Registered Report Identifier (IRRID): DERR1-10.2196/66417 %M 40397937 %R 10.2196/66417 %U https://www.researchprotocols.org/2025/1/e66417 %U https://doi.org/10.2196/66417 %U http://www.ncbi.nlm.nih.gov/pubmed/40397937 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e57866 %T Testing an Innovative Gait Training Program in Immersive Virtual Reality for Healthy Older Adults: Protocol for a Randomized Controlled Trial %A Mascret,Nicolas %A Delbes,Lisa %A Goulon,Cédric %A Montagne,Gilles %+ Aix-Marseille Univ, CNRS, ISM, 163 Avenue de Luminy, Marseille, 13009, France, 33 0681021556, gilles.montagne@univ-amu.fr %K virtual reality %K VR %K exercise %K locomotion %K adaptive behavior %K aging %K accident prevention %K falls %D 2025 %7 21.5.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Impaired gait adaptability is one of the major causes of falls among older adults owing to inappropriate gait adjustments in cluttered environments. Training programs designed to improve gait adaptability behavior in a systemic approach may prevent falls in older adults. Recently, virtual reality (VR) technology has been prominent as a relevant gait training tool because of its training implementation potential. Objective: This study was designed to compare the effectiveness of a VR-based gait training program (VR group) for improving gait adaptability behavior and, thus, reducing the risk of falls relative to a conventional training program such as Nordic walking (NW; NW group). We hypothesized that the VR-based gait training program will lead to greater gait adaptability improvements. Methods: We will be conducting a randomized controlled trial with pretests, posttests, retention tests, and follow-up. In total, 40 healthy independent-living community dwellers (aged between 65 and 80 years) will be allocated, after a general medical examination, to the VR or the NW group for a training program of 6 weeks. Primary outcomes related to gait adaptability capacities (ie, analysis of adjustments made in different locomotor tasks) and acceptance of the VR device (ie, analysis of acceptance) will be assessed before and after the intervention and 1 month after the completion of the training program (retention). A follow-up will be done during the 12 months after the completion of the gait training program. Results: Data collection will begin in September 2025, and the first results are expected in December 2025. Conclusions: The findings of this study may demonstrate the relative relevance of a gait training program in VR versus a conventional one for improving gait adaptability behavior in healthy older adults and, thus, prevent the chances of a fall. International Registered Report Identifier (IRRID): PRR1-10.2196/57866 %M 40397488 %R 10.2196/57866 %U https://www.researchprotocols.org/2025/1/e57866 %U https://doi.org/10.2196/57866 %U http://www.ncbi.nlm.nih.gov/pubmed/40397488 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e63723 %T The Communities Organizing for Power Through Empathy (COPE) Community-Based Intervention to Improve Adult Mental Health During Disasters and Crises: Protocol for a Stepped-Wedge Cluster Randomized Trial %A Scott,Jennifer %A Powell,Tara %A Lee-Johnson,Natasha M %+ , School of Social Work, Louisiana State University, 3212 Huey P. Long Fieldhouse, Baton Rouge, LA, 70803, United States, 1 5126263011, jenscott@lsu.edu %K mental health %K community-based group mental health intervention %K disaster %K community-based participatory research %K stepped wedge cluster randomized trial %K Gulf Coast %D 2025 %7 20.5.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Severe weather events, exacerbated by climate change, can lead to hardships such as displacement, resource scarcity, and social network disruptions. Such disasters impact mental health, triggering conditions such as anxiety, depression, and posttraumatic stress disorder. For communities in the Gulf South, the increasing frequency of disasters often further exacerbates already disastrous levels of inequality. In this context, there is an urgent need for evidence-based, multilevel, community-based interventions to support individual and community mental health and resilience. Objective: This protocol describes the design of a community-based participatory research (CBPR) study to improve individual and community mental health in Gulf South communities by examining the implementation and effects of the multilevel, community-based intervention, Communities Organizing for Power through Empathy (COPE). Specifically, this study aims to (1) examine factors affecting the implementation, effectiveness, and adoption of the COPE intervention and (2) test its effects on mental health and community resilience. We hypothesize that participants in the COPE intervention will experience greater reductions in psychological distress (eg, perceived stress, anxiety, and depression); improvements in protective factors (eg, social support and coping self-efficacy); and community participation as compared with an attention control group. Methods: The Consolidated Framework for Implementation Research guides our analysis of data collected from surveys, fidelity and field notes, interviews, and focus groups to examine aim 1. We examine aim 2 primarily via a 2-arm pragmatic stepped-wedge cluster randomized trial (SW-CRT) with individuals (approximately n=300) in clusters (faith-based and secular community-based organizations; approximately n=15) in a disaster-prone community in the US Gulf Coast. The cluster-based design implemented in steps supports the community-based nature of the study where timelines differ by organization. A total of 5 self-assessments will be conducted both in person and via email at later time points. We will integrate mixed methods in our analyses for aim 1 by combining themes from interviews and focus groups with implementation measures, and for aim 2 by constructing a data matrix to combine findings from the SW-CRT with thematic analyses of field notes and interviews. Results: The SW-CRT is being conducted from June 2022 to June 2025. Recruitment began in April 2023, to conclude in spring 2025, to assess mental health, social support, and community resilience at 5 time points. Data analysis and dissemination of results are expected by spring of 2026. Conclusions: This protocol is among the first to use a CBPR approach to examine the implementation and effectiveness of a multilevel intervention on psychological distress and resilience. This study provides new insights into how CBPR can enhance intervention implementation research and expand the evidence on community-based mental health interventions during disasters. Policy makers should consider integrating CBPR approaches into disaster response frameworks to ensure culturally relevant and sustainable outcomes. Trial Registration: ClinicalTrials.gov NCT06093737; https://clinicaltrials.gov/study/NCT06093737 International Registered Report Identifier (IRRID): DERR1-10.2196/63723 %M 40392582 %R 10.2196/63723 %U https://www.researchprotocols.org/2025/1/e63723 %U https://doi.org/10.2196/63723 %U http://www.ncbi.nlm.nih.gov/pubmed/40392582 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e68280 %T Water, Sanitation, and Hygiene for Everyone Intervention Study: Protocol for a Controlled Before-and-After Trial %A Chidziwisano,Kondwani %A Panulo,Mindy %A MacLeod,Clara %A Vigneri,Marcella %A White,Blessings %A Wells,Joseph %A Ross,Ian %A Morse,Tracy %A Dreibelbis,Robert %+ Centre for Water, Sanitation, Health and Appropriate Technology Development (WASHTED), Malawi University of Business and Applied Sciences, P/Bag 303, Chichiri, Blantyre, Malawi, 265 888384965, kchidziwisano@mubas.ac.mw %K community-led total sanitation %K care group model %K WASH for everyone %K Malawi %K sanitation intervention trial %D 2025 %7 15.5.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Community-based behavior change interventions are a common approach to Water, Sanitation, and Hygiene (WASH). Yet, published evaluations of how these interventions work in district-wide approaches are rare. Objective: This study reports the baseline characteristics and study design for a trial assessing the effectiveness of a district-level Community-led Total Sanitation (CLTS) intervention compared to the additional integration of local care groups (CG) on sanitation coverage and use and hygiene behaviors in Chiradzulu District, Malawi. Methods: This study is a controlled before-and-after trial with 2 treatment arms and a control group. Clusters are rural villages in 3 traditional authorities (TAs). One arm will receive CLTS and the CG model (CLTS+CG group), one arm CLTS only (CLTS group), and one group will serve as the control. The trial is part of the wider WASH for Everyone (W4E) project, led by World Vision Malawi that aims to expand access to WASH services across the entire district by 2025. Study participants were selected from the 3 TAs. Systematic sampling procedures were used to select 20 households per cluster with a total of 1400 households at both baseline and end line. The primary outcome is sanitation coverage. Secondary outcome measures include sanitation use, safe disposal of child feces, observed handwashing facility, and Sanitation-related Quality of Life Index (SanQoL-5). Results: The baseline observations indicate a balanced distribution of potential demographic confounders in the trial arms with a slight variation on some WASH proxy measures. We noted the low coverage of handwashing facilities with soap and water in all 3 arms: 8% in the CLTS group, 4% in the CLTS+CG group, and 4% in the control group. There was a marginal variation in handwashing practices among the study arms with 3% of individuals handwashing with soap and water in the CLTS group, 5% in the CLTS+CG group, and 2% in the control group. Sanitation coverage also varied among the study arms at baseline as 83% of households had access to unimproved sanitation in the CLTS group, 70% in the CLTS+CG group, and 81% in the control group. Conclusions: Results from this trial will provide evidence on whether the CLTS+CG approach is effective at improving sanitation and hygiene practices in the W4E program area compared to CLTS alone and no intervention, as well as inform implementing partners on future interventions in Chiradzulu District, Malawi. The results are expected to be published in 2025. Trial Registration: ClinicalTrials.gov NCT05808218; https://clinicaltrials.gov/study/NCT05808218 International Registered Report Identifier (IRRID): RR1-10.2196/68280 %M 40373302 %R 10.2196/68280 %U https://www.researchprotocols.org/2025/1/e68280 %U https://doi.org/10.2196/68280 %U http://www.ncbi.nlm.nih.gov/pubmed/40373302 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e70953 %T Clinical Efficacy and Safety of the Herbal Prescription, HH333, in Preventing Recurrent Stroke in Patients With Ischemic Stroke Induced by Small-Vessel Disease: Protocol for Multicenter, Double-Blind, Randomized, Prospective, Pilot Clinical Trial %A Lee,Han-Gyul %A Kwon,Seungwon %A Jung,Woo-Sang %A Moon,Sang-Kwan %A Kim,Cheol-Hyun %A Choi,Dong-Jun %+ Department of Cardiology and Neurology, College of Korean Medicine, Kyung Hee University Medical Center, Kyung Hee University, 23 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea, 82 1094117329, kkokkottung@hanmail.net %K HH333 %K ischemic stroke %K herbal medicine %K randomized controlled trial %K protocol %D 2025 %7 13.5.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Patients with ischemic stroke are at high risk of recurrence, making preventive care an important factor. Current antiplatelet therapy for recurrence prevention treatment has several limitations. Recent retrospective observational studies suggested that HH333, an herbal prescription, has an inhibitory effect on stroke recurrence in small-vessel diseases. Objective: This study aims to propose a protocol for evaluating the efficacy and safety of HH333 in patients with ischemic stroke induced by small-vessel disease. Methods: In this multicenter, double-blind, randomized, prospective, pilot clinical trial, 236 patients from 3 university Korean medicine hospitals in South Korea with ischemic stroke caused by small-vessel disease will be recruited and randomly assigned to either the HH333 or the placebo group. Both patients and investigators will be blinded to prevent access to the allocation results. The HH333 group will take 2 capsules of HH333 once daily for 720 days, whereas the placebo group will take HH333 placebo capsules in the same manner. Efficacy will be assessed using the recurrence rate of ischemic stroke, which will be assessed on days 30, 90, 180, 270, 360, 450, 540, 630, 720, and 750 after starting the medication. The effects on quality of life and fatigue with the Fatigue Severity Scale (FSS), Fatigue Assessment Scale (FAS), and Korean Patient Health Questionnaire (K-PHQ-9), functional improvement with Korean National Institutes of Health Stroke Scale (K-NIHSS), modified Rankin Scale (mRS), Korean modified Barthel Index (K-mBI), and Korean Montreal Cognitive Assessment (K-MoCA) and Pattern Identification also will be evaluated on days 0, 90, 180, 270, 360, 450, 540, 630, and 720 after starting the medication. Safety will be evaluated by performing blood and urine tests and electrocardiography on days 30, 90, 180, 270, 360, 450, 540, 630, and 720 after starting the medication. Results: Recruitment for the study started on May 22, 2024, and is scheduled to end on November 30, 2026. As of November 13, 2024, a total of 12 participants have been randomized. Conclusions: The protocol will provide a detailed process for a clinical trial evaluating the efficacy of preventing recurrent ischemic stroke caused by small-vessel disease and improving neurologic symptoms and the safety of HH333 in ischemic stroke. The results of this study provide a basis for alternative treatments to prevent and treat ischemic stroke. Trial Registration: Clinical Research Information Service KCT0009431; https://tinyurl.com/y2ctvje8 International Registered Report Identifier (IRRID): DERR1-10.2196/70953 %M 40358993 %R 10.2196/70953 %U https://www.researchprotocols.org/2025/1/e70953 %U https://doi.org/10.2196/70953 %U http://www.ncbi.nlm.nih.gov/pubmed/40358993 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e66246 %T Evaluating the Efficacy and Safety of 48-Week Low-Dose Dienogest Administration in Patients With Dysmenorrhea Caused by Endometriosis: Protocol for a Randomized, Open-Label, Parallel-Group Trial %A Kikuno,Kyoko %A Asada,Ryuta %A Ishihara,Takuma %A Bomoto,Yoshimasa %A Murase,Saki %A Ueda,Yoko %A Shiga,Tomomi %A Hayasaki,Yoh %A Furui,Tatsuro %A Matsuzaki,Satoko %A Takemura,Masahiko %A Matsunami,Kazutoshi %A Kubo,Makoto %A Ito,Naoki %A Isobe,Masanori %A Morishige,Ken-ichirou %+ Department of Obstetrics and Gynecology, Gifu University Medical School Hospital, 1-1 Yanagido Gifu, Gifu, 5011112, Japan, 81 0582306349, kikuno.kyoko.f0@f.gifu-u.ac.jp %K endometriosis %K dysmenorrhea %K dienogest %K clinical trial %K open-label %D 2025 %7 13.5.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: The treatment of endometriosis includes analgesics, hormone therapy, and surgery. Even after surgical removal of endometriotic lesions, the risk of recurrence remains high once the normal menstrual cycle resumes. Therefore, long-term hormone therapy is essential to prevent recurrence. Among hormonal treatments, low-dose estrogen progestin preparations are not recommended for patients older than 40 years due to the increased risk of thrombotic side effects. In contrast, dienogest does not carry a thrombotic risk, making it a suitable option for older patients. Although dienogest requires long-term administration until menopause in patients with endometriosis, data on its long-term efficacy and potential adverse effects remain limited. In particular, comparative studies assessing the safety and effectiveness of long-term use of dienogest at different doses (1 mg/day vs 2 mg/day) have not been conducted, highlighting the need for further investigation. Objective: The purpose of this study is to investigate the efficacy and the incidence of adverse events of dienogest 1 mg/day after 48 weeks in patients with dysmenorrhea due to endometriosis, compared with dienogest 2 mg/day. Methods: This randomized, open-label, parallel-group, dose-comparison, multicenter trial follows the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 guidelines and is conducted at 6 centers in Japan. Participants are randomly assigned in a 1:1 ratio to receive either dienogest 1 mg/day or 2 mg/day. The drug is administered for 48 weeks, and its therapeutic effects and side effects are evaluated. Hospital visits include the use of questionnaires, vital sign measurements, imaging studies (magnetic resonance imaging and ultrasound), blood tests, and bone density assessments. The primary endpoint is the change in the pain visual analog scale (VAS) score from baseline to 48 weeks. The VAS is a 10 cm horizontal scale where 0 cm represents no pain and 10 cm represents the maximum imaginable pain; participants indicate their pain level on the scale, and the change is analyzed over time. The target sample size is 88, determined with a noninferiority margin based on existing literature. The protocol was approved by the Nagoya City University Hospital Clinical Research Review Board. Findings will be presented at academic conferences and published in peer-reviewed journals. Results: Currently, data collection is ongoing. The first participant was enrolled in August 2021. As of March 22, 2025, a total of 88 participants had been enrolled in this clinical trial. Conclusions: This is the first trial to compare efficacy and safety between 1 mg/day and 2 mg/day of long-term dienogest use in patients with dysmenorrhea caused by endometriosis. Combining diagnostic imaging with patient questionnaires and blood tests allows the determination of efficacy against endometriosis itself. Trial Registration: Japan Registry of Clinical Trials jRCTs041210016; https://jrct.mhlw.go.jp/en-latest-detail/jRCTs041210016 International Registered Report Identifier (IRRID): DERR1-10.2196/66246 %M 40358998 %R 10.2196/66246 %U https://www.researchprotocols.org/2025/1/e66246 %U https://doi.org/10.2196/66246 %U http://www.ncbi.nlm.nih.gov/pubmed/40358998 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e62951 %T Effect of Early Treatment of Spasticity After Stroke on Motor Recovery: Protocol for the Baclotox Multicenter, Double-Blind, Double-Dummy Randomized Controlled Trial %A Montane,Emmeline %A Brihmat,Nabila %A Cormier,Camille %A Thalamas,Claire %A Rousseau,Vanessa %A Tap,Gerard %A De Boissezon,Xavier %A Castel-Lacanal,Evelyne %A , %A Marque,Philippe %+ Department of Physical and Rehabilitation Medicine, Toulouse University Hospital Centre, Place du Dr Baylac, Toulouse, 31059, France, 33 561776700, montane.e@chu-toulouse.fr %K stroke %K rehabilitation %K muscle spasticity %K botulinum toxin A %K baclofen %K hemiplegia %K motor recovery %D 2025 %7 9.5.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Individuals with poststroke hemiplegia often develop spasticity, which increases disability. Antispastic treatments such as baclofen and botulinum toxin are commonly prescribed in poststroke recovery. However, their impact on motor recovery, especially when administered within the first 2 months after stroke, remains unclear. Objective: This study aims to compare the motor recovery effects of botulinum toxin versus oral baclofen. The hypothesis is that botulinum toxin is more supportive of motor recovery than baclofen and enhances functional recovery. Methods: The study is a multicenter, controlled phase IV, comparative, prospective, randomized, double-blind, double-dummy, superiority trial to compare the toxin and baclofen, and a noninferiority trial to compare the toxin and the placebo. It focuses on the time course of the Fugl-Meyer Motor Assessment (FMA) as the primary outcome. The main inclusion criterion is patients with a single stroke in the past 2 months. Treatment comprises 1 intramuscular injection at treatment initiation and oral tablets for 4 months. Randomized patients are allocated to 3 arms: botulinum toxin with placebo baclofen, baclofen with placebo botulinum toxin, and placebo baclofen with placebo botulinum toxin. FMA scores are assessed at pretreatment, 1 month, and 3 months later. Spasticity, functional abilities, activities of daily living, pain, and quality of life are also evaluated. Adverse effects are monitored. A positive difference of 13 points in the FMA time course between the botulinum toxin and baclofen groups is considered a relevant effect. The data analysis plan involves linear regression models to compare primary and secondary outcomes, with adjustments for covariates such as age, center, and associated treatments. Subgroup analyses will examine proportional recovery profiles, and missing data in Fugl-Meyer scores will be addressed using imputation methods. Results: A total of 179 participants were randomized across 18 centers, with inclusions delayed due to the COVID-19 pandemic. As of December 2024, the data manager currently has all the data, and a review of data quality is in progress. No statistical analysis has been conducted so far, and the blind will be lifted after the analysis. Conclusions: This study identifies the most suitable spasticity treatment, considering the specificities of the stroke and constraints during the recovery phase. It will provide recommendations for the primary treatment of early spasticity post stroke. Trial Registration: ClinicalTrials.gov NCT02462317; https://clinicaltrials.gov/study/NCT02462317; European clinical trials (EudraCT) 2010-022881-28; https://www.clinicaltrialsregister.eu/ctr-search/trial/2010-022881-28/FR International Registered Report Identifier (IRRID): DERR1-10.2196/62951 %M 40344664 %R 10.2196/62951 %U https://www.researchprotocols.org/2025/1/e62951 %U https://doi.org/10.2196/62951 %U http://www.ncbi.nlm.nih.gov/pubmed/40344664 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e67570 %T Metabolic Flexibility to Predict Lifestyle Interventions Outcomes (MEPHISTO): Protocol for Predictive Validation Study and Randomized Controlled Trial %A Ludlova,Monika %A Koudelková,Kateřina %A Pallova,Jitka %A Koudelkova,Barbora %A Siklova,Michaela %A Cahova,Monika %A Vetrovsky,Tomas %A Steffl,Michal %A Gojda,Jan %+ Faculty of Physical Education and Sport, Charles University, José Martího 31, Prague, 16000, Czech Republic, 420 778701882, michal.steffl@ftvs.cuni.cz %K obesity %K overweight %K weight loss %K physical activity %K exercise %K gut microbiota %K metabolic flexibility %K diabetes %K endocrinology %K validation study %K randomized control trial %K protocol %D 2025 %7 8.5.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Weight loss is a cornerstone of obesity treatment and diabetes mellitus type 2 (T2D) prevention, but its implementation in clinical practice is limited by its perceived burden and variability in response. Personalizing interventions to increase their success rate is an unmet clinical need. Objective: Identification of predictive factors associated with successful weight loss after sequential exercise in women with obesity. Methods: The study will consist of a 2-stage analytical approach, including a predictive validation study and a 2:1 randomized cross-over controlled trial. Women aged 25-45 years with obesity (BMI>30) will be included in the study. The intervention will consist of a progressive protocol of aerobic exercise on a treadmill and a bicycle ergometer. We will measure weight loss in terms of fat mass (FM) and fat-free mass (FFM), metabolic flexibility (MetFlex) as ΔRQ (change in respiratory quotient (VCO2/VO2) between basal and insulin-stimulated state during glucose clamp), insulin sensitivity, glucose tolerance, hemoglobin A1c, microbiome composition, and metabolomic signatures. Results: Recruitment for the trial began in January 2024. A total of 12 participants were enrolled and randomized. Among them 6 participants have completed the first phase of the A-arm and 6 participants have completed the control period of the B-arm and their intervention is ongoing. Recruitment is ongoing. We expect the preliminary data from this study to be completed in 2026. Conclusions: This intervention will investigate whether whole body and gut MetFlex can be further explored and used as ex ante predictors of successful weight loss following exercise intervention, providing proof of concept and paving the way for personalized lifestyle interventions. Trial Registration: ClinicalTrials.gov NCT06329349; https://clinicaltrials.gov/study/NCT06329349 International Registered Report Identifier (IRRID): DERR1-10.2196/67570 %M 40340957 %R 10.2196/67570 %U https://www.researchprotocols.org/2025/1/e67570 %U https://doi.org/10.2196/67570 %U http://www.ncbi.nlm.nih.gov/pubmed/40340957 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e67557 %T Effects of Traditional Chinese Exercise Yijinjing on Disability and Muscle Strength Among Patients With Chronic Low Back Pain: Protocol for a Randomized Controlled Trial %A Guo,Lei %A Wang,Cheng %A Bai,Xue %A Tian,Yukui %A Shi,Mengni %A Fang,Min %A Li,Jing Xian %A Zhu,Qingguang %A Liu,Junchang %+ College of Traditional Chinese Medicine, Xinjiang Medical University, No.567 Shangde North Road, Shuimogou District, Urumqi, 830000, China, 86 13899969290, 625854402@qq.com %K chronic low back pain %K traditional Chinese exercise %K Yijinjing %K muscle strength %K randomized controlled trial %D 2025 %7 7.5.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Chronic low back pain (CLBP) is a common public health problem. Progressive loss of muscle strength leads to long-term chronic pain and disability. Yijinjing exercises, an ancient therapy dating back thousands of years, are widely used in China to treat low back pain. However, little is known about its benefits and scientific evidence for back extensor strength. This trial aimed to assess the efficacy of Yijinjing on disability and dorsal extensor strength in patients with CLBP. Objective: We present a randomized controlled study to evaluate the efficacy of the traditional Chinese exercise Yijinjing on disability and back extensor strength in patients with CLBP. Methods: This is a 2-arm, parallel-design, assessor-blinded, and analyst-blinded randomized controlled trial. The 106 participants with CLBP who were recruited will first receive basic traditional Chinese manual therapy to help relieve their physical discomfort. Second, they will be randomly divided into a Yijinjing group (n=53) and a control group with functional exercises (n=53) at a ratio of 1:1. The interventions for both groups will be carried out twice a week for 4 weeks. Patients in both groups will be followed up at 1 and 3 months after the intervention. The primary outcome is disability (measured by the Oswestry Disability Index). The secondary outcomes included pain intensity (assessed by the Numerical Rating Scale), data from isokinetic dynamometry, flexibility (assessed by the fingertip-to-floor test), mood (evaluated by the Pain Catastrophizing Scale and Fear Avoidance Beliefs Questionnaire), and quality of life (measured by the EQ-5D-5L). All adverse effects will be assessed using the Treatment Emerging Symptoms Scale, and data will be analyzed using an intention-to-treat analysis. Results: The trial was funded in December 2023. The Institutional Ethics Committee of Yueyang Hospital of Integrative Medicine, Shanghai University of Traditional Chinese Medicine, approved this study. The first patient was enrolled in February 2024, and as of August 2024, a total of 106 participants have been recruited. Data analysis has not yet begun and is expected to be published in January 2025. The protocol has been registered with the Chinese Clinical Trial Registry (ChiCTR2400081105). Conclusions: If this trial proves effective, it will guide the setup of a randomized controlled trial to demonstrate whether traditional Chinese exercise Yijinjing improves disability in patients with CLBP and is more effective than usual stretching exercises. Trial Registration: Chinese Clinical Trial Registry ChiCTR2400081105; https://www.chictr.org.cn/showprojEN.html?proj=214425 International Registered Report Identifier (IRRID): DERR1-10.2196/67557 %M 40334269 %R 10.2196/67557 %U https://www.researchprotocols.org/2025/1/e67557 %U https://doi.org/10.2196/67557 %U http://www.ncbi.nlm.nih.gov/pubmed/40334269 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e66115 %T Short- and Long-Term Effectiveness of Brief Intensive Trauma Treatment for Adolescents With Posttraumatic Stress Disorder and Their Caregivers: Protocol for a Multicenter Randomized Controlled Trial %A Westerveld,Myrna M %A van der Mheen,Malindi %A Knipschild,Rik %A Maijer,Kim %A de Keizer-Altink,Marieke E %A Albisser,Nina %A Hoekstra,Marielle J E %A Timmermans-Jansen,Anne %A Zijp,Rosa %A Krabbendam,Anne A %A van Steensel,Francisca J A (Bonny) %A Kan,Kees-Jan %A Huyser,Chaim %A Staal,Wouter G %A Utens,Elisabeth M W J %A Lindauer,Ramón J L %+ Department of Child and Adolescent Psychiatry, Amsterdam University Medical Center Location University of Amsterdam, Meibergdreef 9, Amsterdam, 1105 AZ, The Netherlands, 31 205669111, r.lindauer@levvel.nl %K brief intensive trauma treatment %K adolescents %K stress disorder %K post-traumatic %K adverse childhood experiences %K eye movement desensitization reprocessing %K trauma-focused cognitive behavioral therapy %K Caribbean %K randomized controlled trials %K multicenter studies %D 2025 %7 30.4.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Childhood trauma is pervasive, with approximately 50% of adolescents experiencing at least one potentially traumatic event before adulthood. Eight percent to 33% of potentially traumatic event–exposed adolescents develop posttraumatic stress disorder (PTSD), which can cause extreme suffering and coincides with numerous comorbid illnesses and high-risk behaviors. PTSD can be effectively treated in adolescents through weekly sessions of eye movement desensitization and reprocessing or trauma-focused cognitive behavioral therapy. Despite the availability of these treatments, numerous severely traumatized adolescents do not receive available treatment options due to high treatment avoidance. In adolescents who receive care, a large group of youth does not experience a sufficient symptom decrease after regular treatment. In addition, dropout rates during prolonged treatment are substantial, varying between 10% and 30%. This underscores the need for innovative and brief trauma treatment. Pilot studies indicate that Brief Intensive Trauma Treatment (BITT) can be a safe and effective treatment for adolescents with PTSD. However, randomized controlled trials on its effectiveness are crucial and urgently needed. Objective: This is the first study to test the effectiveness of a 1-week BITT in adolescents with PTSD and comorbid symptoms and their caregivers. Methods: This multicenter, single-blinded randomized controlled trial will be conducted in 4 youth care centers in the European and Caribbean Netherlands: Levvel, Karakter, Fornhese-GGz Centraal, and Mental Health Caribbean (Bonaire). We will randomize adolescents (12-18 years old) with PTSD to a BITT (n=50) or waitlist control group (WLCG; n=50). BITT comprises 1-week (ie, 5 consecutive workdays) intensive trauma treatment, encompassing daily 90-minute manualized sessions of trauma-focused cognitive behavioral therapy and eye movement desensitization and reprocessing. The day begins and ends with psychomotor therapy. Caregivers receive daily parental counseling sessions consisting of psychoeducation and social support skill training. We will conduct measurements at similar intervals for both groups: at baseline; directly after BITT or WLCG; and at 3, 6, and 9 months’ follow-up. The WLCG will receive BITT after the 3-month follow-up assessment. We will assess all study parameters using digital or face-to-face questionnaires and semistructured interviews. We will assess the primary outcome PTSD symptoms using the Child and Adolescent Trauma Screen 2 (CATS-2) and the Clinician-Administered PTSD Scale for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders [Fifth Edition])-Child/Adolescent Version (CAPS-CA-5). Results: As of September 2022, we enrolled 104 participants. Data will be collected until December 2025. Results are expected to be published in the summer of 2026. Conclusions: This first, innovative study on BITT’s effectiveness may enhance treatment outcomes for PTSD by preventing dropout, reducing avoidance, shortening therapy duration, and empowering therapists by working together intensively. This research will provide valuable insights across cultures for treating severely traumatized adolescents who do not benefit sufficiently from regular treatment. Trial Registration: ClinicalTrials.gov NCT06143982, http://clinicaltrials.gov/ct2/show/NCT06143982 International Registered Report Identifier (IRRID): DERR1-10.2196/66115 %M 40306642 %R 10.2196/66115 %U https://www.researchprotocols.org/2025/1/e66115 %U https://doi.org/10.2196/66115 %U http://www.ncbi.nlm.nih.gov/pubmed/40306642 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e67392 %T Efficacy of DaXianXiong Decoction in Preventing the Progression of Acute Pancreatitis Severity: Protocol for a Randomized Controlled Trial %A Ren,Dongsheng %A Tan,Judan %A Zhou,Yuling %A Luo,Zhenchun %+ Department of Emergency and Intensive Critical Unit, Chongqing Hospital of Traditional Chinese Medicine, No.6, Seventh Branch Road, Panxi, Jiangbei District, Chongqing, 400021, China, 86 18166588991, 35480830@qq.com %K acute pancreatitis %K traditional Chinese medicine %K protocol %K severe acute pancreatitis %K prevent %D 2025 %7 29.4.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Low- and middle-income countries are facing an increase in the incidence of acute pancreatitis (AP)—characterized by rapid onset, fast progression, high rate of severity, and high mortality. Progression of AP into severe AP (SAP) results in a series of complications such as organ dysfunction, local abscesses, pseudocysts, and necrosis. Although the treatment of AP is primarily supportive, including fluid resuscitation and organ support, there is still a lack of consensus on the optimal management regimen for fluid therapy, and strategies to promote gastrointestinal recovery remain limited. As no effective intervention measure has yet been developed, supportive therapy remains the primary approach for the early treatment of AP. DaXianXiong decoction is a widely used traditional Chinese medicine formulation; however, limited research has been conducted on its clinical efficacy. Objective: This study aims to evaluate the efficacy and safety of DaXianXiong decoction in preventing AP from progressing to SAP, assessing its impact on SAP incidence, clinical severity scores, inflammation markers, and gastrointestinal function, and providing evidence for AP management. Methods: This study is a randomized, double-blind, placebo-controlled, single-center clinical trial. The primary outcomes will include the incidence of SAP, modified computed tomography severity index score, APACHE II (Acute Physiology and Chronic Health Evaluation II) score, modified Marshall score, and levels of the inflammation factor. The secondary outcomes will include the effect of the gastrointestinal dysfunction treatment. Evaluations will be conducted at baseline; 24 hours after the intervention; and on days 3, 7, and 28 after the intervention in both groups. A total of 60 eligible patients will be randomly allocated in a 1:1 ratio to the intervention group and the control group. Both groups will receive standard Western medical treatment for pancreatitis. The intervention group will additionally receive DaXianXiong decoction, while the control group will receive a placebo similar to the decoction. Results: This study has been funded by the Performance Incentive Project of Scientific Research Institutions in Chongqing. The trial was registered in April 2024, and data analysis is expected to be completed by April 2025. The study results will be presented at both national and international conferences and published in peer-reviewed journals. Conclusions: This trial will help us assess the effectiveness and safety of DaXianXiong decoction in patients with AP and provide clinical evidence on the efficacy and safety of DaXianXiong decoction in preventing the progression of AP to SAP. By evaluating its impact, the findings will contribute to the understanding of DaXianXiong decoction as an adjunct therapy in AP management and may offer a novel complementary treatment strategy for AP, potentially improving patient outcomes and reducing complications. Trial Registration: Chinese Clinical Trial Registry ChiCTR2300076885; https://www.chictr.org.cn/showproj.html?proj=207084 International Registered Report Identifier (IRRID): DERR1-10.2196/67392 %M 40098229 %R 10.2196/67392 %U https://www.researchprotocols.org/2025/1/e67392 %U https://doi.org/10.2196/67392 %U http://www.ncbi.nlm.nih.gov/pubmed/40098229 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e65958 %T Impact of Tai Chi Therapy on Fatigue and Cognitive Function in Individuals With Chronic Fatigue Syndrome: Protocol for a Pilot Randomized Controlled Trial %A Wang,Bin %A Zhang,Xiaodong %A Lu,Ping %A Sun,Pingping %A He,Tianxiang %+ , Department of Tuina, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Number 528, Zhangheng Road, Pudong New Area, Shanghai, 201203, China, 86 13310009629, hetianxiang@126.com %K Tai Chi %K chronic fatigue syndrome %K cognitive impairment %K ANT %K N-Back %K fatigue %K cognitive function %K cognitive %K protocol %K protocols %K randomized controlled trial %K RCT %K controlled trial %K controlled trials %K psychosomatic disorder %K cognition %K therapy %K efficacy %K safety %K CFS %K intervention %K data analysis %D 2025 %7 25.4.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Chronic fatigue syndrome (CFS) is a psychosomatic disorder characterized by persistent fatigue, primarily involving physical and mental exhaustion, with greater emphasis on the latter. This leads to a deterioration in concentration and memory. These symptoms affect cognitive functions, including attention and memory, to varying degrees. Previous research has shown that Tai Chi can help reduce fatigue in individuals with CFS. However, the relationship between alleviating CFS-related fatigue through Tai Chi and its impact on cognitive functions remains unclear. The effects of Tai Chi on cognitive functions in individuals with CFS have not been clinically validated, and its efficacy and safety have yet to be examined through large-scale randomized controlled trials. Therefore, this protocol outlines a pilot randomized, parallel, single-blind clinical trial designed to evaluate the impact of Tai Chi therapy on fatigue and cognitive functions in individuals with CFS, using both subjective and objective assessments. Objective: This pilot study aims to explore the preliminary efficacy and safety of Tai Chi in reducing fatigue and improving cognitive function in patients with CFS, and to generate data to inform future large-scale trials. Methods: We will conduct a randomized, analyst-blinded, parallel-controlled trial with a 12-week intervention period and a 4-week follow-up. Enrolled patients will be randomly assigned to either the Tai Chi group (30 patients) or the health education group (30 patients). The Tai Chi group will receive the 24-style simplified Tai Chi intervention, while the control group will receive a health education intervention. Following the 12-week intervention, a 4-week follow-up will be conducted. The Tai Chi group will train 3 times per week, consisting of 2 in-person sessions at the Physical Education Center of Shanghai University of Traditional Chinese Medicine and 1 self-directed session guided online by an instructor. The primary outcome measure is the 20-item Multi-Dimensional Fatigue Inventory (MFI-20). The secondary outcome measures include the Montreal Cognitive Assessment (MoCA), Pittsburgh Sleep Quality Index (PSQI), Attention Network Test (ANT), working memory performance (N-Back task), and magnetic resonance imaging. Results: The research protocol and informed consent form were approved by the Shanghai Clinical Research Ethics Committee on March 18, 2024 (approval number SECCR2024-22-01). Participant recruitment began in April 2024. All interventions and concurrent data collection will be completed by October 2025, and the 4-week postintervention follow-up assessments will be finalized by the end of October 2025. Data management is still ongoing; therefore, data analysis has not yet been performed. Conclusions: As a pilot trial, the findings of this study will provide preliminary clinical evidence on the role of Tai Chi in improving cognitive function in patients with CFS and will serve as a foundation for designing future large-scale trials. Trial Registration: China Clinical Trials Registry ChiCTR2400082268; https://tinyurl.com/2tkr7j7x International Registered Report Identifier (IRRID): DERR1-10.2196/65958 %M 40279641 %R 10.2196/65958 %U https://www.researchprotocols.org/2025/1/e65958 %U https://doi.org/10.2196/65958 %U http://www.ncbi.nlm.nih.gov/pubmed/40279641 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e66210 %T A Rent Subsidy and Identity Capital Intervention for Youth Exiting Homelessness: Protocol for the Transitioning Youth Out of Homelessness 2.0 Pilot Randomized Controlled Trial %A Thulien,Naomi S %A Stark,Rowen K %A Amiri,Alexandra %A Abramovich,Alex %A Akdikmen,Alex %A Carasco,Alexandra %A Daley,Mardi %A Downey,Bernice %A Fambegbe,Oluwapelumi (Pukky) %A Frederick,Tyler %A Hwang,Stephen W %A Kozloff,Nicole %A Noble,Amanda %A Pedersen,Cheryl %A Rampersaud,Marsha %A Rodney,Ruth %A Tibebu,Tadios %A Nisenbaum,Rosane %+ MAP Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute of St Michael's Hospital, Unity Health Toronto, 209 Victoria St., Toronto, ON, M5B 1T8, Canada, 1 647 460 0781, naomi.thulien@unityhealth.to %K youth homelessness %K socioeconomic inclusion %K transition %K critical qualitative methodology %K community-based research %K identity capital %K youth %K homeless %K rent %K community %K feasibility %K acceptability %K novel intervention %K socioeconomic %K participatory action research %K pilot study %K protocol %K RCT %K randomized controlled trial %D 2025 %7 25.4.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: For young people who have experienced homelessness, relative housing stability alone is insufficient to achieve socioeconomic inclusion. There is little peer-reviewed research investigating interventions targeting socioeconomic inclusion outcomes for youth who have experienced homelessness. Our previous community-engaged work signaled that identity capital (purpose, control, self-efficacy, and self-esteem) may mediate socioeconomic inclusion outcomes for youth exiting homelessness. This 12-month pilot randomized controlled trial (RCT) explores whether portable rent subsidies and an intervention targeting identity capital hold promise as a way to facilitate socioeconomic inclusion for youth exiting homelessness and living in market rent housing in Ontario, Canada. Objective: The objectives of this study were (1) to examine the feasibility and acceptability of an RCT of targeted economic and identity-based supports to foster socioeconomic inclusion (primary objective), (2) to estimate the effect of adding identity-based supports to economic supports (intervention group) compared with economic supports alone (control group) at the 12-month end point with respect to self-reported proxy indicators of socioeconomic inclusion (secondary objective), and (3) to explore, among the intervention group, whether the estimated effect of the intervention differs by baseline variables or level of engagement with the intervention (exploratory objective). Methods: This study is a convergent mixed methods, 2-arm parallel RCT, open-label design with 1:1 allocation. All youth participants (n=40) received rent subsidies; half were randomly assigned an identity capital intervention (co-designed leadership guide+coach). The overall study was guided by community-based participatory action research axiology. The qualitative component used a qualitative descriptive design underpinned by critical social theory. The measures used were (1) recruitment, enrolment, and dropout metrics; self-report composite checklists regarding intervention engagement; coaching session attendance; and qualitative focus groups (primary measures); (2) education, employment, and training; housing security; and identity capital (secondary measures); and (3) impact of baseline variables (eg, participant demographics such as gender or mental health symptoms as measured by the Global Appraisal of Individual Needs–Short Screener) or level of engagement with intervention (coaching session attendance) on secondary measures (exploratory measures). Results: Recruitment and enrolment began March 1, 2023, and ended June 19, 2023. Data collection began March 7, 2023, and ended June 17, 2024. Qualitative and quantitative data analyses concluded on August 20, 2024. Conclusions: Findings from this RCT will help inform the way we conceptualize the types of supports that are necessary to sustain successful exits from homelessness. The intervention was co-designed with youth who have experienced homelessness, and their voices will continue to inform the next iteration of this work. Trial Registration: ClinicalTrials.gov NCT05781503; https://clinicaltrials.gov/study/NCT05781503 International Registered Report Identifier (IRRID): DERR1-10.2196/66210 %M 40279147 %R 10.2196/66210 %U https://www.researchprotocols.org/2025/1/e66210 %U https://doi.org/10.2196/66210 %U http://www.ncbi.nlm.nih.gov/pubmed/40279147 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e66770 %T Comparison of Efficiency of Closed Kinetic Chain Exercises Versus Proprioceptive Exercises in Improving Balance and Gait in People With Hemophilia: Protocol for a Randomized Controlled Trial %A Poyraz Isleyen,Tugce %A Tarakci,Ela %A Leblebici,Gokce %A Yeldan,Ipek %A Zulfikar,Bulent %+ Department of Physiotherapy and Rehabilitation, Institute of Graduate Studies, Istanbul University-Cerrahpaşa, Bağlariçi Cd No 7, 34320 Avcılar, Istanbul, 34330, Turkey, 90 0 (212) 381 00 ext 9216, fzt.tugcepoyraz@gmail.com %K hemophilia A %K hemophilia B %K exercise %K gait %K postural balance %K efficiency %K hemophilia %K proprioceptive exercises %K balance %K protocol %K randomized controlled trial (RCT) %K bleeding disorder %K protein deficiencies %K blood clotting %K quality of life %K young adult %K teenager %D 2025 %7 24.4.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Inherited bleeding disorders involve prolonged bleeding due to clotting protein deficiencies, with hemophilia A and B being the most common types. The severity of bleeding in people with hemophilia depends on the deficient factor level. Treatment includes coagulation factor concentrates, nonreplacement preparations, gene therapies, and physiotherapy, whereby bleeding is prevented, symptoms are reduced, and the quality of life is improved. Closed kinetic chain exercises improve joint stability and neuromuscular control by stabilizing the proximal base, making them favored in musculoskeletal rehabilitation. Proprioceptive exercise training improves the sensorimotor system’s adaptability and injury prevention through tailored programs involving progressively complex movements and surfaces. Objective: The aim of this study is to investigate the effects of closed kinetic chain exercises and proprioceptive exercise training on improving balance and walking in people with hemophilia. Methods: This study is a 3-arm, parallel-group randomized controlled trial with 63 people with hemophilia aged 13-25 years who meet the inclusion criteria. The primary outcome measures are medio-lateral swing, anterior-posterior swing, walking speed, and Hemophilia Joint Health Score. Secondary outcome measures are kinematic assessment of gait, one-leg stand test, 6-minute walk distance (6MWD) test, proprioception assessment, and the Functional Independence Score in Hemophilia. Participants will be evaluated with the Biodex balance system for postural sway, 10-meters walking test for gait speed, Hemophilia Joint Health Score for joint health, Kinovea 2D motion analysis for kinematic evaluation of gait, one-leg stand test for balance measurement, 6MWD for functional capacity, digital goniometer for proprioception, and Functional Independence Score in Hemophilia for functional independence. Participants will be randomly assigned to a closed kinetic chain exercise group, a proprioceptive exercise group, or a control group. All participants in exercise training groups will receive a 30-minute education session on joint protection techniques and energy conservation prior to the first exercise session. Closed kinetic chain exercises will include progressive lower limb exercises of approximately 45 minutes each session. Proprioceptive exercise training will focus on vibration training; reposition exercises and proprioception exercises will be administered to increase proprioceptive input for the same duration as the other group. The control group will receive no intervention. All participants will undergo 24 exercise sessions (2 days a week for 12 weeks). After the treatment, the initial measurements will be repeated. Results: This study began in September 2023 and is scheduled to be completed in May 2025. A total of 34 participants have completed the study to date. Conclusions: This study will investigate the effects of 2 different exercises on functional parameters in people with hemophilia. The effects of different exercise protocols on parameters such as postural sway, walking speed, and joint health will be evaluated. It is predicted that both exercise methods may have positive effects on balance and gait. Trial Registration: Clinical Trials.gov NCT05879549; https://clinicaltrials.gov/study/NCT05879549 International Registered Report Identifier (IRRID): DERR1-10.2196/66770 %M 40273449 %R 10.2196/66770 %U https://www.researchprotocols.org/2025/1/e66770 %U https://doi.org/10.2196/66770 %U http://www.ncbi.nlm.nih.gov/pubmed/40273449 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e68441 %T The Comprehensive Adaptive Multisite Prevention of University Student Suicide Trial: Protocol for a Randomized Controlled Trial %A Blalock,Kyla %A Pistorello,Jacqueline %A Rizvi,Shireen L %A Seeley,John R %A Kassing,Francesca %A Sinclair,James %A Oshin,Linda A %A Gallop,Robert J %A Fry,Cassidy M %A Snyderman,Ted %A Jobes,David A %A Crumlish,Jennifer %A Krall,Hannah R %A Stadelman,Susan %A Gözenman-Sapin,Filiz %A Davies,Kate %A Steele,David %A Goldston,David B %A Compton,Scott N %+ Duke University, 2608 Erwin Rd, Suite 300, Durham, NC, 27705, United States, 1 9196844686, kyla.machell@duke.edu %K suicide %K adaptive treatment strategies %K Collaborative Assessment and Management of Suicidality %K CAMS %K dialectical behavior therapy %K DBT %K university students %D 2025 %7 22.4.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Suicidal ideation is increasing among university students. Despite growing demand for services, university counseling centers (UCCs) face limited resources to meet the complex needs of students who are suicidal. Objective: The Comprehensive Adaptive Multisite Prevention of University Student Suicide (CAMPUS) Trial evaluates 4 treatment sequences within UCCs to develop evidence-based treatment guidelines. Methods: The CAMPUS Trial consists of a feasibility study followed by a sequential multiple-assignment randomized trial (SMART). The original CAMPUS protocol was modified during the COVID-19 pandemic to accommodate new UCC tele–mental health services, including remote treatment, assessments, and monitoring. A smaller-scale feasibility study was conducted to (1) evaluate implementation of hybrid telehealth and in-person interventions and (2) fine-tune online procedures. Following the feasibility study, university students (aged 18-25 years) seeking UCC services with moderate to severe suicidal ideation will enroll in the CAMPUS Trial. Student participants are randomly assigned to 1 of 4 treatment sequences with 2 stages of intervention. In stage 1, students receive 4 to 6 weeks of either (1) a suicide-focused treatment—Collaborative Assessment and Management of Suicidality—or (2) enhanced treatment as usual. Treatment responders enter the maintenance phase. In stage 2, nonresponders are rerandomized for an additional 1 to 8 weeks of (1) Collaborative Assessment and Management of Suicidality or (2) an intensive skills-based treatment—dialectical behavior therapy for UCC settings. UCC counselors will enroll in the CAMPUS Trial to complete measures about their experience working with students who are suicidal. CAMPUS Trial administration includes representation from all sites to facilitate cross-site coordination and an advisory board of stakeholders from all UCCs to facilitate treatment implementation. Results: Student participant recruitment began on October 25, 2022, and ended on May 16, 2024. As of November 2024, data collection for the SMART was ongoing with active study participants. Data collection was completed in November 2024, and as of April 2025, data analysis is underway. Full results will be available in 2025. Conclusions: The CAMPUS Trial offers a model for future SMARTs for the treatment of suicidal thoughts or behaviors (or both) across various settings. The results will inform treatment guidelines for students presenting with suicidality at UCCs. Trial Registration: ClinicalTrials.gov NCT04707066; http://clinicaltrials.gov/ct2/show/NCT04707066 International Registered Report Identifier (IRRID): DERR1-10.2196/68441 %M 40262131 %R 10.2196/68441 %U https://www.researchprotocols.org/2025/1/e68441 %U https://doi.org/10.2196/68441 %U http://www.ncbi.nlm.nih.gov/pubmed/40262131 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e67120 %T Interventions to Reduce Serum Per- and Poly-Fluoroalkyl Substances Levels, Improve Cardiovascular Risk Profiles, and Improve Epigenetic Age Acceleration in US Firefighters: Protocol for Randomized Controlled Trial %A Conner,Reagan %A Porter,Cynthia %A Lutrick,Karen %A Beitel,Shawn C %A Hollister,James %A Healy,Olivia %A Kern,Krystal J %A Wardenaar,Floris %A Gulotta,John J %A Jack,Kepra %A Huentelman,Matthew %A Burgess,Jefferey L %A Furlong,Melissa %+ Department of Community, Environment and Policy, Mel and Enid Zuckerman College of Public Health, University of Arizona, 1295 N Martin Ave, Tucson, AZ, 85724, United States, 1 512 663 1594, mfurlong@arizona.edu %K firefighters %K PFAS %K epigenetics %K phenotype %K heart disease %K cardiovascular disease %K CVD %K atherosclerosis %K occupational health %K RCT %K cardiovascular %K fasting %K exercise %D 2025 %7 16.4.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Occupational cancer and acute cardiac events are the leading causes of death among firefighters. Increased exposure to toxicants on the fire ground, such as polycyclic aromatic hydrocarbons, benzene, and per- and poly-fluoroalkyl substances (PFAS), has been linked to certain cancers, cardiovascular disease, accelerated epigenetic aging, and other adverse health effects. PFAS are a major concern because they are persistent, can bioaccumulate, and are present in several firefighting tools. Compared to the general population, firefighters have elevated serum levels of some types of PFAS. A randomized clinical trial in Australian firefighters found that routine blood and plasma donation for 1 year led to decreased serum PFAS levels, although health outcomes were not directly measured in that study. Objective: In collaboration with fire service leadership in Arizona, the Firefighter Collaborative Research Project (FCRP) was established to evaluate the effectiveness of 3 interventions in a randomized controlled trial design to reduce serum PFAS levels, reduce cancer and cardiovascular risk, and improve overall health and wellness in US firefighters. Methods: This study aimed to recruit and enroll up to 1500 active firefighters between August 2023 and October 2024. Between August 2023 and October 2024, active firefighters were recruited and randomized into a study arm based on their eligibility, including serum PFOS levels, for the specific arms. The trial arms include (1) blood and plasma donation, (2) zone 2 physical activity, and (3) intermittent fasting. FCRP outcomes include serum PFAS reduction (arm 1), epigenetic age acceleration (all arms), cardiovascular conditioning (arm 2) and cognitive outcomes (all arms), mental health (all arms), and overall disease risk (all arms). Each study arm includes an intervention and a control group. At enrollment and end of the study, participants provide blood and urine samples and complete a comprehensive questionnaire on their occupational and health history, exposures, and lifestyle behaviors. At the end of the study, participants also participated in a cognitive evaluation. Depending on the study arm, participants may additionally complete a cardiopulmonary exercise test at baseline and follow-up, a mid-study survey, and a mid-study blood and urine collection. Results: Participant activities and data collection will conclude by December 2025. Conclusions: The FCRP is a randomized controlled trial that aims to test the effectiveness of fire service–selected interventions in reducing serum PFAS levels. Study results will contribute to potential interventions that could be used to reduce serum PFAS levels in firefighters. Trial Registration: ClinicalTrials.gov NCT05869747; https://clinicaltrials.gov/study/NCT05869747 International Registered Report Identifier (IRRID): DERR1-10.2196/67120 %M 40239196 %R 10.2196/67120 %U https://www.researchprotocols.org/2025/1/e67120 %U https://doi.org/10.2196/67120 %U http://www.ncbi.nlm.nih.gov/pubmed/40239196 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e69829 %T Methadone Patient Access to Collaborative Treatment: Protocol for a Pilot and a Randomized Controlled Trial to Establish Feasibility of Adoption and Impact on Methadone Treatment Delivery and Patient Outcomes %A Meyerson,Beth E %A Davis,Alissa %A Crosby,Richard A %A Linde-Krieger,Linnea B %A Brady,Benjamin R %A Carter,Gregory A %A Mahoney,Arlene N %A Frank,David %A Rothers,Janet %A Coffee,Zhanette %A Deuble,Elana %A Ebert,Jonathon %A Jablonsky,Mary F %A Juarez,Marlena %A Lee,Barbara %A Lorenz,Heather M %A Pava,Michael D %A Tinsely,Kristen %A Yousaf,Sana %+ Harm Reduction Research Lab, University of Arizona College of Medicine-Tucson, 655 N Alvernon Way, Tucson, AZ, 85711, United States, 1 520 626 0275, bmeyerson@arizona.edu %K methadone %K implementation %K patient-centered treatment %K opioid use disorder %K posttraumatic stress symptoms %K vicarious trauma %D 2025 %7 15.4.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Access to methadone treatment can reduce opioid overdose death by up to 60%, but US patient outcomes are suboptimal. Federally allowed methadone treatment accommodations during the COVID-19 public health emergency were not widely adopted. It is likely that staff-level characteristics such as trauma symptoms influence the adoption of treatment innovation. Objective: Methadone Patient Access to Collaborative Treatment (MPACT) is a 2-phased project (pilot and field trial) to develop and test a staff-level, multimodal intervention to increase staff adoption of low-barrier, patient-centered methadone treatment practices and ultimately improve treatment retention and patient outcomes. Methods: A pilot and national trial will measure implementation feasibility, acceptability, and effects of the MPACT intervention on treatment practice change, clinic culture, patient retention, and patient posttraumatic stress symptoms (PTSS). The pilot will be a single-arm 5.5-month pilot study of MPACT conducted in 2 Arizona methadone treatment clinics (rural and urban) among 100 patients and 22 staff. The national trial will be a 20-month cluster randomized trial conducted among 30 clinics, 600 patients (20 per clinic), and 480 staff (18 per clinic). Data will be gathered by staff and patient surveys and patient chart review. The primary study outcome is increased patient methadone treatment retention measured as (1) time to first treatment interruption from study enrollment; (2) active in treatment at enrollment, day 30, 60, 90, and 120; and (3) continuous days in treatment during the study period. Secondary study outcomes include reductions in vicarious trauma and PTSS among enrolled opioid treatment program staff and PTSS among enrolled patients. Results: The pilot study was funded by the National Institute on Drug Abuse (award R61DA059889, funded September 2023), and the field trial will be funded under the associated R33 mechanism in September 2025. The pilot study was completed in March 2025. The randomized controlled trial will begin in December 2025. Both the pilot and trial have been approved by the University of Arizona Human Subjects Protection Program and have been registered with the clinical trials network. Conclusions: The MPACT study will provide a foundation for an evidence-based, staff-level intervention aimed at improving patient retention in methadone treatment. Future studies should examine the individual components of MPACT to determine their differential contributions to the primary outcome of patient methadone treatment retention and to secondary outcomes of staff and patient reduction in stress symptoms. Trial Registration: ClinicalTrials.gov NCT06513728; https://clinicaltrials.gov/study/NCT06513728 and ClinicalTrials.gov NCT06556602; https://clinicaltrials.gov/study/NCT06556602 International Registered Report Identifier (IRRID): DERR1-10.2196/69829 %M 40105313 %R 10.2196/69829 %U https://www.researchprotocols.org/2025/1/e69829 %U https://doi.org/10.2196/69829 %U http://www.ncbi.nlm.nih.gov/pubmed/40105313 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e51434 %T Effect of Continuous Positive Airway Pressure or Positional Therapy Compared to Control for Treatment of Obstructive Sleep Apnea on the Development of Gestational Diabetes Mellitus in Pregnancy: Protocol for Feasibility Randomized Controlled Trial %A Clements,Frances %A Vedam,Hima %A Chung,Yewon %A Smoleniec,John %A Sullivan,Colin %A Shanmugalingam,Renuka %A Hennessy,Annemarie %A Makris,Angela %+ Department of Respiratory and Sleep Medicine, Liverpool Hospital, South Western Sydney Local Health District, 13 Elizabeth St, Sydney, 2170, Australia, 61 287384101, frances.clements@health.nsw.gov.au %K obstructive sleep apnoea %K OSA %K sleep disordered breathing %K pregnancy %K CPAP %K positional therapy %K gestational diabetes %K GDM %K preeclampsia %K fetomaternal %K maternal %K pregnant %K fetus %K fetal %K breathing %K apnoea %K sleep %K respiratory %K eclampsia %K pregnant women %K pregnancy complications %K hypertension %D 2025 %7 11.4.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Obstructive sleep apnea (OSA) is a common sleep disorder, and in pregnancy, it is associated with an increased risk of complications, including gestational diabetes mellitus and preeclampsia. Supine sleep may worsen OSA, and in pregnancy, it is associated with an increased risk of stillbirth due to effects on fetomaternal blood flow. Continuous positive airway pressure (CPAP) therapy is considered the gold-standard treatment for moderate to severe OSA, although compliance is frequently poor; positional therapy (PT) is generally less effective than CPAP in nonpregnant patients but may be better tolerated and more accessible during pregnancy. There is limited data on whether widespread, early screening for sleep disorders in pregnant women with symptoms of sleep-disordered breathing or at high risk of metabolic complications and subsequent early intervention with CPAP or PT attenuates fetomaternal risks. Objective: This study aims to determine the feasibility of conducting a randomized controlled trial to assess improved fetomaternal outcomes in a high-risk pregnant population with OSA, using CPAP or PT, initiated by the 16th week of gestation. Methods: This study is a randomized, controlled, open-label feasibility study in which pregnant women with an apnea-hypopnea index (AHI) or respiratory disturbance index (RDI) ≥5 are treated with CPAP (auto-titrating and fixed pressure) or positional therapy from early gestation (by 16 weeks) until delivery. The primary outcome is the feasibility of the study protocol and the development of gestational diabetes mellitus by the 28-week gestation period. Secondary outcomes include the development of hypertensive disorders of pregnancy (HDP), maternal weight gain, uterine artery blood flow, glycemic control during pregnancy (in participants who develop gestational diabetes), changes in maternal circulating biomarkers, and neonatal birthweight complications. Polysomnography at 28- to 32-week gestation period, postpartum polysomnography, therapy compliance, and patient acceptability are also assessed. Results: The trial commenced on September 30, 2019. The trial is ongoing as of August 6, 2024. Conclusions: The trial intends to contribute to the growing evidence base to support the need for the identification and treatment of OSA occurring during pregnancy and to assess the feasibility of the study protocol. This will be the first trial to compare the early initiation of CPAP (auto-titrating and fixed pressure) and positional therapy in pregnant women from early gestation, providing alternative therapies for the treatment of OSA in this important population. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12619001530112; https://tinyurl.com/yctdzs4u International Registered Report Identifier (IRRID): DERR1-10.2196/51434 %M 40215099 %R 10.2196/51434 %U https://www.researchprotocols.org/2025/1/e51434 %U https://doi.org/10.2196/51434 %U http://www.ncbi.nlm.nih.gov/pubmed/40215099 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e62659 %T Effectiveness of Stromal Vascular Fraction (SVF) and Platelet-Rich Plasma (PRP) in Patients With Knee Osteoarthritis: Protocol for a Phase 3, Prospective, Randomized, Controlled, Multicenter Study (SPOST Study) %A Schwitzguebel,Adrien %A Ramirez Cadavid,David Andres %A Da Silva,Tamara %A Decavel,Pierre %A Benaim,Charles %+ , Sports Medicine Division, Hôpital de la Providence, Av. du Premier-Mars 29, Neuchâtel, 2000, Switzerland, 41 32 720 327, adrien.schwitzguebel@gmail.com %K stromal vascular fraction %K platelet-rich plasma %K osteoarthritis %K adjuvant therapy %K tissue regeneration %K clinical efficacy %D 2025 %7 8.4.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Available evidence on the conservative treatment of knee osteoarthritis still leaves questions about the efficacy of platelet-rich plasma (PRP) and whether stromal vascular fraction (SVF) offers a superior therapeutic tool. Objective: This study aims to assess the clinical efficacy of SVF as adjuvant therapy to PRP on functionality and tissue regeneration for knee osteoarthritis. Methods: In a multicenter, randomized, triple-blind, controlled trial, 108 individuals with knee osteoarthritis will be block-randomized in a 1:1 ratio. Patients will receive an initial single PRP or PRP + SVF injection followed by PRP doses at 1 month and 2 months. The primary endpoint is functional improvement measured with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at the 6-month follow-up. Secondary endpoints, collected at the 1-month, 2-month, 3-month, 6-month, and 12-month follow-ups, will include the pain visual analogue scale during maximal physical activity, WOMAC score, length of time to return to work and sports in days, magnetic resonance imaging (MRI)–based Whole-Organ Magnetic Resonance Imaging Score (WORMS), Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score, MRI Area Measurement and Depth and Underlying Structures (AMADEUS) score at 6 months and at 12 months, adverse events, and serious adverse events. Results: Participant recruitment and data collection are expected to begin in July 2025 and finish in July 2027. Final end points will be gathered in August 2027, and the results are expected to be published in late 2027. Conclusions: The study results will provide insight into the clinical efficacy of SVF as adjuvant therapy to PRP on functionality and tissue regeneration in patients with knee osteoarthritis. Trial Registration: ClinicalTrials.gov (NCT05660824); https://clinicaltrials.gov/study/NCT05660824 International Registered Report Identifier (IRRID): PRR1-10.2196/62659 %M 40198111 %R 10.2196/62659 %U https://www.researchprotocols.org/2025/1/e62659 %U https://doi.org/10.2196/62659 %U http://www.ncbi.nlm.nih.gov/pubmed/40198111 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e67737 %T Effects and Safety of Press-Needle Therapy for Improving Visual Function and Eye Blood Circulation in Patients With Glaucoma With Controlled Intraocular Pressure: Study Protocol for a Multicenter Randomized Controlled Trial %A Liu,Hongji %A Dai,Yan %A Yu,Ming %A Zeng,Jian %A Wang,Chao %A Tan,Sa %A Xiong,Ming %A Zhang,Ran %A Yu,Xuemeng %A Shi,Mingsong %A Yan,Xing %A Lai,Fengming %+ Department of Ophthalmology, Mianyang Central Hospital, School of Medicine, University of Electronic Science and Technology of China, No 12 Changjiaxiang, Alarm Street Fucheng District Mianyang, Sichuan, 621000 China, Mianyang, Sichuan, China, 86 15729639202, carol@sc-mch.cn %K press needle %K press-needle therapy %K needling technique %K glaucoma %K acupuncture %K visual function %K eye blood circulation %K randomized controlled trial %K traditional Chinese medecine %D 2025 %7 1.4.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Glaucoma is the leading cause of irreversible blindness worldwide, causing continuous and progressively worsening damage to visual function, which leads to vision loss. Optic nerve protection is an important treatment for glaucoma with controlled intraocular pressure (GPCI), but to date, there is no universally accepted effective optic nerve protection agent. Acupuncture can protect the optic nerve by increasing blood flow to the eye. However, fear of pain or the limitations of treatment place and time lead to poor patient compliance. Press-needle therapy is a characteristic of traditional Chinese medicine (TCM) external treatment methods; its safety is high, the effect is fast and lasting, it is easy to conduct, and it has high patient compliance. Objective: The objective of the trial is to evaluate the safety and clinical efficacy of press-needle therapy and investigate whether it can improve visual function by regulating eye blood circulation in patients with GPCI. Methods: In total, 192 participants aged 18-75 years with GPCI from the Mianyang Central Hospital, the Mianyang Hospital of Traditional Chinese Medicine, and the Mianyang Wanjiang Eye Hospital will participate in this study. Participants will be allocated to 2 treatment groups (experimental and control groups) in a ratio of 1:1 and will undergo press-needle therapy and sham press-needle therapy, respectively, for the same 4-week period. Primary outcomes will include the best-corrected visual acuity (BCVA), optical coherence tomography angiography (OCTA), color Doppler flow imaging (CDFI), and visual field assessment results. Secondary outcomes will include the intraocular pressure (IOP) and traditional Chinese medicine (TCM) clinical symptom scales. The primary outcomes and safety assessments will be measured at baseline and 4 weeks thereafter, while the secondary outcomes will be measured at baseline and 1, 2, 3, and 4 weeks thereafter. Results: Recruitment and data collection began in February 2023. The final outcomes are expected in September 2025. As of October 2024, the project had recruited 220 eligible participants, of whom 192 (87.3%) will complete the study, exceeding initial projections for the study time frame. The remainder of the participants will provide the ability to explore cross-level interactions that could not be statistically powered at the outset. The strengths of the project include rigorous data collection, good retention rates, and high compliance rates. Conclusions: This study will provide data on the effects of press-needle therapy on visual function and ocular circulation in patients with GPCI, and these results will help demonstrate whether acupuncture can improve patients’ visual function by regulating ocular circulation, thus providing a clinical and theoretical basis for the wider application of acupuncture therapy in GPCI. Trial Registration: Chinese Clinical Trial Registry ChiCTR2300067862；https://tinyurl.com/mrxd58x9 International Registered Report Identifier (IRRID): DERR1-10.2196/67737 %M 40168659 %R 10.2196/67737 %U https://www.researchprotocols.org/2025/1/e67737 %U https://doi.org/10.2196/67737 %U http://www.ncbi.nlm.nih.gov/pubmed/40168659 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e58951 %T Evaluation of the Clinical Nursing Effects of a Traditional Chinese Medicine Nursing Program Based on Care Pathways for Patients With Type 2 Diabetes: Protocol for a Randomized Controlled Clinical Trial %A Zhao,Yanchun %A Huang,Ting %A Chen,Yanli %A Li,Songmei %A Zhao,Juan %A Han,Xu %A Ni,Qing %A Su,Ning %+ Department of Endocrinology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, 5 North Line Pavilion, Xicheng District, Beijing, 100053, China, 86 01088002998, sn9898@163.com %K type 2 diabetes %K traditional Chinese medicine %K TCM nursing program %K clinical pathway %K application research %K diabetes %K diabetes mellitus %K research protocol %K nursing %K nursing program %K nursing care %K chronic disease %K disease monitoring %K prevalence %K China %K adult %K patient recovery %K psychological care %K health education %K quality of life %K blood glucose %K self-care %K medication %K control group %K patient satisfaction %D 2025 %7 31.3.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: To improve the performance of health care institutions, reduce overmedication, and minimize the waste of medical resources, China is committed to implementing a clinical pathway management model. This study aims to standardize nursing practices, foster clinical thinking in nurses, and promote patient recovery. Objective: The purpose of this study is to evaluate the clinical effects of a traditional Chinese medicine (TCM) nursing program based on nursing pathways for patients with type 2 diabetes mellitus (T2DM). Methods: This study uses a prospective, randomized, single-blind, parallel-controlled design. Based on sample size calculations, the study will include 594 patients with diabetes, with 2 groups of 297 patients: an observation group will receive a TCM nursing program based on clinical pathways, while a control group will receive routine care. Both groups will be evaluated before and after the intervention using assessment indicators. The primary outcome is the quality of life score, measured by a diabetes-specific quality of life questionnaire. Secondary outcomes include hospital stay duration, medical expenses, health knowledge, blood glucose control, symptom scores, and patient satisfaction. Results: This study was funded in August 2021 and has received approval from the Ethics Committee of Guang’anmen Hospital, China Academy of Chinese Medical Sciences (2022-022-KY-01). The trial is ongoing, with the first patient enrolled in September 2022. The study is expected to conclude in April 2025. To date, 380 patients have been recruited, with 202 randomized into the study, though no statistical analysis of the data has yet been conducted. A single-blind method is used; nurses are aware of group assignments and intervention plans, while patients remain blinded. Final results are planned for release in the first quarter of 2025. Conclusions: This study seeks to integrate existing national standardized nursing protocols with clinical pathways to implement more efficient and higher-quality nursing practices. The goal is to standardize nursing procedures, enhance patients’ quality of life, and improve self-care and medication adherence after discharge. Trial Registration: International Traditional Medicine Clinical Trial Registry ITMCTR2022000048; https://tinyurl.com/y4jd68h4 International Registered Report Identifier (IRRID): DERR1-10.2196/58951 %M 40163857 %R 10.2196/58951 %U https://www.researchprotocols.org/2025/1/e58951 %U https://doi.org/10.2196/58951 %U http://www.ncbi.nlm.nih.gov/pubmed/40163857 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e57905 %T Comparative Evaluation of Effectiveness of Standard of Care Alone and in Combination With Homoeopathic Treatment in COVID-19–Related Rhino-Orbito-Cerebral Mucormycosis (ROCM): Protocol for a Single Blind, Randomized Controlled Trial %A Kaur,Harleen %A Sachdeva,Jyoti %A Bawaskar,Ramesh %A Goyal,Twinkle %+ , Central Council for Research in Homeopathy, 61-65, Institutional Area, Opp. ‘D’ Block, Janak Puri, New Delhi, 110058, India, 91 011 28525523, dr.harleenkaur@gmail.com %K Rhino-orbital-cerebral mucormycosis, randomized controlled trial, homoeopathy, fungus, CE-MRI PNS mucormycosis %K India %K medical care %K mortality rate %K conventional therapy %K ethical %K mortality %K survival %K recovery %K homoeopathic medicines %K management %D 2025 %7 19.3.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Rhino-orbital-cerebral mucormycosis (ROCM) is the most common (45%-74%) mucormycosis in India. With contemporary medical care, ROCM has a mortality rate of 40%-50% and 70% of survivors are left with residual defects. Recently, several cases of mucormycosis in people with COVID-19 have been increasingly reported worldwide, from India, due to immune dysregulation caused by SARS-CoV-2. To reduce the high mortality rate and residual defect in most survivors under the guidelines of the Ministry of AYUSH, the Government of India recommended homoeopathy as an add-on therapy to maximize the effectiveness of standard treatment in conventional therapy. Objective: This study aimed to evaluate the role of existing homoeopathic treatment as an adjuvant therapy in patients with COVID-19–related ROCM and enhancing the survival of the patients hospitalized due to COVID-19 infection and to access the initial treatment response and duration required for significant or complete recovery in patients receiving adjuvant treatment. Methods: This superiority, randomized controlled clinical trial would include two parallel comparator groups A and B. Group A would be the experimental group and would receive homoeopathic treatment along with the standard line of treatment as per investigational medicinal product (IMP) and group B would be the control arm and would receive standard line of treatment as per IMP along with identical placebo. Allocation would be 1:1 through randomization. Based on the inclusion and exclusion criteria, 36 participants per arm would be screened. Participants would be assessed clinically twice a day and magnetic resonance imagery or endoscopy cum-biopsy would be assessed on days 1, 14, and 28. Laboratory investigations may vary as per demand of disease conditions. Results: In India, the COVID-19 pandemic, particularly during the second wave, resulted in a surge of mucormycosis cases among patients with COVID-19. At the time this protocol was being developed, there was a significant spike in mucormycosis cases in India, particularly in Mumbai (June 2021). However, by the time the Central Council for Research in Homoeopathy obtained the necessary approvals and ethical clearance for the study, the incidence of mucormycosis had drastically declined (September 2021). As a result, the study was not initiated and registered. The authors feel it is their ethical responsibility to share the reviewed protocol with the medical community as a reference for future work. Conclusions: This study aims to evaluate the role of existing homoeopathic medicines as an adjuvant therapy in managing COVID-19–related ROCM, potentially contributing to the use of homoeopathy as an evidence-based medical approach. The protocol can also serve as a valuable resource for clinicians and researchers addressing mucormycosis cases unrelated to COVID-19, particularly in immunocompromised patients. It would help ensure preparedness, whether or not sufficient evidence is available, in the event of a future health emergency. International Registered Report Identifier (IRRID): PRR1-10.2196/57905 %M 40106813 %R 10.2196/57905 %U https://www.researchprotocols.org/2025/1/e57905 %U https://doi.org/10.2196/57905 %U http://www.ncbi.nlm.nih.gov/pubmed/40106813 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e44027 %T Novel Versus Conventional Sequencing of β-Blockers, Sodium/Glucose Cotransportor 2 Inhibitors, Angiotensin Receptor-Neprilysin Inhibitors, and Mineralocorticoid Receptor Antagonists in Stable Patients With Heart Failure With Reduced Ejection Fraction (NovCon Sequencing Study): Protocol for a Randomized Controlled Trial %A Karamchand,Sumanth %A Chipamaunga,Tsungai %A Naidoo,Poobalan %A Naidoo,Kiolan %A Rambiritch,Virendra %A Ho,Kevin %A Chilton,Robert %A McMahon,Kyle %A Leisegang,Rory %A Weich,Hellmuth %A Hassan,Karim %+ School of Law, University of South Africa, Preller Street, Pretoria, 2090, South Africa, 27 662698322, kiolan.naidoo@gmail.com %K heart failure %K SGLT2i %K sodium/glucose cotransporter 2 inhibitors %K ARNi %K angiotensin receptor-neprilysin inhibitors %K HFrEF %K heart failure with reduced ejection fraction %K idiopathic dilated cardiomyopathy %K heart %K chronic heart failure %K patient %K control %K clinical %K adult %K cardiomyopathy %K therapy %D 2025 %7 10.3.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Chronic heart failure has high morbidity and mortality, with approximately half of the patients dying within 5 years of diagnosis. Recent additions to the armamentarium of anti–heart failure therapies include angiotensin receptor-neprilysin inhibitors (ARNIs) and sodium/glucose cotransporter 2 inhibitors (SGLT2is). Both classes have demonstrated mortality and morbidity benefits. Although these new therapies have morbidity and mortality benefits, it is not known whether rapid initiation is beneficial when compared with the conventional, slower-stepped approach. Many clinicians have been taught that starting with low-dose therapies and gradually increasing the dose is a safe way of intensifying treatment regimens. Pharmacologically, it is rational to use a combination of drugs that target multiple pathological mechanisms, as there is potential synergism and better therapeutic outcomes. Theoretically, the quicker the right combinations are used, the more likely the beneficial effects will be experienced. However, rapid up-titration must be balanced with patient safety and tolerability. Objective: This study aims to determine if early addition of ARNIs, SGLT2is, β-blockers, and mineralocorticoid receptor antagonists (within 4 weeks), when compared with the same therapies initiated slower (within 6 months), will reduce all-cause mortality and hospitalizations for heart failure in patients with stable heart failure with reduced ejection fraction. Methods: This is a single-center, randomized controlled, double-arm, assessor-blinded, active control, and pragmatic clinical trial. Adults with stable heart failure with reduced ejection fraction and idiopathic dilated cardiomyopathy will be randomized to conventional sequencing (the control arm; over 6 months) of anti–heart failure therapies, and a second arm will receive rapid sequencing (over 4 weeks). Study participants will be followed for 5 years to assess the safety, efficacy, and tolerability of the 2 types of sequencing. Posttrial access and care will be provided to all study participants throughout their lifespan. Results: We are currently in the process of obtaining ethical clearance and funding. Conclusions: We envisage that this study will help support evidence-based medicine and inform clinical practice guidelines on the optimal rate of sequencing of anti–heart failure therapies. A third placebo arm was considered, but costs would be too much and not providing study participants with therapies with known morbidity and mortality benefits may be unethical, in our opinion. Given the post–COVID-19 economic downturn and posttrial access to interventions, a major challenge will be acquiring funding for this study. International Registered Report Identifier (IRRID): PRR1-10.2196/44027 %M 40063943 %R 10.2196/44027 %U https://www.researchprotocols.org/2025/1/e44027 %U https://doi.org/10.2196/44027 %U http://www.ncbi.nlm.nih.gov/pubmed/40063943 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e56849 %T Evaluation of the Efficacy of the Traditional Chinese Medicine Formulation Ru-Yi-Jin-Huang-Saan on Colles Fracture After Surgery: Protocol for a Randomized, Double-Blind, Placebo-Controlled Trial %A Lin,Lien-Cheng %A Wang,Wei-Hsun %A Chang,Wei-Kai %A Gao,Jyun-Liang %A Yang,Ru-Chang %A Hsu,Po-Chi %A Lo,Lun-Chien %+ School of Chinese Medicine, China Medical University, No. 91, Xueshi Road, North District, Taichung, 404328, Taiwan, 886 422053366 ext 3122, cmulclo@gmail.com %K traditional Chinese medicine %K Ru-Yi-Jin-Huang-Saan %K external application %K Colles fracture %K Patient-Rated Wrist Evaluation %K PRWE %K PRWE score %K surgeries %K fracture %K randomized controlled trial %K RCT %K alternative treatment %K postoperative %K protocol %K Western medicine %K wrist evaluation %K pain relief medication %D 2025 %7 5.3.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Colles fracture, a common wrist injury, often requires surgical intervention. After surgery, patients may experience persistent pain and reduced wrist function, potentially resulting in long-term disability. In clinical practice, traditional Chinese medicine practitioners frequently use Ru-Yi-Jin-Huang-Saan (RYJHS) to treat such patients in Taiwan. RYJHS is a traditional Chinese herbal formula with a history spanning centuries, primarily used topically for the treatment of bone fractures and the promotion of healing. However, there is currently a lack of substantial clinical evidence supporting its efficacy in the management of postsurgical Colles fractures. To the best of our knowledge, there are no studies evaluating the clinical effectiveness of RYJHS. Objective: This study aims to investigate the therapeutic potential of RYJHS in postsurgical Colles fracture cases. An additional objective is to provide an alternative treatment option for postoperative patients unable to take anti-inflammatory and pain relief medications. Methods: This is a protocol for a randomized, double-blind, placebo-controlled trial. A total of 100 postoperative patients with Colles fracture, aged 20-80 years, will be recruited for this study. They will be randomly assigned to either the experimental or control group in a 1:1 allocation ratio. Both groups will receive standard postoperative Colles fracture treatment. The primary outcome measure will assess wrist functional recovery using the Patient-Rated Wrist Evaluation score. Secondary outcomes will include C-reactive protein levels and ultrasound measurements of wrist swelling. All of these examinations will be assessed at baseline, 3 days after surgery, and 6 days after surgery. In addition, the Dyshidrotic Eczema Area and Severity Index will be used to monitor for adverse skin reactions. Results: This protocol was registered at ClinicalTrials.gov on December 6, 2022. It was performed in accordance with the approved guidelines and regulations of the participating institutions. Recruitment began in May 2023, with data collection expected to conclude in May 2025. Study completion is expected in December 2025. Conclusions: This is the first protocol discussing the assessment of the therapeutic efficacy and safety of topical traditional Chinese medicine in patients after fracture surgery. The protocol will establish an integrated care model combining both traditional Chinese medicine and Western medicine for postsurgical fracture cases. Trial Registration: ClinicalTrials.gov NCT05638360; https://clinicaltrials.gov/ct2/show/NCT05638360 International Registered Report Identifier (IRRID): DERR1-10.2196/56849 %M 40053806 %R 10.2196/56849 %U https://www.researchprotocols.org/2025/1/e56849 %U https://doi.org/10.2196/56849 %U http://www.ncbi.nlm.nih.gov/pubmed/40053806 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e59856 %T Auricular Acupressure Versus an Intermittent Low-Carbohydrate Diet in Children With Overweight or Obesity With Gastric-Heat and Dampness-Obstruction Syndrome: Protocol for a Randomized Controlled Trial %A Sun,Wen %A He,Jingwei %A Wang,Wenqin %A Lu,Chen %A Lin,Yating %A Dou,Yalan %A Yan,Weili %A Yu,Jian %+ Department of Clinical Epidemiology and Clinical Trial Unit, Children’s Hospital of Fudan University, National Children’s Medical Center, 399 Wanyuan Road, Shanghai, 201102, China, 86 13761794333, yanwl@fudan.edu.cn %K children with obesity %K traditional Chinese medicine %K TCM auricular acupressure treatment %K intermittent low carbohydrate diet %K study protocol %D 2025 %7 3.3.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Childhood obesity frequently persists into adulthood and is associated with an increased risk and earlier onset of cardiovascular disease in later life. Behavioral change strategies have been proposed as the first-line weight management approach for children and adolescents with obesity. Nonpharmacological interventions, such as traditional Chinese medicine (TCM) auricular acupressure treatment and intermittent low-carbohydrate diet (ILCD), are increasingly being investigated in the young obese population. However, there is limited high-quality evidence about effectiveness and safety in weight control and reducing cardiometabolic risk in the pediatric population. Objective: This study aimed to compare the effect of cardiometabolic risk reduction between TCM auricular acupressure treatment (TAAT) and ILCD in children with overweight or obesity with gastric-heat and dampness-obstruction syndrome. Methods: This is a randomized controlled trial. Eligible participants are children with overweight or obesity and enrolled at the obesity clinic of the department of TCM at a tertiary children’s hospital. Eligible participants must meet the following criteria: (1) be aged between 6 and 18 years, (2) be overweight, and (3) have gastric-heat and dampness-obstruction syndrome. Recruited children will be randomized 3:1 to receive either TAAT or a self-administered ILCD for 1 month: 150 in the TAAT group and 50 in the ILCD group. The primary outcome is the change in body weight from the beginning of treatment to the end of 1 month. Secondary outcomes included body weight, waist circumference, waist-to-height ratio, BMI, blood pressure, body fat content, indexes of liver and renal function, indexes of glucose metabolism, gut microbiota, and TCM syndrome scores at the end of 1 month and 3 months, respectively. Primary statistical analyses were conducted using the intention-to-treat strategy. A generalized linear model was used to compare the difference in weight change between the groups, with the baseline body weight as the covariate, to obtain the estimate of the mean difference in body weight change and its 95% CI, using Gaussian for family function and identity for link function. Results: The study protocol was approved by the institutional ethical committee and registered on ClinicalTrials.gov on May 5, 2023, before recruitment. Recruitment began in June 2023 and is expected to be completed by December 2025. As of November 2024, we have enrolled 112 participants. Conclusions: This randomized controlled trial will provide evidence on the treatment effects and safety of TAAT versus ILCD among children with overweight or obesity with gastric-heat and dampness-obstruction syndrome, in reducing body weight and improving cardiometabolic risks. Exploratory aims include potential underlying mechanisms of the 2 kinds of interventions, based on biosamples. Trial Registration: ClinicalTrials.gov NCT05847478. https://clinicaltrials.gov/study/NCT05847478 International Registered Report Identifier (IRRID): DERR1-10.2196/59856 %M 40053799 %R 10.2196/59856 %U https://www.researchprotocols.org/2025/1/e59856 %U https://doi.org/10.2196/59856 %U http://www.ncbi.nlm.nih.gov/pubmed/40053799 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e66838 %T Neural Mechanism of Cognitive Reserve in Acupuncture Stimulation: Protocol for a Randomized, Placebo-Controlled Functional Near-Infrared Spectroscopy Trial %A Shin,Hyeonsang %A Seong,Woohyun %A Woo,Yeonju %A Kim,Joo-Hee %A Park,Kwang-Rak %A Lee,Dong Hyuk %+ Department of Anatomy, College of Korean Medicine, Sangji University, 83 Sangjidae-gil, Wonju-si, Gangwon-do, 26339, Republic of Korea, 82 01071017317, leedh1103@gmail.com %K cognitive reserve %K acupuncture %K dementia %K mild cognitive impairment %K neuroimaging %K fNIRS %K brain connectivity %K neural mechanism %K RCT %K randomized controlled trial %D 2025 %7 19.2.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Dementia is a clinical syndrome characterized by a progressive decline in various cognitive domains. Since there is still no treatment for dementia, early diagnosis and prevention are the best approaches. In this context, the cognitive reserve (CR) concept has received considerable attention in dementia research with regard to prognosis. It originates from discrepancies between the degree of brain pathology and clinical manifestations. Acupuncture, as a complementary intervention, has long been widely applied in neurological diseases in East Asia. At the macroscale level, how acupuncture stimulation affects neural activity concerning CR in normal aging and dementia is largely unknown. Objective: The aim of this study is to investigate the acute neural mechanisms of acupuncture stimulation concerning CR in the normal aging group and the group with cognitive impairment using neuroimaging methods. Methods: This study is a randomized, placebo-controlled trial. Participants without (n=30) and with cognitive impairment (n=30) will be randomly assigned to the verum or sham acupuncture groups. The verum acupuncture group will receive acupuncture stimulation at acupoints related to cognitive function and gain deqi sensation. The sham acupuncture group will receive superficial needling at nonacupoints not related to cognitive function. Each group will undergo cognitive function tests, functional near-infrared spectroscopy imaging before and after acupuncture stimulation, and an assessment of CR. The primary outcomes will be differences in resting brain activities according to disease status, differences in resting brain connectivity before and after acupuncture stimulation between the 2 groups, and changes in brain activity in relation to the CR index. The secondary outcomes will be brain connectivity or network metrics associated with CR and differences in neural activity between the cognitive task and resting states. Results: The recruitment began in August 2023; to date, there have been 50 participants, divided into 20 in the group with cognitive impairment and 30 in the unimpaired group. The recruitment process will continue until February 2025. Conclusions: CR refers to the individual susceptibility to age-related brain changes and pathologies in cognitive impairment, and it is a factor affecting the trajectories of the disease. Although acupuncture is a widely used intervention for various neurological diseases, including dementia, its mechanism associated with CR at the macroscale has not been clearly identified. This study could contribute to identifying the neural mechanisms of acupuncture stimulation associated with CR using neuroimaging methods and provide a basis for future longitudinal research. Trial Registration: Clinical Research Information Service of the Republic of Korea KCT0008719; https://tinyurl.com/ydv5537n International Registered Report Identifier (IRRID): DERR1-10.2196/66838 %M 39970435 %R 10.2196/66838 %U https://www.researchprotocols.org/2025/1/e66838 %U https://doi.org/10.2196/66838 %U http://www.ncbi.nlm.nih.gov/pubmed/39970435 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e56826 %T Effectiveness of Adaptation of a Resilience-Building Intervention Among Individuals With Adverse Childhood Experience: Protocol for a Randomized Controlled Trial %A Kiat,Jun %A Ahmad,Mahadir %A Mei Hsien Chan,Caryn %A Zainalabidin,Satirah %A Ungar,Michael %A Subramaniam,Ponnusamy %+ Clinical Psychology and Behavioural Health Program, National University of Malaysia, Universiti Kebangsaan Malaysia Fakulti Sains Kesihatan Kampus, Jalan Raja Muda Abdul Aziz, Kuala Lumpur, 50300, Malaysia, 60 3 26878168, mahadir@ukm.edu.my %K adverse childhood experience %K resilience %K resilience-building intervention %K young adults %K stress %K psychological well-being %D 2025 %7 12.2.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: The impact of adverse childhood experiences (ACEs) has been the focus of most studies for the past decade. There is an indication that developing resilience can help youth overcome these ACEs. Objective: This article presents a study protocol for a randomized controlled trial (RCT) to investigate the effects of a resilience-building intervention on psychological well-being, coping strategies, stress, quality of life, resilience, resource finding, and resilience among individuals affected with ACEs in Malaysia. Methods: The is a 2-armed, single-blind, RCT, whereby 50 participants (25 in each group) with ACEs will be randomly assigned to intervention and control groups. The former will be exposed to a resilience-building program (R2), which entails a multisystemic approach to resilience and recognizes the importance of rugged qualities and access to resources among individuals affected with ACEs. The intervention will be delivered via internet-based by a facilitator and broadly divided into 5 sessions, focusing on self-exploration and social support, coping techniques and coping skills, resource finding, spirituality, and resilience building. Meanwhile, the control group participants will not receive any form of intervention. Saliva samples will also be collected from both groups and assessed for salivary cortisol levels. Outcome measures will be assessed during baseline and postintervention using validated instruments. Another follow-up measurement will be conducted 4 weeks later. Results: The clinical trial has been registered with the Australia New Zealand Clinical Trials Registry. Ethical approval was obtained from the Research Ethics Board at the National University of Malaysia (UKM PPI/111/8/JEP-2021-894). A total of 28 participants have been recruited to the RCT Participant recruitment will be completed by January 2025. The final analysis will be conducted by March 2025. Conclusions: This is among the first studies to provide evidence in the context of RCTs for resilience-building intervention that combines self-report and physiological measures (ie, saliva and heart blood pressure) among individuals with ACEs. The findings will assist relevant authorities in the health and policy sectors to develop effective strategies for addressing the negative impacts of ACEs on the vulnerable population in Malaysia. Trial Registration: ACTRN12622000604707; https://www.anzctr.org.au/Trial/Result/DataSharingStatement.aspx?id=383614 International Registered Report Identifier (IRRID): DERR1-10.2196/56826 %M 39938084 %R 10.2196/56826 %U https://www.researchprotocols.org/2025/1/e56826 %U https://doi.org/10.2196/56826 %U http://www.ncbi.nlm.nih.gov/pubmed/39938084 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e56062 %T Proposal and Strategy for Nursing-Led Research: Protocol for an Unfunded Clinical Trial %A Simón-López,Leticia Carmen %A Ortuño-Soriano,Ismael %A Luengo-González,Raquel %A Posada-Moreno,Paloma %A Zaragoza-García,Ignacio %A Sánchez-Gómez,Rubén %+ Nursing Department, Universidad Complutense de Madrid, Plaza Ramón y Cajal, s/n. Ciudad Universitaria, Madrid, 28040, Spain, 34 913941346, iortunos@ucm.es %K clinical trial %K academic trial %K nonfunded %K commercial %K nurse-led %K low intervention %K health product %K peripheral venous cannulation %K PVC %K protocol %K randomized controlled trial %K RCT %K adults %K healthy adults %K funding %K academic sponsors %K cause-effect results %K insurance %D 2025 %7 10.2.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Clinical trials are known to provide cause-and-effect results and data with low levels of bias. However, a lack of funding for clinical trials, which are considered expensive, means that academic sponsors are rarely able to conduct them. Academic trials are considered highly relevant for the valuable results they provide for clinical questions. This is why initiatives to conduct unfunded clinical trials have been identified as an important issue to pay attention to in future studies. Therefore, we present our initiative through Rogers’ theory, which is highlighted in the literature for diffusing innovative change across organizations. Objective: The purpose of this paper was to describe our case regarding management for conducting a nonfunded nurse-led clinical trial based on our previous low-interventional clinical trial across a specific health organization and with nurses. Methods: We conducted a low-intervention, nonexternally funded clinical trial using the human and material resources available on site. We managed our trial in a clinical trial unit where there were staff, sources, and ongoing commercial clinical trials. We conducted our trial based on an ongoing commercial trial, and, to do so, we needed behavioral changes. We relied on Rogers’ theory, and we identified strengths and barriers to change by analyzing actors' characteristics, perceptions of the situation, motivation, and information. Afterward, we divided the staff according to their characteristics related to innovation and change into permanent staff (research staff with a culture of change) and nonpermanent staff (nursing staff with occasional attendance and resistance to change). First, we preselected only those nurses who were more aware of change (innovators and pioneers) to participate in our trial to avoid a massive rejection, and later, we asked others to join (late adopters). We followed Rogers’ phases. For research staff who were aware of the funding, we focused on the “persuasion phase,” while for nursing staff, we mixed the “knowledge and persuasion phases” and used pioneers and early adopters as a positive example for other nurses as well as nonfinancial incentives (persuasion). Our trial consisted of different methods of vein cannulation, which was performed in the ongoing commercial trial. Thus, the entire development of our low-interventional clinical trial was conducted without interfering at any point with the parallel commercial clinical trial. Results: Our management allowed effective conduct of our study, and we met our aims without external funding and without ethical impact during the commercial clinical trial. Costs remained low, primarily because the major expenses were covered by the commercial clinical trial as an inherent part of its design. Conclusions: Our initiative to conduct a low-intervention clinical trial with no or limited funding was cost-effective. This initiative can be used by researchers with valuable academic research questions who do not have the external funding to conduct studies. Trial Registration: ClinicalTrials.gov NCT04027218; https://clinicaltrials.gov/study/NCT04027218 International Registered Report Identifier (IRRID): RR1-10.2196/56062 %M 39927682 %R 10.2196/56062 %U https://www.researchprotocols.org/2025/1/e56062 %U https://doi.org/10.2196/56062 %U http://www.ncbi.nlm.nih.gov/pubmed/39927682 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e63887 %T ChatGPT-4 Performance on German Continuing Medical Education—Friend or Foe (Trick or Treat)? Protocol for a Randomized Controlled Trial %A Burisch,Christian %A Bellary,Abhav %A Breuckmann,Frank %A Ehlers,Jan %A Thal,Serge C %A Sellmann,Timur %A Gödde,Daniel %+ State of North Rhine-Westphalia, Regional Government Düsseldorf, Leibniz-Gymnasium, Stankeitstraße 22, Essen, 45326, Germany, 49 201 79938720, christian.burisch@rub.de %K ChatGPT %K artificial intelligence %K large language model %K postgraduate education %K continuing medical education %K self-assessment program %D 2025 %7 6.2.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: The increasing development and spread of artificial and assistive intelligence is opening up new areas of application not only in applied medicine but also in related fields such as continuing medical education (CME), which is part of the mandatory training program for medical doctors in Germany. This study aimed to determine whether medical laypersons can successfully conduct training courses specifically for physicians with the help of a large language model (LLM) such as ChatGPT-4. This study aims to qualitatively and quantitatively investigate the impact of using artificial intelligence (AI; specifically ChatGPT) on the acquisition of credit points in German postgraduate medical education. Objective: Using this approach, we wanted to test further possible applications of AI in the postgraduate medical education setting and obtain results for practical use. Depending on the results, the potential influence of LLMs such as ChatGPT-4 on CME will be discussed, for example, as part of a SWOT (strengths, weaknesses, opportunities, threats) analysis. Methods: We designed a randomized controlled trial, in which adult high school students attempt to solve CME tests across six medical specialties in three study arms in total with 18 CME training courses per study arm under different interventional conditions with varying amounts of permitted use of ChatGPT-4. Sample size calculation was performed including guess probability (20% correct answers, SD=40%; confidence level of 1–α=.95/α=.05; test power of 1–β=.95; P<.05). The study was registered at open scientific framework. Results: As of October 2024, the acquisition of data and students to participate in the trial is ongoing. Upon analysis of our acquired data, we predict our findings to be ready for publication as soon as early 2025. Conclusions: We aim to prove that the advances in AI, especially LLMs such as ChatGPT-4 have considerable effects on medical laypersons’ ability to successfully pass CME tests. The implications that this holds on how the concept of continuous medical education requires reevaluation are yet to be contemplated. Trial Registration: OSF Registries 10.17605/OSF.IO/MZNUF; https://osf.io/mznuf International Registered Report Identifier (IRRID): PRR1-10.2196/63887 %M 39913914 %R 10.2196/63887 %U https://www.researchprotocols.org/2025/1/e63887 %U https://doi.org/10.2196/63887 %U http://www.ncbi.nlm.nih.gov/pubmed/39913914 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e63063 %T Efficacy and Safety of Murivenna Anal Infiltration Compared to Diltiazem Topical Application in Chronic Anal Fissure: Protocol for a Prospective, Randomized, Open-Label Clinical Trial %A Shankar KM,Pratap %A Puthan Purayil,Indu %A Binitha,Palengara %A Rai,Amit Kumar %A Jameela,Sophia %A Ahmad,Azeem %A Bhogavalli,Chandra Sekhara Rao %A Srikanth,Narayanam %A Acharya,Rabinarayan %+ National Ayurveda Research Institute for Panchakarma, Central Council for Research in Ayurvedic Sciences, D Block, Janakpuri Institutional Area, New Delhi, 110058, India, 91 9744824014, kmpvarma@gmail.com %K chronic anal fissure %K murivenna anal infiltration %K Ayurveda %K efficacy %K anal infiltration %K murivenna %K diltiazem %K app %K chronic %K study protocol %K randomized clinical trial %K proctologic condition %K proctologic %K pain %K quality of life %K well-being %K surgical intervention %K defecation %K cessation of bleeding %K treatment %D 2025 %7 3.2.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Anal fissure is a common proctologic condition that causes significant pain and anguish to patients, significantly impacting their quality of life and well-being. There are various treatment options for anal fissure, ranging from pharmacological agents that reduce anal sphincter tone to surgical interventions for cases resistant to medical management. Ayurvedic treatments have shown potential for the therapeutic management of anal fissure. Objective: This clinical study aims to analyze the efficacy and safety of murivenna anal infiltration compared to diltiazem topical application in chronic anal fissure. Methods: This is an open-labeled, randomized, controlled parallel group clinical trial with a sample size of 66 participants to be randomized and allocated in a 1:1 ratio to 2 groups. The intervention group will be treated with murivenna anal infiltration, and the control group will be treated with topical application of diltiazem for a period of 4 weeks. The primary outcome will be the proportion of participants demonstrating complete healing after 4 weeks of treatment. The secondary outcomes will be the proportion of participants demonstrating complete healing after 7 days and 14 days of treatment, change in pain at or after defecation, cessation of bleeding, and any recurrence during the study period. Any adverse events will also be recorded during the trial period. Results: The project was funded in July 2023, and the study period is 24 months. Participant recruitment started in December 2023. As of August 2024, we have enrolled 50 participants. The data analysis will be complete by June 2025, and the results are expected to be published by August 2025. Conclusions: High recurrence rates, adverse effects, incomplete healing, and the negative impact on patients’ daily activities and quality of life underscore the need for alternative therapeutic options. Ayurveda offers potential for more sustainable relief with fewer adverse effects. Murivenna oil is a time-tested medicated oil effectively used by Ayurvedic physicians for various ulcers of traumatic and pathological origin. This study will provide scientific evidence on the efficacy and safety of murivenna anal infiltration; further, it can be incorporated into the cost-effective management of chronic anal fissure. Trial Registration: Clinical Trials Registry India CTRI/2023/09/057330; https://tinyurl.com/y4ut9e8p International Registered Report Identifier (IRRID): DERR1-10.2196/63063 %M 39899833 %R 10.2196/63063 %U https://www.researchprotocols.org/2025/1/e63063 %U https://doi.org/10.2196/63063 %U http://www.ncbi.nlm.nih.gov/pubmed/39899833 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e64277 %T Impact of the Mediterranean Diet on Patients With Psoriasis: Protocol for a Randomized Controlled Trial %A Perez-Bootello,Javier %A Berna-Rico,Emilio %A Abbad-Jaime de Aragon,Carlota %A Cova-Martin,Ruth %A Goni,Leticia %A Ballester-Martinez,Asuncion %A Jaen-Olasolo,Pedro %A Mehta,Nehal %A Gelfand,Joel M %A Martinez-Gonzalez,Miguel Angel %A Gonzalez-Cantero,Alvaro %+ Department of Dermatology, Hospital Universitario Ramon y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), Madrid, Spain, M-607, Km. 9, 100, Fuencarral-El Pardo, Madrid, 28034, Spain, 34 91 336 82 47, alvarogc261893@hotmail.com %K psoriasis %K Mediterranean diet %K MedDiet %K nutritional intervention %K olive oil %K inflammatory disease %K Impact of the Mediterranean Diet on Patients with Psoriasis %K MEDIPSO %K dietary intervention %K methodological analysis %K randomized controlled trial %K RCT %K clinical trial %K nutrition %K diet %K Europe %D 2025 %7 29.1.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Psoriasis is an inflammatory disease primarily treated through molecular-targeted therapies. However, emerging evidence suggests that dietary interventions may also play a role in managing inflammation associated with this condition. The Mediterranean diet (MedDiet), prevalent in southern European countries, has been widely recognized for its ability to reduce cardiovascular mortality, largely due to its anti-inflammatory properties. This anti-inflammatory potential has prompted interest in exploring the MedDiet’s role in immune-mediated diseases, including psoriasis. Observational studies have indicated potential benefits, such as reductions in the Psoriasis Area and Severity Index. However, there is a need for well-designed clinical trials to address the methodological limitations of these studies and to establish specific dietary recommendations for psoriasis. Objective: This study aims to evaluate the impact of an intensive dietary intervention based on the MedDiet in patients with psoriasis. The study will assess the effects of this intervention on skin involvement, metabolic parameters, and inflammatory cytokines. In addition, the emotional well-being and quality of life of participants will be evaluated using validated questionnaires. A methodological analysis will also be conducted to enhance the design of future large-scale clinical trials. Methods: An open-label, single-blinded (evaluator) randomized controlled trial was designed to assess the impact of a high-intensity MedDiet intervention in patients with mild-to-moderate psoriasis. A total of 38 patients will be randomly assigned into 2 groups—an intervention group receiving the MedDiet intervention and a control group receiving standard care. The intervention group will participate in dietary education sessions aimed at adopting the MedDiet over 4 months, with monthly monitoring by experienced nutritionists. Participants will receive 500 mL of extra virgin olive oil per week, along with informative materials, recipes, and weekly menus. In contrast, the control group will receive standard low-fat diet recommendations without nutritionist monitoring. All participants will undergo a baseline visit, a 2-month follow-up visit, and a final visit at 4 months. Blood tests will be conducted at the beginning and end of the study. This study protocol was approved by the Institutional Review Board of the Hospital Ramón y Cajal (Madrid) in July 2023. Results: Enrollment concluded in October 2024, with data collection set to finish by February 2025. The findings will be presented at national and international conferences and published in peer-reviewed journals. Conclusions: This protocol outlines the design of a clinical trial that implements the MedDiet in patients with psoriasis to evaluate its benefits on skin involvement, systemic inflammation, and quality of life. Trial Registration: ClinicalTrials.gov NCT06257641; https://clinicaltrials.gov/study/NCT06257641 International Registered Report Identifier (IRRID): DERR1-10.2196/64277 %M 39879606 %R 10.2196/64277 %U https://www.researchprotocols.org/2025/1/e64277 %U https://doi.org/10.2196/64277 %U http://www.ncbi.nlm.nih.gov/pubmed/39879606 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 14 %N %P e58037 %T Evaluating the Effectiveness of a Multimodal Psychotherapy Training Program for Medical Students in China: Protocol for a Randomized Controlled Trial %A Pei,Tao %A Ding,Yinan %A Tang,Jinsong %A Liao,Yanhui %+ Department of Psychiatry, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, 866 Yuhangtang Road, Hangzhou, 310000, China, 86 18814898844, liaoyanhui@zju.edu.cn %K multimodal teaching %K psychotherapy training %K Chinese medical students %K randomized controlled trial %D 2025 %7 3.1.2025 %9 Protocol %J JMIR Res Protoc %G English %X Background: Psychotherapy is central to the treatment of mental disorders, highlighting the importance of medical students and residents developing competencies in this area. Chinese medical residents have expressed a strong need for psychotherapy training, yet they are generally dissatisfied with the current offerings. This paper presents the protocol for an evidence-based, well-structured psychotherapy teaching program aimed at medical students and residents. Objective: This study involves a randomized controlled trial of a 2-day multimodal intensive educational intervention designed to evaluate the effectiveness of a new psychotherapy teaching program for medical students and residents in China. The primary outcomes include participants’ knowledge and utilization of psychotherapy, training program acceptability, self-reported self-efficacy, and motivation to apply psychotherapy. Methods: This 2-arm randomized controlled trial was conducted at Sir Run Run Shaw Hospital. The study aimed to recruit approximately 160 medical students and residents, with about 80 participants in the intervention group and 80 in the control group. Both groups completed a baseline survey before participation, reporting their psychotherapy knowledge, utilization of psychotherapy, self-efficacy, and self-motivation. The intervention group received a 2-day multimodal intensive educational intervention (supervision-based online teaching), while the waitlist control group did not receive any intervention during this period. Both groups were followed up for 8 weeks, completing the same survey administered at baseline. At the end of the study, the control group received the intervention. The primary outcome measure was the change in trainees’ psychotherapy knowledge before and after the intervention training. Secondary outcome measures included changes in the trainees’ utilization of psychotherapy, self-reported self-efficacy, and self-reported motivation for psychotherapy. Additionally, training program acceptability was assessed. Analysis of covariance was used to analyze the primary outcomes. Pearson correlations and regression analysis explored factors associated with the knowledge score at baseline. The secondary outcomes, including participants’ psychotherapy utilization, confidence, and motivation, were analyzed using the same methods as for knowledge. All tests were 2-tailed, with a significance level set at P<.05. Results: A total of 160 participants were recruited and randomized between January 4 and 12, 2024. Baseline assessments were conducted from January 28 to February 1, 2024. The psychotherapy training program for the intervention group took place on February 3 and 4, 2024. Posttraining assessments were conducted starting April 1, 2024. Due to withdrawals, incomplete surveys, and data loss, we had a total of 113 participants: 57 in the intervention group and 56 in the control group. The amount of data varied across measures. The data analysis was finished in August 2024. Conclusions: This study aims to evaluate the effectiveness of the multimodal psychotherapy training program for medical students in China. If this brief, cognitive behavioral therapy–based psychotherapy skill training proves effective, the potential mental health impact of its nationwide expansion could be significant. Trial Registration: ClinicalTrials.gov NCT06258460; https://clinicaltrials.gov/ct2/show/NCT06258460 International Registered Report Identifier (IRRID): DERR1-10.2196/58037 %M 39752191 %R 10.2196/58037 %U https://www.researchprotocols.org/2025/1/e58037 %U https://doi.org/10.2196/58037 %U http://www.ncbi.nlm.nih.gov/pubmed/39752191 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e60817 %T Improving Oral Health in Prisons (PriOH): Protocol for a Randomized Controlled Trial %A Bryne,Emilie %A Bergum,Kathrine Høyvik %A Gjedrem,William Gilje %+ Oral Health Centre of Expertise Rogaland, Postbox 130 Sentrum, Stavanger, 4001, Norway, 47  51 50 68 46 , emilie.bryne@throg.no %K intervention %K motivational interviewing %K oral care %K marginalized groups %K correctional services %K implementation %K oral hygiene %K oral health %K randomized controlled trial %K RCT %K prison %K dental care %K pilot study %K people living in prison %D 2024 %7 11.12.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: People living in prisons often experience poor oral health, which could be attributed to their limited access to (dental) care, financial constraints, and a general lack of awareness and prioritization toward their oral hygiene. A pilot study involving motivational interviewing (MI) has shown promising results for improving the oral health outcomes of people living in prisons. Objective: The protocol for this study aims to assess the efficacy of integrated MI and oral hygiene packages in improving oral health among people living in prisons, compared to controls without added MI. Methods: This oral health in prisons study is a multicenter, randomized, double-blinded controlled trial that recruited inmates from 4 prisons in Rogaland County. The trial aimed to recruit 320 participants before randomly allocating them to either a control or intervention group. The intervention group received MI, consisting of a 30-minute session encouraging inmates to discuss their current and desired oral health behaviors and attitudes, highlighting discrepancies to motivate change. Assessments were conducted at 4 and 12 weeks after initiation. The primary outcome measurement is the mucosal-plaque scores to assess oral health behaviors, attitudes, and oral hygiene. Secondary outcome measurements are oral hygiene routines, sugary food and drink intake, oral health perception, and oral health-related questions. Results: Data collection started in November 2021 and ended in June 2023. A total of 327 participants were recruited, of which 126 received the intervention. Conclusions: Integrating MI in oral health programs at prisons can significantly improve the oral health of incarcerated individuals. Should the results from this study demonstrate efficacy, it could be valuable insight for policy makers, oral health practitioners, and correctional services in addressing the needs of a traditionally underserved group before being scaled up to enhance dental care practices in prisons. Trial Registration: ClinicalTrials.gov NCT05695443; https://clinicaltrials.gov/study/NCT05695443 International Registered Report Identifier (IRRID): DERR1-10.2196/60817 %M 39661440 %R 10.2196/60817 %U https://www.researchprotocols.org/2024/1/e60817 %U https://doi.org/10.2196/60817 %U http://www.ncbi.nlm.nih.gov/pubmed/39661440 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e54619 %T Remotely Delivered Video Interaction Guidance for Families of Children With an Intellectual Disability Referred to Specialist Mental Health Services: Protocol for a Feasibility Randomized Controlled Trial %A Kohn,Charmaine %A Turner,Lauren %A Yang,Zhixing %A Absoud,Michael %A Casbard,Angela %A Gomes,Manuel %A Grant,Gemma %A Hassiotis,Angela %A Kennedy,Eilis %A Levitt,Sophie %A McNamara,Rachel %A Randell,Elizabeth %A Totsika,Vasiliki %+ University College London, 149 Tottenham Court Road, London, W1T 7NF, United Kingdom, 44 0207 679 2000, v.totsika@ucl.ac.uk %K learning disability %K intellectual disability %K ID %K child mental health %K challenging behavior %K family therapy %K parent-child relations %K parenting %D 2024 %7 5.12.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Children with an intellectual disability (ID) are 3-4 times more likely to present with behaviors that challenge and mental health problems than typically developing children. Parenting and the quality of parent-child relationships are risk factors for these families. The COVID-19 pandemic further exacerbated difficulties, leading to an increase in child mental health problems and behaviors that challenge, a deterioration in parental mental health, and further strain on family relationships. Remote family interventions could be an effective solution for both families and specialist mental health services. Video interaction guidance (VIG) has shown promise for improving child mental health. However, it is unclear whether it is widely acceptable to families and feasible to implement across specialist child mental health services. Objective: This randomized controlled trial aims to evaluate the feasibility of delivering VIG as a remote intervention for parents of children aged 6-12 years with ID who have been referred to specialist mental health services. Methods: The study will be undertaken across 5-7 National Health Service specialist mental health services in England, involving 50 participants randomly allocated on a 1:1 basis to either the intervention group (receiving remote VIG) or the treatment-as-usual (TAU) group. The intervention group will engage in 3-5 cycles of VIG delivered remotely over 12 weeks. The primary feasibility outcomes include the recruitment rate, retention at 6-month follow-up, and VIG cycle completion rate. The secondary outcomes will assess the acceptability of VIG and the feasibility of remote implementation, including fidelity to the intervention protocol. Data will be gathered through online surveys and telephone interviews at baseline, 3 months, and 6 months. Feasibility outcomes will be summarized using descriptive statistics, while thematic analysis will be applied to qualitative data from semistructured interviews with participants, VIG practitioners, and service managers. An embedded process evaluation will explore barriers and facilitators to engagement with VIG, and a parallel health economics evaluation will assess the feasibility of capturing service use data and intervention costs. Results: The trial was open to recruitment between December 2022 and March 2024. The first results should be available in 2025. Conclusions: The study is the first randomized evaluation of VIG as offered to parents of children with ID who have been referred to specialist mental health settings. The outcomes from this feasibility trial will inform the decision to proceed with a definitive trial, using a traffic light system to evaluate recruitment, retention, and VIG completion rates alongside qualitative insights and economic evaluations. Trial Registration: ISRCTN Registry ISRCTN13171328; http://www.isrctn.com/ISRCTN13171328 International Registered Report Identifier (IRRID): DERR1-10.2196/54619 %M 39636678 %R 10.2196/54619 %U https://www.researchprotocols.org/2024/1/e54619 %U https://doi.org/10.2196/54619 %U http://www.ncbi.nlm.nih.gov/pubmed/39636678 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e59014 %T Influence of Distraction Factors on Performance in Laparoscopic Surgery in Immersive Virtual Reality: Study Protocol of a Cross-Over Trial in Medical Students and Residents—DisLapVR %A Hanke,Laura %A Schulte,Richard %A Boedecker,Christian %A Huettl,Florentine %A Saalfeld,Patrick %A Chheang,Vuthea %A Wessels,Marlene %A von Castell,Christoph %A Hecht,Heiko %A Hansen,Christian %A Lang,Hauke %A Huber,Tobias %+ Department of General, Visceral and Transplant Surgery, University Medical Center of the Johannes Gutenberg-University Mainz, Langenbeckstr. 1, Mainz, 55131, Germany, 49 06131177291, tobias.huber@unimedizin-mainz.de %K immersive virtual reality %K distractions in surgery %K %K laparoscopy %K medical training %K medical students %K surgical education %K surgical training %K VR %K cognitive load %K multitasking %K stress resilience %D 2024 %7 5.11.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Working in an operating room (OR) is physically and mentally challenging: the operation itself demands the surgeon's full attention, while time and cost efficiency constraints, daily planning, and emergency care interfere with the procedure. Thus, multitasking becomes an integral surgical competence. This study aims to examine the effect of disruptions during surgery in a highly immersive virtual reality (IVR) operation environment combined with a virtual reality (VR) laparoscopy simulator. Objective: This study aims to identify distractions in the OR and their importance in the clinical setting. Methods: An IVR environment was created using a high-resolution, stereoscopic 360° video of the OR. Different distractions were identified, classified as auditory, visual, or audio-visual, and recorded accordingly. The surrounding was combined with a VR laparoscopic simulator. Participants—medical students and surgical residents—received proficiency-based training in basic laparoscopic skills and were blinded to the aim of the experiment. Following a cross-over design, each participant received a unique order of virtual distraction factors while performing tasks on the laparoscopic simulator. During the experiment, subjective passing of time, stress, heart rate, and visually induced motion sickness are recorded. After the experiment, validated questionnaires for usability, immersion, and stress were completed, as well as subjective evaluation of the distractions. The questionnaires used included the system usability scale, Self-Assessment Manikin score, National Aeronautics and Space Administration Task Load Index, and the immersion rating scale as described by Nichols. Performance in the laparoscopic tasks in relation to distractions will be evaluated by the Wilcoxon test and ANOVA for continuous variables. Subgroup analyses in regard to age, gender, and expertise (medical students vs surgical residents) are planned. Results: The described trial started in August 2022 and is ongoing. By July 2024, a total of 30 medical students and 9 surgeons have completed the study. Conclusions: We present a study protocol aiming to identify the impact of different disruptions in OR during laparoscopic training in IVR. Hence, it may lead to an improved awareness of distractions and facilitate accommodations toward an improved work environment. Prior research leads to the hypothesis that the performance of a more experienced surgeon is less impacted by distractions than the performance of inexperienced surgeons and medical students. Furthermore, we investigate which type of distraction has the largest impact on performance. With this knowledge, specific multitasking training can be devised, which may be particularly useful in medical education, for which VR might play a leading role. Additionally, workplace surroundings in the OR can be optimized with this knowledge. Trial Registration: German Registry for Clinical Trials DRKS00030033; https://drks.de/search/en/trial/DRKS00030033 International Registered Report Identifier (IRRID): DERR1-10.2196/59014 %M 39500487 %R 10.2196/59014 %U https://www.researchprotocols.org/2024/1/e59014 %U https://doi.org/10.2196/59014 %U http://www.ncbi.nlm.nih.gov/pubmed/39500487 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e59018 %T Impact of Dance or Music and Meditation on the Progression of Parkinson Disease With Mild or Moderate Severity: Protocol for a Pilot Randomized Controlled Trial %A Mehrotra,Bhagyashree %A Rai,Neha %A MR,Rajani %A Budhakar,Aparna %A Aggarwal,Ritika %A Agarbattiwala,Raj Vinodkumar %A Thomas,Mona %A Patole,Sampada %A Doshi,Paresh %+ Stereotactic and Functional Neurosurgery Department, Jaslok Hospital and Research Centre, 15, G Deshmukh Marg, Pedder Road, IT Colony, Tardeo, Mumbai, 400026, India, 91 9820063854, pdoshi@neurologicalsurgery.in %K music therapy %K dance therapy %K neurodegenerative disorders %K meditation %K quality of life %K music %K pilot study %K Parkinson disease %K well-being %D 2024 %7 29.10.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Parkinson disease (PD) is a progressive neurodegenerative disorder characterized by motor dysfunctions and nonmotor symptoms. Current treatments do not alter disease progression, highlighting the need for alternative therapies. Music, dance, and mindfulness meditation have shown the potential to improve symptoms and quality of life in patients with PD. Objective: This study aims to evaluate the effectiveness of dance or music and meditation on PD progression, cognitive functions, mood, behavior, and caregiver burden. Methods: This study is a single-blinded, longitudinal, parallel, randomized controlled trial. The participants consist of 30 patients with mild to moderate PD residing in Mumbai, India, who can physically participate in the activities. The exclusion criteria include advanced PD, severe balance issues, age >80 years, and other movement disorders. Participants in the intervention group will engage in dance or music sessions and guided meditation thrice weekly for 6 months. The control group will continue their usual activities and medication. The primary outcome is the progression of PD symptoms, measured using the Unified Parkinson’s Disease Rating Scale I-III, and quality of life, measured using the Parkinson’s Disease Questionnaire-39. The secondary outcomes include cognitive functions (Mini-Mental State Examination), mood (Beck Depression Inventory and Parkinson Anxiety Scale), mobility (timed up and go and Berg Balance Test), behavioral disorders (Questionnaire for Impulsive-Compulsive Disorders in Parkinson’s Disease Rating Scale), and caregiver burden (Zarit Burden Interview and Parkinson’s Disease Questionnaire-Carer). Results: Data collection was completed in February 2024, with 28 participants finishing the study (intervention group: n=15, 54% and control group: n=13, 46%). Data analysis is underway, with results expected to be published in December 2024. Conclusions: This study aims to provide significant insights into the effectiveness of dance or music and meditation in improving the quality of life and slowing the progression of PD. The findings are anticipated to support using these nonpharmaceutical therapies as complementary approaches to managing PD. Trial Registration: CTRI/2023/03/051064; https://tinyurl.com/2xdus53j International Registered Report Identifier (IRRID): DERR1-10.2196/59018 %M 39471378 %R 10.2196/59018 %U https://www.researchprotocols.org/2024/1/e59018 %U https://doi.org/10.2196/59018 %U http://www.ncbi.nlm.nih.gov/pubmed/39471378 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e56869 %T High Potassium Diet Rich in Spices and Herbs-Salt Substitution (HPSH-SS) for Blood Pressure Reduction in Older Adults: Protocol for Diet Concept and Randomized Controlled Trial %A Farapti,Farapti %A Putri,Sheila Amara %A Furqonia,Annisaa Wulida %A Rejeki,Purwo Sri %A Miftahussurur,Muhammad %+ Gastroentero-Hepatology Division, Department of Internal Medicine, Dr Soetomo Teaching Hospital, Jl. Prof. DR. Moestopo No.6-8, Airlangga, Surabaya, 60286, Indonesia, 62 812 5232 68, muhammad-m@fk.unair.ac.id %K sodium %K potassium %K spices and herbs %K blood pressure %K hypertension %K elderly %K vascular %K kidney %K gerontology %K aging %K protocol study %K dietary %K phytochemical %K anti-hypertensive %K Indonesia %K molecular mechanism %K control group %K oxidative stress %D 2024 %7 29.10.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Hypertension increases with age, often due to high sodium (Na) and low potassium (K) intake. Reducing salt and increasing K intake is challenging, especially for older adults due to taste preferences. Culinary herbs and spices, rich in K, offer a potential solution. The High Potassium Diet Rich in Spices and Herbs-Salt Substitution (HPSH-SS) diet has not yet been studied for its effectiveness in lowering blood pressure. Objective: This study aims to create an HPSH-SS diet, analyze its effects on blood pressure in older adults, and study the molecular mechanism occurring in the kidneys and blood vessels influenced by this diet. Methods: This study consists of 2 phases. The first phase involved formulating and assessing the HPSH-SS diet tailored for older adults. The intervention group (IG) received a diet of 1800 kcal/day, with 3500 mg K and 1500 mg Na, while the control group (CG) received 1500 mg K and 2000 mg Na. The diet was administered for 14 days and standardized using the NutriSurvey program and biochemistry analysis by atomic absorbance spectrophotometry (AAS). The second phase was a 14-day parallel randomized controlled trial (RCT) with the older adult participants divided into IG and CG. Primary outcomes included blood pressure; serum potassium; aldosterone; F2 isoprostane; nitric oxide plasma levels; and urine analysis of Na, K, and the Na/K ratio. Confounding variables were controlled through randomization and stratified analysis. Results: The menu formulation and organoleptic assessment of the HPSH-SS diet began in mid-2022 and was approved by the Ethics Committee of the Faculty of Public Health at Universitas Airlangga (78/EA/KEPK/2022) on May 11, 2022. The diet was standardized to achieve daily nutritional values of 1800 kcal energy, 3500 mg K, and 1500 mg Na. K and Na contents were analyzed using AAS from several participants’ spice diet menus. Recruitment for the RCT started in March 2023, with approval from the Health Research Ethics Committee Universitas Airlangga School of Medicine, Surabaya (35/EC/KEPK/FKUA/2023). The study was registered from February 9, 2023, to February 9, 2024. Between March and June 2023, 64 participants were recruited, with 32 participants in the IG and CG. The intervention and data collection will take place over 1 year. Data management is in progress, and data analysis is yet to be performed. Conclusions: This RCT protocol hypothesizes that the diet will increase serum K, plasma aldosterone, and nitric oxide levels; decrease plasma F2 isoprostane; increase urinary Na and K levels; lower the urinary Na/K ratio; and reduce systolic and diastolic blood pressure. If effective, it will offer valuable insights into dietary strategies for blood pressure regulation in older adults. International Registered Report Identifier (IRRID): DERR1-10.2196/56869 %M 39470696 %R 10.2196/56869 %U https://www.researchprotocols.org/2024/1/e56869 %U https://doi.org/10.2196/56869 %U http://www.ncbi.nlm.nih.gov/pubmed/39470696 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e59894 %T Over-the-Counter Hearing Aids Versus Traditional Hearing Aids in Patients With Mild-to-Moderate Hearing Loss: Protocol for a Noninferiority Randomized Controlled Trial %A Kim,Ga-Young %A Jo,Mini %A Cho,Young Sang %A Moon,Il Joon %+ Department of Otorhinolaryngology - Head and Neck Surgery, Sungkyunkwan University School of Medicine, Samsung Medical Center, 81, Irwon-ro, Seoul, 06342, Republic of Korea, 82 3410 3579, moonij@skku.edu %K hearing aids %K over-the-counter hearing aids %K correction of hearing impairment %K randomized controlled trial %K evidence-based medicine %K hearing loss %K aging %K hearing sensitivity %K mobile phone %D 2024 %7 25.10.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: With the aging of society, the prevalence of hearing loss (HL) is increasing. Currently, approximately 5% of the global population has HL, and this number is projected to reach 7 million by 2050. Although hearing aids (HAs) are the primary treatment for HL, their use is limited by barriers such as high costs and social stigma. To address these limitations, over-the-counter (OTC) HAs have been introduced, but their effectiveness and drawbacks require further investigation. Objective: This study aims to conduct a noninferiority randomized controlled trial comparing OTC HAs with traditional HAs to assess the clinical effectiveness of OTC HAs. Methods: We designed a noninferiority randomized controlled trial comparing OTC HAs and traditional HAs in adults with mild-to-moderate HL. A total of 64 participants (32 per group) will be recruited. Randomization will be performed using block randomization (block sizes of 2 or 4) with an equal allocation ratio. The study will include 2 types of HAs: an OTC HA (Jabra Enhance Pro) and a traditional HA (LiNX Quattro LE561-DRW) by GN ReSound A/S. OTC HAs will be self-fitted using a smartphone app, while traditional HAs will be fitted by a licensed audiologist using the National Acoustics Laboratories–Non-Linear Prescription, second generation. Assessments, including functional gain, real-ear measurement, speech audiometry, and questionnaires, will be conducted at 6-month intervals over the course of 3 visits. Statistical analysis will compare the 2 outcomes, focusing on functional gain, to determine noninferiority. Results: This study is scheduled to begin in August 2024 and has not yet recruited any participants. The study will be conducted over 2 years, from August 2024 to July 2026. Each participant will have 2 follow-up visits at 6-month intervals, making the total follow-up period 1 year. Conclusions: Since 2022, the introduction of OTC HAs has revolutionized access to these devices. Researchers, clinicians, and the general public are keen to evaluate the clinical effectiveness of OTC HAs, as more individuals will likely use them for HL. This increased usage will provide valuable real-world data to understand the benefits and limitations of OTC HAs. Monitoring the outcomes and user feedback will provide insights into their effectiveness and impact on hearing rehabilitation. International Registered Report Identifier (IRRID): PRR1-10.2196/59894 %M 39454188 %R 10.2196/59894 %U https://www.researchprotocols.org/2024/1/e59894 %U https://doi.org/10.2196/59894 %U http://www.ncbi.nlm.nih.gov/pubmed/39454188 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e57888 %T Acupuncture as Adjuvant Therapy for Glaucoma: Protocol for a Randomized Controlled Trial %A Liao,Yi-Fang %A Lee,Yu-Chen %A Lin,Hui-Ju %A Shao,Yi-Ching %+ Department of Ophthalmology, Eye Center, China Medical University Hospital, No. 2, Yude Road, North District, No. 91, Xueshi Road, North District, Taichung, 404327, Taiwan, 886 937511948, baba6467@yahoo.com.tw %K acupuncture %K open-angle glaucoma %K optical coherence tomography %K intraocular pressure %K glaucoma %K adjuvant therapy %K optic neuropathy %K disease progression %K ophthalmic disorders %K optic %K conventional treatment %K efficacy %K adjunctive therapy %D 2024 %7 8.10.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Glaucoma is a chronic progressive optic neuropathy that necessitates lifelong treatment to reduce the decline of the optic nerve. Due to the extended and continuous treatments required for patients, complementary therapies are often considered alongside conventional treatments to enhance the effectiveness of the treatment. Acupuncture has demonstrated the potential to lower intraocular pressure in previous clinical trials, making it a promising glaucoma intervention. Objective: The primary objective of this study is to conduct a single-center randomized control trial involving patients with glaucoma. Acupuncture will be evaluated as an adjunctive therapy. The trial aims to explore its effectiveness for glaucoma. Methods: In this single-center randomized controlled trial, participants (N=50) with primary open-angle glaucoma will be randomly assigned to the treatment group, receiving ophthalmic acupuncture with “De Qi” sensation, or the control group, receiving minimum acupuncture stimulation on nonophthalmic acupoints. The intervention will consist of weekly acupuncture treatments for a total of 6 sessions. Participants will be assessed at 8 time points, which are baseline, during the intervention (6 times), and at a 3-month follow-up. The primary outcome measure is a change in the intraocular pressure before and after each acupuncture treatment. Secondary outcomes will include measurements of heart rate and blood pressure before and after acupuncture, best-corrected visual acuity, visual field, optical coherence tomography, optical coherence tomography angiography, the Glaucoma Symptom Scale, and the Glaucoma Quality of Life-15 questionnaire. Results: Recruitment of participants for the trial commenced on June 28, 2023. A total of 10 participants have been enrolled to test the feasibility of the experiment. We anticipate that the preliminary data from this trial will be completed by December 2025. Conclusions: This trial uses rigorous methodology and comprehensive outcome measurements to assess the clinical efficacy of acupuncture as an adjunctive therapy for glaucoma, providing valuable insights for future clinical treatment guidelines. Trial Registration: ClinicalTrials.gov NCT05753137; https://clinicaltrials.gov/study/NCT05753137 International Registered Report Identifier (IRRID): DERR1-10.2196/57888 %M 39378079 %R 10.2196/57888 %U https://www.researchprotocols.org/2024/1/e57888 %U https://doi.org/10.2196/57888 %U http://www.ncbi.nlm.nih.gov/pubmed/39378079 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e58316 %T Graded Intensity Aerobic Exercise to Improve Cerebrovascular Function and Performance in Older Veterans: Protocol for a Randomized Controlled Trial %A Bello,Medina Oneyi %A Mammino,Kevin Michael %A Vernon,Mark Anthony %A Wakeman,Daniel G %A Denmon,Chanse Aerius %A Krishnamurthy,Lisa Crystal %A Krishnamurthy,Venkatagiri %A McGregor,Keith Matthew %A Novak,Thomas Samuel %A Nocera,Joe Robert %+ Joseph Maxwell Cleland Atlanta Veteran Affairs Medical Center, 1670 Clairmont Rd, Decatur, GA, 30033, United States, 1 404 321 6111 ext 207099, Medina.Bello@va.gov %K aerobic exercise %K exercise %K functional magnetic resonance imaging %K fMRI %K veterans %K quality of life %K sedentary lifestyle %K elderly %K geriatrics %K geriatric %K older adults %K cardiovascular disease %K health promotion %K aging %K cognitive %K cognitive health %K physical health %D 2024 %7 26.9.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Growing health care challenges resulting from a rapidly expanding aging population necessitate examining effective rehabilitation techniques that mitigate age-related comorbidity and improve quality of life. To date, exercise is one of a few proven interventions known to attenuate age-related declines in cognitive and sensorimotor functions critical to sustained independence. Objective: This work aims to implement a multimodal imaging approach to better understand the mechanistic underpinnings of the beneficial exercise-induced adaptations to sedentary older adults’ brains and behaviors. Due to the complex cerebral and vascular dynamics that encompass neuroplastic change with aging and exercise, we propose an imaging protocol that will model exercise-induced changes to cerebral perfusion, cerebral vascular reactivity (CVR), and cognitive and sensorimotor task-dependent functional magnetic resonance imaging (fMRI) after prescribed exercise. Methods: Sedentary older adults (aged 65-80 years) were randomly assigned to either a 12-week aerobic-based interval-based cycling intervention or a 12-week balance and stretching intervention. Assessments of cardiovascular fitness used the YMCA submaximal VO2 test, basal cerebral perfusion using arterial spin labeling (ASL), CVR using hypercapnic fMRI, and cortical activation using fMRI during verbal fluency and motor tapping tasks. A battery of cognitive-executive and motor function tasks outside the scanning environment will be performed before and after the interventions. Results: Our studies and others show that improved cardiovascular fitness in older adults results in improved outcomes related to physical and cognitive health as well as quality of life. A consistent but unexplained finding in many of these studies is a change in cortical activation patterns during task-based fMRI, which corresponds with improved task performance (cognitive-executive and motor). We hypothesize that the 12-week aerobic exercise intervention will increase basal perfusion and improve CVR through a greater magnitude of reactivity in brain areas susceptible to neural and vascular decline (inferior frontal and motor cortices) in previously sedentary older adults. To differentiate between neural and vascular adaptations in these regions, we will map changes in basal perfusion and CVR over the inferior frontal and the motor cortices—regions we have previously shown to be beneficially altered during fMRI BOLD (blood oxygen level dependent), such as verbal fluency and motor tapping, through improved cardiovascular fitness. Conclusions: Exercise is one of the most impactful interventions for improving physical and cognitive health in aging. This study aims to better understand the mechanistic underpinnings of improved health and function of the cerebrovascular system. If our hypothesis of improved perfusion and cerebrovascular reactivity following a 12-week aerobic exercise intervention is supported, it would add critically important insights into the potential of exercise to improve brain health in aging and could inform exercise prescription for older adults at risk for neurodegenerative disease brought on by cerebrovascular dysfunction. Trial Registration: ClinicalTrials.gov NCT05932069; https://clinicaltrials.gov/study/NCT05932069 International Registered Report Identifier (IRRID): DERR1-10.2196/58316 %M 39326042 %R 10.2196/58316 %U https://www.researchprotocols.org/2024/1/e58316 %U https://doi.org/10.2196/58316 %U http://www.ncbi.nlm.nih.gov/pubmed/39326042 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e56063 %T Ayurveda Management of Allergic Rhinitis: Protocol for a Randomized Controlled Trial %A Mata,Shweta %A Rajput,Shivshankar %A Tuli,Isha Preet %A Mundada,Pallavi %A Gupta,Bharti %A Srikanth,Narayanam %A Acharya,Rabinarayanan %+ Central Ayurveda Research Institute, Central Council for Research in Ayurvedic Sciences, Ministry of Ayush, Road no. 66 Punjabi Bagh West, New Delhi, 110026, India, 91 08866014946, drshwetamataccras@gmail.com %K allergic rhinitis %K AR %K Anu Taila Nasya %K fluticasone propionate nasal spray %K Naradiya Laxmivilas Rasa %K randomized controlled trial %K Shrishadi Kwath %D 2024 %7 25.9.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Allergic rhinitis (AR) is the inflammation of the membranes lining the nose due to allergen exposure and is characterized by sneezing, nasal congestion, itching of the nose, or postnasal discharge. The prevalence varies worldwide, perhaps due to the geographic and aeroallergen differences, with 10% to 30% of the world’s population experiencing AR. In this study, Anu Taila Nasya, Naradiya Laxmivilas Rasa, and Shirishadi Kwath will be compared to a fluticasone nasal spray. Objective: The primary aim is to assess the efficacy of Ayurvedic management for AR (or vataja pratishyaya) by comparing it to a conventional control group. The secondary aims are to determine the mean change in the nasal endoscopy index and the mean change in the laboratory tests. Methods: This ongoing study is an open-label randomized controlled interventional trial, with a sample size of 90 both in the trial and standard control group (including dropouts, 20%), and will be carried out for 24 months. Participants in the trial group will receive Ayurvedic treatment, that is, Anu Taila Nasya (6 drops in each nostril for 7 days for 3 consecutive weeks), Naradiya Laxmivilas Rasa (250 mg twice per day), and Shirishadi Kwath (40 ml twice per day for 45 days). The participants in the control group will receive a fluticasone propionate nasal spray (2 sprays once per day for 45 days). The primary outcome will include the mean change in the Control of Allergic Rhinitis and Asthma Test score, and the secondary outcomes will include the mean change in the nasal endoscopy index (assessment of nasal membrane color, pale or hyperemia; rhinorrhea, watery or yellow; and inferior turbinate swelling, hypertrophy) and the mean change in the laboratory tests. Results: As of May 2024, 72 patients have been enrolled in both groups. Data analysis should be completed by February 2025. The study will be reported following standard guidelines for reporting randomized controlled trials. Clinical results will be disseminated through conferences and peer-reviewed publication in a relevant journal. Conclusions: The Ayurvedic approach could be an evidence-based therapeutic tactic for the management of AR. Trial Registration: Clinical Trials Registry India CTRI/2023/06/053395; https://tinyurl.com/564d2zz8 International Registered Report Identifier (IRRID): DERR1-10.2196/56063 %M 39321461 %R 10.2196/56063 %U https://www.researchprotocols.org/2024/1/e56063 %U https://doi.org/10.2196/56063 %U http://www.ncbi.nlm.nih.gov/pubmed/39321461 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e60277 %T Peer Intervention to Link Overdose Survivors to Treatment (PILOT): Protocol for a Multisite, Randomized Controlled Trial Conducted Within the National Institute on Drug Abuse Clinical Trials Network %A Papa,Carrie %A McClure,Erin A %A McCauley,Jenna %A Haynes,Louise %A Matheson,Timothy %A Jones,Richard %A Jennings,Lindsey %A Lawdahl,Tricia %A Ward,Ralph %A Brady,Kathleen %A Barth,Kelly Stephenson %+ Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, United States, 1 843 876 1507, papa@musc.edu %K opioids %K overdose %K nonfatal overdose involving opioids %K peer support specialist %K harm reduction %K emergency department %D 2024 %7 17.9.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: The increase in opioid-related overdoses has caused a decrease in average life expectancy, highlighting the need for effective interventions to reduce overdose risk and prevent subsequent overdoses. Peer support specialists (PSSs) offer an appealing strategy to engage overdose survivors and reduce overdose risk, but randomized controlled trials are needed to formalize peer-led interventions and evaluate their effectiveness. Objective: This National Institute on Drug Abuse Clinical Trials Network (CTN) study is a multisite, prospective, pilot randomized (1:1) controlled trial (CTN protocol 0107) that aims to evaluate the effectiveness of an emergency department (ED)–initiated, peer-delivered intervention tailored for opioid overdose survivors (Peer Intervention to Link Overdose survivors to Treatment [PILOT]), compared with treatment as usual (TAU). Methods: This study evaluates the effectiveness of the 6-month, PSS-led PILOT intervention compared with TAU on the primary outcome of reducing overdose risk behavior 6 months after enrollment. Adults (aged ≥18 years; N=150) with a recent opioid-related overdose were identified and approached in the ED. Participants were screened and enrolled, either in the ED or within 7 days of ED discharge at research offices or in the community and then asked to complete study visits at months 1, 3, 6 (end of intervention), and 7 (follow-up). Participants were enrolled at 3 study sites in the United States: Greenville, South Carolina; Youngstown, Ohio; and Everett, Washington. Participants randomized to the PILOT intervention received a 6-month, PSS-led intervention tailored to each participant’s goals to reduce their overdose risk behavior (eg, overdose harm reduction, housing, medical, and substance use treatment or recovery goals). Participants randomized to TAU received standard-of-care overdose materials, education, and services provided through the participating EDs. This paper describes the study protocol and procedures, explains the design and inclusion and exclusion decisions, and provides details of the peer-led PILOT intervention and supervision of PILOT PSSs. Results: Study enrollment opened in December 2021 and was closed in July 2023. A total of 150 participants across 3 sites were enrolled in the study, meeting the proposed sample size for the trial. Primary and secondary analyses are underway and expected to be published in early 2025. Conclusions: There is an urgent need to better understand the characteristics of overdose survivors presenting to the ED and for rigorous trials evaluating the effectiveness of PSS-led interventions on engaging overdose survivors and reducing overdose risk. Results from this pilot randomized controlled trial will provide a description of the characteristics of overdose survivors presenting to the ED; outline the implementation of PSS services research in ED settings, including PSS implementation of PSS supervision and activity tracking; and inform ED-initiated PSS-led overdose risk reduction interventions and future research to better understand the implementation and efficacy of these interventions. Trial Registration: ClinicalTrials.gov NCT05123027; https://clinicaltrials.gov/study/NCT05123027 International Registered Report Identifier (IRRID): DERR1-10.2196/60277 %M 39288373 %R 10.2196/60277 %U https://www.researchprotocols.org/2024/1/e60277 %U https://doi.org/10.2196/60277 %U http://www.ncbi.nlm.nih.gov/pubmed/39288373 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e55290 %T Examining the Acceptability of Helminth Education Packages “Magic Glasses Lower Mekong” and “Magic Glasses Opisthorchiasis” and Their Impact on Knowledge, Attitudes, and Practices Among Schoolchildren in the Lower Mekong Basin: Protocol for a Cluster Randomized Controlled Trial %A O'Connor,Suji Y %A Mationg,Mary Lorraine %A Kelly,Matthew J %A Williams,Gail M %A Clements,Archie CA %A Sripa,Banchob %A Sayasone,Somphou %A Khieu,Virak %A Wangdi,Kinley %A Stewart,Donald E %A Tangkawattana,Sirikachorn %A Suwannatrai,Apiporn T %A Savathdy,Vanthanom %A Khieu,Visal %A Odermatt,Peter %A Gordon,Catherine A %A Wannachart,Sangduan %A McManus,Donald P %A Gray,Darren J %+ National Centre for Epidemiology and Population Health, Australian National University, 62 Mills Road, Acton, 2601, Australia, 61 026125 2378, suji.oconnor@anu.edu.au %K attitude %K child %K health education %K helminths %K knowledge %K practices %K Opisthorchis viverrini %K randomized controlled trial %K schools %K Ascaris lumbricoides %K Trichuris trichiura %K hookworm %K Magic Glasses %D 2024 %7 16.9.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Helminths are a major global health issue, impacting health, educational, and socioeconomic outcomes. Infections, often starting in childhood, are linked to anemia, malnutrition, cognitive deficit, and in chronic cases of Opisthorchis viverrini (OV), cholangiocarcinoma. The main control strategy for helminth infection is mass drug administration; however, this does not prevent reinfection. As such, prevention strategies are needed. The “Magic Glasses” is a school-based cartoon health education package that has demonstrated success in improving knowledge, attitudes, and practices (KAP) surrounding soil-transmitted helminths (STH) in China and the Philippines. This study is designed to assess the acceptability and impact of the 2 new versions of the Magic Glasses targeting STH and OV designed for the Lower Mekong audience in Cambodia, Lao People’s Democratic Republic (PDR), and Thailand. Objective: The objective of this study is to evaluate the acceptability of the “Magic Glasses Lower Mekong” and “Magic Glasses Opisthorchiasis” education packages among schoolchildren in the Lower Mekong Basin, and the impact of these education packages on students’ KAP surrounding STH and OV, respectively. Methods: Schoolchildren will be recruited into a cluster randomized controlled trial with intervention and control arms in rural schools in Cambodia, Lao PDR, and Thailand. Schoolchildren’s initial acceptability of the intervention will be evaluated using an adapted questionnaire. Sustained acceptability will be assessed at 9-month follow-up through focus group discussions with students and interviews with teachers. Impact will be evaluated by KAP questionnaires on STH and OV. KAP questionnaires will be administered to children at baseline and at follow-up. Indirect impact on parents' KAP of OV and STH will be assessed through focus group discussions at follow-up. Results: The trial is in progress in Lao PDR and Thailand and is expected to commence in Cambodia in January 2024. The results of the study are expected to be available 18 months from the start of recruitment. We hypothesize that participants enrolled in the intervention arm of the study will have higher KAP scores for STH and OV, compared with the participants in the control arm at follow-up. We expect that students will have initial and sustained acceptability of these intervention packages. Conclusions: This trial will examine the acceptability of the “Magic Glasses Opisthorchiasis” and “Magic Glasses Lower Mekong” interventions and provide evidence on the effectiveness of the “Magic Glasses” on KAP related to OV and STH among schoolchildren in the Lower Mekong Basin. Study results will provide insight on acceptability and impact indicators and inform a scaling up protocol for the “Magic Glasses” education packages in Cambodia, Lao PDR, and Thailand. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12623000271606; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385315&isReview=true International Registered Report Identifier (IRRID): DERR1-10.2196/55290 %M 39283663 %R 10.2196/55290 %U https://www.researchprotocols.org/2024/1/e55290 %U https://doi.org/10.2196/55290 %U http://www.ncbi.nlm.nih.gov/pubmed/39283663 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e57287 %T Evaluation of Comparative Efficacy of Levothyroxine Versus Kshar Basti and Kanchanar Guggul in the Treatment of Hypothyroidism: Protocol for a Randomized Controlled Trial %A Kulkarni,Satyajit Pandurang %A Parwe,Shweta %+ Mahatma Gandhi Ayurved College Hospital and Research Centre, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, 442001, India, 91 9970765965, satyajitkulkarni2001@gmail.com %K ayurveda %K complementary and alternative medicine %K hypothyroidism %K levothyroxine %K rectal enema %K massage therapy %K sudation %D 2024 %7 10.9.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: The thyroid gland is an endocrine gland that has an impact on the body’s general metabolism. Thus, the secretions of the thyroid gland can modify the overall metabolism of the entire body. The prevalence of hypothyroidism is increasing quickly, with rates of 2%-5% in affluent countries and 11% in India. Individuals diagnosed with hypothyroidism need to take medication for the rest of their lives, resulting in significant stress. Therefore, conducting a study in this area is imperative. Objective: This study aims to assess the effectiveness of the therapeutic enema (Kshar Basti) and oral Kanchanar Guggul in the treatment of hypothyroidism. Methods: The trial group (n=45) will receive a therapeutic enema (Kshar Basti) followed by oral Ayurvedic drugs for 180 days. The control group (n=45) will be given levothyroxine tablets at a dosage of 1.6 µg/kg/day for the same duration. The objective is to examine the alterations in thyroid stimulating hormone (TSH) levels before and after the treatment. Results: Any deviation of the serum TSH by more than 20% from the initial values, while keeping triiodothyronine (T3), and thyroxine (T4) levels within the normal range, will be deemed statistically significant. Consequently, we anticipate a statistically significant variation in serum TSH levels between the therapeutic enema and Kanchanar Guggul treatments. Presently, the drug preparation operations are in progress. We expect to start enrolling patients in June 2024, do data analysis in December 2025, and acquire results by early 2026, marking the end of this trial. Conclusions: This study will evaluate the efficacy of the therapeutic enema, specifically Kshar Basti, in treating hypothyroidism. Furthermore, more research can determine the efficacy of a therapeutic enema (Kshar Basti) in treating overt hypothyroidism and hypothyroidism during pregnancy. Trial Registration: Clinical Trials Registry India CTRI/2023/05/052389; https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=Nzk1NjY=&Enc=&userName=052389 International Registered Report Identifier (IRRID): PRR1-10.2196/57287 %M 39255475 %R 10.2196/57287 %U https://www.researchprotocols.org/2024/1/e57287 %U https://doi.org/10.2196/57287 %U http://www.ncbi.nlm.nih.gov/pubmed/39255475 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e59428 %T Using Systems Engineering and Implementation Science to Design an Implementation Package for Preoperative Comprehensive Geriatric Assessment Among Older Adults Having Major Abdominal Surgery: Protocol for a 3-Phase Study %A Berian,Julia R %A Schwarze,Margaret L %A Werner,Nicole E %A Mahoney,Jane E %A Shah,Manish N %+ Department of Surgery, School of Medicine and Public Health, University of Wisconsin-Madison, 600 Highland Ave, Madison, WI, 53792, United States, 1 6082634224, berian@wisc.edu %K systems engineering %K participatory design %K user-centered design %K implementation science %K surgery %K aging research %K randomized controlled trial %D 2024 %7 9.9.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Older Americans, a growing segment of the population, have an increasing need for surgical services, and they experience a disproportionate burden of postoperative complications compared to their younger counterparts. A preoperative comprehensive geriatric assessment (pCGA) is recommended to reduce risk and improve surgical care delivery for this population, which has been identified as vulnerable. The pCGA optimizes multiple chronic conditions and factors commonly overlooked in routine preoperative planning, including physical function, polypharmacy, nutrition, cognition, mental health, and social and environmental support. The pCGA has been shown to decrease postoperative morbidity, mortality, and length of stay in a variety of surgical specialties. Although national guidelines recommend the use of the pCGA, a paucity of strategic guidance for implementation limits its uptake to a few academic medical centers. By applying implementation science and human factors engineering methods, this study will provide the necessary evidence to optimize the implementation of the pCGA in a variety of health care settings. Objective: The purpose of this paper is to describe the study protocol to design an adaptable, user-centered pCGA implementation package for use among older adults before major abdominal surgery. Methods: This protocol uses systems engineering methods to develop, tailor, and pilot-test a user-centered pCGA implementation package, which can be adapted to community-based hospitals in preparation for a multisite implementation trial. The protocol is based upon the National Institutes of Health Stage Model for Behavioral Intervention Development and aligns with the goal to develop behavioral interventions with an eye to real-world implementation. In phase 1, we will use observation and interviews to map the pCGA process and identify system-based barriers and facilitators to its use among older adults undergoing major abdominal surgery. In phase 2, we will apply user-centered design methods, engaging health care providers, patients, and caregivers to co-design a pCGA implementation package. This package will be applicable to a diverse population of older patients undergoing major abdominal surgery at a large academic hospital and an affiliate community site. In phase 3, we will pilot-test and refine the pCGA implementation package in preparation for a future randomized controlled implementation-effectiveness trial. We anticipate that this study will take approximately 60 months (April 2023-March 2028). Results: This study protocol will generate (1) a detailed process map of the pCGA; (2) an adaptable, user-centered pCGA implementation package ready for feasibility testing in a pilot trial; and (3) preliminary pilot data on the implementation and effectiveness of the package. We anticipate that these data will serve as the basis for future multisite hybrid implementation-effectiveness clinical trials of the pCGA in older adults undergoing major abdominal surgery. Conclusions: The expected results of this study will contribute to improving perioperative care processes for older adults before major abdominal surgery. International Registered Report Identifier (IRRID): DERR1-10.2196/59428 %M 39250779 %R 10.2196/59428 %U https://www.researchprotocols.org/2024/1/e59428 %U https://doi.org/10.2196/59428 %U http://www.ncbi.nlm.nih.gov/pubmed/39250779 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e55129 %T Dexmedetomidine Versus Midazolam for End-of-Life Sedation and Agitation: Protocol for a Randomized Controlled Trial (The DREAMS Trial) %A Thomas,Benjamin %A Barclay,Greg %A Lo,Wing-Shan Angela %A Mullan,Judy %A Mansfield,Kylie %+ Graduate School of Medicine, University of Wollongong, Northfields Avenue, Wollongong, Australia, 61 42213155, benjamin.thomas@health.nsw.gov.au %K palliative %K sedation %K delirium %K dexmedetomidine %K midazolam %K antipsychotics %K deep sedation %K palliative care %K sedative %K adult %K inpatient %K Australia %K quality of life %K end of life %K protocol %K dexmedetomidine for the reduction of end-of-life agitation and for optiMised sedation %K DREAMS trial %K DREAMS %K deep sedation %D 2024 %7 4.9.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Sedation at the end of life is used to relieve distressing symptoms including agitation and delirium. Standard care may include infused benzodiazepines or antipsychotics. These agents often result in deep sedation with loss of interaction with loved ones, which may be distressing. Objective: The DREAMS (Dexmedetomidine for the Reduction of End-of-life Agitation and for optiMised Sedation) trial aimed to compare the sedative and antidelirium effects of the alpha-2 agonist dexmedetomidine, a novel palliative care sedative, compared with midazolam, a benzodiazepine when administered by subcutaneous infusion at the end of life, with doses of both agents targeting lighter, or potentially interactive sedation. Methods: Participants were recruited from adult inpatients admitted for end-of-life care under a palliative care team in regional New South Wales, Australia. Inclusion criteria included patients older than 18 years, with a preference for lighter sedation at the end of life. Exclusion criteria included severe cardiac dysfunction (contraindication to dexmedetomidine). Participants consented and were placed on a treatment-pending list. Upon experiencing terminal deterioration, patients were randomized to either arm 1 (dexmedetomidine) or arm 2 (midazolam) as their treatment arm. These treatments were administered by continuous subcutaneous infusion. The level of consciousness and agitation of the patients were measured by the Richmond Agitation-Sedation Scale–Palliative version and the Memorial Delirium Assessment Score. Richmond Agitation-Sedation Scale–Palliative version assessments were performed by both nursing and medical staff, while Memorial Delirium Assessment Score assessments were carried out by medical staff only. Families and patients were asked to complete, as able, a patient comfort assessment form, to gauge perceptions of distress. Data were collected and matched with the breakthrough medication doses administered, along with qualitative comments in the medical record. In addition, the study tracked symptoms and patient functional status that were recorded as part of the Palliative Care Outcomes Collaborative, a national tracking project for monitoring symptom outcomes in palliative care. Results: The DREAMS trial was funded in May 2020, approved by the ethics committee in November 2020, and started recruiting participants in May 2021. Data collection commenced in May 2021 and is anticipated to continue until December 2024. Publication of results is anticipated from 2024 to 2026. Conclusions: The evidence base for sedative dosing in palliative care for distress and agitation is not robust, with standard care based primarily on clinical experience and not robust scientific evidence. This study is important because it will compare a standard and a novel sedative used in end-of-life treatment. By assessing the potential efficacy and benefits of both, it seeks to optimize the quality of dying by providing targeted sedation that can improve the communication between dying patients and their loved ones. Trial Registration: Australia New Zealand Clinical Trials Register ACTRN12621000052831; https://uat.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380889 International Registered Report Identifier (IRRID): DERR1-10.2196/55129 %M 39230940 %R 10.2196/55129 %U https://www.researchprotocols.org/2024/1/e55129 %U https://doi.org/10.2196/55129 %U http://www.ncbi.nlm.nih.gov/pubmed/39230940 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e57236 %T Adapting and Evaluating a Brief Advice Tobacco Cessation Intervention in High-reach, Low-resource Settings in India: Protocol for a Cluster Randomized Controlled Trial %A Mahtani,Sitara L %A Viswanath,Kasisomayajula %A Gupte,Himanshu A %A Mandal,Gauri %A Jagiasi,Dinesh %A Chawla,Ratandeep %A D'Costa,Marina %A Xuan,Ziming %A Minsky,Sara %A Ramanadhan,Shoba %+ Dana-Farber Cancer Institute, 450 Brookline Avenue, LW, 6th Floor, Boston, MA, 02215, United States, 1 617 582 9487, sitara_mahtani@dfci.harvard.edu %K tobacco use Cessation %K India %K resource-limited settings %K task-shifting %K counseling %K nonprofit organizations %K dental health services %K tuberculosis %K social media %K mobile app %D 2024 %7 3.9.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: About 1.35 million deaths annually are attributed to tobacco use in India. The main challenge, given the magnitude of tobacco use and limited resources, is delivering cessation support at scale, low cost, and through a coordinated cross-system effort; one such example being brief advice interventions. However, highly credentialed staff to identify and counsel tobacco users are scarce. Task-shifting is an important opportunity for scaling these interventions. Objective: The LifeFirst SWASTH (Supporting Wellbeing among Adults by Stopping Tobacco Habit) program—adapted from the LifeFirst program (developed by the Narotam Sekhsaria Foundation, Mumbai, India)—is a tobacco cessation program focusing on lower-socioeconomic status patients in Mumbai receiving private health care. This parallel-arm, cluster randomized controlled trial investigates whether the LifeFirst SWASTH program increases tobacco cessation rates in low-resource, high-reach health care settings in Mumbai. Methods: This study will target tuberculosis-specific nongovernmental organizations (NGOs), dental clinics, and NGOs implementing general health programs serving lower-socioeconomic status patients. Intervention arm patients will receive a pamphlet explaining tobacco’s harmful effects. Practitioners will be trained to deliver brief cessation advice, and interested patients will be referred to a Narotam Sekhsaria Foundation counselor for free telephone counseling for 6 months. Control arm patients will receive the same pamphlet but not brief advice or counseling. Practitioners will have a customized mobile app to facilitate intervention delivery. Practitioners will also have access to a peer network through WhatsApp. The primary outcome is a 30-day point prevalence abstinence from tobacco. Secondary outcomes for patients and practitioners relate to intervention implementation. Results: The study was funded in June 2020. Due to the COVID-19 pandemic, the study experienced some delays, and practitioner recruitment commenced in November 2023. As of July 2024, all practitioners have been recruited, and practitioner recruitment and training are complete. Furthermore, 36% (1687/4688) of patients have been recruited. Conclusions: It is hypothesized that those patients who participated in the LifeFirst SWASTH program will be more likely to have been abstinent from tobacco for 30 consecutive days by the end of 6 months or at least decreased their tobacco use. LifeFirst SWASTH, if found to be effective in terms of cessation outcomes and implementation, has the potential to be scaled to other settings in India and other low- and middle-income countries. The study will be conducted in low-resource settings and will reach many patients, which will increase the impact if scaled. It will use task-shifting and an app that can be tailored to different settings, also enabling scalability. Findings will build the literature for translating evidence-based interventions from high-income countries to low- and middle-income countries and from high- to low-resource settings. Trial Registration: ClinicalTrials.gov NCT05234983; https://clinicaltrials.gov/study/NCT05234983 International Registered Report Identifier (IRRID): DERR1-10.2196/57236 %M 39225384 %R 10.2196/57236 %U https://www.researchprotocols.org/2024/1/e57236 %U https://doi.org/10.2196/57236 %U http://www.ncbi.nlm.nih.gov/pubmed/39225384 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e56772 %T Nourishing the Infant Gut Microbiome to Support Immune Health: Protocol of SUN (Seeding Through Feeding) Randomized Controlled Trial %A Wall,Clare R %A Roy,Nicole C %A Mullaney,Jane A %A McNabb,Warren Charles %A Gasser,Olivier %A Fraser,Karl %A Altermann,Eric %A Young,Wayne %A Cooney,Janine %A Lawrence,Robyn %A Jiang,Yannan %A Galland,Barbara C %A Fu,Xiaoxi %A Tonkie,Jacqueline N %A Mahawar,Nisha %A Lovell,Amy Luisa %+ Department of Nutrition and Dietetics, University of Auckland, Medical School Campus, 85, Park Road, Grafton, Auckland, 1041, New Zealand, 64 0276306529, c.wall@auckland.ac.nz %K infant %K complementary feeding %K gut microbiota %K immune %K complementary food %K feeding %K gut microbiome %K microbiome %K immune system %K kūmara %K infancy %K immune development %K infant health %K prevalence %K respiratory tract infections %K RTI %D 2024 %7 2.9.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: The introduction of complementary foods during the first year of life influences the diversity of the gut microbiome. How this diversity affects immune development and health is unclear. Objective: This study evaluates the effect of consuming kūmara or kūmara with added banana powder (resistant starch) compared to a reference control at 4 months post randomization on the prevalence of respiratory tract infections and the development of the gut microbiome. Methods: This study is a double-blind, randomized controlled trial of mothers and their 6-month-old infants (up to n=300) who have not yet started solids. Infants are randomized into one of 3 groups: control arm (C), standard kūmara intervention (K), and a kūmara intervention with added banana powder product (K+) to be consumed daily for 4 months until the infant is approximately 10 months old. Infants are matched for sex using stratified randomization. Data are collected at baseline (prior to commencing solid food) and at 2 and 4 months after commencing solid food (at around 8 and 10 months of age). Data and samples collected at each timepoint include weight and length, intervention adherence (months 2 and 4), illness and medication history, dietary intake (months 2 and 4), sleep (diary and actigraphy), maternal dietary intake, breast milk, feces (baseline and 4 months), and blood samples (baseline and 4 months). Results: The trial was approved by the Health and Disability Ethics Committee of the Ministry of Health, New Zealand (reference 20/NTA/9). Recruitment and data collection did not commence until January 2022 due to the COVID-19 pandemic. Data collection and analyses are expected to conclude in January 2024 and early 2025, respectively. Results are to be published in 2024 and 2025. Conclusions: The results of this study will help us understand how the introduction of a specific prebiotic complementary food affects the microbiota and relative abundances of the microbial species, the modulation of immune development, and infant health. It will contribute to the expanding body of research that aims to deepen our understanding of the connections between nutrition, gut microbiota, and early-life postnatal health. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12620000026921; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378654 International Registered Report Identifier (IRRID): DERR1-10.2196/56772 %M 39222346 %R 10.2196/56772 %U https://www.researchprotocols.org/2024/1/e56772 %U https://doi.org/10.2196/56772 %U http://www.ncbi.nlm.nih.gov/pubmed/39222346 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e59227 %T Effects of Defatted Rice Bran–Fortified Bread on the Gut Microbiota Composition of Healthy Adults With Low Dietary Fiber Intake: Protocol for a Crossover Randomized Controlled Trial %A Ng,Hwei Min %A Maggo,Jasjot %A Wall,Catherine Louisa %A Bayer,Simone Brigit %A McNabb,Warren C %A Mullaney,Jane Adair %A Foster,Meika %A Cabrera,Diana L %A Fraser,Karl %A Cooney,Janine %A Trower,Tania %A Günther,Catrin S %A Frampton,Chris %A Gearry,Richard Blair %A Roy,Nicole Clemence %+ Department of Human Nutrition, University of Otago, 362 Leith Street, Dunedin North, Dunedin, 9016, New Zealand, 64 4797000, nicole.roy@otago.ac.nz %K dietary fiber %K defatted rice bran %K bread %K healthy adults %K gut microbiota %K metabolites %K gut physiome %K randomized controlled trial %K mobile phone %D 2024 %7 29.8.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Inadequate dietary fiber (DF) intake is associated with several human diseases. Bread is commonly consumed, and its DF content can be increased by incorporating defatted rice bran (DRB). Objective: This first human study on DRB-fortified bread primarily aims to assess the effect of DRB-fortified bread on the relative abundance of a composite of key microbial genera and species in fecal samples. Secondary outcomes include clinical (cardiovascular risk profile), patient-reported (daily bread consumption and bowel movement, gut comfort, general well-being, and total DF intake), biological (fecal microbiota gene abundances, and fecal and plasma metabolites), and physiome (whole-gut and regional transit time and gas fermentation profiles) outcomes in healthy adults with low DF intake. Methods: This is a 2-armed, placebo-controlled, double-blinded, crossover randomized controlled trial. The study duration is 14 weeks: 2 weeks of lead-in, 4 weeks of intervention per phase, 2 weeks of washout, and 2 weeks of follow-up. Overall, 60 healthy adults with low DF intake (<18 g [female individuals] or <22 g [male individuals] per day) were recruited in Christchurch, New Zealand, between June and December 2022. Randomly assigned participants consumed 3 (female individuals) or 4 (male individuals) slices of DRB-fortified bread per day and then placebo bread, and vice versa. The DRB-fortified bread provided 8 g (female individuals) or 10.6 g (male individuals) of total DF, whereas the placebo (a matched commercial white toast bread) provided 2.7 g (female individuals) or 3.6 g (male individuals) of total DF. Before and after each intervention phase, participants provided fecal and blood samples to assess biological responses; completed a 3-day food diary to assess usual intakes and web-based questionnaires to assess gut comfort, general and mental well-being, daily bread intake, and bowel movement via an app; underwent anthropometry and blood pressure measurements; and drank blue food dye to assess whole-gut transit time. Additionally, 25% (15/60) of the participants ingested Atmo gas-sensing capsules to assess colonic gas fermentation profile and whole-gut and regional transit time. Mean differences from baseline will be compared between the DRB and placebo groups, as well as within groups (after the intervention vs baseline). For metabolome analyses, comparisons will be made within and between groups using postintervention values. Results: Preliminary analysis included 56 participants (n=33, 59% female; n=23, 41% male). Due to the large dataset, data analysis was planned to be fully completed by the last quarter of 2024, with full results expected to be published in peer-reviewed journals by the end of 2024. Conclusions: This first human study offers insights into the prospect of consuming DRB-fortified bread to effectively modulate health-promoting gut microbes, their metabolism, and DF intake in healthy adults with low DF intake. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12622000884707; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=383814 International Registered Report Identifier (IRRID): DERR1-10.2196/59227 %M 39207833 %R 10.2196/59227 %U https://www.researchprotocols.org/2024/1/e59227 %U https://doi.org/10.2196/59227 %U http://www.ncbi.nlm.nih.gov/pubmed/39207833 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e57865 %T Efficacy and Safety of Shi Cervical Rotational Manipulation in Patients With Atlantoaxial Joint Subluxation: Protocol for a Randomized Controlled Trial %A Zhen,Deng %A Haibin,Shang %A Youli,Ai %A Weian,Yuan %A Huihao,Wang %A Hongsheng,Zhan %A Guozhong,Li %A Ren,Ding %A Zhibi,Shen %+ Department of Orthopedics & Traumatology, Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine, No. 301 You yi zhi lu Road, Baoshan Area, Shanghai, 201999, China, 86 15921667516, bs0873@shutcm.edu.cn %K atlantoaxial joint subluxation %K Shi cervical rotational manipulation %K efficacy %K safety %K randomized controlled trial %D 2024 %7 13.8.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: The clinical diagnosis of atlantoaxial joint subluxation (AJS) in traditional Chinese medicine (TCM) is characterized by an unequal distance between the lateral mass of the atlas and the odontoid process on imaging, resulting in neck pain accompanied by symptoms such as dizziness, headache, and limited cervical mobility. In Shanghai, Shi cervical rotational manipulation (SCRM) is a commonly employed TCM manual therapy for treating this condition. Nevertheless, there is a lack of evidence-based medical information regarding the clinical efficacy and safety of this technique. Objective: The principal aim of this study is to evaluate the efficacy and safety of SCRM in patients diagnosed with AJS. Methods: This study is a prospective randomized controlled clinical trial that will be conducted at a single center and that has a follow-up period of 24 weeks. A total of 96 patients diagnosed with AJS will be recruited from outpatient and inpatient clinics at Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine. These patients will be randomly assigned to either the experimental group (SCRM) or the comparison group (basic cervical manipulation [BCM]). Treatment sessions consisting of SCRM or BCM will be administered twice a week for a duration of 4 weeks. Clinical monitoring indicators include the presence or absence of clinical symptoms as recorded on a symptom recording form, cervical imaging examination findings using cervical computed tomography, degree of neck pain measured by a visual analog scale (VAS), cervical range of motion assessed through cervical mobility measurement, degree of vertigo evaluated using the Vertigo Symptoms Scale-Chinese Version (VSS-C), and adverse events that may occur during the follow-up period. The time points for data collection and follow-up are baseline and postintervention (weeks 4, 8, 12, 16, 20, and 24). Results: This paper presents an overview of the reasoning and structure of a prospective randomized controlled trial with the objective of investigating the clinical efficacy and safety of SCRM in patients with AJS by assessing improvements in clinical symptoms, neck pain severity, and vertigo severity and evaluating changes in cervical imaging findings. Recruitment was started in March 2023. By the end of May 2024, 76 patients were included in this project. The last follow-up data are predicted to be collected by the end of February 2025. Conclusions: This investigation will yield dependable evidence regarding the efficacy and safety of SCRM in patients with AJS. Trial Registration: Chinese Clinical Trial Registry ChiCTR2300068510; https://www.chictr.org.cn/showprojEN.html?proj=186883 International Registered Report Identifier (IRRID): DERR1-10.2196/57865 %M 39137417 %R 10.2196/57865 %U https://www.researchprotocols.org/2024/1/e57865 %U https://doi.org/10.2196/57865 %U http://www.ncbi.nlm.nih.gov/pubmed/39137417 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e54376 %T Efficacy and Mechanism of Acupoint Catgut Embedding in the Treatment of Chronic Spontaneous Urticaria: Protocol for a Randomized Double-Blind Placebo-Controlled Trial %A Bi,Jianing %A Liu,Li %A Fan,Zhu %A Qu,Shengyuan %A Yang,Jiao %A Xu,Chenchen %A Cui,Bingnan %+ Guang'anmen Hospital, China Academy of Chinese Medical Sciences, No. 5, Beixiange, Xicheng District, Beijing, 100053, China, 86 10 88001009, cbn1998@163.com %K chronic spontaneous urticaria %K acupoint catgut embedding %K functional magnetic resonance imaging %K randomized controlled trial %K mechanism of action %D 2024 %7 31.7.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Chronic spontaneous urticaria (CSU) is a common chronic inflammatory skin disease that manifests as itching and wheals, seriously affecting quality of life. Clinical observations and previous research trials have shown that acupuncture is safe and effective for the treatment of CSU. However, there are problems, such as a short duration of action and frequent treatment. Compared with traditional acupuncture, acupoint catgut embedding (ACE) has the advantages of a longer effect and higher compliance. Clinical trials are needed to prove its efficacy and mechanism of action. Objective: This trial aims to provide definitive evidence for the treatment of CSU with ACE and explore the mechanism of ACE. Methods: This is a randomized, double-blind, placebo-controlled trial. In this trial, 108 participants aged 18-60 years with a diagnosis of CSU and no history of ACE will be randomly assigned to 2 groups (1:1 ratio) using the Statistical Analysis System: treatment (ACE) and control (sham ACE). The participants and efficacy evaluators will be blinded to the grouping. Both the ACE and sham ACE groups will undergo acupuncture, but the sham ACE group will not receive catgut sutures. Treatment will be performed twice weekly for 8 weeks, with a 1-week run-in period and a 16-week follow-up period. Twenty patients will be randomly selected to undergo functional magnetic resonance imaging before and after the treatment period. The primary outcome will be the urticaria activity score over 7 days (UAS7). We will use R (version 4.0.1; R Project for Statistical Computing) to perform ANOVA and independent samples t tests to compare the differences within and between groups before and after treatment by judging the rejection range based on a significance level of .05. Results: The study protocol has been approved by the Ethics Committee of Guang’anmen Hospital on September 7, 2022, and has been registered on November 30, 2022. Recruitment began on March 1, 2023. A total of 4-6 participants are expected to be recruited each month. The recruitment is planned to be completed on March 1, 2025, and we expect to publish our results by the winter of 2025. As of November 1, 2023, we have enrolled 25 participants with CSU. Conclusions: This randomized, double-blind, placebo-controlled trial aims to provide definitive evidence for the treatment of CSU with ACE and explore the mechanism of ACE. We hypothesize that wheals and itching will show greater improvement in participants receiving active therapy than in those receiving sham treatment. The limitations of this study include its single-center trial design, small sample size, and short treatment duration, which may have certain impacts on the research results. Trial Registration: Chinese Clinical Trial Registry ChiCTR2200066274; https://www.chictr.org.cn/showprojEN.html?proj=179056 International Registered Report Identifier (IRRID): DERR1-10.2196/54376 %M 39083341 %R 10.2196/54376 %U https://www.researchprotocols.org/2024/1/e54376 %U https://doi.org/10.2196/54376 %U http://www.ncbi.nlm.nih.gov/pubmed/39083341 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e56277 %T Deprescribing as a Way to Reduce Inappropriate Use of Drugs for Overactive Bladder in Primary Care (DROP): Protocol for a Cluster Randomized Controlled Trial With an Embedded Explanatory Sequential Mixed Methods Study %A Soerensen,Ann Lykkegaard %A Haase Juhl,Marie %A Krogh,Marlene Lunddal %A Grønkjær,Mette %A Kristensen,Jette Kolding %A Olesen,Anne Estrup %+ Department of Pharmacology, Aalborg University Hospital, Gartnerboligen, ground floor, Mølleparkvej 8a, Aalborg, 9000, Denmark, 45 72691086, ann.lykkegaard@rn.dk %K deprescribing %K overactive bladder %K general practice %K patient safety %K potentially inappropriate medication %K geriatric %K elderly %K medication safety %K geriatrics %K anticholinergic drugs %K safety %K prescription %K Denmark %K general practitioner %K evidence-based intervention %K evidence-based %K intervention %K health care %K medication %K efficacy %K DROP study %K DROP %D 2024 %7 23.7.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Potentially inappropriate medication remains a significant concern in general practices, particularly in the context of overactive bladder (OAB) treatment for individuals aged 65 years and older. This study focuses on the exploration of alternative options for treating OAB and the deprescribing of anticholinergic drugs commonly used in OAB. The research aims to comprehensively evaluate the efficiency of deprescribing through a mixed methods approach, combining quantitative assessment and qualitative exploration of perceptions, experiences, and potential barriers among patients and health care personnel. Objective: This study aims to evaluate the efficiency and safety of the intervention in which health care staff in primary care encourage patients to participate in deprescribing their drugs for OAB. In addition, we aim to identify factors contributing to or obstructing the deprescribing process that will drive more informed decisions in the field of deprescribing and support effective and safe treatment of patients. Methods: The drugs for overactive bladder in primary care (DROP) study uses a rigorous research design, using a randomized controlled trial (RCT) with an embedded sequential explanatory mixed methods approach. All general practices within the North Denmark Region will be paired based on the number of general practitioners (GPs) and urban or rural locations. The matched pairs will be randomized into intervention and control groups. The intervention group will receive an algorithm designed to guide the deprescribing of drugs for OAB, promoting appropriate medication use. Quantitative data will be collected from the RCT including data from Danish registries for prescription analysis. Qualitative data will be obtained through interviews and focus groups with GPs, staff members, and patients. Finally, the quantitative and qualitative findings are merged to understand deprescribing for OAB comprehensively. This integrated approach enhances insights and supports future intervention improvement. Results: The DROP study is currently in progress, with randomization of general practices underway. While they have not been invited to participate yet, they will be. The inclusion of GP practices is scheduled from December 2023 to April 2024. The follow-up period for each patient is 6 months. Results will be analyzed through an intention-to-treat analysis for the RCT and a thematic analysis for the qualitative component. Quantitative outcomes will focus on changes in prescriptions and symptoms, while the qualitative analysis will explore experiences and perceptions. Conclusions: The DROP study aims to provide an evidence-based intervention in primary care that ensures the deprescription of drugs for OAB when there is an unfavorable risk-benefit profile. The DROP study’s contribution lies in generating evidence for deprescribing practices and influencing best practices in health care. Trial Registration: ClinicalTrials.gov NCT06110975; https://clinicaltrials.gov/study/NCT06110975 International Registered Report Identifier (IRRID): DERR1-10.2196/56277 %M 39042875 %R 10.2196/56277 %U https://www.researchprotocols.org/2024/1/e56277 %U https://doi.org/10.2196/56277 %U http://www.ncbi.nlm.nih.gov/pubmed/39042875 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e51087 %T Evaluation of Staining Propensity of Silver Diamine Fluoride With and Without Potassium Iodide in Children (Project Healthy Smiles): Protocol for a Randomized Controlled Trial %A Navaneethan,Praveena %A Mohammed,Imran Pasha %A Shenoy,Rekha P %A Junaid,Junaid %A Amanna,Supriya %A Alsughier,Zeyad %A Kolarkodi,Shaul Hameed %+ Department of Public Health Dentistry, Yenepoya Dental College, University Road, Deralakatte, Mangaluru, 575018, India, 91 9844215889, drimranpasha@yenepoya.edu.in %K silver diamine fluoride %K SDF %K potassium iodide %K KI %K tooth discoloration %K dental caries %K dental esthetics %K dental %K teeth %K healthy smile %K staining %K treatment %K oral health %K child %D 2024 %7 23.7.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Silver diamine fluoride (SDF) is becoming more widely recognized as a simple, cost-effective approach to minimize sensitivity and arrest caries. However, SDF results in caries that are stained black. Potassium iodide (KI) treatment with SDF may minimize or lessen the staining. However, the effectiveness of KI on staining has not been investigated. Studies demonstrating that potassium iodide reduces the black staining are still insufficient. This paper presents the study protocol for Healthy Smiles, a randomized controlled trial implemented to compare the staining propensity of SDF and SDF+KI. Objective: This study, Healthy Smiles, aims to evaluate the staining propensity of SDF and SDF+KI using a Nix Mini color sensor among children aged 4 to 6 years. Another objective of the study is to evaluate the caries-arresting effect of SDF and SDF+KI in the treatment of carious primary teeth. Methods: This study is a randomized controlled trial. A total of 60 children with caries that meet the criteria of the International Caries Detection and Assessment System (code 1 or above) will be randomly assigned to treatment groups, where group 1 will be treated with SDF and group 2 will be treated with SDF+KI. Discoloration of treated lesions will be assessed digitally using a Nix Mini color sensor. Participants will be followed up at 1, 3, and 6 months after treatment to digitally record the ∆L and ∆E values using the Nix Mini color sensor. Data will be analyzed using SPSS (version 28; IBM Corp). Independent sample t tests and the Mann-Whitney U test will be used to compare the 2 groups. Results: Enrollment started in October 2023. It is estimated that the enrollment period will be 12 months. Data collection is planned to be completed in 2024. Conclusions: The presented paper describes Happy Smiles, a project that provides an opportunity to address the aesthetic inconvenience of patients without compromising the effectiveness of the SDF treatment. The trial findings will contribute to the limited evidence base related to discoloration after SDF intervention to improve aesthetic appearances in child oral health. If the results from the trial are promising, it will lead to the development of a model for child oral health and pave the way for further research in child oral health. International Registered Report Identifier (IRRID): PRR1-10.2196/51087 %M 39042887 %R 10.2196/51087 %U https://www.researchprotocols.org/2024/1/e51087 %U https://doi.org/10.2196/51087 %U http://www.ncbi.nlm.nih.gov/pubmed/39042887 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e60671 %T Leveraging Parents and Peer Recovery Supports to Increase Recovery Capital in Emerging Adults With Polysubstance Use: Protocol for a Feasibility, Acceptability, and Appropriateness Study of Launch %A Drazdowski,Tess K %A Castedo de Martell,Sierra %A Sheidow,Ashli J %A Chapman,Jason E %A McCart,Michael R %+ Lighthouse Institute, Chestnut Health Systems, 1003 Martin Luther King Jr Dr., Bloomington, IL, 61701, United States, 1 541 525 0821, tkdrazdowski@chestnut.org %K peer recovery support services %K contingency management %K emerging adults %K rural %D 2024 %7 22.7.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Emerging adults (aged 18-26 years) are the most at-risk yet underserved age group among people with substance use disorder, especially rural emerging adults, and polysubstance use is common. Recovery capital is lower among emerging adults than older adults, and evidence-based treatments are typically unavailable or not developmentally tailored, especially in rural areas. Both supportive parents (or parental figures) and peer recovery support services (PRSS) can be leveraged to better support these emerging adults. Previous research indicates parents can be engaged to deliver contingency management (CM), an extensively researched evidence-based intervention for substance use. Objective: This protocol describes a funded pilot of Launch, a novel, scalable service package that pairs web-based coaching for parents to deliver CM for emerging adults (CM-EA) at home and in-person PRSS with educational and vocational goal setting. Specifically, this protocol describes feasibility, acceptability, and appropriateness testing (implementation-related outcomes) and steps taken to prepare for a future large-scale trial of Launch. Methods: Upon the recruitment of 48 emerging adult and parent pairs from sites serving primarily rural clients, participants will be randomized into 1 of 3 conditions for this randomized controlled trial: virtual parent coaching to deliver CM-EA, in-person PRSS for emerging adults, or both sets of services. Emerging adult eligibility includes polysubstance use, a substance use disorder, and availability of a consenting parent. Emerging adults will be interviewed at baseline and 6 months about substance use, quality of life, recovery capital, parental relationship, and Launch implementation-related outcomes (6-month follow-up only). Parents, peer workers delivering PRSS, and parent CM-EA coaches will be interviewed about implementation-related outcomes at the end of the study period. Peer workers and CM-EA coaches will be asked to complete checklists of services delivered after each session. Finally, payers and providers will be interviewed for additional insights into Launch implementation and to identify key outcomes of Launch. Data analysis for emerging adult outcomes will be primarily descriptive, but parent CM-EA training adherence will be assessed using nested mixed-effects regression models of repeated measures. Results: Launch is currently ongoing, with funding received in August 2023, and is expected to end in September 2025, with data analysis and results in December 2026. Participants are expected to begin enrolling in June 2024. Conclusions: While this pilot is limited by the small sample size and restriction to emerging adults with an involved parent, this is mitigated by the study’s strengths and is appropriate for the pilot stage. Launch uses an innovative combination of existing strategies to generate better outcomes for emerging adults while remaining scalable. This pilot will provide insights into the feasibility and acceptability of Launch from the perspectives of service recipients, providers, and payers to inform a larger-scale effectiveness trial. Trial Registration: ClinicalTrials.gov NCT06414993; https://clinicaltrials.gov/study/NCT06414993 International Registered Report Identifier (IRRID): PRR1-10.2196/60671 %M 39037768 %R 10.2196/60671 %U https://www.researchprotocols.org/2024/1/e60671 %U https://doi.org/10.2196/60671 %U http://www.ncbi.nlm.nih.gov/pubmed/39037768 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e54970 %T Combination of Curcuminoids and Acupressure for Inflammation and Pain in Older People with Osteoarthritis Genu: Protocol for a Randomized Controlled Trial %A Mahanani,Srinalesti %A Kertia,Nyoman %A Madyaningrum,Ema %+ Department of Internal Medicine, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada, Jl Kesehatan Sendowo No 1, Sendowo, Sinduadi, Kec. Mlati, Kabupaten Sleman, Yogyakarta, 55281, Indonesia, 62 274 545458, nyoman.kertia@ugm.ac.id %K osteoarthritis %K acupressure %K curcuminoids %K endorphins %K biomarkers %K genu %K older people %K randomized controlled trial %D 2024 %7 24.6.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Curcuminoids and acupressure have beneficial effects in reducing pain and inflammation in patients with osteoarthritis. However, only a few clinical trials are investigating biomarkers to prove this objectively. Objective: This study aims to investigate the effect of acupressure and curcuminoids on inflammatory markers and pain in older people with osteoarthritis genu. Methods: A randomized controlled trial (RCT) was conducted among older people with osteoarthritis. All participants were randomized to a group that received 30 mg of curcuminoids in turmeric extract capsules and acupressure (group 1) or a group that received a placebo and sham acupressure (group 2) for 3 weeks. Results: The study was approved by the research ethics board; ClinicalTrials.gov reviewed this protocol. The extracts were manufactured from May 2023 to June 2023. Participant recruitment was conducted in September and October 2023; a total of 72 participants aged 60 years or older participated, of whom 75% (n=54) were female. Data were analyzed in April 2024, and dissemination of results is expected by the end of 2024. Conclusions: Primary outcomes were assessed at baseline and after the intervention. Relationships were assessed with inflammatory markers, endorphin hormones, and blood level of cycloxygenase-2 hormone. Additionally, secondary outcomes included pain, ability to perform activities of daily living, and quality of life. The beneficial effects that may be found in this trial may be exceptionally relevant in clinical practice, justifying this scientific inquiry. The benefits of herbs and acupressure can be helpful as additional options in treating inflammation and pain in patients with osteoarthritis. Trial Registration: ClinicalTrials.gov NCT06105840; https://clinicaltrials.gov/study/NCT06105840 International Registered Report Identifier (IRRID): DERR1-10.2196/54970 %M 38771152 %R 10.2196/54970 %U https://www.researchprotocols.org/2024/1/e54970 %U https://doi.org/10.2196/54970 %U http://www.ncbi.nlm.nih.gov/pubmed/38771152 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e48549 %T Testing a Biobehavioral Model of Chronic Stress and Weight Gain in Young Children (Family Stress Study): Protocol and Baseline Demographics for a Prospective Observational Study %A Pare,Shannon M %A Gunn,Elizabeth %A Morrison,Katherine M %A Miller,Alison L %A Duncan,Alison M %A Buchholz,Andrea C %A Ma,David W L %A Tremblay,Paul F %A Vallis,Lori Ann %A Mercer,Nicola J %A Haines,Jess %+ Department of Family Relations and Applied Nutrition, University of Guelph, 50 Stone Road East, Guelph, ON, N1G 2W1, Canada, 1 5198244120 ext 58820, spare@uoguelph.ca %K stress %K child, preschool %K adiposity %K household chaos %K cortisol %K COVID-19 %K behavioral mechanisms %K caregiver-child relationship quality %D 2024 %7 20.6.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Chronic stress is an important risk factor in the development of obesity. While research suggests chronic stress is linked to excess weight gain in children, the biological or behavioral mechanisms are poorly understood. Objective: The objectives of the Family Stress Study are to examine behavioral and biological pathways through which chronic stress exposure (including stress from COVID-19) may be associated with adiposity in young children, and to determine if factors such as child sex, caregiver-child relationship quality, caregiver education, and caregiver self-regulation moderate the association between chronic stress and child adiposity. Methods: The Family Stress Study is a prospective cohort study of families recruited from 2 Canadian sites: the University of Guelph in Guelph, Ontario, and McMaster University in Hamilton, Ontario. Participants will be observed for 2 years and were eligible to participate if they had at least one child (aged 2-6 years) and no plans to move from the area within the next 3 years. Study questionnaires and measures were completed remotely at baseline and will be assessed using the same methods at 1- and 2-year follow-ups. At each time point, caregivers measure and report their child’s height, weight, and waist circumference, collect a hair sample for cortisol analysis, and fit their child with an activity monitor to assess the child’s physical activity and sleep. Caregivers also complete a web-based health and behaviors survey with questions about family demographics, family stress, their own weight-related behaviors, and their child’s mental health, as well as a 1-day dietary assessment for their child. Results: Enrollment for this study was completed in December 2021. The final second-year follow-up was completed in April 2024. This study’s sample includes 359 families (359 children, 359 female caregivers, and 179 male caregivers). The children’s mean (SD) age is 3.9 years (1.2 years) and 51% (n=182) are female. Approximately 74% (n=263) of children and 80% (n=431) of caregivers identify as White. Approximately 34% (n=184) of caregivers have a college diploma or less and nearly 93% (n=499) are married or cohabiting with a partner. Nearly half (n=172, 47%) of the families have an annual household income ≥CAD $100,000 (an average exchange rate of 1 CAD=0.737626 USD applies). Data cleaning and analysis are ongoing as of manuscript publication. Conclusions: Despite public health restrictions from COVID-19, the Family Stress Study was successful in recruiting and using remote data collection to successfully engage families in this study. The results from this study will help identify the direction and relative contributions of the biological and behavioral pathways linking chronic stress and adiposity. These findings will aid in the development of effective interventions designed to modify these pathways and reduce obesity risk in children. Trial Registration: ClinicalTrials.gov NCT05534711; https://clinicaltrials.gov/study/NCT05534711 International Registered Report Identifier (IRRID): DERR1-10.2196/48549 %M 38900565 %R 10.2196/48549 %U https://www.researchprotocols.org/2024/1/e48549 %U https://doi.org/10.2196/48549 %U http://www.ncbi.nlm.nih.gov/pubmed/38900565 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e54126 %T Behavioral Weight Loss Programs for Cancer Survivors Throughout Maryland: Protocol for a Pragmatic Trial and Participant Characteristics %A Jerome,Gerald J %A Appel,Lawrence J %A Bunyard,Linda %A Dalcin,Arlene T %A Durkin,Nowella %A Charleston,Jeanne B %A Kanarek,Norma F %A Carducci,Michael A %A Wang,Nae-Yuh %A Yeh,Hsin-Chieh %+ Department of Medicine, Johns Hopkins University, 2024 East Monument Street, Baltimore, MD, 21287, United States, 1 4106144316, hyeh1@jhmi.edu %K cancer %K obesity %K weight loss %K pragmatic trial %K oncology %K weight %K overweight %K obese %K USA %K United States %K survivor %K survivors %K remote %K self-directed %K self-guided %K coach %K coaching %K mHealth %K mobile health %K app %K apps %K application %K applications %K EHR %K health record %K health records %K mobile phone %D 2024 %7 12.6.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Clinical trials examining lifestyle interventions for weight loss in cancer survivors have been demonstrated to be safe, feasible, and effective. However, scalable weight loss programs are needed to support their widespread implementation. The ASPIRE trial was designed to evaluate real-world, lifestyle-based, weight loss programs for cancer survivors throughout Maryland. Objective: The objectives of this protocol paper are to describe the design of a nonrandomized pragmatic trial, study recruitment, and baseline characteristics of participants. Methods: Participants were aged ≥18 years, residing in Maryland, with a BMI ≥25 kg/m2, who reported a diagnosis of a malignant solid tumor, completed curative treatment, and had no ongoing or planned cancer treatment. Enrollment criteria were minimized to increase generalizability. The primary recruitment source was the Johns Hopkins Health System electronic health records (EHRs). Participants selected 1 of 3 remotely delivered weight loss programs: self-directed, app-supported, or coach-supported program. Results: Participants were recruited across all 5 geographic regions of Maryland. Targeted invitations using EHRs accounted for 287 (84.4%) of the 340 participants enrolled. Of the 5644 patients invited through EHR, 5.1% (287/5644) enrolled. Participants had a mean age of 60.7 (SD 10.8) years, 74.7% (254/340) were female, 55.9% (190/340) identified as non-Hispanic Black, 58.5% (199/340) had a bachelor’s degree, and the average BMI was 34.1 kg/m2 (SD 5.9 kg/m2). The most common types of cancers were breast (168/340, 49.4%), prostate (72/340, 21.2%), and thyroid (39/340, 8.5%). The self-directed weight loss program (n=91) included 25 participants who agreed to provide weights through a study scale; the app-supported program (n=142) included 108 individuals who agreed to provide their weight measurements; and the coach-supported weight loss program included 107 participants. We anticipate final analysis will take place in the fall of 2024. Conclusions: Using EHR-based recruitment efforts, this study took a pragmatic approach to reach and enroll cancer survivors into remotely delivered weight loss programs. Trial Registration: ClinicalTrials.gov NCT04534309; https://clinicaltrials.gov/study/NCT04534309 International Registered Report Identifier (IRRID): DERR1-10.2196/54126 %M 38865181 %R 10.2196/54126 %U https://www.researchprotocols.org/2024/1/e54126 %U https://doi.org/10.2196/54126 %U http://www.ncbi.nlm.nih.gov/pubmed/38865181 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e53703 %T The Effects of a Dietary Supplement (PediaFlù) Plus Standard of Care in Children With Acute Tonsillopharyngitis/Rhinopharyngitis: Protocol for a Randomized Controlled Trial %A Cardinale,Fabio %A Barattini,Dionisio Franco %A Sbrocca,Federica %A Centi,Alessandro %A Giuntini,Greta %A Morariu Bordea,Maria %A Herteg,Dorina %A Rosu,Serban %A Matei,Cristian Radu %+ Complex Operating Unit Paediatrics, Giovanni XXIII Paediatric Hospital, University of Bari, Via Amendola, 207, Bari, 70123, Italy, 39 080 5596732, fabiocardinale1961@gmail.com %K dietary supplements %K tonsillitis %K pharyngitis %K nasopharyngitis %K Pelargonium %K propolis %K zinc %K severity score %D 2024 %7 31.5.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: A dietary supplement containing Pelargonium sidoides extract, propolis, zinc, and honey has been recently developed and proven to be an effective adjuvant in clinical practice for seasonal diseases and the treatment of respiratory tract disorders. Objective: This trial aims to verify the efficacy of the tested dietary supplement in a pediatric population with acute tonsillopharyngitis/rhinopharyngitis (ATR). Methods: The trial includes children aged between 3 and 10 years with ATR ≤48 h, a negative rapid test for beta-hemolytic streptococcus or culture identification of nasal and/or pharyngeal exudates, and SARS-CoV-2 infection. The dietary supplement tested is an oral solution already on the market based on Pelagon P-70 (equivalent to Pelargonium sidoides d.e. 133.3 mg/100 ml), propolis, zinc, and honey. The product is administered at 5 ml 3 times a day for 6 days for children younger than 6 years and 10 ml 3 times a day for 6 days for children older than 6 years. The study design is open label, randomized, and controlled, with the tested dietary supplement plus standard of care (SoC) versus SoC alone. Patients are enrolled from 3 sites in Romania. The change in Tonsillitis Severity Score and number of treatment failures (using ibuprofen or high-dose paracetamol as rescue medication) are the primary end points. Based on the Tonsillitis Severity Score and the 2-sample comparison of the means formula with a 5% significance level, 80% power, and a minimally clinically important difference of 2 (SD 3.85) points, 120 patients are required. To account for potential screening failures and dropouts, we need to screen a population of approximately 150 children. Results: Patient enrollment began on June 3, 2021 (first patient’s first visit), and ended on August 12, 2021 (last patient’s last visit). The data collection period was from June 3, 2021, to September 16, 2021. The study was funded in February 2023. Data analysis is currently ongoing (April 2024). We expect the results to be published in a peer-reviewed clinical journal in the third quarter of 2024 and presented at scientific meetings in the last quarter of 2024. Conclusions: The data from this trial may help identify new adjuvant treatments for children with ATR when streptococcal infection is excluded by a negative rapid test, thereby avoiding unnecessary antibiotic administration. Trial Registration: ClinicalTrials.gov NCT04899401 https://clinicaltrials.gov/study/NCT04899401 International Registered Report Identifier (IRRID): DERR1-10.2196/53703 %M 38819917 %R 10.2196/53703 %U https://www.researchprotocols.org/2024/1/e53703 %U https://doi.org/10.2196/53703 %U http://www.ncbi.nlm.nih.gov/pubmed/38819917 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e56067 %T Effects of Empagliflozin in Type 2 Diabetes With and Without Chronic Kidney Disease and Nondiabetic Chronic Kidney Disease: Protocol for 3 Crossover Randomized Controlled Trials (SiRENA Project) %A Nielsen,Steffen Flindt %A Duus,Camilla Lundgreen %A Buus,Niels Henrik %A Bech,Jesper Nørgaard %A Mose,Frank Holden %+ University Clinic in Nephrology and Hypertension, Gødstrup Hospital and Aarhus University, Hospitalsparken 15, Herning, 7400, Denmark, 45 21278747, stfnel@rm.dk %K SGLT2i %K empagliflozin %K renal function %K blood flow %K DM2 %K diabetes mellitus type 2 %K CKD %K chronic kidney disease %K vascular function %K sodium-glucose cotransporter 2 inhibitors %K T2DM %K type 2 diabetes mellitus %K randomized controlled trial %K RCT %K CVD %K placebo %K renal %K recruitment %K Denmark %K cardiovascular disease %D 2024 %7 29.5.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Sodium-glucose-cotransporter 2 inhibitors (SGLT2is) have revolutionized the treatment of type 2 diabetes mellitus (DM2) and chronic kidney disease (CKD), reducing the risk of cardiovascular and renal end points by up to 40%. The underlying mechanisms are not fully understood. Objective: The study aims to examine the effects of empagliflozin versus placebo on renal hemodynamics, sodium balance, vascular function, and markers of the innate immune system in patients with DM2, DM2 and CKD, and nondiabetic CKD. Methods: We conducted 3 double-blind, crossover, randomized controlled trials, each with identical study protocols but different study populations. We included patients with DM2 and preserved kidney function (estimated glomerular filtration rate >60 mL/min/1.73 m2), DM2 and CKD, and nondiabetic CKD (both with estimated glomerular filtration rate 20-60 mL/min/1.73 m2). Each participant was randomly assigned to 4 weeks of treatment with either 10 mg of empagliflozin once daily or a matching placebo. After a wash-out period of at least 2 weeks, participants were crossed over to the opposite treatment. End points were measured at the end of each treatment period. The primary end point was renal blood flow measured with 82Rubidium positron emission tomography–computed tomography (82Rb-PET/CT). Secondary end points include glomerular filtration rate measured with 99mTechnetium-diethylene-triamine-pentaacetate (99mTc-DTPA) clearance, vascular function assessed by forearm venous occlusion strain gauge plethysmography, measurements of the nitric oxide (NO) system, water and sodium excretion, body composition measurements, and markers of the complement immune system. Results: Recruitment began in April 2021 and was completed in September 2022. Examinations were completed by December 2022. In total, 49 participants completed the project: 16 participants in the DM2 and preserved kidney function study, 17 participants in the DM2 and CKD study, and 16 participants in the nondiabetic CKD study. Data analysis is ongoing. Results are yet to be published. Conclusions: This paper describes the rationale, design, and methods used in a project consisting of 3 double-blind, crossover, randomized controlled trials examining the effects of empagliflozin versus placebo in patients with DM2 with and without CKD and patients with nondiabetic CKD, respectively. Trial Registration: EU Clinical Trials Register 2019-004303-12; https://www.clinicaltrialsregister.eu/ctr-search/search?query=2019-004303-12, EU Clinical Trials Register 2019-004447-80; https://www.clinicaltrialsregister.eu/ctr-search/search?query=2019-004447-80, EU Clinical Trials Register 2019-004467-50; https://www.clinicaltrialsregister.eu/ctr-search/search?query=and+2019-004467-50 International Registered Report Identifier (IRRID): DERR1-10.2196/56067 %M 38680116 %R 10.2196/56067 %U https://www.researchprotocols.org/2024/1/e56067 %U https://doi.org/10.2196/56067 %U http://www.ncbi.nlm.nih.gov/pubmed/38680116 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e53587 %T Effectiveness of Gerontechnology Empowerment Program on Awareness and Use of Mobile Apps Among Older Adults for Instrumental Activities of Daily Living: Protocol for a Cluster Randomized Controlled Trial %A Shashidhara,Y N %A Raghavendra,G %A P Kundapur,Poornima %A Binil,V %+ Welcomgroup Graduate School of Hotel Administration, Manipal Academy of Higher Education, Madhava Nagar, Manipal, 576104, India, 91 9880328604, rag.wgsha@manipal.edu %K gerontechnology %K older adults %K awareness %K older people %K instrumental activities of daily living %K iADLs %K mobile apps %K mobile phone %K empowerment %D 2024 %7 13.5.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Instrumental activities of daily living (iADLs) are crucial for older adults to live independently. Health care and technological advancements will increase the older adult population and life expectancy globally. Difficulties with iADLs impact older adults’ quality of life. Mobile apps can assist older adults, but many require help due to limited awareness. Lack of awareness is a barrier to app use. Existing literature mainly covers health care and app design, needing more focus on iADL apps for older adults. Objective: The study objectives encompass 2 main aspects: first, to evaluate the awareness, use, and factors influencing the use of apps among older adults for iADLs; and second, to create and assess the effectiveness of a gerontechnology empowerment program (GEP) for older adults on the awareness and use of apps for iADLs. Methods: This research uses a quantitative approach divided into 2 distinct phases. In phase 1, we conduct a descriptive survey to assess the level of awareness and use of mobile apps for iADLs and identify the factors that influence the use of such apps among older adults. To ensure clarity and comprehension among participants, we provide them with a subject information sheet in both Kannada and English. The data collected during this phase enable us to gain insights into awareness levels, use patterns, and factors that shape older adults’ use of apps for iADLs. The results serve as the foundation for designing the GEP. In phase 2, a cluster randomization method will be used to select older adults aged 60 to 75 years in Udupi district, Karnataka, India, who are active smartphone users. These participants will be divided into 2 groups: the experimental and the control groups. The experimental group will join the GEP. The sample size for phase 1 is 554, and phase 2 is 50. To assess the effectiveness of this program, we will measure the outcomes before and after its implementation using the same assessment tools used in phase 1. Results: This study is funded by the Indian Council of Medical Research (Adhoc/193/2022/SBHSR on November 18, 2022). Phase 1 data collection is expected to be completed by November 2023, and phase 2 is scheduled to commence in the upcoming months. Phase 1 and 2 findings will be analyzed and discussed in the main paper, which we intend to submit to a high-quality peer-reviewed journal for publication. The research protocol, informed consent forms, and associated documentation received approval from institutional ethics committees (214/2020). Conclusions: Upon the successful testing of the GEP, it can be recommended that welfare departments encourage older adults to use mobile apps for iADLs and establish training programs to provide support to older adults in using these apps. Trial Registration: Clinical Trials Registry - India CTRI/2020/09/027977; https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=NDUxMzM=&Enc=&userName=027977 International Registered Report Identifier (IRRID): DERR1-10.2196/53587 %M 38739442 %R 10.2196/53587 %U https://www.researchprotocols.org/2024/1/e53587 %U https://doi.org/10.2196/53587 %U http://www.ncbi.nlm.nih.gov/pubmed/38739442 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e55297 %T Effect of Rural Trauma Team Development on the Outcomes of Motorcycle Accident–Related Injuries (Motor Registry Project): Protocol for a Multicenter Cluster Randomized Controlled Trial %A Lule,Herman %A Mugerwa,Micheal %A Ssebuufu,Robinson %A Kyamanywa,Patrick %A Bärnighausen,Till %A Posti,Jussi P %A Wilson,Michael Lowery %+ Injury Epidemiology and Prevention (IEP) Research Group, Turku Brain Injury Centre, Department of Clinical Neurosciences, Turku University Hospital and University of Turku, Turun Yliopisto, Turku, FI-20014, Finland, 358 465699821, helule@utu.fi %K randomized controlled trial %K medical education %K trauma team %K trauma registry %K rural health %K global health %K team development %K Africa %K rural %K trauma %K motorcycle injury %K multicenter cluster randomized controlled clinical trial %K injury %K accident %K low- and middle-income countries %K patient outcomes %K education program %D 2024 %7 7.5.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Injury is a global health concern, and injury-related mortality disproportionately impacts low- and middle-income countries (LMICs). Compelling evidence from observational studies in high-income countries shows that trauma education programs, such as the Rural Trauma Team Development Course (RTTDC), increase clinician knowledge of injury care. There is a dearth of such evidence from controlled clinical trials to demonstrate the effect of the RTTDC on process and patient outcomes in LMICs. Objective: This multicenter cluster randomized controlled clinical trial aims to examine the impact of the RTTDC on process and patient outcomes associated with motorcycle accident–related injuries in an African low-resource setting. Methods: This is a 2-arm, parallel, multi-period, cluster randomized, controlled, clinical trial in Uganda, where rural trauma team development training is not routinely conducted. We will recruit regional referral hospitals and include patients with motorcycle accident–related injuries, interns, medical trainees, and road traffic law enforcement professionals. The intervention group (RTTDC) and control group (standard care) will include 3 hospitals each. The primary outcomes will be the interval from the accident to hospital admission and the interval from the referral decision to hospital discharge. The secondary outcomes will be all-cause mortality and morbidity associated with neurological and orthopedic injuries at 90 days after injury. All outcomes will be measured as final values. We will compare baseline characteristics and outcomes at both individual and cluster levels between the intervention and control groups. We will use mixed effects regression models to report any absolute or relative differences along with 95% CIs. We will perform subgroup analyses to evaluate and control confounding due to injury mechanisms and injury severity. We will establish a motorcycle trauma outcome (MOTOR) registry in consultation with community traffic police. Results: The trial was approved on August 27, 2019. The actual recruitment of the first patient participant began on September 01, 2019. The last follow-up was on August 27, 2023. Posttrial care, including linkage to clinical, social support, and referral services, is to be completed by November 27, 2023. Data analyses will be performed in Spring 2024, and the results are expected to be published in Autumn 2024. Conclusions: This trial will unveil how a locally contextualized rural trauma team development program impacts organizational efficiency in a continent challenged with limited infrastructure and human resources. Moreover, this trial will uncover how rural trauma team coordination impacts clinical outcomes, such as mortality and morbidity associated with neurological and orthopedic injuries, which are the key targets for strengthening trauma systems in LMICs where prehospital care is in the early stage. Our results could inform the design, implementation, and scalability of future rural trauma teams and trauma education programs in LMICs. Trial Registration: Pan African Clinical Trials Registry (PACTR202308851460352); https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=25763 International Registered Report Identifier (IRRID): DERR1-10.2196/55297 %M 38713507 %R 10.2196/55297 %U https://www.researchprotocols.org/2024/1/e55297 %U https://doi.org/10.2196/55297 %U http://www.ncbi.nlm.nih.gov/pubmed/38713507 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e52922 %T Motor Effects of Intervention With Transcranial Direct Current Stimulation for Physiotherapy Treatment in Children With Cerebral Palsy: Protocol for a Randomized Clinical Trial %A Cangussu,Anna Izabel %A Lucarini,Beatriz %A Melo,Igor de Freitas %A Diniz,Paula Araújo %A Mancini,Marisa %A Viana,Bernardo de Mattos %A Romano-Silva,Marco Aurélio %A Miranda,Débora Marques de %+ Faculdade de Medicina da Universidade Federal de Minas Gerais, Federal University of Minas Gerais, Avenida Professor Alfredo Balena, 190 - Santa Efigênia, Belo Horizonte, 30130-100, Brazil, 55 3134099670, anna_izabel@yahoo.com.br %K cerebral palsy %K tDCS %K motor %K development %K randomized clinical trial %K RCT %K clinical trial %K randomized %K transcranial direct current stimulation %K stimulation %K children %K child %K brain stimulation %K physical therapy %K quality of life %K researchers %K researcher %K neurological injuries %K injury %K injuries %K gait %K patient %K patients %D 2024 %7 30.4.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Children diagnosed with cerebral palsy (CP) often experience various limitations, particularly in gross motor function and activities of daily living. Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that has been used to improve movement, gross motor function, and activities of daily living. Objective: This study aims to evaluate the potential additional effects of physiotherapy combined with tDCS in children with CP in comparison with physiotherapy only. Methods: This is a 2-arm randomized controlled trial that will compare the effects of tDCS as an adjunctive treatment during rehabilitation sessions to rehabilitation without tDCS. Children with CP classified by the Gross Motor Function Classification System as levels I and II will be randomly assigned to either the sham + rehabilitation group or the tDCS + rehabilitation group. The primary outcome will be the motor skills assessed using the Gross Motor Function Measure domain E scores, and the secondary outcome will be the measurement scores of the children’s quality of life. The intervention will consist of a 10-day stimulation protocol with tDCS spread over 2 weeks, with stimulation or sham tDCS administered for 20 minutes at a frequency of 1 Hz, in combination with physiotherapy. Physical therapy exercises will be conducted in a circuit based on each child’s baseline Gross Motor Function Measure results. The participants’ changes will be evaluated and compared in both groups. Intervenient features will be tested. Results: Data collection is ongoing and is expected to be completed by January 2025. A homogeneous sample and clear outcomes may be a highlight of this protocol, which may allow us to understand the potential use of tDCS and for whom it should or should not be used. Conclusions: A study with good evidence and clear outcomes in children with CP might open an avenue for the potential best use of neurostimulation. Trial Registration: Brazilian Registry of Clinical Trials RBR-104h4s4y; https://tinyurl.com/47r3x2e4 International Registered Report Identifier (IRRID): PRR1-10.2196/52922 %M 38687586 %R 10.2196/52922 %U https://www.researchprotocols.org/2024/1/e52922 %U https://doi.org/10.2196/52922 %U http://www.ncbi.nlm.nih.gov/pubmed/38687586 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e55102 %T Marital Self-Disclosure Intervention for the Fear of Cancer Recurrence in Chinese Patients With Gastric Cancer: Protocol for a Quasiexperimental Study %A Zhao,Haiyan %A Zhou,Ye %A Che,Chong Chin %A Chong,Mei Chan %A Zheng,Yu %A Hou,Yuzhu %A Chen,Canjuan %A Zhu,Yantao %+ Chinese Nursing Journals Publishing House Co, Ltd, 28/F, Tower C, Chengming Building, Xizhimen South Street, Xicheng District, Beijing, 806054, China, 86 18801155781, yeyecrystal@126.com %K fear of cancer recurrence %K dyadic coping ability %K gastric cancer %K intervention %K nursing %K protocol %K psychological %K marital self-disclosure %D 2024 %7 29.4.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Patients with gastric cancer experience different degrees of fear of cancer recurrence. The fear of cancer recurrence can cause and worsen many physical and psychological problems. We considered the “intimacy and relationship processes in couples’ psychosocial adaptation” model. Objective: The study aims to examine the effectiveness of a marital self-disclosure intervention for improving the level of fear of cancer recurrence and the dyadic coping ability among gastric cancer survivors and their spouses. Methods: This is a quasiexperimental study with a nonequivalent (pretest-posttest) control group design. The study will be conducted at 2 tertiary hospitals in Taizhou City, Jiangsu Province, China. A total of 42 patients with gastric cancer undergoing chemotherapy and their spouses will be recruited from each hospital. Participants from Jingjiang People’s Hospital will be assigned to an experimental group, while participants from Taizhou People’s Hospital will be assigned to a control group. The participants in the experimental group will be involved in 4 phases of the marital self-disclosure (different topics, face-to-face) intervention. Patients will be evaluated at baseline after a diagnosis of gastric cancer and reassessed 2 to 4 months after baseline. The primary outcome is the score of the Fear of Progression Questionnaire-Short Form (FoP-Q-SF) for patients. The secondary outcomes are the scores of the FoP-Q-SF for partners and the Dyadic Coping Inventory. Results: Research activities began in October 2022. Participant enrollment and data collection began in February 2023 and are expected to be completed in 12 months. The primary results of this study are anticipated to be announced in June 2024. Conclusions: This study aims to assess a marital self-disclosure intervention for improving the fear of cancer recurrence in Chinese patients with gastric cancer and their spouses. The study is likely to yield desirable positive outcomes as marital self-disclosure is formulated based on evidence and inputs obtained through stakeholder interviews and expert consultation. The study process will be carried out by nurses who have received psychological training, and the quality of the intervention will be strictly controlled. Trial Registration: ClinicalTrials.gov NCT05606549; https://clinicaltrials.gov/study/NCT05606549 International Registered Report Identifier (IRRID): DERR1-10.2196/55102 %M 38684089 %R 10.2196/55102 %U https://www.researchprotocols.org/2024/1/e55102 %U https://doi.org/10.2196/55102 %U http://www.ncbi.nlm.nih.gov/pubmed/38684089 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e53362 %T Needs and Experiences With Health Care Providers of Adult Rare Disease Patients and Caregivers of People With Rare Diseases: Protocol for a Qualitative Study %A Černe,Tina %A Turk,Eva %A Mirosevic,Spela %A Rotar Pavlič,Danica %+ Deparment of Family Medicine, Univeristy of Ljubljana, Poljanski nasip 58, Ljubljana, 1000, Slovenia, 386 041920083, tina.cerne@mf.uni-lj.si %K rare diseases %K patients %K caregivers %K needs %K barriers %K access to health care %D 2024 %7 22.4.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Rare diseases in Europe are defined as diseases with a prevalence of less than 5 per 10,000 people. Despite their individual rarity, the total number of rare diseases is considerable. Rare diseases are often chronic and complex, affecting physical, mental, and neurological health. People with rare diseases face challenges such as delayed diagnosis, limited medical support, and financial burden. Caregivers, usually family members, bear significant physical and emotional burdens. Understanding the experiences of patients with rare disease and their caregivers is critical to effective care, but this is still underresearched. Better support and understanding of the challenges faced by both patients and caregivers is clearly needed. Our study will explore the experiences and needs of people with rare diseases and caregivers of people with rare diseases in relation to accessing health services. Objective: This study aims to explore the experiences of patients with rare disease and their caregivers with Slovenian health care providers and to create a theoretical model of needs and experiences. Methods: This is a qualitative thematic analysis study, using the codebook approach. The study will conduct semi–open-ended interviews to understand the experiences and needs of people with rare diseases and caregivers of people with rare diseases in relation to accessing health services. The interview questions will be based on an extensive literature review. Data from the interviews will be analyzed using thematic analysis to identify patterns and build a thematic map. Data will be analyzed by at least 2 coders. To ensure reliability, respondent validation will be conducted and negative cases investigated. Any discrepancies will be resolved by consulting the entire research team until a consensus is reached. Results: This study was not specifically funded. However, author TČ is supported by grant number P3-0339 from the Slovenian Agency for Research and Innovation. This study was approved by the Medical Ethics Committee of the Republic of Slovenia (0120-47/2022/3), and recruitment is expected to begin in May 2024, with data analysis results anticipated by the end of 2025. Conclusions: This study will fill an important research gap in Slovenia by exploring the needs and experiences of people living with rare diseases and their caregivers. The results will contribute to the broader field of rare diseases and add knowledge that can inform future research processes and intervention strategies. It also aims to identify neglected areas that have a significant impact on the lives of people with rare diseases. This study is important not only because it addresses the immediate needs of the Slovenian rare disease community, but also because it contributes to a discussion on patient-centered care, health policy design, and the inclusion of psychosocial components in health care. International Registered Report Identifier (IRRID): PRR1-10.2196/53362 %M 38648088 %R 10.2196/53362 %U https://www.researchprotocols.org/2024/1/e53362 %U https://doi.org/10.2196/53362 %U http://www.ncbi.nlm.nih.gov/pubmed/38648088 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e52106 %T Effectiveness of Sensitization Campaigns in Reducing Leprosy-Related Stigma in Rural Togo: Protocol for a Mixed Methods Cluster Randomized Controlled Trial %A Jockers,Dominik %A Bakoubayi,Akila Wimima %A Bärnighausen,Kate %A Bando,P'tanam P'kontème %A Pechar,Stefanie %A Maina,Teresia Wamuyu %A Wachinger,Jonas %A Vetter,Mark %A Djakpa,Yawovi %A Saka,Bayaki %A Gnossike,Piham %A Schröder,Nora Maike %A Liu,Shuyan %A Gadah,Denis Agbenyigan Yawovi %A Kasang,Christa %A Bärnighausen,Till %+ Heidelberg Insititute of Global Health, Faculty of Medicine and University Hospital, Heidelberg University, INF 130.3, Heidelberg, 69120, Germany, 49 6221560, dominik.jockers@uni-heidelberg.de %K audio %K community health worker %K information campaign %K knowledge, attitude, and practices %K language %K leprosy-related stigma %K qualitative and quantitative research %K stigma intervention %K Togo %K West Africa %D 2024 %7 18.4.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: In the global strategy to eliminate leprosy, there remains a need for early case detection to successfully interrupt transmissions. Poor knowledge about leprosy and leprosy-related stigma are key drivers of delayed diagnosis and treatment. Sensitization campaigns to inform and increase awareness among the general population are an integral part of many national neglected tropical disease programs. Despite their importance, the effectiveness of such campaigns has not been rigorously studied in the West African context. A multilingual rural setting with low health literacy in this region presents challenges to the potential impact of sensitization campaigns. Objective: The primary objective of this study is to assess the causal effect of common practice community sensitization campaigns on leprosy-related knowledge and stigma at the community level and among community health volunteers. Additionally, we will test the potential of novel educational audio tools in the 15 most prominent local languages to overcome literacy and language barriers and amplify sensitization campaigns. Methods: We will conduct a cluster randomized controlled trial using a sequential mixed methods approach in 60 rural communities across all regions of Togo, West Africa. The study features 2 intervention arms and 1 control arm, with intervention and control assignments made at the community level through randomization. Communities in intervention arm 1 will receive a sensitization campaign in line with the current Togolese national neglected tropical disease program. Communities in intervention arm 2 will receive the same sensitization campaign along with educational audio tools distributed to community households. The control arm will receive no intervention before data collection. Quantitative outcome measures on knowledge and stigma will be collected from a random sample of 1200 individuals. Knowledge will be assessed using the 9-item standardized Knowledge, Attitudes, and Practices Questionnaire. Stigma will be measured using the 7-item Social Distance Scale and the 15-item Explanatory Model Interview Catalogue Community Stigma Scale. We will estimate intention-to-treat effects at the individual level, comparing the outcomes of the intervention and control arms. In an accompanying qualitative component, we will conduct in-depth interviews with community members, community health volunteers, and health care workers in both treatment arms and the control arm to explore intervention and stigma-related experiences. Results: This paper describes and discusses the protocol for a mixed methods cluster randomized controlled trial. Data collection is planned to be completed in June 2024, with ongoing data analysis. The first results are expected to be submitted for publication by the end of 2024. Conclusions: This trial will be among the first to test the causal effectiveness of community-based sensitization campaigns and audio tools to increase knowledge and reduce leprosy-related stigma. As such, the results will inform health policy makers, decision-makers, and public health practitioners designing sensitization campaigns in rural multilingual settings. Trial Registration: German Clinical Trials Register DRKS00029355; https://drks.de/search/en/trial/DRKS00029355 International Registered Report Identifier (IRRID): DERR1-10.2196/52106 %M 38635983 %R 10.2196/52106 %U https://www.researchprotocols.org/2024/1/e52106 %U https://doi.org/10.2196/52106 %U http://www.ncbi.nlm.nih.gov/pubmed/38635983 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e52959 %T Assessing the Effectiveness of a Multicomponent Intervention on Hand Hygiene and Well-Being in Primary Health Care Centers and Schools Lacking Functional Water Supply in Protracted Conflict Settings: Protocol for a Cluster Randomized Controlled Trial %A Galli,Anaïs %A Ma'ani Abuzahra,Yaman %A Bänziger,Carola %A Ballo,Aboubacar %A Friedrich,Max N D %A Gross,Karin %A Harter,Miriam %A Hattendorf,Jan %A Peter,Maryna %A Tamas,Andrea %A Owen,Branwen N %A Winkler,Mirko S %+ Department of Epidemiology and Public Health, Swiss Tropical and Public Health Institute, Kreuzstrasse 2, Allschwil, 4123, Switzerland, 41 612849252, anais.galli@swisstph.ch %K water, sanitation, and hygiene %K WASH %K hand hygiene %K impact evaluation %K conflict settings %K behavior change %K handwashing %K students %K handwashing stations %K primary schools, primary health care facilities %K humanitarian crisis %K mobile phone %D 2024 %7 3.4.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Hand hygiene is crucial in health care centers and schools to avoid disease transmission. Currently, little is known about hand hygiene in such facilities in protracted conflict settings. Objective: This protocol aims to assess the effectiveness of a multicomponent hand hygiene intervention on handwashing behavior, underlying behavioral factors, and the well-being of health care workers and students. Moreover, we report our methodology and statistical analysis plan transparently. Methods: This is a cluster randomized controlled trial with 2 parallel arms taking place in 4 countries for 1 year. In Burkina Faso and Mali, we worked in 24 primary health care centers per country, whereas in Nigeria and Palestine, we focused on 26 primary schools per country. Facilities were eligible if they were not connected to a functioning water source but were deemed accessible to the implementation partners. Moreover, health care centers were eligible if they had a maternity ward and ≥5 employees, and schools if they had ≤7000 students studying in grades 5 to 7. We used covariate-constrained randomization to assign intervention facilities that received a hardware, management and monitoring support, and behavior change. Control facilities will receive the same or improved intervention after endline data collection. To evaluate the intervention, at baseline and endline, we used a self-reported survey, structured handwashing observations, and hand-rinse samples. At follow-up, hand-rinse samples were dropped. Starting from the intervention implementation, we collected longitudinal data on hygiene-related health conditions and absenteeism. We also collected qualitative data with focus group discussions and interviews. Data were analyzed descriptively and with random effect regression models with the random effect at a cluster level. The primary outcome for health centers is the handwashing rate, defined as the number of times health care workers performed good handwashing practice with soap or alcohol-based handrub at one of the World Health Organization 5 moments for hand hygiene, divided by the number of moments for hand hygiene that presented themselves during the patient interaction within an hour of observation. For schools, the primary outcome is the number of students who washed their hands before eating. Results: The baseline data collection across all countries lasted from February to June 2023. We collected data from 135 and 174 health care workers in Burkina Faso and Mali, respectively. In Nigeria, we collected data from 1300 students and in Palestine from 1127 students. The endline data collection began in February 2024. Conclusions: This is one of the first studies investigating hand hygiene in primary health care centers and schools in protracted conflict settings. With our strong study design, we expect to support local policy makers and humanitarian organizations in developing sustainable agendas for hygiene promotion. Trial Registration: ClinicalTrials.gov NCT05946980 (Burkina Faso and Mali); https://www.clinicaltrials.gov/study/NCT05946980 and NCT05964478 (Nigeria and Palestine); https://www.clinicaltrials.gov/study/NCT05964478 International Registered Report Identifier (IRRID): DERR1-10.2196/52959 %M 38569182 %R 10.2196/52959 %U https://www.researchprotocols.org/2024/1/e52959 %U https://doi.org/10.2196/52959 %U http://www.ncbi.nlm.nih.gov/pubmed/38569182 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e54352 %T Heat and Acupuncture to Manage Osteoarthritis of the Knee (HARMOKnee): Protocol for an Effectiveness-Implementation Hybrid Randomized Controlled Trial %A Tan,Bryan Yijia %A Tan,Chun Yue %A Tan,Tong Leng %A Yang,Su-Yin %A Chew,Gillian Long Szu %A Tan,Siang Ing %A Chua,Yu Chun %A Yan,Yew Wai %A Soh,Derrick Bing Quan %A Goh,Tong Hwee %A Ng,Pu Jue %A Ng,Yee Teck %A Kuan,Swee Boey %A Teo,Bo Siang %A Kong,Keng He %A Pereira,Michelle Jessica %A Ng,Hui Ping %+ Department of Orthopaedic Surgery, Woodlands Health, National Healthcare Group, 17 Woodlands Dr 17, Singapore, 737628, Singapore, 65 90057277, bryan_tan@wh.com.sg %K knee osteoarthritis %K acupuncture %K heat therapy %K effectiveness-implementation hybrid study %K randomized controlled trial %K RCT %D 2024 %7 3.4.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Knee osteoarthritis (KOA) is one of most prevalent and fastest-growing causes of pain, impaired mobility, and poor quality of life in the rapidly aging population worldwide. There is a lack of high-quality evidence on the efficacy of traditional Chinese medicine (TCM), particularly acupuncture, and a lack of KOA practice guidelines that are tailored to unique population demographics and tropical climates. Objective: Our HARMOKnee (Heat and Acupuncture to Manage Osteoarthritis of the Knee) trial aims to address these gaps by evaluating the short- and medium-term clinical and cost-effectiveness of acupuncture with heat therapy in addition to standard care, compared to standard care alone. Through a robust process and economic evaluation, we aim to inform evidence-based practice for patients with KOA to facilitate the large-scale implementation of a comprehensive and holistic model of care that harmonizes elements of Western medicine and TCM. We hypothesize that acupuncture with heat therapy as an adjunct to standard care is clinically more effective than standard care alone. Methods: A multicenter, pragmatic, parallel-arm, single-blinded, effectiveness-implementation hybrid randomized controlled trial will be conducted. We intend to recruit 100 patients with KOA randomized to either the control arm (standard care only) or intervention arm (acupuncture with heat therapy, in addition to standard care). The inclusion criteria are being a community ambulator and having primary KOA, excluding patients with secondary arthritis or previous knee replacements. The primary outcome measure is the Knee Osteoarthritis Outcome Score at 6 weeks. Secondary outcome measures include psychological, physical, quality of life, satisfaction, and global outcome measures at 6, 12, and 26 weeks. A mixed method approach through an embedded process evaluation will facilitate large-scale implementation. An economic evaluation will be performed to assess financial sustainability. Results: Patient enrollment has been ongoing since August 2022. The recruitment process is anticipated to conclude by July 2024, and the findings will be analyzed and publicized as they are obtained. As of November 6, 2023, our patient enrollment stands at 65 individuals. Conclusions: The findings of our HARMOKnee study will contribute substantial evidence to the current body of literature regarding the effectiveness of acupuncture treatment for KOA. Additionally, we aim to facilitate the creation of standardized national guidelines for evidence-based practice that are specifically tailored to our unique population demographics. Furthermore, we seek to promote the adoption and integration of acupuncture and heat therapy into existing treatment models. Trial Registration: ClinicalTrials.gov NCT05507619; https://clinicaltrials.gov/study/NCT05507619 International Registered Report Identifier (IRRID): DERR1-10.2196/54352 %M 38568718 %R 10.2196/54352 %U https://www.researchprotocols.org/2024/1/e54352 %U https://doi.org/10.2196/54352 %U http://www.ncbi.nlm.nih.gov/pubmed/38568718 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e50864 %T Improving Health Professional Recognition and Response to Child Maltreatment and Intimate Partner Violence: Protocol for Two Mixed Methods Pilot Randomized Controlled Trials %A Kimber,Melissa %A Baker-Sullivan,Elizabeth %A Stewart,Donna E %A Vanstone,Meredith %+ Offord Centre for Child Studies, Department of Psychiatry & Behavioural Neurosciences, McMaster University, WHC 120, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada, 1 905 525 9140 ext 27220, kimberms@mcmaster.ca %K medical education %K health professions education %K child maltreatment %K intimate partner violence %K mixed methods %K pilot trial %K qualitative description %K family violence %D 2024 %7 21.3.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: The optimal educational approach for preparing health professionals with the knowledge and skills to effectively recognize and respond to family violence, including child maltreatment and intimate partner violence, remains unclear. The Violence, Evidence, Guidance, and Action (VEGA) Family Violence Education Resources is a novel intervention that can be completed via self-directed learning or in a workshop format; both approaches focus on improving health professional preparedness to address family violence. Objective: Our studies aim to determine the acceptability and feasibility of conducting a randomized controlled trial to evaluate the effectiveness of the self-directed (experimental intervention) and workshop (active control) modalities of VEGA, as an adjunct to standard education, to improve learner (Researching the Impact of Service provider Education [RISE] with Residents) and independent practice (RISE with Veterans) health professional preparedness, knowledge, and skills related to recognizing family violence in their health care encounters. Methods: The RISE with Residents and RISE with Veterans research studies use embedded experimental mixed methods research designs. The quantitative strand for each study follows the principles of a pilot randomized controlled trial. For RISE with Residents, we aimed to recruit 80 postgraduate medical trainees; for RISE with Veterans, we intended to recruit 80 health professionals who work or have worked with Veterans (or their family members) of the Canadian military or the Royal Canadian Mounted Police in a direct service capacity. Participants complete quantitative assessments at baseline, after intervention, and at 3-month follow-up. A subset of participants from each arm also undergoes a qualitative semistructured interview with the aim of describing participants’ perceptions of the value and impact of each VEGA modality, as well as research burden. Scores on potential outcome measures will be mapped to excerpts of qualitative data via a mixed methods joint display to aid in the interpretation of findings. Results: We consented 71 individuals to participate in the RISE with Residents study. Data collection was completed on August 31, 2023, and data are currently being cleaned and prepared for analysis. As of January 15, 2024, we consented 34 individuals in the RISE with Veterans study; data collection will be completed in March 2024. For both studies, no data analysis had taken place at the time of manuscript submission. Results will be disseminated through peer-reviewed publications; academic conferences; and posting and sharing of study summaries and infographics on social media, the project website, and via professional network listserves. Conclusions: Reducing the impacts of family violence remains a pressing public health challenge. Both research studies will provide a valuable methodological contribution about the feasibility of trial methods in health professions education focused on family violence. They will also contribute to education science about the differences in the effectiveness of self-directed versus facilitator-led learning strategies. Trial Registration: ClinicalTrials.gov NCT05490121, https://clinicaltrials.gov/study/NCT05490121; ClinicalTrials.gov NCT05490004, https://clinicaltrials.gov/study/NCT05490004 International Registered Report Identifier (IRRID): DERR1-10.2196/50864 %M 38512307 %R 10.2196/50864 %U https://www.researchprotocols.org/2024/1/e50864 %U https://doi.org/10.2196/50864 %U http://www.ncbi.nlm.nih.gov/pubmed/38512307 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e49940 %T Matrix Metalloproteinase-9 Testing of Golden Rice Cookies With Piper Crocatum Active Extract for Preventing Foot Ulcers in Patients With Diabetes: Protocol for a Randomized Controlled Trial %A Setyawati,Andina %A Saleh,Ariyanti %A Tahir,Takdir %A Yusuf,Saldy %A Syahrul,Syahrul %A Aminuddin,Aminuddin %A Raihan,Muhammad %A Jafar,Nuurhidayat %A Hamzah,Hasyrul %A Arfian,Nur %+ Medical Surgical Nursing Department, Faculty of Nursing, Hasanuddin University, Jl Perintis Kemerdekaan km 10, Tamalanrea, Makassar, 92111, Indonesia, 62 8121521639, andina@unhas.ac.id %K diabetic foot ulcer %K prevention %K diabetic neuropathy %K cookies %K food supplement %K study protocol %D 2024 %7 29.2.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Diabetic foot ulcers (DFUs) present a formidable challenge to both patients and health care systems. DFUs significantly reduce the quality of life for patients, prolong hospital stays, and are the cause of approximately 70,000 lower limb amputations across the globe annually. Prevention of DFUs primarily involves the optimization of blood sugar levels and the effective management of complications, particularly peripheral neuropathy. Golden Rice has been proven to lower blood sugar levels due to its beta-carotene content, and Piper crocatum (P. crocatum) has been found to be effective in reducing the risk factors of DFUs through biomolecular regulation because of its polyphenol content. Objective: The principal objective of this study is to identify the efficacy of P. crocatum–enriched cookies, with Golden Rice as their primary ingredient, in preventing DFUs. The evaluation will center on their impact on the expression of matrix metalloproteinase-9 (MMP-9), a pivotal factor in the development of DFUs. Methods: This study is an experimental clinical research that follows the randomized controlled trial method and uses a single-blind design. The participants in the study are outpatients from primary health centers in Makassar, Indonesia, who have been diagnosed with diabetes mellitus. The sample for the study will be randomly selected and subsequently categorized into 2 groups: the intervention group and the control group. The intervention group consumes P. crocatum–enriched Golden Rice cookies, while the control group receives cookies without these additives. The participants from both groups will consume their respective cookies (packaged identically) twice a day for 14 days. The cookies will be prepared according to a modified recipe with an emphasis on low glucose content, resulting in 51 calories per cookie, comprising 1% carbohydrates, 6% fat, 4% cholesterol, and 4% fiber, excluding gluten, sugar, and salt. They will be baked at 158°C for 20 minutes. The process involves the addition of 20% Golden Rice and 10% P. crocatum ethanol extract, both prepared via maceration with 96% ethanol. The dependent variable in this study is the expression of gelatinases matrix metalloproteinase, to be assessed at 2 distinct time points—preintervention (pretest) and postintervention (posttest)—with the evaluation conducted through the western blotting method. Results: The recruitment and testing phase started in January 2024. The study is scheduled to be completed by the end of March 2024. Data analysis will commence in April 2024, and the publication of the results is anticipated in the same year (2024). The study will report on the changes in primary data, encompassing gelatinases matrix metalloproteinase, as well as secondary data, including the ankle-brachial index, neuropathy score, and random blood glucose level. Conclusions: The findings of this trial are expected to significantly impact the selection of strategies by health care practitioners to enhance diabetes self-management, particularly in the domain of therapeutic snacking, for patients diagnosed with diabetes mellitus. Trial Registration: Thai Clinical Trials Registry TCTR20230502001; https://www.thaiclinicaltrials.org/show/TCTR20230502001 International Registered Report Identifier (IRRID): PRR1-10.2196/49940 %M 38422498 %R 10.2196/49940 %U https://www.researchprotocols.org/2024/1/e49940 %U https://doi.org/10.2196/49940 %U http://www.ncbi.nlm.nih.gov/pubmed/38422498 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e53347 %T Effects of the Prolong Life With Nine Turn-Method Qigong on Fatigue, Insomnia, Anxiety, and Gastrointestinal Disorders in Patients With Chronic Fatigue Syndrome: Protocol for a Randomized Controlled Trial %A Xie,Fangfang %A You,Yanli %A Gu,Yuanjia %A Xu,Jiatuo %A Yao,Fei %+ Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, 200071, No.274, Middle Zhijiang Road, Shanghai, 200071, China, 86 13585975106, doctoryaofei@shutcm.edu.cn %K chronic fatigue syndrome %K prolong life with nine turn method Qigong %K fMRI %K gut microbiota %K gastrointestinal %K fatigue %K insomnia %K CFS %K study protocol %K Qigong %K efficacy %K safety %K cognitive behavioral therapy %K CBT %K randomized trial %D 2024 %7 26.2.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Chronic fatigue syndrome (CFS) is a debilitating multisystem disorder that can lead to various pathophysiological abnormalities and symptoms, including insomnia, gastrointestinal disorders, and anxiety. Due to the side effects of currently available drugs, there is a growing need for safe and effective nondrug therapies. The Prolong Life With Nine Turn (PLWNT) Qigong method is a system of mind-body exercise with restorative benefits that can alleviate the clinical symptoms of CFS and impart a significant inhibitory effect. Various studies have proven the treatment efficacy of PLWNT; however, the impact on insomnia, gastrointestinal disorders, and anxiety in patients with CFS has not yet been investigated. Objective: This study aims to evaluate the efficacy and safety of the PLWNT method in terms of its effects on fatigue, insomnia, anxiety, and gastrointestinal symptoms in patients with CFS. Methods: We will conduct a randomized, analyst-blinded, parallel-controlled trial with a 12-week intervention and 8-week follow-up. A total of 208 patients of age 20-60 years will be recruited. The patients will be randomly divided into a PLWNT Qigong exercise group (PLWNT Group) and a control group treated with cognitive behavioral therapy at a ratio of 1:1. Participants from the treatment groups will be taught by a highly qualified professor at the Shanghai University of Traditional Chinese Medicine once a week and will be supervised via web during the remaining 6 days at home, over 12 consecutive weeks. The primary outcome will be the Multidimensional Fatigue Inventory 20, while the secondary outcomes include the Pittsburgh Sleep Quality Index, Gastrointestinal Symptom Rating Scale, Hospital Anxiety and Depression Scale, functional magnetic resonance imaging, gut microbiota, and peripheral blood. Results: The study was approved by the ethics committee of Shanghai Municipal Hospital of Traditional Chinese Medicine in March 2022 (Ethics Approval Number 2022SHL-KY-05). Recruitment started in July 2022. The intervention is scheduled to be completed in December 2024, and data collection will be completed by the end of January 2025. Over the 3-year recruitment period, 208 participants will be recruited. Data management is still in progress; therefore, data analysis has yet to be performed. Conclusions: This randomized trial will evaluate the effectiveness of the PLWNT method in relieving fatigue, insomnia, anxiety, and gastrointestinal symptoms in patients with CFS. If proven effective, it will provide a promising alternative intervention for patients with CFS. Trial Registration: China Clinical Trials Registry ChiCTR2200061229; https://www.chictr.org.cn/showproj.html?proj=162803 International Registered Report Identifier (IRRID): PRR1-10.2196/53347 %M 38407950 %R 10.2196/53347 %U https://www.researchprotocols.org/2024/1/e53347 %U https://doi.org/10.2196/53347 %U http://www.ncbi.nlm.nih.gov/pubmed/38407950 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e53222 %T Changes in Oral Health and Dental Esthetic in Smokers Switching to Combustion-Free Nicotine Alternatives: Protocol for a Multicenter and Prospective Randomized Controlled Trial %A Conte,Gianluca %A Pacino,Sebastiano Antonio %A Urso,Salvatore %A Greiling,Doris %A Caponnetto,Pasquale %A Pedullà,Eugenio %A Generali,Luigi %A Consolo,Ugo %A Checchi,Vittorio %A Gospodaru,Stefan %A Bordeniuc,Gheorghe %A Fala,Valeriu %A Kowalski,Jan %A Nowak,Maciej %A Górska,Renata %A Amaliya,Amaliya %A Chapple,Iain %A Milward,Michael %A Maclure,Robert %A Nardi,Gianna Maria %A Polosa,Riccardo %+ Department of Clinical and Experimental Medicine, University of Catania, via S. Sofia, 78 - Ed. 4, p. 2, Catania, 95123, Italy, 39 0953781566, polosa@unict.it %K electronic cigarettes %K heated tobacco products %K tobacco harm reduction %K smoking %K oral health %K gingivitis %K periodontitis %K Modified Gingival Index %K MGI %K dental plaque imaging %K dental shade %K smartphone %K mobile phone %D 2024 %7 23.2.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Although the detrimental effects of conventional combustible cigarettes on oral health and dental esthetics are well known, there is limited information about the long-term impact of combustion-free nicotine alternatives (C-F NA) such as e-cigarettes or heated tobacco products. Objective: This multicenter, prospective, 3-parallel-arm randomized controlled trial will investigate whether switching from combustible cigarettes to C-F NA will lead to measurable improvements in oral health parameters and dental esthetics over 18 months in adult smokers with limited gum disease. Methods: Regular smokers not intending to quit and without clinical signs of periodontitis will be randomly assigned (1:4 ratio) to either standard of care with brief cessation advice (control group; arm A) or C-F NA use (intervention group; arm B). The study will also include a reference group of never smokers (reference group; arm C). The primary end point is the change in the Modified Gingival Index (MGI) score from baseline between the control arm (arm A) and the intervention arm (arm B) at the 18-month follow-up. In addition, the study will analyze the within- and between-group (arms A, B, and C) changes in MGI assessment, plaque imaging, dental shade quantitation, tooth stain scores, and oral health–related quality of life questionnaires measured at each study time point. All participants will attend a total of 7 clinic visits: screening, enrollment, and randomization (visit 0); baseline visit—day 14 (visit 1); day 90 (visit 2); day 180 (visit 3); day 360 (visit 4); and day 540 (visit 5). This multicenter study will be conducted in 4 dental clinics in 4 countries. The statistical analysis will involve descriptive statistics for continuous and categorical data. Primary end points will undergo tests for normality and, based on distribution, either a 2-sided t test or Mann-Whitney U test. Linear mixed model with random factors center and study arms by center will also be applied. Secondary end points, including MGI assessment and quality of life, will be subjected to similar tests and comparisons. Only if one value of the parameter MGI is missing after day 1, the last available observation will be carried forward. The analysis will be performed on the substituted data. Secondary parameters will not have missing value replacement. Results: Participant recruitment began in October 2021, and enrollment was completed in June 2023. Results will be reported in 2025. Conclusions: This will be the first study to provide key insights into oral health benefits or risks associated with using C-F NA in smokers who are seeking alternatives to cigarette smoking. Trial Registration: ClinicalTrials.gov NCT04649645; https://clinicaltrials.gov/ct2/show/NCT04649645 International Registered Report Identifier (IRRID): DERR1-10.2196/53222 %M 38393754 %R 10.2196/53222 %U https://www.researchprotocols.org/2024/1/e53222 %U https://doi.org/10.2196/53222 %U http://www.ncbi.nlm.nih.gov/pubmed/38393754 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e54882 %T The Efficacy of Bepotastine Besilate Compared With Hydroxyzine Pamoate for Preventing Infusion Reactions to the First Dose of Rituximab in Patients With Non-Hodgkin Lymphoma: Protocol for a Phase II, Double-Blind, Multicenter Randomized Trial %A Kitahiro,Yumi %A Yamamoto,Kazuhiro %A Yakushijin,Kimikazu %A Ioroi,Takeshi %A Tanda,Masaaki %A Itohara,Kotaro %A Omura,Tomohiro %A Minami,Hironobu %A Yano,Ikuko %+ Department of Pharmacy, Kobe University Hospital, 7-5-2, Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan, 81 78 382 6640, iyano@med.kobe-u.ac.jp %K non-Hodgkin lymphoma %K rituximab %K infusion reactions %K bepotastine besilate %K histamine H1-receptor antagonist %K hydroxyzine pamoate %K drowsiness %D 2024 %7 22.2.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Rituximab, an anti-CD20 monoclonal antibody, can cause infusion reactions (IRs), especially during the initial rituximab infusion therapy. Generally, patients are administered a histamine H1-receptor antagonist before the rituximab infusion, along with an antipyretic analgesic, to prevent or reduce IRs. Multiple retrospective case-control studies indicate that the second generation of histamine H1-receptor antagonists might be more effective than the first generation in suppressing IRs caused by the rituximab infusion. Objective: This study aimed to assess the efficacy of first- and second-generation histamine H1-receptor antagonists for preventing IRs resulting from the initial infusion of rituximab in patients diagnosed with non-Hodgkin lymphoma. Methods: This is a phase II, double-blind, active-controlled randomized trial. It will be a multicenter study conducted across 3 facilities that aims to enroll a total of 40 patients diagnosed with non-Hodgkin lymphoma who will receive their initial rituximab infusion. Participating patients will be administered hydroxyzine pamoate or bepotastine besilate, representing first- or second-generation histamine H1-receptor antagonists, respectively. This will be combined with 400-mg acetaminophen tablets taken approximately 30 minutes before the first infusion of rituximab. The primary end point of this trial is to assess severe IRs, equivalent to grade 2 or higher as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0, that occur within a 4-hour period after the initiation of rituximab infusion. The secondary end points include assessing the severity of the initial IR, the maximum severity of the IR, and the duration between rituximab infusion initiation and the onset of the first IR within a 4-hour period. Additionally, the trial will evaluate histamine H1-receptor antagonist–induced drowsiness using the visual analogue scale, with each patient providing their individual response. Results: This study began with patient recruitment in April 2023, with 17 participants enrolled as of November 12, 2023. The anticipated study completion is set for February 2026. Conclusions: This study is the first randomized controlled trial comparing the effects of oral first- and second-generation histamine H1-receptor antagonists in preventing IRs induced by the initial administration of rituximab. The findings from this study hold the potential to establish the rationale for a phase III study aimed at determining the standard premedication protocol for rituximab infusion. Trial Registration: Japan Registry of Clinical Trials jRCTs051220169; https://jrct.niph.go.jp/latest-detail/jRCTs051220169 International Registered Report Identifier (IRRID): DERR1-10.2196/54882 %M 38386393 %R 10.2196/54882 %U https://www.researchprotocols.org/2024/1/e54882 %U https://doi.org/10.2196/54882 %U http://www.ncbi.nlm.nih.gov/pubmed/38386393 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e54672 %T Pan-Indian Clinical Registry of Invasive Fungal Infections Among Patients in the Intensive Care Unit: Protocol for a Multicentric Prospective Study %A Ojha,Anup Kumar %A Albert,Venencia %A Sharma,Saurabh %A Hallur,Vinaykumar %A Singh,Gagandeep %A Pamidimukkala,Umabala %A Singh,Kh Jitenkumar %A Kaur,Harleen %A Karuna,Tadepalli %A Savio,Jayanthi %A Nath,Reema %A Xess,Immaculata %A Gupta,Prashant %A Shetty,Anjali %A Das,Madhuchhanda %+ Indian Council of Medical Research, Ansari Nagar, New Delhi, 110029, India, 91 2658 8895 ext 11, dasm.hq@icmr.gov.in %K mycology %K invasive fungal infections %K diagnosis %K clinical registry %K public health %K fungal infections %K fungal infection %K ICU patients %K ICU patient %K in-patient %K in-patients %K long-term stay %K mortality %K mycoses %K India %K knowledge gaps %K epidemiological %K epidemiological factor %K antifungal resistance %K antifungal %K descriptive method %D 2024 %7 16.2.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Fungal infections are now a great public health threat, especially in those with underlying risk factors such as neutropenia, diabetes, high-dose steroid treatment, cancer chemotherapy, prolonged intensive care unit stay, and so on, which can lead to mycoses with higher mortality rates. The rates of these infections have been steadily increasing over the past 2 decades due to the increasing population of patients who are immunocompromised. However, the data regarding the exact burden of such infection are still not available from India. Therefore, this registry was initiated to collate systematic data on invasive fungal infections (IFIs) across the country. Objective: The primary aim of this study is to create a multicenter digital clinical registry and monitor trends of IFIs and emerging fungal diseases, as well as early signals of any potential fungal outbreak in any region. The registry will also capture information on the antifungal resistance patterns and the contribution of fungal infections on overall morbidity and inpatient mortality across various conditions. Methods: This multicenter, prospective, noninterventional observational study will be conducted by the Indian Council of Medical Research through a web-based data collection method from 8 Advanced Mycology Diagnostic and Research Centers across the country. Data on age, gender, clinical signs and symptoms, date of admission, date of discharge or death, diagnostic tests performed, identified pathogen details, antifungal susceptibility testing, outcome, and so on will be obtained from hospital records. Descriptive and multivariate statistical methods will be applied to investigate clinical manifestations, risk variables, and treatment outcomes. Results: These Advanced Mycology Diagnostic and Research Centers are expected to find the hidden cases of fungal infections in the intensive care unit setting. The study will facilitate the enhancement of the precision of fungal infection diagnosis and prompt treatment modalities in response to antifungal drug sensitivity tests. This registry will improve our understanding of IFIs, support evidence-based clinical decision-making ability, and encourage public health policies and actions. Conclusions: Fungal diseases are a neglected public health problem. Fewer diagnostic facilities, scanty published data, and increased vulnerable patient groups make the situation worse. This is the first systematic clinical registry of IFIs in India. Data generated from this registry will increase our understanding related to the diagnosis, treatment, and prevention of fungal diseases in India by addressing pertinent gaps in mycology. This initiative will ensure a visible impact on public health in the country. International Registered Report Identifier (IRRID): DERR1-10.2196/54672 %M 38363632 %R 10.2196/54672 %U https://www.researchprotocols.org/2024/1/e54672 %U https://doi.org/10.2196/54672 %U http://www.ncbi.nlm.nih.gov/pubmed/38363632 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e53023 %T Comparing Repeated (Annual) Couples HIV Testing and Counseling to Individual HIV Testing and Counseling Among Male Couples at High Risk of HIV Infection: Protocol for a Randomized Control Trial %A Starks,Tyrel J %A Kyre,Kory %A Castiblanco,Juan %A Parker,Jayelin N %A Kahle,Erin %A Stephenson,Rob %A Cain,Demetria %+ Department of Psychology, Hunter College, City University of New York, 611 Hunter North, 695 Park Ave, New York, NY, 10065, United States, 1 2122067919, tstarks@hunter.cuny.edu %K club drugs %K counseling %K dyadic interventions %K emerging adults %K gay and bisexual men %K HIV %K male couples %K men who have sex with men %K randomized controlled trial %K RCT %K relationships %D 2024 %7 13.2.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Couples HIV testing and counseling (CHTC) is now a standard of care prevention strategy recommended by the Centers for Disease Control and Prevention for sexual minority men (SMM) in relationships. Despite standard recommendations that couples complete CHTC every 6-12 months, no study has empirically evaluated the effects associated with CHTC retesting. Objective: This study aims to understand the benefits associated with continued dyadic engagement in the HIV prevention continuum through routine CHTC retesting, which is of particular importance for emerging-adult SMM in relationships who use drugs. Methods: Eligible couples for this CHTC retesting trial must already be enrolled in the 4Us trial, where they completed a CHTC session after their baseline survey. The purpose of the original 4Us trial was to test the efficacy of 2 intervention components for CHTC: a communication skills training video and a substance use module. Couples were eligible for the original 4Us trial if they identified as cisgender male, were in a relationship for 3 months or longer, were aged 17 years or older, and communicated in English. At least 1 partner had to be aged 17-29 years, report HIV negative or unknown serostatus, report use of at least 1 drug (cannabis, cocaine or crack, crystal methamphetamine, ketamine, gamma-hydroxybuterate [GHB], psychedelics, ecstasy, prescription medication misuse, opiates, and nitrates) use, and engage in condomless anal sex (CAS) acts with a casual partner or have a main partner who is nonmonogamous or serodiscordant. Those who complete the 4Us 12-month follow-up and remain in a relationship with the partner they participated in 4Us with are offered the opportunity to participate in this CHTC retesting trial. Those consenting are randomized to either CHTC retesting or individual HIV testing. Follow-up assessments are conducted 3 and 6 months after randomization to evaluate the effects of repeat CHTC on 2 primary outcomes: (1) CAS with a casual partner in the absence of preexposure prophylaxis (PrEP), and (2) CAS with a serodiscordant main partner who is not virally suppressed or concurrent CAS between main and casual partners in the absence of PrEP. Results: The CHTC retesting trial launched in January 2023, and enrollment is ongoing. As of February 2024, the study had enrolled 106 eligible participants (n=53 couples). Conclusions: Findings from this CHTC retesting study will contribute to knowledge about the benefits associated with regular (repeated) CHTC testing versus routine individual HIV testing for SMM in relationships. The results of this trial will inform CHTC retesting guidance. Trial Registration: ClinicalTrials.gov NCT05833074; htps://www.clinicaltrials.gov/study/NCT05833074 International Registered Report Identifier (IRRID): DERR1-10.2196/53023 %M 38349737 %R 10.2196/53023 %U https://www.researchprotocols.org/2024/1/e53023 %U https://doi.org/10.2196/53023 %U http://www.ncbi.nlm.nih.gov/pubmed/38349737 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e52820 %T Cerebral Mechanism of Tuina on the Descending Pain Inhibitory System in Knee Osteoarthritis: Protocol for a Randomized Controlled Trial %A Xu,Hui %A Wang,Zheng %A Wang,Zhen %A Zhou,Hang %A Guo,Juan %A Li,Wanyu %A Zhou,Yunfeng %+ School of Acupuncture-moxibustion and Tuina, Henan University of Chinese Medicine, 63 Dongming Road, Jinshu District, China, Zhengzhou, 450046, China, 86 15036065036, zyf5680198@126.com %K brain %K knee osteoarthritis %K magnetic resonance imaging %K pain %K Tuina %D 2024 %7 12.2.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Knee osteoarthritis (KOA) is reputedly the most common musculoskeletal disease of the lower limbs and the main cause of pain and disability among older individuals. Pain is the most significant and widespread symptom of KOA. The descending pain inhibitory system has a cardinal role in normal pain consciousness, and its malfunction may be one of the pathophysiological mechanisms in KOA. Crucially, the rostral ventromedial medulla (RVM) and periaqueductal gray (PAG), as important components of the descending pain inhibitory system, directly modulate the activity of the spinal neurons involved in pain transmission. Tuina, a manual therapy, is effective and safe for reducing clinical symptoms of KOA; however, the mechanism that influences pain through the descending pain inhibitory system in KOA is unclear. Objective: This study aims to investigate the modulatory implications of Tuina on the RVM and PAG, which have critical roles in the descending pain inhibitory system in patients with KOA. Methods: This randomized controlled parallel trial will be conducted at the Tuina Clinic of the Third Affiliated Hospital of Henan University of Chinese Medicine (Zhengzhou, China). Patients with KOA will be randomly assigned (1:1) to 6 weeks of health education or Tuina. All patients in both groups will accept a resting-state functional magnetic resonance scan at the beginning and end of the experiment, and the resting-state functional connectivity and the voxel-based morphometry analysis will be performed to detect the RVM and PAG function and structure changes. The clinical outcome assessments will be (1) the pressure pain thresholds, (2) the Numerical Rating Scale, (3) the Hamilton Depression Scale (HAMD), and (4) the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Considering that this trial is a study of resting-state functional magnetic resonance imaging technology, resting-state functional connectivity and voxel-based morphometry are the primary outcomes, and clinical outcome assessments are secondary outcomes. Adverse events will be documented and assessed throughout. All main analyses will be carried out on the basis of the intention-to-treat principle. The outcome evaluators and data statisticians will be masked to the treatment group assignment to reduce the risk of bias. Results: This trial was approved by the ethics committee of the Third Affiliated Hospital of Henan University of Chinese Medicine. Enrollment began in December 2023, and the results of this trial are expected to be submitted for publication in May 2025. Conclusions: This trial will identify a possible relationship between function and structure changes of RVM and PAG and the improvement of clinical variables, elucidating the effect of Tuina on the descending pain inhibitory system of patients with KOA. This trial will provide much-needed knowledge for Tuina for patients with KOA. Trial Registration: Chinese Clinical Trial Registry ChiCTR2300070289; https://www.chictr.org.cn/showproj.html?proj=182570 International Registered Report Identifier (IRRID): PRR1-10.2196/52820 %M 38238645 %R 10.2196/52820 %U https://www.researchprotocols.org/2024/1/e52820 %U https://doi.org/10.2196/52820 %U http://www.ncbi.nlm.nih.gov/pubmed/38238645 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e48069 %T Survivorship Care for Women Living With Ovarian Cancer: Protocol for a Randomized Controlled Trial %A Kvale,Elizabeth %A Phillips,Farya %A Ghosh,Samiran %A Lea,Jayanthi %A Hoppenot,Claire %A Costales,Anthony %A Sunde,Jan %A Badr,Hoda %A Nwogu-Onyemkpa,Eberechi %A Saleem,Nimrah %A Ward,Rikki %A Balasubramanian,Bijal %+ Section of Geriatrics and Palliative Medicine, Department of Medicine, Baylor College of Medicine, 1 Baylor Plaza, Houston, TX, 77030, United States, 1 713 798 2272, Elizabeth.kvale@bcm.edu %K chronic survivorship %K metastatic survivor %K metavivor %K ovarian cancer %K persons living with cancer %K quality of life %K survivor %K survivorship care %K survivorship transition %D 2024 %7 9.2.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Ovarian cancer ranks 12th in cancer incidence among women in the United States and 5th among causes of cancer-related death. The typical treatment of ovarian cancer focuses on disease management, with little attention given to the survivorship needs of the patient. Qualitative work alludes to a gap in survivorship care; yet, evidence is lacking to support the delivery of survivorship care for individuals living with ovarian cancer. We developed the POSTCare survivorship platform with input from survivors of ovarian cancer and care partners as a means of delivering patient-centered survivorship care. This process is framed by the chronic care model and relevant behavioral theory. Objective: The overall goal of this study is to test processes of care that support quality of life (QOL) in survivorship. The specific aims are threefold: first, to test the efficacy of the POSTCare platform in supporting QOL, reducing depressive symptom burden, and reducing recurrence worry. In our second aim, we will examine factors that mediate the effect of the intervention. Our final aim focuses on understanding aspects of care platform design and delivery that may affect the potential for dissemination. Methods: We will enroll 120 survivors of ovarian cancer in a randomized controlled trial and collect data at 12 and 24 weeks. Each participant will be randomized to either the POSTCare platform or the standard of care process for survivorship. Our population will be derived from 3 clinics in Texas; each participant will have received some combination of treatment modalities; continued maintenance therapy is not exclusionary. Results: We will examine the impact of the POSTCare-O platform on QOL at 12 weeks after intervention as the primary end point. We will look at secondary outcomes, including depressive symptom burden, recurrence anxiety, and physical symptom burden. We will identify mediators important to the impact of the intervention to inform revisions of the intervention for subsequent studies. Data collection was initiated in November 2023 and will continue for approximately 2 years. We expect results from this study to be published in early 2026. Conclusions: This study will contribute to the body of survivorship science by testing a flexible platform for survivorship care delivery adapted for the specific survivorship needs of patients with ovarian cancer. The completion of this project will contribute to the growing body of science to guide survivorship care for persons living with cancer. Trial Registration: ClinicalTrials.gov NCT05752448; https://clinicaltrials.gov/study/NCT05752448 International Registered Report Identifier (IRRID): PRR1-10.2196/48069 %M 38335019 %R 10.2196/48069 %U https://www.researchprotocols.org/2024/1/e48069 %U https://doi.org/10.2196/48069 %U http://www.ncbi.nlm.nih.gov/pubmed/38335019 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e52497 %T An Individual Music Intervention for Adults With Intellectual Disabilities and Challenging Behavior: Protocol for a Randomized Controlled Trial %A Smeets,Gerianne %A Volkers,Karin %A Scherder,Erik %A Moonen,Xavier %+ Philadelphia Care Foundation, PO Box 1255, Amersfoort, 3800 BG, Netherlands, 31 610886011, g.smeets@philadelphia.nl %K music intervention %K intellectual disability %K challenging behavior %K executive functioning %K self-esteem %K anxiety %K depression %K randomized controlled trial %K RCT %K study protocol %K well-being %D 2024 %7 7.2.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Individuals with intellectual disabilities (ID) are more likely to have problems with executive functioning (EF) and challenging behavior (CB), which are negatively linked to well-being. Among clinical populations, music interventions have been shown to improve various outcome measures, such as CB and EF. Until now, no randomized controlled trials (RCTs) have been conducted to examine the effectiveness of an individual music intervention for adults with ID and CB. Objective: The study aims to identify the effect and feasibility of an individual music intervention compared with care-as-usual for people with ID and CB. Methods: In this study, a 2-group RCT with a pretest, posttest, and follow-up assessment after 8 weeks is presented. Participants of the music intervention condition will receive 16 individual music sessions within 8 to 10 weeks. The music intervention will be guided by a manual for music workers, in which every session will have a different focus (introduction, emotions, different EF, and end performance). Participants receiving care as usual will function as a control group. After the research is finished, they will be offered a budget, which they can spend on musical activities or musical instruments as they wish. Assessments will include caregiver rating scales and self-report questionnaires and tests, which will assess outcome measures of CB, well-being, depression, anxiety, self-esteem, and 4 domains of EF. A process evaluation will be conducted after the completion of the study, which entails the analysis of data on multiple aspects of the intervention and the study overall. Results: Enrollment commenced in July 2021, and data collection ended in May 2023. A total of 97 participants were recruited, with 44 participants allocated to the intervention group and 53 allocated to the control group. Data will be analyzed after this protocol has been accepted for publication. Conclusions: Because there are currently no published RCTs of an individual music intervention for adults with ID and CB, this study will provide insight into the effectiveness and experiences of an individual music intervention for this target group. Trial Registration: International Clinical Trials Registry Platform NL8482; http://tinyurl.com/4565s5pd International Registered Report Identifier (IRRID): DERR1-10.2196/52497 %M 38324357 %R 10.2196/52497 %U https://www.researchprotocols.org/2024/1/e52497 %U https://doi.org/10.2196/52497 %U http://www.ncbi.nlm.nih.gov/pubmed/38324357 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e53644 %T Investigation of the Association Between e-Cigarette Smoking and Oral Mucosal Health Status Among Young People: Protocol for a Case-Control Trial %A Cheng,Siyuan %+ Massachusetts College of Pharmacy and Health Sciences, 179 Longwood Avenue, Boston, MA, 02115, United States, 1 617 732 2850, m0496197@stu.mcphs.edu %K oral mucosal lesions %K e-cigarette %K youth %K oral %K moth %K lesion %K lesions %K cigarette %K cigarettes %K smoker %K smoking %K smokers %K smoke %K mucosa %K mucosal %K dental %K dentist %K dentistry %D 2024 %7 26.1.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Given the paucity of current safety studies related to e-cigarettes, there are no definitive studies on whether e-cigarettes cause oral mucosal lesions or even oral cancer. Although it is still undetermined whether e-cigarettes are harmless, an increasing number of teenagers choose to smoke e-cigarettes and believe that they are not harmful to the human body. Objective: This aims to determine whether e-cigarettes cause damage to the oral mucosa. This study also aims to evaluate the association between e-cigarette smoking and oral mucous membrane lesions in young adults. The objectives are to (1) compare the oral mucosal conditions in participants with and without e-cigarette smoking habits, (2) assess the effect of the amount of e-cigarette smoking on oral mucosal conditions, and (3) assess the effect of the duration of e-cigarette smoking on oral mucosal conditions. Methods: In this prospective study, 304 youths aged 15 to 24 years (n=152, 50% who smoke only e-cigarettes and n=152, 50% who do not smoke e-cigarettes or cigarettes) will be divided into 2 groups for a controlled study. Whether e-cigarettes cause oral mucosal lesions will be verified by comparing the odds of oral mucosal lesions in the 2 experimental groups. For this experiment, the predefined power is 80% (P=.04), and the predefined proportions of groups 1 and 2 are 11% and 2.5%, respectively. Results: This experiment is at the conceptualization phase and has not yet been carried out. Experimenters have not been recruited and no data have been collected. Conclusions: e-Cigarettes are still an unfamiliar topic to the public, and it is still unknown whether they can cause damage to the oral mucosa. This experiment aims to find out whether there is a link between the 2. There are still many limitations in this study, such as the lack of categorization of e-cigarettes and the lack of testing methods for oral mucosal status. These limitations are expected to be addressed in the future as the experiment is formally conducted and further optimized. International Registered Report Identifier (IRRID): PRR1-10.2196/53644 %M 38171545 %R 10.2196/53644 %U https://www.researchprotocols.org/2024/1/e53644 %U https://doi.org/10.2196/53644 %U http://www.ncbi.nlm.nih.gov/pubmed/38171545 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e47175 %T Implementation of a Primary Prevention Program for Posttraumatic Stress Disorder in a Cohort of Professional Soldiers (PREPAR): Protocol for a Randomized Controlled Trial %A Le Barbenchon,Emmanuelle %A Trousselard,Marion %A Pellissier,Sonia %A Moisseron-Baudé,Mathilde %A Chachignon,Philippine %A Bouny,Pierre %A Touré Cuq,Emma %A Jacob,Sandrine %A Vigier,Cécile %A Hidalgo,Maud %A Claverie,Damien %A Duffaud,Anais M %+ French Armed Forces Biomedical Research Institute, 1, Place Général Valérie André, Brétigny-sur-Orge, 91223, France, 33 0618942117, anaisduffaud1@gmail.com %K posttraumatic stress disorder, military, primary prevention, biopsychosocial, resilience, coping, stigma, biophysiology %K PTSD %K implementation %K soldier %K veterans %K prevention program %D 2024 %7 26.1.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Posttraumatic stress disorder (PTSD) is a psychiatric disorder that can manifest after a traumatic event where the individual perceives a threat to his or her life or that of others. Its estimated prevalence in the European population is 0.7% to 1.9%. According to the “dose-response” model, individuals who are most exposed to traumatic events are most at risk of developing PTSD. Hence, it is unsurprising that studies have observed a higher prevalence among the military population, ranging from 10% to 18%, or even up to 45%. This project’s overall goal is to evaluate the primary prevention actions that can strengthen the resilience of at-risk professionals, notably military personnel, in the short term, with the medium- to long-term aim of preventing the occurrence of PTSD and improving the patient’s prognosis. Objective: This study’s objectives are (1) to design a primary prevention program for PTSD, tailored to the studied military population and compatible with operational constraints; and (2) to implement and validate the Primary Prevention of Posttraumatic Stress Disorder in Military Professionals (PREPARE) program in the short term with operational personnel belonging to the French Mountain Infantry Brigade. Methods: This is a single-center, prospective, randomized, parallel-group controlled cohort study. The cohort is divided into 2 groups: the nonintervention group receives no training, and the intervention group follows a dedicated prevention program (structured into 8 workshops and 2 debriefing and practice reinforcement workshops). Each participant is evaluated 4 times (at inclusion, +4 months, +6 months, and +12 months). During each visit, participants complete several psychosocial questionnaires (which take 15-80 minutes to complete). Samples (a 30-mL blood sample and three 5-mL saliva samples) are collected on 3 occasions: at inclusion, +4 months, and +12 months. Emotional reactivity (electrocardiogram and electrodermal activity) is measured before, during, and after the classic and the emotional Stroop task. Results: The project is currently ongoing, and results are expected to be published by the end of 2024. Conclusions: The study adopts an integrative approach to the processes that play a role in the risk of developing PTSD. Our biopsychosocial perspective makes it possible to target levers related to factors specific to the individual and socio-professional factors. The following dimensions are addressed: (1) biophysiology (by studying markers of the neurobiological stress response, wear and tear, and vulnerability phenomena and reinforcing the flexibility of the autonomic nervous system), (2) psychology (by facilitating and measuring the development of flexible coping strategies to deal with stress and evaluating the moderating role of the individual’s sense of duty in the development of PTSD), and (3) social (by facilitating community strategies aimed at reducing stigmatization and supporting the use of care by professionals in difficulty, in the institutional context). Trial Registration: ClinicalTrials.gov NCT05094531; https://clinicaltrials.gov/study/NCT05094531 International Registered Report Identifier (IRRID): DERR1-10.2196/47175 %M 38277204 %R 10.2196/47175 %U https://www.researchprotocols.org/2024/1/e47175 %U https://doi.org/10.2196/47175 %U http://www.ncbi.nlm.nih.gov/pubmed/38277204 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 13 %N %P e50300 %T Novel Strategy to Assess the Neurotoxicity of Organic Solvents Such as Glycol Ethers: Protocol for Combining In Vitro and In Silico Methods With Human-Controlled Exposure Experiments %A Hopf,Nancy B %A Suter-Dick,Laura %A Huwyler,Jörg %A Borgatta,Myriam %A Hegg,Lucie %A Pamies,David %A Paschoud,Hélène %A Puligilla,Ramya Deepthi %A Reale,Elena %A Werner,Sophie %A Zurich,Marie-Gabrielle %+ Department of Biomedical Sciences, University of Lausanne, Bugnon 7, Lausanne, 1005, Switzerland, 41 21 692 5542, mzurich@unil.ch %K organic solvent exposure %K workers %K general population %K neurotoxicity %K blood-brain barrier %K liver toxicity %K human cell cultures %D 2024 %7 18.1.2024 %9 Protocol %J JMIR Res Protoc %G English %X Background: Chemicals are not required to be tested systematically for their neurotoxic potency, although they may contribute to the development of several neurological diseases. The absence of systematic testing may be partially explained by the current Organisation for Economic Co-operation and Development (OECD) Test Guidelines, which rely on animal experiments that are expensive, laborious, and ethically debatable. Therefore, it is important to understand the risks to exposed workers and the general population exposed to domestic products. In this study, we propose a strategy to test the neurotoxicity of solvents using the commonly used glycol ethers as a case study. Objective: This study aims to provide a strategy that can be used by regulatory agencies and industries to rank solvents according to their neurotoxicity and demonstrate the use of toxicokinetic modeling to predict air concentrations of solvents that are below the no observed adverse effect concentrations (NOAECs) for human neurotoxicity determined in in vitro assays. Methods: The proposed strategy focuses on a complex 3D in vitro brain model (BrainSpheres) derived from human-induced pluripotent stem cells (hiPSCs). This model is accompanied by in vivo, in vitro, and in silico models for the blood-brain barrier (BBB) and in vitro models for liver metabolism. The data are integrated into a toxicokinetic model. Internal concentrations predicted using this toxicokinetic model are compared with the results from in vivo human-controlled exposure experiments for model validation. The toxicokinetic model is then used in reverse dosimetry to predict air concentrations, leading to brain concentrations lower than the NOAECs determined in the hiPSC-derived 3D brain model. These predictions will contribute to the protection of exposed workers and the general population with domestic exposures. Results: The Swiss Centre for Applied Human Toxicology funded the project, commencing in January 2021. The Human Ethics Committee approval was obtained on November 16, 2022. Zebrafish experiments and in vitro methods started in February 2021, whereas recruitment of human volunteers started in 2022 after the COVID-19 pandemic–related restrictions were lifted. We anticipate that we will be able to provide a neurotoxicity testing strategy by 2026 and predicted air concentrations for 6 commonly used propylene glycol ethers based on toxicokinetic models incorporating liver metabolism, BBB leakage parameters, and brain toxicity. Conclusions: This study will be of great interest to regulatory agencies and chemical industries needing and seeking novel solutions to develop human chemical risk assessments. It will contribute to protecting human health from the deleterious effects of environmental chemicals. International Registered Report Identifier (IRRID): DERR1-10.2196/50300 %M 38236630 %R 10.2196/50300 %U https://www.researchprotocols.org/2024/1/e50300 %U https://doi.org/10.2196/50300 %U http://www.ncbi.nlm.nih.gov/pubmed/38236630 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e51178 %T Effectiveness of a Health Education Program for Patients Who Had a Stroke and Their Caregivers by Controlling Modifiable Risk Factors to Reduce Stroke Recurrence in a Tertiary Hospital in Bangladesh: Protocol for a Randomized Controlled Trial %A Afrin,Mahabuba %A Khan,Sharif Uddin %A Das,Subir Chandra %A Huq,K A T M Ehsanul %A Moriyama,Michiko %+ Department of Health Science, Graduate School of Biomedical and Health Sciences, Hiroshima University, Kasumi 1-2-3 Minami-Ku, Hiroshima, 734-8553, Japan, 81 082 257 ext 5365, morimich@hiroshima-u.ac.jp %K stroke %K caregiver %K recurrence of stroke %K health education %K Bangladesh %K modifiable risk factor %K recurrence %K hospital %K disability %K lifestyle change %K behavioral change %K risk factor %K quality of life %K tertiary %D 2023 %7 15.12.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Stroke is a significant public health concern that causes severe and long-lasting disability. The recurrence of stroke is increasing due to lack of patients’ knowledge and compliance with treatment to control modifiable risk factors and lifestyle changes. Health education can be an effective way to increase knowledge about behavioral changes in patients who had a stroke. Objective: The aim of this study is to evaluate the effectiveness of a health education program in Bangladesh for patients who had their first stroke and their family caregivers in order to reduce the recurrence of stroke by controlling modifiable risk factors. Methods: This is a parallel, open-label, prospective randomized controlled trial conducted at the National Institute of Neurosciences & Hospital in Dhaka, Bangladesh. We enrolled ≥18-year-old patients of both sexes who had a history of first stroke attack (transient ischemic attack, hemorrhagic stroke, lacunar stroke, atherothrombotic stroke, or cardioembolic stroke). We stratified patients into those aged <65 years and those aged ≥65 years and according to types of strokes for randomization. Our estimated sample size was 432. The intervention group receives face-to-face counseling on lifestyle modifications, blood pressure monitoring, and medication compliance–related health education during enrollment and monthly follow-ups. However, the control group receives only usual care from the hospital. The primary end point of this study is the reduction in the stroke recurrence rates at the end of the 12-month follow-up period. The secondary end points are to (1) assess the occurrence of all adverse events such as other cardiac events and all-cause mortality, (2) evaluate the status of the controlling modifiable risk factors such as blood pressure, glycated hemoglobin, and non–high-density lipoprotein cholesterol, (3) assess the knowledge related to stroke by using the investigator-developed questionnaire, (4) evaluate the lifestyle behavior related to stroke by using the investigator-developed questionnaire, (5) assess medication adherence, and (6) evaluate the quality of life of patients who had a stroke and their family caregivers. The evaluation points will be at baseline, 6 months, and 12 months for both groups. Results: Patients’ enrollment started on October 2022, and follow-up will be completed in March 2024. A total of 432 participants were included in both the intervention (n=216) and control groups (n=216). This study was approved by the institutional review board and the ethics review board of the National Institute of Neurosciences & Hospital (IRB/NINSH/2022/151) on August 30, 2022. Conclusions: Our health education program is expected to reduce the recurrence of stroke and improve the quality of life of patients who have had the first stroke. The results of this study will provide insights into the importance of health education for (self)-management and prevention of stroke. Trial Registration: ClinicalTrials.gov NCT05520034; https://clinicaltrials.gov/ct2/show/NCT05520034 International Registered Report Identifier (IRRID): DERR1-10.2196/51178 %M 38100172 %R 10.2196/51178 %U https://www.researchprotocols.org/2023/1/e51178 %U https://doi.org/10.2196/51178 %U http://www.ncbi.nlm.nih.gov/pubmed/38100172 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e50091 %T Intravenous Ascorbic Acid for the Prevention of Postreperfusion Syndrome in Orthotopic Liver Transplantation: Protocol for a Randomized Controlled Trial %A Gajate,Luis %A de la Hoz,Inés %A Espiño,Mercedes %A Martin Gonzalez,Maria del Carmen %A Fernandez Martin,Cristina %A Martín-Grande,Ascensión %A Parise Roux,Diego %A Pastor,Oscar %A Villahoz,Judith %A Rodriguez-Gandía,Miguel Ángel %A Nuño Vazquez,Javier %+ Department of Anesthesiology and Critical Care, Instituto Ramon y Cajal de Investigacion Sanitaria, Hospital Universitario Ramon y Cajal, Ctra de Colmenar Viejo Km 9,100, Madrid, 28034, Spain, 34 913368269, gajate.luis@gmail.com %K antioxidant therapy %K antioxidant %K ascorbic acid %K blood %K controlled trials %K hepatic %K ischemia %K ischemic %K liver transplantation %K liver %K postreperfusion syndrome %K randomization %K randomized controlled trial %K RCT %K reperfusion injury %K reperfusion %K surgery %K surgical %K transplant %K transplantation %K vascular %K vitamin C %K vitamin %K vitamins %D 2023 %7 15.12.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Liver transplantation is the last therapeutic option for patients with end-stage liver disease. Postreperfusion syndrome (PRS), defined as a fall in mean arterial pressure of more than 30% within the first 5 minutes after reperfusion of at least 1 minute, can occur in liver transplantation as a deep hemodynamic instability with associated hyperfibrinolysis immediately after reperfusion of the new graft. Its incidence has remained unchanged since it was first described in 1987. PRS is related to ischemia-reperfusion (I/R) injury, whose pathophysiology involves the release of several mediators from both the donor and the recipient. The antioxidant effect of ascorbic acid has been studied in resuscitating patients with septic shock and burns. Even today, there are publications with conflicting results, and there is a need for further studies to confirm or rule out the usefulness of this drug in this group of patients. The addition of ascorbic acid to preservation solutions used in solid organ transplantation is under investigation to harness its antioxidant effect and mitigate I/R injury. Since PRS could be considered a manifestation of I/R injury, we believe that the possible beneficial effect of ascorbic acid on the occurrence of PRS should be investigated. Objective: The aim of this randomized controlled trial is to assess the benefits of ascorbic acid over saline in the development of PRS in adult liver transplantation. Methods: We plan to conduct a single-center randomized controlled trial at the Hospital Universitario Ramón y Cajal in Spain. A total of 70 participants aged 18 years or older undergoing liver transplantation will be randomized to receive either ascorbic acid or saline. The primary outcome will be the difference between groups in the incidence of PRS. The randomized controlled trial will be conducted under conditions of respect for fundamental human rights and ethical principles governing biomedical research involving human participants and in accordance with the international recommendations contained in the Declaration of Helsinki and its subsequent revisions. Results: The enrollment process began in 2020. A total of 35 patients have been recruited so far. Data cleaning and analysis are expected to occur in the first months of 2024. Results are expected around the middle of 2024. Conclusions: We believe that this study could be particularly relevant because it will be the first to analyze the clinical effect of ascorbic acid in liver transplantation. Moreover, we believe that this study fills an important gap in the knowledge of the potential benefits of ascorbic acid in the field of liver transplantation, particularly in relation to PRS. Trial Registration: European Union Drug Regulating Authorities Clinical Trials Database 2020-000123-39; https://tinyurl.com/2cfzddw8; ClinicalTrials.gov NCT05754242; https://tinyurl.com/346vw7sm International Registered Report Identifier (IRRID): DERR1-10.2196/50091 %M 38100226 %R 10.2196/50091 %U https://www.researchprotocols.org/2023/1/e50091 %U https://doi.org/10.2196/50091 %U http://www.ncbi.nlm.nih.gov/pubmed/38100226 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e51480 %T FORWARD Study of GORE VIABAHN Balloon-Expandable Endoprostheses and Bare Metal Stents in the United States, European Union, United Kingdom, Australia, and New Zealand When Placed to Treat Complex Iliac Occlusive Disease: Protocol for a Randomized Superiority Trial %A Kirkwood,Melissa L %A Armstrong,Ehrin J %A Ansari,Mohammad M %A Holden,Andrew %A Reijnen,Michel M P J %A Steinbauer,Markus %A Crannell,Zachary %A Novoa,Hector %A Phillips,Austin %A Schneider,Darren B %+ Division of Vascular and Endovascular Surgery, The University of Texas Southwestern Medical Center, 5959 Harry Hines Blvd, POB I, Ste. 620, Dallas, TX, 75390-3157, United States, 1 214 645 2040, Melissa.Kirkwood@UTSouthwestern.edu %K iliac artery occlusive disease %K VIABAHN VBX balloon expandable endoprosthesis %K covered stent %K stent graft %K stent %K randomized control trial %K FORWARD %K endoprosthesis %K atherosclerosis %K endovascular %K stenting %K occlusion %K RCT %K iliac occlusion %D 2023 %7 4.12.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: The recommendations for the use of and selection of covered stent grafts in patients with aortoiliac occlusive disease are limited. Objective: The GORE VBX FORWARD clinical study aims to demonstrate the superiority of the GORE VIABAHN VBX Balloon Expandable Endoprosthesis (VBX device) for primary patency when compared to bare metal stenting (BMS) for the treatment of complex iliac artery occlusive disease. Methods: A prospective, multicenter, randomized control study in the United States, European Union, United Kingdom, Australia, and New Zealand will enroll patients with symptomatic, complex iliac artery occlusive disease. In this study, iliac artery occlusive disease is defined as a unilateral or bilateral disease with single or multiple lesions (with >50% stenosis or chronic total occlusion) each between 4 and 11 cm in length. In an attempt to more closely match real-world practices, patients with minor tissue loss (Rutherford class 5) and patients requiring hemodialysis will be included. Baseline aortoiliac angiography will be performed to assess target lesion characteristics and determine final patient eligibility. Once the patient is confirmed and guidewires are in place across the target lesions, the patient will be randomized in a 1:1 format to treatment with either the VBX device or a BMS. The BMS can be balloon- or self-expanding and must be approved for the iliac artery occlusive disease indication. Patients, the independent core laboratory reviewers, and Clinical Events Committee members will be blinded from the assigned treatment. Dual antithrombotic medical therapy is required through a minimum of 3 months post procedure. The primary end point is 12‑month primary patency and will be adjudicated by an independent imaging core laboratory and Clinical Events Committee. Key secondary end points will be tested for superiority and include technical, acute procedural, and clinical success; changes in Ankle-brachial index; patient quality of life; primary patency; freedom from restenosis; primary-assisted patency; secondary patency; freedom from target lesion revascularizations; cumulative reintervention rate; amputation-free survival; survival; and change in Rutherford category. Study follow-up will continue through 5 years. Results: Outcomes will be reported following study completion. Enrollment is anticipated to start in October 2023. Conclusions: The results of this study will provide definitive, level 1 clinical evidence to clinicians on the optimal choice of stent device to use for the treatment of complex iliac artery occlusive disease. The FORWARD study is powered for superiority and includes only complex, unilateral, or bilateral lesions involving the common or external iliac arteries. This study is a multidisciplinary endeavor involving vascular surgery, interventional cardiology, and interventional radiology across multiple countries with a blinded core laboratory review of end points in hopes that the outcomes will be widely accepted and incorporated into practice guidelines for optimal treatment of patients with complex iliac artery occlusive disease. Trial Registration: ClinicalTrials.gov NCT05811364; https://clinicaltrials.gov/study/NCT05811364 International Registered Report Identifier (IRRID): PRR1-10.2196/51480 %M 38048145 %R 10.2196/51480 %U https://www.researchprotocols.org/2023/1/e51480 %U https://doi.org/10.2196/51480 %U http://www.ncbi.nlm.nih.gov/pubmed/38048145 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e49723 %T Training Australian Dietitians in Behavior Change Techniques Through Educational Workshops: Protocol for a Randomized Controlled Trial %A Breare,Hayley %A Mullan,Barbara %A Kerr,Deborah A %A Maxwell-Smith,Chloe %+ School of Population Health, Curtin University, Kent Street, Bentley, 6102, Australia, 61 9266 2468, barbara.mullan@curtin.edu.au %K BCT %K behavior change %K COM-B %K continuing education %K dietitians %K health professional %K intervention %K professional development %K psychology %K randomized controlled trial %K training %K workshop %D 2023 %7 4.12.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: The use of education alone as a technique to change behavior in interventions is usually insufficient, particularly in health interventions. Behavior change techniques have been shown to be effective in fostering positive changes in health behaviors such as diet and physical activity. The upskilling of health professionals can increase perceived capability and motivation toward eliciting change in clients’ behaviors. However, to date, dietitians have received limited training in behavior change and have expressed a need for continuous professional development. Objective: The study objectives are to (1) develop and evaluate the effectiveness and acceptability of two 2-hour behavior change workshops on changing dietitians behavior (ie, range of behavior change techniques used and frequency of use) across 3 time points; (2) determine if participation in these workshops will elicit changes in dietitians’ perceived capability, opportunity, and motivation toward using behavior change techniques; and (3) determine the acceptability of the training and its application in practice by dietitians. Methods: We will recruit registered dietitians (N=140) in Australia to participate in this randomized controlled trial. Participants will be randomly assigned to either the intervention or 3-month waitlist control condition and complete outcome measures at 3 time points: baseline, after the workshop, and follow-up at 3 months. Both groups will complete 2 workshops on behavior change that are guided by the COM-B (Capability, Opportunity, Motivation, and Behavior) Model and embedded with behavior change techniques. The primary outcome is changes in behavior, (ie, the range of behavior change techniques used and their frequency of use). Secondary outcomes include changes in perceived capability, opportunity, motivation, and preparedness as a health professional toward delivering behavior change techniques. The acceptability of the workshops will also be assessed after the workshop through the postworkshop survey and semistructured interviews. A series of 2-way repeated measures ANOVAs and regressions will be used. Qualitative data will be analyzed using thematic analysis. Results: Participant recruitment commenced in June 2023. The results of the study are expected to be published in November 2024. The results will allow us to assess comparisons between the intervention and waitlist control groups, as well as changes in perceived capability, opportunity, motivation, and preparedness over a 3-month period. It will also provide an understanding of the acceptability of the training as a form of continuous professional development for dietitians. Conclusions: If found to be effective, the results of this 2-arm randomized controlled trial will guide future training and continuous professional development for health professionals in changing behavior in practice. Our findings will contribute to our understanding of the application of behavior change techniques in practice with clients and identify components of COM-B where dietitians may need future support. Trial Registration: ACTRN12623000525684; https://www.anzctr.org.au/ACTRN12623000525684.aspx International Registered Report Identifier (IRRID): PRR1-10.2196/49723 %M 38048151 %R 10.2196/49723 %U https://www.researchprotocols.org/2023/1/e49723 %U https://doi.org/10.2196/49723 %U http://www.ncbi.nlm.nih.gov/pubmed/38048151 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e49412 %T The Primary Prevention of Poststroke Epilepsy in Patients With Middle Cerebral Artery Infarct: Protocol for a Randomized Controlled Trial %A Chen,Yu-Shiue %A Sung,Pi-Shan %A Lai,Ming-Chi %A Huang,Chin-Wei %+ Department of Neurology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, 138, Sheng-Li Rd, North District, Tainan, 704302, Taiwan, 886 62353535 ext 5485, huangcw@mail.ncku.edu.tw %K poststroke epilepsy %K middle cerebral artery infarct %K seizure %K randomized control trial %K epilepsy %K stroke %K stroke survivor %K prognosis %K mortality %K drug therapy %K development %K seizure severity %K efficacy %K heart attack %K angina %K cardiovascular %K cardiology %K cardiologist %D 2023 %7 24.11.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Poststroke epilepsy poses a significant clinical challenge for individuals recovering from strokes, leading to a less favorable long-term outlook and increased mortality rates. Existing studies have primarily concentrated on administering antiseizure or anticonvulsant treatments only after the onset of late-onset seizures, without intervening during the epileptogenesis phase following a stroke. Objective: This research protocol is designed to conduct a randomized controlled trial to assess whether the early, preventive introduction of low-dose antiepileptic drug therapy (levetiracetam [LEV] or perampanel [PER]) in patients who have experienced middle cerebral artery (MCA) infarction can reduce the risk of developing poststroke epilepsy (primary prevention). Methods: Participants with MCA infarction, either with or without reperfusion treatments, will be recruited and promptly receive preventive intervention within 72 hours of the stroke occurrence. These participants will be randomly assigned to receive either PER (4 mg per day), LEV (1000 mg per day), or a placebo that matches the active drugs. This treatment will continue for 12 weeks after allocation. Brain magnetic resonance imaging will be used to confirm the presence of MCA territory infarction, and an electroencephalography will be used to ensure the absence of epileptiform discharges or electrographic seizures at the time of the stroke. All participants will undergo follow-up assessments for 72 weeks after allocation. Results: The primary outcome under evaluation will be the incidence of poststroke epilepsy in the 3 groups following the 18-month study period. Secondary outcomes will encompass the time to the occurrence of the first seizure, the severity of seizures, any treatment-related adverse events, and the modified Rankin scale score at 3 and 18 months. Exploratory outcomes will involve comparing the effectiveness and safety of PER and LEV. Conclusions: We anticipate that the intervention groups will experience a lower incidence and reduced severity of poststroke epilepsy compared to the control group after 18 months. We aim to establish evidence supporting the potential preventive effects of LEV and PER on poststroke seizures and epilepsy in patients with MCA infarction, as well as to explore the antiepileptogenic potential of both LEV and PER in patients with major ischemic strokes. Trial Registration: ClinicalTrials.gov NCT04858841; https://clinicaltrials.gov/study/NCT04858841 International Registered Report Identifier (IRRID): DERR1-10.2196/49412 %M 37999939 %R 10.2196/49412 %U https://www.researchprotocols.org/2023/1/e49412 %U https://doi.org/10.2196/49412 %U http://www.ncbi.nlm.nih.gov/pubmed/37999939 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e48576 %T Dobutamine and Goal-Directed Fluid Therapy for Improving Tissue Oxygenation in Deep Inferior Epigastric Perforator (DIEP) Flap Breast Reconstruction Surgery: Protocol for a Randomized Controlled Trial %A Mizubuti,Glenio B %A Ho,Anthony M-H %A Phelan,Rachel %A DuMerton,Deborah %A Shelley,Jessica %A Vowotor,Elorm %A Xiong,Jessica %A Smethurst,Bethany %A McMullen,Michael %A Hopman,Wilma M %A Martou,Glykeria %A Edmunds,Robert Wesley %A Tanzola,Robert %+ Department of Anesthesiology and Perioperative Medicine, Queen's University, Kingston Health Sciences Centre, 76 Stuart Street, Kingston, ON, K7L 2V7, Canada, 1 613 548 7827, glenio.mizubuti@kingstonhsc.ca %K breast cancer %K breast cancer care %K breast reconstruction %K DIEP flap %K dobutamine %K epigastric perforator %K implant-based surgery %K flap surgery %K flap oxygenation %K fluid therapy %K goal-directed therapy %K oxygenation %K perioperative care %K tissue oxygenation %K treatment algorithm %D 2023 %7 22.11.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Breast reconstruction is an integral part of breast cancer care. There are 2 main types of breast reconstruction: alloplastic (using implants) and autologous (using the patient’s own tissue). The latter creates a more natural breast mound and avoids the long-term need for surgical revision—more often associated with implant-based surgery. The deep inferior epigastric perforator (DIEP) flap is considered the gold standard approach in autologous breast reconstruction. However, complications do occur with DIEP flap surgery and can stem from poor flap tissue perfusion/oxygenation. Hence, the development of strategies to enhance flap perfusion (eg, goal-directed perioperative fluid therapy) is essential. Current perioperative fluid therapy is traditionally guided by subjective criteria, which leads to wide variations in clinical practice. Objective: The main objective of this trial is to determine whether the use of minimally invasive cardiac output (CO) monitoring for guiding intravenous fluid administration, combined with low-dose dobutamine infusion (via a treatment algorithm), will increase tissue oxygenation in patients undergoing DIEP flap surgery. Methods: With appropriate institutional ethics board and Health Canada approval, patients undergoing DIEP flap surgery are randomly assigned to receive CO monitoring for the guidance of intraoperative fluid therapy in addition to a low-dose dobutamine infusion (which potentially improves flap oxygenation) versus the current standard of care. The primary outcome is tissue oxygenation measured via near-infrared spectroscopy at the perfusion zone furthest from the perforator vessels 45 minutes after vascular reanastomosis of the DIEP flap. Low dose (2.5 μg/kg/hr) dobutamine infusion continues for up to 4 hours postoperatively, provided there are no associated complications (ie, persistent tachycardia). Flap oxygenation, hemodynamic parameters, and any medication-associated side effects/complications are monitored for up to 48 hours postoperatively. Complications, rehospitalizations, and patient satisfaction are also collected until 30 days postoperatively. Results: Funding and regulatory approvals were obtained in 2019, but the study recruitment was interrupted by the COVID-19 pandemic. As of October 4, 2023, 34 participants have been recruited. Because of the significant delays associated with the pandemic, the expected completion date was extended. We expect the study to be completed and ready for potential news release (as appropriate) and publication by July 2024. No patients have suffered any adverse effects/complications from participating in this study, and none have been lost to follow-up. Conclusions: CO-directed fluid therapy in combination with a low-dose dobutamine infusion via a treatment algorithm has the potential to improve DIEP flap tissue oxygenation and reduce complications following DIEP flap breast reconstruction surgery. However, given that the investigators remain blinded to group randomization, no comment can be made regarding the efficacy of this intervention for improving tissue oxygenation at this time. Nevertheless, no patients have been withdrawn for safety concerns thus far, and compliance remains high. Trial Registration: Clinicaltrials.gov NCT04020172; https://clinicaltrials.gov/study/NCT04020172 %M 37991835 %R 10.2196/48576 %U https://www.researchprotocols.org/2023/1/e48576 %U https://doi.org/10.2196/48576 %U http://www.ncbi.nlm.nih.gov/pubmed/37991835 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e52565 %T Sitafloxacin- Versus Moxifloxacin-Based Sequential Treatment for Mycoplasma Genitalium Infections: Protocol for a Multicenter, Open-Label Randomized Controlled Trial %A Ando,Naokatsu %A Mizushima,Daisuke %A Shimizu,Yosuke %A Uemura,Yukari %A Takano,Misao %A Mitobe,Morika %A Kobayashi,Kai %A Kubota,Hiroaki %A Miyake,Hirofumi %A Suzuki,Jun %A Sadamasu,Kenji %A Nakamoto,Takato %A Aoki,Takahiro %A Watanabe,Koji %A Oka,Shinichi %A Gatanaga,Hiroyuki %+ AIDS Clinical Center, National Center for Global Health and Medicine, 1-21-1 Toyama, Tokyo, 1628655, Japan, 81 332027181, nandou@hosp.ncgm.go.jp %K bacteria %K bacterial %K clinical trial %K clinical trials %K controlled trials %K doxycycline %K drug %K drugs %K genital %K genitalia %K infection %K medication %K medications %K moxifloxacin %K Mycoplasma genitalium %K pharmaceutic %K pharmaceutical %K pharmaceuticals %K pharmaceutics %K pharmacology %K pharmacotherapy %K pharmacy %K quinolone resistance-associated mutation %K randomized controlled trial %K RCT %K sexual transmission %K sexually transmitted infection %K sexually transmitted %K sitafloxacin %K STD %K STI %D 2023 %7 14.11.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Mycoplasma genitalium is an emerging sexually transmitted pathogen associated with increasing antibiotic resistance. The current treatment guidelines recommend moxifloxacin-sequential therapy for macrolide-resistant Mgenitalium or strains with unknown resistance profiles. However, it is unclear whether sitafloxacin, a 4th-generation fluoroquinolone antibiotic, is effective against resistant strains. Objective: This study aims to assess and compare the efficacy and safety of sitafloxacin- and moxifloxacin-based treatment regimens for managing Mgenitalium infections. Methods: We will conduct this randomized controlled trial at multiple centers in Japan. Eligible participants include adults aged 18 years or older with a confirmed Mgenitalium infection, as determined through the nucleic acid amplification test. Patients will be randomly assigned using a stratified approach based on the treatment facility and infection site. The interventions comprise oral sitafloxacin (200 mg) daily for 7 days (with optional pretreatment of oral doxycycline, 200 mg, daily for up to 7 days), with a control group receiving oral doxycycline (200 mg) daily for 7 days followed by moxifloxacin (400 mg) daily for another 7 days. The primary outcome is the treatment success rate with a superiority margin of 10%, as confirmed through the nucleic acid amplification test. Secondary outcomes encompass changes in the bacterial load at the urogenital or rectal sites and the emergence of posttreatment-resistant mutant strains. Results: Enrollment commenced in June 2023 and will conclude in December 2024, with findings anticipated by 2025. The expected success rates fall within the range of 80% for sitafloxacin and 42% for moxifloxacin against Mgenitalium carrying the G248T (S83I) mutation, based on previous studies. Accordingly, with a 5% significance level (2-sided) and 80% statistical power, we aim to recruit 50 participants per group, factoring in a 10% expected dropout rate. Conclusions: This study will provide valuable insights into the efficacy and safety of sitafloxacin- versus moxifloxacin-based sequential therapy in treating Mgenitalium infections. These findings have the potential to influence clinical guidelines, favoring more effective therapeutic choices. The multicenter approach enhances the robustness of this study. However, a limitation is the potential insufficiency of statistical power to detect posttreatment-resistant mutant strains in each group, rendering posttreatment-resistance mutations a notable concern. In the future, we may need to increase the sample size to enhance power. Trial Registration: Japan Registry of Clinical Trials (jRCTs031230111); https://jrct.niph.go.jp/en-latest-detail/jRCTs031230111 International Registered Report Identifier (IRRID): DERR1-10.2196/52565 %M 37962941 %R 10.2196/52565 %U https://www.researchprotocols.org/2023/1/e52565 %U https://doi.org/10.2196/52565 %U http://www.ncbi.nlm.nih.gov/pubmed/37962941 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e50500 %T The Efficacy of Carbon Dioxide Paste in Alleviating Pain in Patients After Neck Dissection: Protocol for a Double-Blinded, Randomized Controlled Trial %A Tadokoro,Yoshiaki %A Takeda,Daisuke %A Saito,Izumi %A Yatagai,Nanae %A Kakei,Yasumasa %A Akashi,Masaya %A Hasegawa,Takumi %+ Department of Oral and Maxillofacial Surgery, Kobe University Graduate School of Medicine, 7-5-1, Kusunoki-cho, Chuo-ku, Kobe, 6500017, Japan, 81 78 382 6213, hasetaku@med.kobe-u.ac.jp %K carbon dioxide %K double-blind %K neck dissection %K pain %K paste %K postoperative %K randomized controlled trial %K surgery %K surgical %D 2023 %7 13.11.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Head and neck cancers that cause severe aesthetic and functional disorders normally metastasize to the cervical lymph nodes. Patients with cervical lymph node metastasis are undergoing neck dissection. Shoulder complaints are common after neck dissection, with patients reporting symptoms such as pain, weakness, shoulder droop, and disability. However, no safe and effective treatment is available for this condition at present. We will conduct a double-blinded, randomized controlled trial to evaluate the efficacy of carbon dioxide (CO2) paste in relieving pain in patients after neck dissection. Objective: This will be the first clinical study to compare the efficacy of CO2 paste with placebo in relieving postoperative pain in patients who underwent neck dissection. Methods: We will perform this trial at the Kobe University Hospital in Japan. Patients will be randomized 1:1 into the CO2 paste and control groups. Patients in the CO2 paste group will have the CO2 paste applied to the cervical surface skin for 10 minutes once per day for 14 consecutive days. The primary end point of the study is a change in the visual analog scale (VAS) scores of neck pain from baseline on day 1 (preapplication) to the end of drug application (day 15). Secondary end points include changes in the following parameters from baseline on day 1 to the end of drug application (day 15) or the study (day 29): neck pain VAS score (days 1-29), grip strength (days 1-15 and 1-29), VAS scores for subjective symptoms (the feeling of strangulation, numbness, swelling, and warmth in the neck and shoulder region) for days 1-15 and 1-29, whether the VAS score improved more than 30% (days 1-15), the arm abduction test (days 1-15 and 1-29), shoulder range of motion (abduction and flexion) for days 1-15 and 1-29, occurrence of skin disorders, and occurrence of serious side effects. Periodic monitoring will be conducted for participants during the trial. This study was approved by the certified review board of Kobe University. Results: The intervention commenced in May 2021 and will continue until March 2024. The collected data will provide information on the efficacy of the CO2 paste treatment. The primary end point will be compared using the Wilcoxon test, with the 1-sided significance level set at 5%. Each evaluation item will be summarized. Secondary efficacy end points will be analyzed to provide additional insights into the primary analysis. Findings based on the treatment effects are expected to be submitted for publication in 2025. Conclusions: This trial will provide exploratory evidence of the efficacy and safety of CO2 paste in relieving pain in patients after neck dissection. Trial Registration: Japan Registry of Clinical Trials (jRCT) identifier: jRCTs051210028; https://jrct.niph.go.jp/en-latest-detail/jRCTs051210028 International Registered Report Identifier (IRRID): DERR1-10.2196/50500 %M 37955944 %R 10.2196/50500 %U https://www.researchprotocols.org/2023/1/e50500 %U https://doi.org/10.2196/50500 %U http://www.ncbi.nlm.nih.gov/pubmed/37955944 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e51767 %T Effect of Electroacupuncture Versus Cognitive Behavioral Therapy for Perimenopausal Insomnia: Protocol for a Noninferiority Randomized Controlled Trial %A Wang,Huixian %A Yu,Xintong %A Hu,Jing %A Zheng,Yanting %A Hu,Jia %A Sun,Xuqiu %A Ren,Ying %A Chen,Yunfei %+ Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese Medicine and Western Medicine, Shanghai University of Traditional Chinese Medicine, 110 Ganhe Road, Shanghai, , China, 86 18930568221, icyf1968@163.com %K perimenopausal insomnia %K acupuncture %K electroacupuncture %K cognitive behavioral therapy %K randomized controlled trial %K CBT %K sleep disorder %K insomnia %K perimenoupause %K effectiveness %D 2023 %7 9.11.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Perimenopausal insomnia (PMI) has a high global incidence, which is common in middle-aged women and is more severe than nonmenopausal insomnia. Effective treatments with fewer side effects and more consistent repeatable results are needed. Acupuncture, a therapy based on traditional Chinese medicine, is safe and may be effective for PMI. It is widely accepted in Western countries, and evidence supports the use of acupuncture as a main or supplementary therapy. Cognitive behavioral therapy is also used to improve sleep quality. It has structured sessions and has been recommended as a first-line treatment for insomnia (cognitive behavioral therapy for insomnia [CBT-I]) by the American Association of Physicians. However, few randomized controlled trials have been conducted to compare the effectiveness of these 2 therapies. This study will be performed in perimenopausal women with insomnia to determine the efficacy of electroacupuncture (EA) versus CBT-I. Objective: This study aimed to compare the preliminary effectiveness and safety of EA and CBT-I for PMI through a randomized controlled noninferiority study design. Methods: This study is designed as an assessor-blinded, noninferiority, randomized controlled trial. A total of 160 eligible participants with PMI will be randomly divided into 2 groups to receive either EA or CBT-I. Participants in the EA group will receive electroacupuncture for 8 weeks. The intervention will be delivered 3 times weekly for a total of 12 sessions and 2 times weekly for the next 4 weeks. Meanwhile, participants in the control group will undergo CBT-I (once a week) for 8 weeks. Treatment will use 7 main acupoints (GV20, DU24, EX-HN3, EX-HN18, EX-CA1, RN6, and RN4) and an extra 4 acupoints based on syndrome differentiation. The primary outcome is the Insomnia Severity Index. The secondary outcome measures are the Pittsburgh Sleep Quality Index; Menopause-Specific Quality of Life; Menopause Rating Scale; Hamilton Depression Scale; Hamilton Anxiety Scale; hot flash score; and the level of estradiol, follicle-stimulating hormone, and luteinizing hormone in serum. Sleep architecture will be assessed using polysomnograms. Results: Participants are currently being recruited. The first participant was enrolled in January 2023, marking the initiation of the recruitment phase. The recruitment process is expected to continue until January 2025, at which point data collection will commence. Conclusions: This trial represents a pioneering effort to investigate the efficacy and safety of EA and CBT-I as interventions for PMI. It is noteworthy that this study is conducted solely within a single center and involves Chinese participants, which is a limitation. Nonetheless, the findings of this study are expected to contribute valuable insights for clinicians engaged in the management of PMI. Trial Registration: Chinese Clinical Trial Registry ChiCTR2300070981; https://www.chictr.org.cn/showprojEN.html?proj=194561 International Registered Report Identifier (IRRID): DERR1-10.2196/51767 %M 37943587 %R 10.2196/51767 %U https://www.researchprotocols.org/2023/1/e51767 %U https://doi.org/10.2196/51767 %U http://www.ncbi.nlm.nih.gov/pubmed/37943587 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e50714 %T Transcranial Magnetic Stimulation for Reducing the Relative Reinforcing Value of Food in Adult Patients With Obesity Pursuing Metabolic and Bariatric Surgery: Protocol for a Pilot, Within-Participants, Sham-Controlled Trial %A Bond,Dale S %A Papasavas,Pavlos K %A Raynor,Hollie A %A Grilo,Carlos M %A Steele,Vaughn R %+ Department of Surgery, Hartford Hospital/HealthCare, 80 Seymour Street, Hartford, CT, 06106, United States, 1 860 972 4318, Dale.Bond@hhchealth.org %K obesity %K repetitive transcranial magnetic stimulation %K food reinforcement %K hedonic hunger %K electroencephalography %K metabolic and bariatric surgery %D 2023 %7 6.11.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Metabolic and bariatric surgery (MBS) is the most effective and durable obesity treatment. However, there is heterogeneity in weight outcomes, which is partially attributed to variability in appetite and eating regulation. Patients with a strong desire to eat in response to the reward of palatable foods are more likely to overeat and experience suboptimal outcomes. This subgroup, classified as at risk, may benefit from repetitive transcranial magnetic stimulation (rTMS), a noninvasive brain stimulation technique that shows promise for reducing cravings and consumption of addictive drugs and food; no study has evaluated how rTMS affects the reinforcing value of food and brain reward processing in the context of MBS. Objective: The goal of the Transcranial Magnetic Stimulation to Reduce the Relative Reinforcing Value of Food (RESTRAIN) study is to perform an initial rTMS test on the relative reinforcing value (RRV) of food (the reinforcing value of palatable food compared with money) among adult patients who are pursuing MBS and report high food reinforcement. Using a within-participants sham-controlled crossover design, we will compare the active and sham rTMS conditions on pre- to posttest changes in the RRV of food (primary objective) and the neural modulation of reward, measured via electroencephalography (EEG; secondary objective). We hypothesize that participants will show larger decreases in food reinforcement and increases in brain reward processing after active versus sham rTMS. Methods: Participants (n=10) will attend 2 study sessions separated by a washout period. They will be randomized to active rTMS on 1 day and sham rTMS on the other day using a counterbalanced schedule. For both sessions, participants will arrive fasted in the morning and consume a standardized breakfast before being assessed on the RRV of food and reward tasks via EEG before and after rTMS of the left dorsolateral prefrontal cortex. Results: Recruitment and data collection began in December 2022. As of October 2023, overall, 52 patients have been screened; 36 (69%) screened eligible, and 17 (47%) were enrolled. Of these 17 patients, 3 (18%) were excluded before rTMS, 5 (29%) withdrew, 4 (24%) are in the process of completing the protocol, and 5 (29%) completed the protocol. Conclusions: The RESTRAIN study is the first to test whether rTMS can target neural reward circuits to reduce behavioral (RRV) and neural (EEG) measures of food reward in patients who are pursuing MBS. If successful, the results would provide a rationale for a fully powered trial to examine whether rTMS-related changes in food reinforcement translate into healthier eating patterns and improved MBS outcomes. If the results do not support our hypotheses, we will continue this line of research to evaluate whether additional rTMS sessions and pulses as well as different stimulation locations produce clinically meaningful changes in food reinforcement. Trial Registration: ClinicalTrials.gov NCT05522803; https://clinicaltrials.gov/study/NCT05522803 International Registered Report Identifier (IRRID): DERR1-10.2196/50714 %M 37930756 %R 10.2196/50714 %U https://www.researchprotocols.org/2023/1/e50714 %U https://doi.org/10.2196/50714 %U http://www.ncbi.nlm.nih.gov/pubmed/37930756 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e46227 %T Causes of Patient Nonattendance at Medical Appointments: Protocol for a Mixed Methods Study %A Schwalbe,Daria %A Sodemann,Morten %A Iachina,Maria %A Nørgård,Bente Mertz %A Chodkiewicz,Nina Høy %A Ammentorp,Jette %+ Centre for Patient Communication (CFPK), Department of Clinical Research, Odense University Hospital, University of Southern Denmark, Kløvervænget 12B, 116, Odense, 5000, Denmark, 45 26826039, dschwalbe@sdu.dk %K missed appointments %K nonattendance %K hospital appointments %K Danish health care %K prevention strategies %K positive deviance %K quality of treatment %K mixed methods %D 2023 %7 3.11.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Approximately one-third of patient appointments in Danish health care result in failures, leading to patient risk and sizable resource waste. Existing interventions to alleviate no-shows often target the patients. The underlying reason behind these interventions is a view that attendance or nonattendance is solely the patient’s problem. However, these interventions often prove to be ineffective and can perpetuate social biases and health inequalities, leaving behind patients who are more vulnerable or disadvantaged (in terms of social, economical, and linguistic factors, etc). A more holistic understanding of no-shows is needed to optimize processes, reduce waste, and support patients who are vulnerable. Objective: This study aims to gain a deep and more comprehensive understanding of the causes, mechanisms, and recurring patterns and elements contributing to nonattendance at Danish hospitals in the Region of Southern Denmark. It emphasizes the patient perspective and analyzes the relational and organizational processes surrounding no-shows in health care. In addition, the study aims to identify effective communicative strategies and organizational processes that can support the development and implementation of successful interventions. Methods: The study uses mixed quantitative-qualitative methods, encompassing 4 analytical projects focusing on nonattendance patterns, patient knowledge and behavior, the management of hospital appointments, and in situ communication. To address the complexity of no-shows in health care, the study incorporates various data sources. The quantitative data sources include the electronic patient records, Danish central registries, Danish National Patient Registry, and Register of Medicinal Product Statistics. Baseline characteristics of patients at different levels are compared using chi-square tests and Kruskal-Wallis tests. The qualitative studies involve observational data, individual semistructured interviews with patients and practitioners, and video recordings of patient consultations. Results: This paper presents the protocol of the study, which was funded by the Novo Nordisk Foundation in July 2022. Recruitment started in February 2023. It is anticipated that the quantitative data analysis will be completed by the end of September 2023, with the qualitative investigation starting in October 2023. The first study findings are anticipated to be available by the end of 2024. Conclusions: The existing studies of nonattendance in Danish health care are inadequate in addressing relational and organizational factors leading to hospital no-shows. Interventions have had limited effect, highlighting the Danish health care system’s failure to accommodate patients who are vulnerable. Effective interventions require a qualitative approach and robust ethnographic data to supplement the description and categorization of no-shows at hospitals. Obtaining comprehensive knowledge about the causes of missed patient appointments will yield practical benefits, enhancing the safety, coherence, and quality of treatment in health care. International Registered Report Identifier (IRRID): PRR1-10.2196/46227 %M 37723870 %R 10.2196/46227 %U https://www.researchprotocols.org/2023/1/e46227 %U https://doi.org/10.2196/46227 %U http://www.ncbi.nlm.nih.gov/pubmed/37723870 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e50030 %T The Effects of Exercise on Synaptic Plasticity in Individuals With Mild Cognitive Impairment: Protocol for a Pilot Intervention Study %A Ramdeo,Karishma R %A Fahnestock,Margaret %A Gibala,Martin %A Selvaganapathy,Ponnambalam Ravi %A Lee,Justin %A Nelson,Aimee Jennifer %+ Department of Kinesiology, McMaster University, 1280 Main Street W, Hamilton, ON, L8S4L8, Canada, 1 905 525 9140, nelsonaj@mcmaster.ca %K mild cognitive impairment %K exercise %K brain-derived neurotrophic factor %K cognition %K brain plasticity %K repetitive transcranial magnetic stimulation %K transcranial magnetic stimulation %K magnetic stimulation %K aging %K interval training %K intermittent theta-burst stimulation %K repetitive transcranial magnetic stimulation %K ageing %K gerontology %K geriatric %K cognitive %K physical activity %K fitness %K neurology %K neuroscience %K synapse %K synaptic %K plasticity %K brain %K neurotrophic %K hormone %K hormones %K endocrinology %D 2023 %7 18.10.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Mild cognitive impairment (MCI) is a syndrome preceding more severe impairment characterized by dementia. MCI affects an estimated 15% to 20% of people older than 65 years. Nonpharmacological interventions including exercise are recommended as part of overall MCI management based on the positive effects of exercise on cognitive performance. Interval training involves brief intermittent bouts of exercise interspersed with short recovery periods. This type of exercise promotes cognitive improvement and can be performed in individuals with MCI. Synaptic plasticity can be assessed in vivo by the neurophysiological response to repetitive transcranial magnetic stimulation (rTMS). A method to assess synaptic plasticity uses an intermittent theta burst stimulation (iTBS), which is a patterned form of rTMS. Individuals with MCI have decreased responses to iTBS, reflecting reduced synaptic plasticity. It is unknown whether interval training causes changes in synaptic plasticity in individuals living with MCI. Objective: This research will determine whether interval training performed using a cycle ergometer enhances synaptic plasticity in individuals with MCI. The three aims are to (1) quantify synaptic plasticity after interval training performed at a self-determined intensity in individuals with MCI; (2) determine whether changes in synaptic plasticity correlate with changes in serum brain-derived neurotrophic factor, osteocalcin, and cognition; and (3) assess participant compliance to the exercise schedule. Methods: 24 individuals diagnosed with MCI will be recruited for assignment to 1 of the 2 equally sized groups: exercise and no exercise. The exercise group will perform exercise 3 times per week for 4 weeks. Synaptic plasticity will be measured before and following the 4-week intervention. At these time points, synaptic plasticity will be measured as the response to single-pulse TMS, reflected as the percent change in the average amplitude of 20 motor-evoked potentials before and after an iTBS rTMS protocol, which is used to induce synaptic plasticity. In addition, individuals will complete a battery of cognitive assessments and provide a blood sample from the antecubital vein to determine serum brain-derived neurotrophic factor and osteocalcin. Results: The study began in September 2023. Conclusions: The proposed research is the first to assess whether synaptic plasticity is enhanced after exercise training in individuals with MCI. If exercise does indeed modify synaptic plasticity, this will create a new avenue by which we can study and manipulate neural plasticity in these individuals. Trial Registration: ClinicalTrials.gov NCT05663918; https://clinicaltrials.gov/study/NCT05663918 International Registered Report Identifier (IRRID): PRR1-10.2196/50030 %M 37851488 %R 10.2196/50030 %U https://www.researchprotocols.org/2023/1/e50030 %U https://doi.org/10.2196/50030 %U http://www.ncbi.nlm.nih.gov/pubmed/37851488 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e48672 %T Evaluation of Incremental Validity of Casper in Predicting Program and National Licensure Performance of Undergraduate Nursing Students: Protocol for a Mixed Methods Study %A Stevens,Kathleen %A Moralejo,Donna %A Crossman,Renee %+ Faculty of Nursing, Memorial University, 300 Prince Phillip Drive, St John's, NL, A1B 3V6, Canada, 1 7098647100, kathleen.stevens@mun.ca %K communication %K empathy %K incremental validity %K mixed methods %K nursing school admissions %K problem-solving %K professionalism %K situational judgement testing %K undergraduate nursing students %D 2023 %7 18.10.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Academic success has been the primary criterion for admission to many nursing programs. However, academic success as an admission criterion may have limited predictive value for success in noncognitive skills. Adding situational judgment tests, such as Casper, to admissions procedures may be one strategy to strengthen decisions and address the limited predictive value of academic admission criteria. In 2021, admissions processes were modified to include Casper based on concerns identified with noncognitive skills. Objective: This study aims to (1) assess the incremental validity of Casper scores in predicting nursing student performance at years 1, 2, 3, and 4 and on the National Council Licensing Examination (NCLEX) performance; and (2) examine faculty members’ perceptions of student performance and influences related to communication, professionalism, empathy, and problem-solving. Methods: We will use a multistage evaluation mixed methods design with 5 phases. At the end of each year, students will complete questionnaires related to empathy and professionalism and have their performance assessed for communication and problem-solving in psychomotor laboratory sessions. The final phase will assess graduate performance on the NCLEX. Each phase also includes qualitative data collection (ie, focus groups with faculty members). The goal of the focus groups is to help explain the quantitative findings (explanatory phase) as well as inform data collection (eg, focus group questions) in the subsequent phase (exploratory sequence). All students enrolled in the first year of the nursing program in 2021 were asked to participate (n=290). Faculty will be asked to participate in the focus groups at the end of each year of the program. Hierarchical multiple regression will be conducted for each outcome of interest (eg, communication, professionalism, empathy, and problem-solving) to determine the extent to which scores on Casper with admission grades, compared to admission grades alone, predict nursing student performance at years 1-4 of the program and success on the national exam. Thematic analysis of focus group transcripts will be conducted using interpretive description. The quantitative and qualitative data will be integrated after each phase is complete and at the end of the study. Results: This study was funded in September 2021, and data collection began in March 2022. Year 1 data collection and analysis are complete. Year 2 data collection is complete, and data analysis is in progress. Conclusions: At the end of the study, we will provide the results of a comprehensive analysis to determine the extent to which the addition of scores on Casper compared to admission grades alone predicts nursing student performance at years 1-4 of the program and on the NCLEX exam. International Registered Report Identifier (IRRID): RR1-10.2196/48672 %M 37851504 %R 10.2196/48672 %U https://www.researchprotocols.org/2023/1/e48672 %U https://doi.org/10.2196/48672 %U http://www.ncbi.nlm.nih.gov/pubmed/37851504 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e47293 %T Nursing Training for Early Clinical Deterioration Risk Assessment: Protocol for an Implementation Study %A Lourenço,Laura Bacelar de Araujo %A Meszaros,Mariana de Jesus %A Silva,Michele de Freitas Neves %A São-João,Thaís Moreira %+ School of Nursing, University of Campinas, Rua Tessália Vieira de Camargo, 126, Campinas, 13083-887, Brazil, 55 19974082753, laurabalourenco@gmail.com %K nursing %K hospitalization %K clinical deterioration %K patient safety %K early warning score %K education %D 2023 %7 17.10.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: During the hospitalization period, it is possible to observe considerable changes in the vital parameters of patients, which may require emergency interventions or intensive treatment. The alteration of signs and symptoms that lead to physiological instability that can worsen the clinical picture with progression to shock, respiratory failure, or cardiorespiratory arrest is currently defined as clinical deterioration. Identifying signs of clinical deterioration at an early stage can lead to substantial decreases in mortality rates, the need for emergency interventions, and unscheduled treatments in intensive care units. Identifying and appropriately referring patients who show signs of clinical deterioration can be facilitated by applying early warning systems that provide rapid responses. The nursing team is usually the first to identify clinical changes in patients. Although the literature demonstrates that early recognition of clinical deterioration is the key to early intervention and leads to better outcomes, we only sometimes pursue the most appropriate intervention. Objective: This study aims to implement and evaluate an evidence-based professional training program designed for nurses and coordinated by a nurse using the “just-in-time” methodology and the National Early Warning Score 2 (NEWS2) to assess the risk of early clinical deterioration and appropriate referral in inpatient units of a public university hospital in southeastern Brazil. Methods: This intervention protocol is structured according to the recommendations of the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) Declaration 2013. The type of training to be offered, “Just-in-Time Training,” consists of a teaching modality that facilitates the delivery of a time-based and work-based education, with greater emphasis on providing on-the-job learning as needed. A qualitative stage will also be conducted through focus groups and interviews with nurses to verify the factors that influence the professional practice related to the early evaluation of the clinic. A script of previously tested questions will guide and standardize the different groups. The data will define the intervention’s elements: the strategy, the type of training, the location, the teaching methodology, and the teaching material. Results: The study has received authorization from the ethics committee, and participants will be recruited in July 2023. Data collection should be completed in October of the same year. The results obtained at the end of this research will be shared with the participating nursing team through the presentation of reports. In addition, the research results will be submitted to scientific journals and presented at international scientific conferences. Conclusions: This study will support nurses and possibly other clinicians to improve their approach to early recognition of clinical deterioration in patients. Trial Registration: Brazilian Registry of Clinical Trials RBR-5hq9y3k; https://ensaiosclinicos.gov.br/rg/RBR-5hq9y3k International Registered Report Identifier (IRRID): PRR1-10.2196/47293 %M 37847547 %R 10.2196/47293 %U https://www.researchprotocols.org/2023/1/e47293 %U https://doi.org/10.2196/47293 %U http://www.ncbi.nlm.nih.gov/pubmed/37847547 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e48387 %T Optimizing Noninvasive Vagus Nerve Stimulation for Systemic Lupus Erythematosus: Protocol for a Multicenter Randomized Controlled Trial %A Contreras,Ivan %A Navarro-Otano,Judith %A Rodríguez-Pintó,Ignasi %A Güemes,Amparo %A Alves,Eduarda %A Rios-Garcés,Roberto %A Espinosa,Gerard %A Alejaldre,Aida %A Beneyto,Aleix %A Ramkissoon,Charrise Mary %A Vehi,Josep %A Cervera,Ricard %+ Modeling, Identification and Control Engineering (MICELab), Institut d’Informatica i Applicacions, Universitat de Girona, Edifici P4 C/ de la Universitat de Girona, 6, Girona, 17003, Spain, 34 690162043, josep.vehi@udg.edu %K vagus nerve stimulation %K autonomic nervous system %K computational models %K systemic lupus erythematosus %K vagus %K vagal %K nerve stimulation %K noninvasive %K RCT %K randomized %K lupus %K inflammation %K autoimmune %K chronic %K nerve %K nerve damage %K vagus nerve %D 2023 %7 13.10.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Systemic lupus erythematosus is a chronic, multisystem, inflammatory disease of autoimmune etiology occurring predominantly in women. A major hurdle to the diagnosis, treatment, and therapeutic advancement of this disease is its heterogeneous nature, which presents as a wide range of symptoms such as fatigue, fever, musculoskeletal involvement, neuropsychiatric disorders, and cardiovascular involvement with varying severity. The current therapeutic approach to this disease includes the administration of immunomodulatory drugs that may produce unfavorable secondary effects. Objective: This study explores the known relationship between the autonomic nervous system and inflammatory pathways to improve patient outcomes by treating autonomic nervous system dysregulation in patients via noninvasive vagus nerve stimulation. In this study, data including biomarkers, physiological signals, patient outcomes, and patient quality of life are being collected and analyzed. After completion of the clinical trial, a computer model will be developed to identify the biomarkers and physiological signals related to lupus activity in order to understand how they change with different noninvasive vagus nerve stimulation frequency parameters. Finally, we propose building a decision support system with integrated noninvasive wearable technologies for continuous cardiovascular and peripheral physiological sensing for adaptive, patient-specific optimization of the noninvasive vagus nerve stimulation frequency parameters in real time. Methods: The protocol was designed to evaluate the efficacy and safety of transauricular vagus nerve stimulation in patients with systemic lupus erythematosus. This multicenter, national, randomized, double-blind, parallel-group, placebo-controlled study will recruit a minimum of 18 patients diagnosed with this disease. Evaluation and treatment of patients will be conducted in an outpatient clinic and will include 12 visits. Visit 1 consists of a screening session. Subsequent visits up to visit 6 involve mixing treatment and evaluation sessions. Finally, the remaining visits correspond with early and late posttreatment follow-ups. Results: On November 2022, data collection was initiated. Of the 10 participants scheduled for their initial appointment, 8 met the inclusion criteria, and 6 successfully completed the entire protocol. Patient enrollment and data collection are currently underway and are expected to be completed in December 2023. Conclusions: The results of this study will advance patient-tailored vagus nerve stimulation therapies, providing an adjunctive treatment solution for systemic lupus erythematosus that will foster adoption of technology and, thus, expand the population with systemic lupus erythematosus who can benefit from improved autonomic dysregulation, translating into reduced costs and better quality of life. Trial Registration: ClinicalTrials.gov NCT05704153; https://clinicaltrials.gov/study/NCT05704153 International Registered Report Identifier (IRRID): DERR1-10.2196/48387 %M 37831494 %R 10.2196/48387 %U https://www.researchprotocols.org/2023/1/e48387 %U https://doi.org/10.2196/48387 %U http://www.ncbi.nlm.nih.gov/pubmed/37831494 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e47512 %T Effects of a Community Health Worker–Led Health Literacy Intervention on Lifestyle Modification Among Patients With Hypertension and Diabetes in the City of Harare, Zimbabwe: Protocol for a Cluster Randomized Controlled Trial %A Katena,Nyaradzai Arster %A Shamu,Shepherd %A Fana,Golden Tafadzwa %A Rusakaniko,Simbarashe %+ Family Medicine, Global and Public Health Unit, Department of Primary Health Care Sciences, University of Zimbabwe, PO Box A178, Avondale, Harare, Zimbabwe, 263 773851093, nyarikatena@gmail.com %K hypertension %K diabetes %K community health worker %K lifestyle modification %K cluster randomized controlled trial %K protocol %K Harare %K Zimbabwe %K RCT %K randomized controlled trial %K hypertensive %K blood pressure %K CHW %K diabetic %K Africa %K healthy lifestyle %K health literacy %D 2023 %7 3.10.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Hypertension and diabetes are among the most common noncommunicable diseases in Zimbabwe. These 2 conditions are largely prevented and controlled by lifestyle modifications, such as healthy eating habits, physical activity, and avoiding the use of tobacco and alcohol. Objective: This study aims to evaluate the effects of a community health worker (CHW)–led health literacy intervention on lifestyle modification among patients with diabetes and hypertension in the City of Harare, Zimbabwe, in terms of (1) adherence to recommended lifestyle changes, (2) blood pressure and blood glucose levels, and (3) medication adherence. Methods: This is a 6-month–long cluster randomized controlled trial, which will be conducted in primary health care clinics in the city of Harare. A total of 14 clinics will be randomly allocated into either the intervention or control group. A total of 680 (49 participants per clinic) adult patients with hypertension and diabetes will be enrolled for the trial. Participants in the intervention arm will receive a simple health literacy intervention on lifestyle modification, which will be delivered by trained CHWs, while those in the control arm will receive usual care. The intervention consists of 4 face-to-face interactive educational sessions and monthly support visits by trained CHWs and will be carried out over a period of 6 months. The primary study outcomes will be blood pressure and blood glucose levels and levels of adherence to the recommended lifestyle modifications. Other outcomes will include adherence to medication. Data management and analysis will be done using Epi Info software, and the data will be analyzed using the intention-to-treat principle. Results: Recruitment of study participants commenced on June 1, 2023, and was completed on July 30, 2023. Baseline data are being collected after participants’ recruitment, and the final data collection will be completed by January 31, 2024. Conclusions: There is an information dearth regarding the effectiveness of CHW-led interventions for the management and control of hypertension in Zimbabwe. Our study offers an opportunity to show the effectiveness of CHWs in addressing the gaps in the management of hypertension and diabetes. The findings from our study will provide crucial evidence on the effectiveness and feasibility of a simple intervention delivered by CHWs in resource-constrained areas. International Registered Report Identifier (IRRID): PRR1-10.2196/47512 %M 37788044 %R 10.2196/47512 %U https://www.researchprotocols.org/2023/1/e47512 %U https://doi.org/10.2196/47512 %U http://www.ncbi.nlm.nih.gov/pubmed/37788044 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e42450 %T Vitalizing Community for Health Promotion Against Modifiable Risk Factors of Noncommunicable Diseases (V-CaN) in Rural Central India: Protocol for a Hybrid Type II Implementation Effectiveness Trial %A Mundra,Anuj %A Kalantri,Ashwini %A Jakasania,Arjunkumar %A Sathe,Harshal %A Raut,Abhishek %A Maliye,Chetna %A Bahulekar,Pramod %A Dawale,Ajay %A Paradkar,Rameshwar J %A Siriah,Sakshi %A Kumar,Satish %A Gupta,Subodh S %A Garg,Bishan %+ Department of Community Medicine, Mahatma Gandhi Institute of Medical Sciences, Kasturba Health Society, Old hospital building, 1st Floor, Bapu kuti road, Sevagram, Wardha, 442102, India, 91 9422518347, abhishekvraut@gmail.com %K noncommunicable diseases %K action research %K implementation research %K community-based participatory research %K salutogenesis %K primary prevention %D 2023 %7 29.9.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Low- and middle-income countries are facing the emerging burden of chronic noncommunicable diseases (NCDs). Apart from loss of human lives and premature deaths, NCDs result in huge costs for treatment to individuals and the health system. Although NCDs develop in later life, the risk factors begin at an early age. The key to the control of the global epidemic of NCDs is primary prevention based on comprehensive community-based programs. Objective: This study aims to develop, implement, and evaluate the effect of a participatory health promotion initiative utilizing the existing mechanisms of Village Health Nutrition and Sanitation Committees (VHNSCs), women’s self-help groups (SHGs), and schools on modifiable risk factors for NCDs among young people aged 10-30 years. Methods: The proposed type II hybrid effectiveness implementation cluster randomized field trial will be conducted in the catchment area of 4 primary health centers (PHCs) in Wardha district, India, comprising 100 villages with a population of 144,000. Each PHC will be randomly allocated to one of the 3 intervention arms or the control arm. The 3-intervention arm PHCs will utilize a unique strategy with either VHNSC or SHG members or school students as change agents for health action against common modifiable NCD risk factors. This study will be implemented in 3 phases from January 2022 to December 2024. First, the preparatory phase for baseline assessments includes anthropometry, behavioral and biochemical risk factors for NCDs, and participatory development of the health promotion intervention modules. Second, the implementation phase will focus on capacity building of the change agents and implementation of the participatory health promotion initiative. The implementation will include organization of community-based events, 6-monthly participatory assessment of change, and preparation of a sustainability and exit plan toward the end of this phase. Third, the evaluation phase will consist of studying the effectiveness of each intervention strategy in the reduction of risk factor prevalence at the population level. Results: We will assess 12,000 (3000 in each arm) randomly selected individuals for behavioral risk factors and 1600 (400 in each arm) individuals for biochemical risk factors during baseline as well as endline assessments. Difference in differences, ANOVA or multivariate analysis of covariance, and regression analysis will be performed to assess the effectiveness of the interventions. Qualitative methods such as focus group discussions and stories of change will be documented and analyzed using thematic framework analysis. The implementation outcomes will be reported using the PRISM (Practical Robust Implementation and Sustainability Model) RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework. The results are expected to be published by mid-2025. Conclusions: This study will show the magnitude of risk factors for NCDs, its determinants, feasibility, effectiveness of community-based interventions, and health promotion models for NCD prevention. Trial Registration: Clinical Trials Registration India CTRI/2020/10/028700; https://ctri.nic.in/Clinicaltrials/showallp.php?mid1=47597&EncHid=&userName=V-CaN International Registered Report Identifier (IRRID): DERR1-10.2196/42450 %M 37773622 %R 10.2196/42450 %U https://www.researchprotocols.org/2023/1/e42450 %U https://doi.org/10.2196/42450 %U http://www.ncbi.nlm.nih.gov/pubmed/37773622 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e46690 %T Evaluating the Effectiveness of the Housing First for Youth Intervention for Youth Experiencing Homelessness in Canada: Protocol for a Multisite, Mixed Methods Randomized Controlled Trial %A Gaetz,Stephen %A Bonakdar,Ahmad %A Ecker,John %A MacDonald,Cora %A Ilyniak,Sophia %A Ward,Ashley %A Kimura,Lauren %A Vijayaratnam,Aranie %A Banchani,Emmanuel %+ The Canadian Observatory on Homelessness, York University, 6th Floor Kaneff Tower, 4700 Keele St., Toronto, ON, M3J 1P3, Canada, 1 416 736 2100 ext 30208, bonakdar@yorku.ca %K youth homelessness %K Housing First for Youth %K Canada %K randomized controlled trial %K RCT %K Making the Shift %D 2023 %7 19.9.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Emerging evidence at the international level suggests that the Housing First approach could improve the housing stability of young people experiencing homelessness. However, there is a dearth of literature in Canada on whether the Housing First intervention for young people experiencing homelessness can improve outcomes including housing stability, health and well-being, and access to complementary supports. Adapted from the original Housing First model, Housing First for Youth (HF4Y) was developed in Canada as a rights-based approach tailored specifically for young people aged 16 to 24 years who are experiencing or are at risk of homelessness. Objective: The Making the Shift Youth Homelessness Social Innovation Lab is testing the effectiveness of the HF4Y intervention in Canada. The objective of this study is to determine whether the HF4Y model results in better participant-level outcomes than treatment-as-usual services for young people experiencing homelessness in 2 urban settings: Ottawa and Toronto, Ontario. Primary outcomes include housing stability, health and well-being, and complementary supports, and secondary outcomes include employment and educational attainment and social inclusion. Methods: The HF4Y study used a multisite, mixed methods, randomized controlled trial research approach for data collection and analysis. Eligible participants included young people aged 16 to 24 years who were experiencing homelessness or housing precarity. The participants were randomly assigned to either the treatment-as-usual group or the housing first intervention group. Survey and interview data in Ottawa and Toronto, Ontario are being collected at multiple time points (3-6 months) over 4 years to capture a range of outcomes. Analytic strategies for quantitative data will include mixed-effects modeling for repeated measures and logistic models. A thematic analysis will be used to analyze qualitative data based on participants’ narratives and life journeys through homelessness. Furthermore, program fidelity evaluations are conducted within each HF4Y program. These evaluations assess how well the intervention aligns with the HF4Y model and identify any areas that may require adjustments or additional support. Results: The HF4Y study has received human participant research ethics approval from the Office of Research Ethics at York University. Recruitment was conducted between February 2018 and March 2020. Data collection is expected to be completed at both sites by March 2024. A preliminary analysis of the quantitative and qualitative data collected between baseline and 24 months is underway. Conclusions: This pilot randomized controlled trial is the first to test the effectiveness of the HF4Y intervention in Canada. The findings of this study will enhance our understanding of how to effectively deliver and scale up the HF4Y intervention, with the aim of continually improving the HF4Y model to promote better outcomes for youth. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN) ISRCTN10505930; https://www.isrctn.com/ISRCTN10505930 International Registered Report Identifier (IRRID): DERR1-10.2196/46690 %M 37725430 %R 10.2196/46690 %U https://www.researchprotocols.org/2023/1/e46690 %U https://doi.org/10.2196/46690 %U http://www.ncbi.nlm.nih.gov/pubmed/37725430 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e46865 %T Colorectal Cancer Screening Decision Based on Predicted Risk: Protocol for a Pilot Randomized Controlled Trial %A Plys,Ekaterina %A Bulliard,Jean-Luc %A Chaouch,Aziz %A Durand,Marie-Anne %A van Duuren,Luuk A %A Brändle,Karen %A Auer,Reto %A Froehlich,Florian %A Lansdorp-Vogelaar,Iris %A Corley,Douglas A %A Selby,Kevin %+ Center for Primary Care and Public Health (Unisanté), University of Lausanne, Route de Berne 113, Lausanne, 1010, Switzerland, ekaterina.plys@unisante.ch %K colorectal cancer screening %K personalized screening %K risk communication %K shared decision-making %K screening behavior %K Switzerland %D 2023 %7 7.9.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Incidence of and mortality from colorectal cancer (CRC) can be effectively reduced by screening with the fecal immunochemical test (FIT) or colonoscopy. Individual risk to develop CRC within 15 years varies from <1% to >15% among people aged 50 to 75 years. Communicating personalized CRC risk and appropriate screening recommendations could improve the risk-benefit balance of screening test allocations and optimize the use of limited colonoscopy resources. However, significant uncertainty exists regarding the feasibility and efficacy of risk-based screening. Objective: We aim to study the effect of communicating individual CRC risk and a risk-based recommendation of the FIT or colonoscopy on participants’ choice of screening test. We will also assess the feasibility of a larger clinical trial designed to evaluate the impact of personalized screening on clinical outcomes. Methods: We will perform a pilot randomized controlled trial among 880 residents aged 50 to 69 years eligible to participate in the organized screening program of the Vaud canton, Switzerland. Participants will be recruited by mail by the Vaud CRC screening program. Primary and secondary outcomes will be self-assessed through questionnaires. The risk score will be calculated using the open-source QCancer calculator that was validated in the United Kingdom. Participants will be stratified into 3 groups—low (<3%), moderate (3% to <6%), and high (≥6%) risk—according to their 15-year CRC risk and randomized within each risk stratum. The intervention group participants will receive a newly designed brochure with their personalized risk and screening recommendations. The control group will receive the usual brochure of the Vaud CRC screening program. Our primary outcome, measured using a self-administered questionnaire, is appropriate screening uptake 6 months after the intervention. Screening will be defined as appropriate if participants at high risk undertake colonoscopy and participants at low risk undertake the FIT. We will also measure the acceptability of the risk score and screening recommendations and the psychological factors influencing screening behavior. We will also assess the feasibility of a full-scale randomized controlled trial. Results: We expect that a total sample of 880 individuals will allow us to detect a difference of 10% (α=5%) between groups. The main outcome will be analyzed using a 2-tailed chi-squared test. We expect that appropriate screening uptake will be higher in the intervention group. No difference in overall screening uptake is expected. Conclusions: We will test the impact of personalized risk information and screening recommendations on participants’ choice of screening test in an organized screening program. This study should advance our understanding of the feasibility of large-scale risk-based CRC screening. Our results may provide insights into the optimization of CRC screening by offering screening options with a better risk-benefit balance and optimizing the use of resources. Trial Registration: ClinicalTrials.gov NCT05357508; https://www.clinicaltrials.gov/study/NCT05357508 International Registered Report Identifier (IRRID): DERR1-10.2196/46865 %M 37676720 %R 10.2196/46865 %U https://www.researchprotocols.org/2023/1/e46865 %U https://doi.org/10.2196/46865 %U http://www.ncbi.nlm.nih.gov/pubmed/37676720 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e47887 %T Effects of Melatonin on Glycemic Variability in Type 2 Diabetes Mellitus: Protocol for a Crossover, Double-Blind, Placebo-Controlled Trial %A Martorina,Wagner %A Tavares,Almir %+ Institute of Biological Sciences, Federal University of Minas Gerais, Av Pres Antônio Carlos, 6627, Belo Horizonte, 31270-901, Brazil, 55 31 3409 5000, wmartorina@yahoo.com %K type 2 diabetes mellitus %K glycemic control %K melatonin %K randomized controlled trial %K cross-over studies %K T2DM %K glucose %K glycemic variability %K circadian rhythm %D 2023 %7 16.8.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Glycemic variability is recognized as a significant factor contributing to the development of micro- and macrovascular complications in individuals with type 2 diabetes mellitus (T2DM). Numerous studies have shown that melatonin, a hormone involved in regulating various biological rhythms, including those related to glucose regulation, such as hunger, satiety, sleep, and circadian hormone secretion (ie, cortisol, growth hormone, catecholamines, and insulin), is deficient in individuals with T2DM. This raises an important question: Could melatonin replacement potentially reduce glycemic variability in these patients? This warrants investigation as a novel approach to improving glycemic control and reducing the risk of complications associated with T2DM. Objective: We aimed to investigate whether melatonin replacement in individuals with T2DM who supposedly have melatonin deficiency can positively impact the regulation of insulin secretion rhythms and improve insulin sensitivity, ultimately resulting in a reduction in glycemic variability. Methods: This study will use a crossover, randomized, double-blind, placebo-controlled trial design. Patients with T2DM in group 1 will receive 3 mg of melatonin at 9:00 PM in the first week, undergo a washout period in the second week, and receive a placebo in the third week (melatonin-washout-placebo). Group 2 will be randomized to receive a placebo-washout-melatonin sequence (3 mg). Capillary blood glucose levels will be measured at 6 different times before and after meals during the last 3 days of the first and third weeks. The study aims to compare the mean differences in blood glucose levels and the coefficient of glycemic variability in patients receiving melatonin and placebo during the first and third weeks. After analyzing the initial results, the number of needed patients will be recalculated. If the recalculated number is higher than 30, new participants will be recruited. Thirty patients with T2DM will be randomized into the 2 groups: melatonin-washout-placebo or placebo-washout-melatonin. Results: Participant recruitment took place between March 2023 to April 2023. In all, 30 participants were eligible and completed the study. We expect that patients will show different glycemic variability on the days they receive placebo or melatonin. Studies on melatonin and glycemic control have shown both positive and negative results. We hope that there will be a positive outcome regarding glycemic variability (ie, a reduction in glycemic variability), as melatonin has a well-described chronobiotic effect in the literature. Conclusions: This study aims to determine whether melatonin supplementation can effectively reduce glycemic variability in patients with T2DM. The crossover design is necessary due to the multiple variables involved in the circadian variations of glucose, including diet, physical activity, sleep parameters, and pharmacological treatments. The relatively low cost of melatonin and its potential role in reducing the severe complications associated with T2DM have motivated this research effort. Furthermore, the indiscriminate use of melatonin in current times makes conducting this study essential to evaluate the effect of this substance in patients with T2DM. Trial Registration: Brazilian Registry of Clinical Trials RBR-6wg54rb; https://ensaiosclinicos.gov.br/rg/RBR-6wg54rb International Registered Report Identifier (IRRID): DERR1-10.2196/47887 %M 37410852 %R 10.2196/47887 %U https://www.researchprotocols.org/2023/1/e47887 %U https://doi.org/10.2196/47887 %U http://www.ncbi.nlm.nih.gov/pubmed/37410852 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e45917 %T Feasibility and Effectiveness of an Intervention to Reduce Intimate Partner Violence and Psychological Distress Among Women in Nepal: Protocol for the Domestic Violence Intervention (DeVI) Cluster-Randomized Trial %A Shrestha,Rachana %A Sapkota,Diksha %A Mehra,Devika %A Ekström,Anna Mia %A Deuba,Keshab %+ Department of Global Public Health, Karolinska Institutet, Tomtebodavägen 18A, Widerströmska Huset, Stockholm, 171 77, Sweden, 977 9843064279, keshab.deuba@ki.se %K intimate partner violence %K intervention %K violence prevention %K mental health %K cluster-randomized trial %K depression %K anxiety %K posttraumatic stress disorder %K low-income country %K women %K Nepal %D 2023 %7 15.8.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Intimate partner violence (IPV) disproportionately affects people in low-and middle-income countries (LMICs), such as Nepal. Women experiencing IPV are at higher risk of developing depression, anxiety, and posttraumatic stress disorder. The shortage of trained frontline health care providers, coupled with stigma related to IPV and mental health disorders, fuels low service uptake among women experiencing IPV. The Domestic Violence Intervention (DeVI) combines the Problem Management Plus counseling program developed by the World Health Organization with a violence prevention component. Objective: This study aims to implement and evaluate the feasibility, acceptability, and effectiveness of DeVI in addressing psychological distress and enabling the secondary prevention of violence for women experiencing IPV. Methods: A parallel cluster-randomized trial will be conducted across 8 districts in Madhesh Province in Nepal, involving 24 health care facilities. The study will include women aged 18-49 years who are either nonpregnant or in their first trimester, have experienced IPV within the past 12 months, have a 12-item General Health Questionnaire (GHQ-12) score of 3 or more (indicating current mental health issues), and have lived with their husbands or in-laws for at least 6 months. A total sample size of 912 was estimated at 80% power and α<.05 statistical significance level to detect a 15% absolute risk reduction in the IPV frequency and a 50% reduction in the GHQ-12 score in the intervention arm. The health care facilities will be randomly assigned to either the intervention or the control arm in a 1:1 ratio. Women visiting the health care facilities in the intervention and control arms will be recruited into the respective arms. In total, 38 participants from each health care facility will be included in the trial to meet the desired sample size. Eligible participants allocated to either arm will be assessed at baseline and follow-up visits after 6, 17, and 52 weeks after baseline. Results: This study received funding in 2019. As of December 29, 2022, over 50% of eligible women had been recruited from both intervention and control sites. In total, 269 eligible women have been enrolled in the intervention arm and 309 eligible women in the control arm. The trial is currently in the recruitment phase. Data collection is expected to be completed by December 2023, after which data analysis will begin. Conclusions: If the intervention proves effective, it will provide evidence of how nonspecialist mental health care providers can address the harmful effects of IPV in resource-constrained settings with a high burden of IPV, such as Nepal. The study findings could also contribute evidence for integrating similar services into routine health programs in LMICs to prevent IPV and manage mental health problems among women experiencing IPV. Trial Registration: ClinicalTrials.gov NCT05426863; https://clinicaltrials.gov/ct2/show/NCT05426863 International Registered Report Identifier (IRRID): DERR1-10.2196/45917 %M 37581909 %R 10.2196/45917 %U https://www.researchprotocols.org/2023/1/e45917 %U https://doi.org/10.2196/45917 %U http://www.ncbi.nlm.nih.gov/pubmed/37581909 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e37857 %T Evaluation of Lactobacillus Coryniformis K8 Consumption by Health Care Workers Exposed to COVID-19 (LactoCor2 Project): Protocol for a Randomized Controlled Trial %A Rodríguez-Blanque,Raquel %A Sánchez-García,Juan Carlos %A Cobos Vargas,Angel %A Leyva Martínez,M Socorro %A Martínez Diz,Silvia %A Cortés-Martín,Jonathan %A Tovar-Gálvez,María Isabel %+ Grupo de Investigación CTS-1068, Departamento de Enfermería, Facultad de Ciencias de la Salud, Universidad de Granada, Avda. Ilustracion, 60, Granada, 18071, Spain, 34 644322567, jsangar@ugr.es %K COVID-19 %K coronavirus %K Lactobacillus %K health care workers %K Lactobacilo %K trabajadores de la salud %K SARS-CoV-2 %K probiótico %D 2023 %7 28.6.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Lactobacillus coryniformis K8 CECT5711 has immune-modulating properties, enhances the immune response to viral antigens leading to the production of specific antibodies, and has anti-inflammatory activity, which may help to prevent uncontrolled inflammatory processes leading to respiratory and other organ failures. Objective: The purpose of this study is to evaluate the effect of the consumption of a probiotic strain on the incidence and severity of COVID-19 in health personnel who carry out their professional work among patients with infection or suspected infection by SARS-CoV-2. Methods: This is a double-blind randomized clinical trial in which the experimental group will receive a capsule of L coryniformis K8 per day (3×109 colony former units/day), and the control group will receive a daily placebo capsule consisting of maltodextrin. A sample size of 314 volunteers was calculated. Volunteers must meet the following inclusion criteria: older than 20 years and active health personnel caring for patients with COVID-19, including all professionals such as medical doctors, nurses, and caretakers at the 2 referral hospitals that treat patients with COVID-19. The main outcome of the clinical trial will be the incidence of symptomatic infection by SARS-CoV-2 in personnel who care for patients with suspected or confirmed COVID-19. Results: The study had to be extended to the 2 referral hospitals that treat patients with COVID-19 in the province of Granada (Andalusia, Spain); Hospital San Cecilio and Hospital Virgen de las Nieves. A total of 255 individuals met the inclusion criteria and were randomly assigned to one of the 2 groups. Conclusions: The results of this randomized controlled trial will provide valuable information regarding the administration of L coryniformis K8 against COVID-19, including whether there are fewer infectious processes due to this virus or, in case of occurrence, whether the disease is milder in participants taking the probiotic strain. Trial Registration: ClinicalTrials.gov NCT04366180; http://www.clinicaltrials.gov/ct2/show/NCT04366180 International Registered Report Identifier (IRRID): RR1-10.2196/37857 %M 37285326 %R 10.2196/37857 %U https://www.researchprotocols.org/2023/1/e37857 %U https://doi.org/10.2196/37857 %U http://www.ncbi.nlm.nih.gov/pubmed/37285326 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e45992 %T Ascertaining the Career Intentions of Medical Students (AIMS) in the United Kingdom Post Graduation: Protocol for a Mixed Methods Study %A Ferreira,Tomas %A Collins,Alexander M %A Horvath,Rita %+ School of Clinical Medicine, University of Cambridge, Cambridge Centre For Brain Repair, Ed Adrian Building, Cambridge, CB2 0PY, Cambridge, United Kingdom, 44 7887382199, tf385@cam.ac.uk %K medical students %K NHS %K National Health Service %K career intent %K attitude %K opinion %K workforce %K workforce planning %K medical education %K career %K doctor %K medical training %K medical graduate %K cross-sectional %K thematic analysis %K degree %K rotation %D 2023 %7 19.6.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Among doctors in the United Kingdom, there is growing sentiment regarding delaying specialist training, emigrating to practice medicine abroad, or leaving the profession altogether. This trend may have substantial implications for the future of the profession in the United Kingdom. The extent to which this sentiment is also present in the medical student population is not well understood. Objective: Our primary outcome is to determine current medical students’ career intentions after graduation and upon completing the foundation program and to establish the motivations behind these intentions. Secondary outcomes include determining which, if any, demographic factors alter the propensity to pursue different career paths available to a medical graduate, determining which specialties medical students plan on pursuing, and understanding current views on the prospect of working in the National Health Service (NHS). Methods: The Ascertaining the Career Intentions of Medical Students (AIMS) study is a national, multi-institution, and cross-sectional study in which all medical students at all medical schools in the United Kingdom are eligible to participate. It was administered via a novel, mixed methods, and web-based questionnaire and disseminated through a collaborative network of approximately 200 students recruited for this purpose. Both quantitative and thematic analyses will be performed. Results: The study was launched nationally on January 16, 2023. Data collection was closed on March 27, 2023, and data analysis has commenced. The results are expected to be available later in the year. Conclusions: Doctors’ career satisfaction within the NHS is a well-researched topic; however, there is a shortage of high-powered studies that are able to offer insight into medical students’ outlook on their future careers. It is anticipated that the results of this study will bring clarity to this issue. Identified areas of improvement in medical training or within the NHS could be targeted to improve doctors’ working conditions and help retain medical graduates. Results may also aid future workforce-planning efforts. International Registered Report Identifier (IRRID): DERR1-10.2196/45992 %M 37335615 %R 10.2196/45992 %U https://www.researchprotocols.org/2023/1/e45992 %U https://doi.org/10.2196/45992 %U http://www.ncbi.nlm.nih.gov/pubmed/37335615 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e38087 %T Conditioning of the Cortisol Awakening Response in Healthy Men: Study Protocol for a Randomized Controlled Trial %A Wolters,Fabian %A van Middendorp,Henriët %A Van den Bergh,Omer %A Biermasz,Nienke R %A Meijer,Onno C %A Evers,Andrea WM %+ Health, Medical and Neuropsychology Unit, Faculty of Social Sciences, Leiden University, Pieter de la Courtgebouw, room 2C.01, Wassenaarseweg 52, Leiden, 2333 AK, Netherlands, 31 71 527 2993, f.wolters@fsw.leidenuniv.nl %K conditioning %K cortisol %K cortisol awakening response %K sleep %K olfactory learning %D 2023 %7 19.6.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: The hormone cortisol plays important roles in human circadian and stress physiology and is an interesting target for interventions. Cortisol varies not only in response to stress but also as part of a diurnal rhythm. It shows a particularly sharp increase immediately after awakening, the cortisol awakening response (CAR). Cortisol can be affected by medication, but it is less clear whether it can also be affected by learning. Animal studies have consistently shown that cortisol can be affected by pharmacological conditioning, but the results in humans have been mixed. Other studies have suggested that conditioning is also possible during sleep and that the diurnal rhythm can be conditioned, but these findings have not yet been applied to cortisol conditioning. Objective: The objective of our study was to introduce a novel avenue for conditioning cortisol: by using the CAR as an unconditioned response and using scent conditioning while the participant is asleep. This study investigates an innovative way to study the effects of conditioning on cortisol and the diurnal rhythm, using a variety of devices and measures to make measurement possible at a distance and at unusual moments. Methods: The study protocol takes 2 weeks and is performed from the participant’s home. Measures in week 1 are taken to reflect the CAR and waking under baseline conditions. For the first 3 nights of week 2, participants are exposed to a scent from 30 minutes before awakening until their normal time of awakening to allow the scent to become associated with the CAR. On the final night, participants are forced to wake 4 hours earlier, when cortisol levels are normally low, and either the same (conditioned group) or a different (control group) scent is presented half an hour before this new time. This allows us to test whether cortisol levels are higher after the same scent is presented. The primary outcome is the CAR, assessed by saliva cortisol levels, 0, 15, 30, and 45 minutes after awakening. The secondary outcomes are heart rate variability, actigraphy measures taken during sleep, and self-reported mood after awakening. To perform manipulations and measurements, this study uses wearable devices, 2 smartphone apps, web-based questionnaires, and a programmed scent device. Results: We completed data collection as of December 24, 2021. Conclusions: This study can provide new insights into learning effects on cortisol and the diurnal rhythm. If the procedure does affect the CAR and associated measures, it also has potential clinical implications in the treatment of sleep and stress disorders. Trial Registration: Netherlands Trial Register NL58792.058.16; https://trialsearch.who.int/Trial2.aspx?TrialID=NL7791 International Registered Report Identifier (IRRID): DERR1-10.2196/38087 %M 37335592 %R 10.2196/38087 %U https://www.researchprotocols.org/2023/1/e38087 %U https://doi.org/10.2196/38087 %U http://www.ncbi.nlm.nih.gov/pubmed/37335592 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e46101 %T Efficacy and Safety of Mizoribine for the Treatment of Refractory Nephrotic Syndrome: Protocol for a Multicenter, Controlled, Open-label, Randomized Controlled Trial %A Dong,Zheyi %A Zhou,Jianhui %A Xu,Zhonggao %A Ni,Zhaohui %A He,Yani %A Lin,Hongli %A Jiang,Gengru %A Sun,Xuefeng %A Zhang,Li %A Chen,Xiangmei %+ Department of Nephrology, First Medical Center of Chinese People's Liberation Army General Hospital, 28 Fuxing Road, Beijing, 100853, China, 86 010 66935462, xmchen301@126.com %K refractory nephrotic syndrome %K mizoribine %K cyclophosphamide %D 2023 %7 16.6.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Nephrotic syndrome that is resistant to steroid therapy is termed refractory nephrotic syndrome (RNS), a condition that is associated with an increased risk of end-stage renal disease. Immunosuppressants are used to treat RNS; however, prolonged use may lead to significant adverse effects. Mizoribine (MZR) is a novel agent used in long-term immunosuppressive therapy, which has few adverse effects, but data on its long-term use in patients with RNS are unavailable. Objective: We propose a trial to examine the efficacy and safety of MZR compared with cyclophosphamide (CYC) in Chinese adult patients with RNS. Methods: This is a multicenter, randomized, controlled interventional study with a screening phase (1 week) and a treatment phase (52 weeks). This study has been reviewed and approved by the Medical Ethics Committees of all 34 medical centers that are participating. Patients with RNS consent to participation, and are enrolled and randomized to an MZR group or a CYC group (1:1 ratio), with each group receiving tapering doses of oral corticosteroids. Participants are assessed for adverse effects, and laboratory results are collected at 8 visits during the treatment phase (weeks 4, 8, 12, 16, 20, 32, 44, and 52 [exit visit]). Participants are able to withdraw voluntarily, and investigators are required to remove patients when there are safety concerns or deviations from the protocol. Results: The study started in November 2014 and was completed in March 2019. A total of 239 participants from 34 hospitals in China have been enrolled. Data analysis has been completed. The results are being finalized by the Center for Drug Evaluation. Conclusions: This study examines the safety and efficacy of MZR as a long-term treatment approach for Chinese adults with RNS. It is the longest lasting and largest randomized controlled trial to examine MZR in Chinese patients. The results can help determine whether RNS should be considered as an additional indication for MZR treatment in China. Trial Registration: ClinicalTrials.gov NCT02257697; https://clinicaltrials.gov/ct2/show/NCT02257697 International Registered Report Identifier (IRRID): RR1-10.2196/46101 %M 36990111 %R 10.2196/46101 %U https://www.researchprotocols.org/2023/1/e46101 %U https://doi.org/10.2196/46101 %U http://www.ncbi.nlm.nih.gov/pubmed/36990111 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e42043 %T The Effect of Positive Therapeutic Communication on Pain (POPAIN) and Anxiety During Arterial Blood Gas Standardized Procedures in the Emergency Department Compared to Traditional Communication: Protocol for a Monocentric Randomized Controlled Trial %A Schmutz,Thomas %A Le Terrier,Christophe %A Ribordy,Vincent %A Iglesias,Katia %A Guechi,Youcef %+ Department of Emergency Medicine, Fribourg Hospital, Fribourg Faculty of Medicine, Fribourg University, Chemin des pensionnats 4-6, Fribourg, 1704, Switzerland, 41 26 306 00 00, youcef.guechi@h-fr.ch %K pain %K therapeutic communication %K nocebo %K emergency department %K arterial blood gas %K anxiety %K positive therapeutic communication %D 2023 %7 13.6.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: In the emergency department (ED), medical procedures, such as arterial blood gas (ABG) testing, can cause pain and high stress levels. However, ABG testing is a routine procedure assessing the severity of the patient's condition. To reduce the pain of ABG, several methods have been investigated without significant difference in pain perception. Communication, a key element of care, has shown a significant effect on pain perception. A positive communication strategy, including positive, kind, or reassuring words, can reduce pain perception, while negative words can raise this perception, causing discomfort, known as the “nocebo effect.” Although some studies have compared the impact of verbal attitudes, particularly in anesthesia and mainly with staff already trained in hypnosis, to the best of our knowledge, none have investigated the effect of communication in the emergency setting, where patients may be more suggestible to the words used. Objective: In this study, we will investigate the effect of positive therapeutic communication on pain, anxiety, discomfort, and global satisfaction in patients requiring ABG compared to nocebo and neutral communication. Methods: A single-center, double-blind randomized controlled trial (RCT) with 3 parallel arms will be conducted with 249 patients requiring ABG during their ED visit. Patients will be randomly assigned to 1 of 3 groups before receiving ABG: positive communication group, negative communication (nocebo) group, or neutral communication (neutral) group. The communication and the words used by the physicians during hygiene preparation, artery location, and puncture will be imposed in each group. The study will be proposed to each patient corresponding to the inclusion criteria. The physicians will not be trained in hypnosis or in positive therapeutic communication. The procedure will be recorded with audio recorders to test its quality. Intention-to-treat analysis will be performed. The primary endpoint is the onset of pain. The secondary outcomes are patient comfort, patient anxiety, and global satisfaction of the patient with the communication strategy used. Results: On average, 2000 ABG procedures are performed each year in the EDs of hospitals. In this study, 249 patients are expected to be included. With a projected positive response rate of 80%, we intend to include 25 (10%) patients per month. The inclusion period began in April 2023 and will run until July 2024. We hope to publish the results of the study during the fall of 2024. Conclusions: To the best of our knowledge, this study is the first RCT assessing the use of positive communication on pain and anxiety in patients undergoing the ABG procedure in the ED. A reduction in pain, discomfort, and anxiety is expected when using positive communication. If the results are positive, this could be useful to the medical community and encourage clinicians to monitor their communication during care. Trial Registration: ClinicalTrials.gov NCT05434169; https://clinicaltrials.gov/ct2/show/NCT05434169 International Registered Report Identifier (IRRID): PRR1-10.2196/42043 %M 37310776 %R 10.2196/42043 %U https://www.researchprotocols.org/2023/1/e42043 %U https://doi.org/10.2196/42043 %U http://www.ncbi.nlm.nih.gov/pubmed/37310776 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e46144 %T Effectiveness of Silver Diamine Fluoride for Early Childhood Caries Among Children Aged 24 to 72 Months: Protocol for a Randomized Controlled Trial %A Basheer N,Amitha %A Jodalli,Praveen S %A Nayak,Namratha %A K S,Aparna %A Badekkila,Avinash R %+ Department of Public Health Dentistry, Manipal College of Dental Sciences Mangalore, Manipal Academy of Higher Education, Light House Hill Road, Manipal, 5756104, India, 91 9886244093, praveen.jodalli@manipal.edu %K silver diamine fluoride %K children %K caries %K childhood %K dental %K dentist %K oral health %K child %K pediatric %K RCT %K randomized %K fluoride %K prevention %D 2023 %7 7.6.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Dental caries is a serious public health issue globally. It is one of the most prevalent chronic disease in children worldwide. An important public health concern is the existence of one or more decayed, missing, or filled tooth surfaces in any primary teeth of preschool children. Early childhood caries (ECC) can be halted with the use of silver diamine fluoride (SDF) solution. Previous research has indicated that it may have a preventive impact in the treatment of ECC. It is well known that 38% silver diamine fluoride (SDF) is helpful at preventing dental caries. On the other hand, there is not enough evidence on SDF’s ability to prevent caries in primary teeth. To date, no well-planned clinical study has been carried out to investigate SDF’s impact on caries protection. Objective: The study’s objective is to evaluate and compare the efficacy of 12%, 30%, and 38% silver diamine fluoride in preventing ECC in children aged 24 to 72 months in Mangaluru Taluk. Methods: This is a single-center, randomized, active-controlled, parallel-group pragmatic trial. Children attending preschool in Mangalore Taluk aged 24 to 72 months will be included in the study. There will be three study groups: group 1 will receive 12% SDF semiannually; group 2 will receive 30% SDF semiannually; and group 3 will receive 38% SDF semiannually. After 6 and 12 months, the principal examiner will conduct a clinical examination of the teeth with a visual and tactile assessment. The effectiveness of the various concentrations of SDF will be determined after 12 months. Results: The research was funded in September 2020, and data collection started in September 2022. As of February 2023, 150 participants have enrolled in the study. The project is still underway, and it is expected to be completed in December 2023. Conclusions: Uncertainty surrounds the efficacy of 38% SDF in preventing ECC. Consensus-Based Clinical Case Reporting (CARE) guidelines recommending the use of SDF for ECC prevention will be modified if the findings are as expected. Additionally, since the findings will be broadly disseminated, more nations will implement the use of SDF, easing the burden of ECC on the entire world. Future research on the treatment and prevention of ECC will benefit from the study results. If SDF is successful in preventing caries in a classroom or community context, it will mark an important turning point for preventive dentistry. Trial Registration: Clinical Trial Registry of India CTRI/2020/02/023420; https://tinyurl.com/3ju2apab International Registered Report Identifier (IRRID): PRR1-10.2196/46144 %M 37285186 %R 10.2196/46144 %U https://www.researchprotocols.org/2023/1/e46144 %U https://doi.org/10.2196/46144 %U http://www.ncbi.nlm.nih.gov/pubmed/37285186 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e46054 %T Efficacy of Naprapathy in Brachial Plexus Injury: Protocol for a Randomized Clinical Trial %A Xiao,Bin %A Zhao,Lishu %A Huang,Yong %A Ma,Anqi %A Pei,Baoshun %A Li,Zhengyu %A Gu,Fei %+ Shanghai University of Traditional Chinese Medicine, No.1200 Cailun Road Pudong, Shanghai, 201203, China, 86 021 51322166, lzy1855@aliyun.com %K naprapathy %K brachial plexus injury %K traditional Chinese medicine %K study protocol %K clinical rehabilitation %K chronic pain %K physical therapy %K randomized controlled trial %K neuromusculoskeletal %K acupuncture %K moxibustion %K Tuina %K TCM %K pain %K edema %K blood circulation %K brachial plexus %K spinal cord %K limb %K electromyography %K EMG %D 2023 %7 29.5.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Clinical rehabilitation for brachial plexus injury is difficult in terms of chronic pain and dysfunction. Physiotherapy is considered a routine intervention for rehabilitation. Common physical therapy may require a variety of instruments. One approach that does not need instruments, but belongs to the field of complementary and alternative medicine, is naprapathy. Naprapathy, also called Tuina in China, has been applied in rehabilitation after brachial plexus injury for a long time. Naprapathy can relieve chronic neuropathic pain, promote local blood circulation, and improve body edema. Naprapathy can passively help improve motor functions in patients with peripheral nerve injury. However, the efficacy of naprapathy in improving rehabilitation after brachial plexus injury is unclear. Objective: This study aims to evaluate the additional value of naprapathy when combined with conventional physical therapy for the treatment of brachial plexus injury. Methods: This will be a single-center randomized controlled trial. A total of 116 eligible patients with brachial plexus injury will be randomly divided into an experimental group (naprapathy plus physical therapy group) or a control group (physical therapy group). The participants will be followed up for 4 weeks of treatment. Observation outcomes will include the visual analog scale score, upper limb index, electromyography findings, and adverse reactions, among others. The measuring points for outcomes will be the baseline and the completion of treatment. In addition, a quality control group independent from the research team will be set up to control the quality of the trial. Finally, the data will be analyzed using SPSS software (version 21.0; IBM Corp). Results: The study is recruiting participants. The first participant was enrolled in September 2021. As of January 2023, a total of 100 participants have been enrolled. The trial is expected to be completed by September 2023. The study protocol was approved by the Ethics Review Committee of Yue Yang Hospital affiliated with the Shanghai University of Traditional Chinese Medicine (2021-012). Conclusions: One limitation of this trial is that we will be unable to achieve strict double-blinding because of the features of naprapathy. The trial aims to contribute reliable evidence for decision-making in naprapathy for treating brachial plexus injury. Trial Registration: Chinese Clinical Trial Registry ChiCTR2100043515; http://www.chictr.org.cn/showproj.aspx?proj=122154 International Registered Report Identifier (IRRID): DERR1-10.2196/46054 %M 37247222 %R 10.2196/46054 %U https://www.researchprotocols.org/2023/1/e46054 %U https://doi.org/10.2196/46054 %U http://www.ncbi.nlm.nih.gov/pubmed/37247222 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e43547 %T Effects of Semisupervised Exercise Training on Health Outcomes in People With Lung or Head and Neck Cancer: Protocol for a Randomized Controlled Trial %A Grigoletto,Isis %A Cavalheri,Vinicius %A Gobbo,Luis Alberto %A Pozo,Karina %A Maia Filho,Enio Rodrigues %A Ribeiro,Diogo Gonçalves %A Ielo,Nara %A De Lima,Fabiano Francisco %A Ramos,Ercy Mara Cipulo %+ Department of Physiotherapy, Faculty of Science and Technology, São Paulo State University, Roberto Simonsen Street, 305, Centro Educacional, Presidente Prudente, São Paulo, 19060-900, Brazil, 55 1832295821, isis.grigoletto@unesp.br %K lung neoplasms %K head and neck neoplasms %K drug therapy %K radiotherapy %K exercise %K muscle strength %K lung cancer %K neck cancer %K head cancer %K aerobic exercise %K pulmonary %K neoplasm %K ENDT %K ear nose throat %K ear, nose, and throat %K RCT %K oncology %K outpatient %K cancer treatment %K Eastern Cooperative Oncology Group %K ECOG %K HRQoL %K quality of life %K QoL %K physical activity %D 2023 %7 24.5.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Lung or head and neck cancers are known for their high prevalence and mortality rates. Chemotherapy and radiotherapy are usually recommended as cancer treatment for these malignancies; however, they can negatively impact both the physical and mental status of patients. Hence, it is reasonable to consider resistance and aerobic exercise training to prevent these negative health outcomes. Further, several factors prevent patients from attending outpatient exercise training programs, and, therefore, a semisupervised home-based exercise training program may be seen as a well-accepted alternative. Objective: The aim of this study will be to investigate the effects of a semisupervised home-based exercise training program on physical performance, body composition, and self-reported outcomes; changes in the initial cancer treatment dose prescribed; number of hospitalizations at 3, 6, and 9 months; and 12-month survival in people with primary lung or head and neck cancer. Methods: Participants will be randomly allocated to the training group (TG) or control group (CG). The TG will undergo semisupervised home-based resistance and aerobic exercise training throughout their cancer treatment. The resistance training will be performed using elastic bands (TheraBand) twice a week. The aerobic training (ie, brisk walk) will be performed for at least 20 minutes per day outdoors. The equipment and tools used during the training sessions will be provided. This intervention will start the week before treatment commencement, will be performed throughout the duration of the treatment, and will continue for 2 weeks after treatment completion. The CG will undergo usual care (ie, cancer treatment with no formal exercise prescription). Assessments will take place 2 weeks before the beginning of the usual cancer treatment and 2 weeks after treatment completion. The measures of physical function (peripheral muscle strength, functional exercise capacity, and physical activity), body composition, and self-reported outcomes (symptoms of anxiety and depression, health-related quality of life, and symptoms related to the disease and treatment) will be collected. We will report on any change in the initial cancer treatment dose prescribed; number of hospitalizations at 3, 6, and 9 months; and 12-month survival. Results: In February 2021, the clinical trial registration was approved. Recruitment and data collection for the trial are ongoing (as of April 2023, 20 participants had already been randomized), and findings of this study are likely to be published late in 2024. Conclusions: This exercise training as a complementary treatment for patients with cancer is likely to promote positive effects on the health outcomes assessed, over and above any change in the CG, and prevent the reduction of initial cancer treatment dose prescribed. If these positive effects are shown, they will likely impact long-term outcomes such as hospitalizations and 12-month survival. Trial Registration: Brazilian Clinical Trials Registry (ReBEC) RBR-5cyvzh9; https://ensaiosclinicos.gov.br/rg/RBR-5cyvzh9. International Registered Report Identifier (IRRID): PRR1-10.2196/43547 %M 37223986 %R 10.2196/43547 %U https://www.researchprotocols.org/2023/1/e43547 %U https://doi.org/10.2196/43547 %U http://www.ncbi.nlm.nih.gov/pubmed/37223986 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e39223 %T Memantine for Refractory Obsessive-Compulsive Disorder: Protocol for a Pragmatic, Double-blind, Randomized, Parallel-Group, Placebo-Controlled, Monocenter Trial %A Maraone,Annalisa %A Trebbastoni,Alessandro %A Di Vita,Antonella %A D'Antonio,Fabrizia %A De Lena,Carlo %A Pasquini,Massimo %+ Sapienza University of Rome, Viale dell'Università 30, Roma, 00185, Italy, 39 3393865263, massimo.pasquini@uniroma1.it %K obsessive-compulsive disorder %K refractory patients %K antiglutamatergic agents %K glutamate %K augmentation medication %K memantine %K double blind %K parallel group %K placebo %K OCD %K psychiatric %K distress %K symptoms %K neuropsychiatric %K disability %K overactivity %K drug %K treatment %K Alzheimer %K cognitive %K titration %K medication %K mental health %K psychiatric disorder %D 2023 %7 11.5.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Obsessive-compulsive disorder (OCD) is a psychiatric syndrome characterized by unwanted and repetitive thoughts and repeated ritualistic compulsions for decreasing distress. Symptoms can cause severe distress and functional impairment. OCD affects 2% to 3% of the population and is ranked within the 10 leading neuropsychiatric causes of disability. Cortico-striatal-thalamo-cortical circuitry dysfunction has been implicated in OCD, including altered brain activation and connectivity. Complex glutamatergic signaling dysregulation within cortico-striatal circuitry has been proposed in OCD. Data obtained by several studies indicate reduced glutamatergic concentrations in the anterior cingulate cortex, combined with overactive glutamatergic signaling in the striatum and orbitofrontal cortex. A growing number of randomized controlled trials have assessed the utility of different glutamate-modulating drugs as augmentation medications or monotherapies for OCD, including refractory OCD. However, there are relevant variations among studies in terms of patients’ treatment resistance, comorbidity, age, and gender. At present, 4 randomized controlled trials are available on the efficacy of memantine as an augmentation medication for refractory OCD. Objective: Our study’s main purpose is to conduct a double-blind, randomized, parallel-group, placebo-controlled, monocenter trial to assess the efficacy and safety of memantine as an augmentative agent to a selective serotonin reuptake inhibitor in the treatment of moderate to severe OCD. The study’s second aim is to evaluate the effect of memantine on cognitive functions in patients with OCD. The third aim is to investigate if responses to memantine are modulated by variables such as gender, symptom subtypes, and the duration of untreated illness. Methods: Investigators intend to conduct a double-blind, randomized, parallel-group, placebo-controlled, monocenter trial to assess the efficacy and safety of memantine as an augmentative agent to a selective serotonin reuptake inhibitor in the treatment of patients affected by severe refractory OCD. Participants will be rated via the Yale-Brown Obsessive Compulsive Scale at baseline and at 2, 4, 6, 8, 10, and 12 months. During the screening period and T4 and T6 follow-up visits, all participants will undergo an extensive neuropsychological evaluation. The 52-week study duration will consist of 4 distinct periods, including memantine titration and follow-up periods. Results: Recruitment has not yet started. The study will be conducted from June 2023 to December 2024. Results are expected to be available in January 2025. Throughout the slow-titration period, we will observe the minimum effective dose of memantine, and the follow-up procedure will detail its residual efficacy after drug withdrawal. Conclusions: The innovation of this research proposal is not limited to the evaluation of the efficacy and safety of memantine as an augmentation medication for OCD. We will also test if memantine acts as a pure antiobsessive medication or if memantine’s ability to improve concentration and attention mimics an antiobsessive effect. Trial Registration: ClinicalTrials.gov NCT05015595; https://clinicaltrials.gov/ct2/show/NCT05015595 International Registered Report Identifier (IRRID): PRR1-10.2196/39223 %M 37166948 %R 10.2196/39223 %U https://www.researchprotocols.org/2023/1/e39223 %U https://doi.org/10.2196/39223 %U http://www.ncbi.nlm.nih.gov/pubmed/37166948 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e43221 %T Combining Intensive Rehabilitation With a Nonfunctional Isokinetic Strengthening Program in Adolescents With Cerebral Palsy: Protocol for a Randomized Controlled Trial %A Guérin,Mathias %A Sijobert,Benoit %A Zaragoza,Benjamin %A Cambon,Flore %A Boyer,Laurence %A Patte,Karine %+ Unité de rééducation, Institut Saint-Pierre, 371, avenue de l'Évêché-de-Maguelone, Palavas-les-Flots, 34250, France, 33 467077500, mathias.guerin74370@gmail.com %K isokinetic %K cerebral palsy %K gait analysis %K spasticity %K muscle strength %D 2023 %7 3.5.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Cerebral palsy is the most common brain injury in the pediatric population. Patients with cerebral palsy present different affectations such as decreased muscle strength, gait deviations, impaired proprioception, and spasticity. Isokinetic strengthening programs combined with intensive rehabilitation may improve muscle strength and therefore gait efficiency. Objective: The primary aim of this randomized controlled trial is to compare the effect of an intensive rehabilitation combined with a nonfunctional isokinetic progressive strengthening program to an intensive rehabilitation alone on gait parameters and muscle strength in patients with cerebral palsy. Another goal of this study is to determine whether adding an isokinetic program to intensive rehabilitation is more effective than intensive rehabilitation alone at decreasing spasticity and improving joint position sense in patients with cerebral palsy. Methods: A total of 30 adolescents with spastic diplegia cerebral palsy (Gross Motor Function Classification System levels I to III) will be randomized, by an independent researcher, into a 3-week intensive rehabilitation and isokinetic progressive strengthening group or an intensive rehabilitation control group. Gait parameters, muscle strength, spasticity, and knee joint position sense will be assessed. These variables will be evaluated at baseline (T0) and at the end of the intervention (T1). The intensive rehabilitation will consist of physiotherapy sessions twice a day and hydrotherapy and virtual reality gait training once a day. The isokinetic training group will have a total of 9 supervised isokinetic strength training sessions focusing on knee flexors and extensors with different execution speeds. Results: The protocol has been accepted by the French National Ethics Committee in October 2022. The inclusion of patients will start in November 2022. Conclusions: The combination of intensive rehabilitation with an isokinetic program on knee flexors and extensors has not been studied yet. The findings of this study may determine if an isokinetic strength training program of knee flexors and extensors is beneficial for the improvement of gait parameters, muscle strength, spasticity, and joint position sense in adolescents with spastic diplegia. International Registered Report Identifier (IRRID): PRR1-10.2196/43221 %M 36790338 %R 10.2196/43221 %U https://www.researchprotocols.org/2023/1/e43221 %U https://doi.org/10.2196/43221 %U http://www.ncbi.nlm.nih.gov/pubmed/36790338 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e41485 %T Addressing the Shortage of Health Professionals in Official Language Minority Communities to Strengthen Retention Strategies for the Benefit of New Brunswick Francophone and Acadian Communities: Protocol for a Mixed Methods Design %A Collin,Stéphanie %A Johnson,Claire %A Dubé,Anik %A Laforest,Marie-Eve %A Lauzier,Martin %A Landry,Michel H %A Cormier,Manon %A Sonier-Ferguson,Brigitte %+ École des hautes études publiques, Secteur administration publique et gestion des services de santé, Faculté des arts et des sciences sociales, Université de Moncton, Pavillon Léopold-Taillon (room 490), 18, avenue Antonine-Maillet, Moncton, NB, E1A 3E9, Canada, 1 5068584000 ext 3726, stephanie.collin@umoncton.ca %K human resource shortage %K retention %K health care professional %K health care provider %K shortage %K health care professionals’ retention %K registered nurse retention %K physicians’ retention %K retention factors %K Francophone communities %K linguistic minorities %K rural communities %K minority %K minorities %K language %K rural %K ethnic %K French %K Francophone %K Acadian %K Canada %D 2023 %7 3.5.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: COVID-19 has highlighted already existing human resource gaps in health care systems. New Brunswick health care services are significantly weakened by a shortage of nurses and physicians, affecting regions where Official Language Minority Communities (OLMCs) reside. Since 2008, Vitalité Health Network (the “Network”), whose work language is French (with services delivered in both official languages, English and French), has provided health care to OLMCs in New Brunswick. The Network currently needs to fill hundreds of vacant physician and nurse positions. It is imperative to strengthen the network’s retention strategies to ensure its viability and maintain adequate health care services for OLMCs. The study is a collaborative effort between the Network (our partner) and the research team to identify and implement organizational and structural strategies to upscale retention. Objective: The aim of this study is to support one of New Brunswick health networks in identifying and implementing strategies to promote physician and registered nurse retention. More precisely, it wishes to make 4 important contributions to identify (and enhance our understanding of) the factors related to the retention of physicians and nurses within the Network; determine, based on the “Magnet Hospital” model and the “Making it Work” framework, on which aspects of the Network’s environment (internal or external) it should focus for its retention strategy; define clear and actionable practices to help the Network replenish its strength and vitality; and improve the quality of health care services to OLMCs. Methods: The sequential methodology combines quantitative and qualitative approaches based on a mixed methods design. For the quantitative part, data collected through the years by the Network will be used to take stock of vacant positions and examine turnover rates. These data will also help determine which areas have the most critical challenges and which ones have more successful approaches regarding retention. Recruitment will be made in those areas for the qualitative part of the study to conduct interviews and focus groups with different respondents, either currently employed or who have left it in the last 5 years. Results: This study was funded in February 2022. Active enrollment and data collection started in the spring of 2022. A total of 56 semistructured interviews were conducted with physicians and nurses. As of manuscript submission, qualitative data analysis is in progress and quantitative data collection is intended to end by February 2023. Summer and fall 2023 is the anticipated period to disseminate the results. Conclusions: Applying the “Magnet Hospital” model and the “Making it Work” framework outside urban settings will offer a novel outlook to the knowledge of professional resource shortages within OLMCs. Furthermore, this study will generate recommendations that could contribute to a more robust retention plan for physicians and registered nurses. International Registered Report Identifier (IRRID): DERR1-10.2196/41485 %M 37133908 %R 10.2196/41485 %U https://www.researchprotocols.org/2023/1/e41485 %U https://doi.org/10.2196/41485 %U http://www.ncbi.nlm.nih.gov/pubmed/37133908 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e44980 %T Developing a System of Health Support for Young People Experiencing First-Episode Psychosis: Protocol for a Co-design Process %A Jenkins,Matthew %A Gardiner,Tracey %A Pekepo,Crystal %A Ramritu,Pāyal %A Drysdale,Briony %A Every-Palmer,Susanna %A Chinn,Victoria %+ Department of Psychological Medicine, University of Otago Wellington, 29 Brandon Street, Lambton Quay, Wellington / Te Whanganui-a-Tara, 6011, New Zealand, 64 221740904, matthew.jenkins@otago.ac.nz %K psychosis %K health %K well-being %K co-design %K lived experience %K early intervention %D 2023 %7 2.5.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: People living with psychosis face a substantially increased risk of poor psychological well-being and physical health and premature mortality. Encouraging positive health behaviors from an early stage is crucial to the health and well-being of this population but is often overshadowed by symptom management within early intervention services. Objective: Experience-based co-design is a participant-centered approach that aims to combine service user narratives with service design methods to design systems of support for health and well-being. This study aims to use experience-based co-design principles to co-design a system that supports the health and well-being of young people experiencing first-episode psychosis (FEP), which considers the lived experience of these people within the context of early intervention services. We also aim to develop a set of principles to guide future systems to support the health and well-being of young people experiencing FEP. Methods: Up to 15 young people living with FEP aged 16 to 24 years who are service users of early intervention services in psychosis, their immediate support networks (family or friends), and health professionals involved with early intervention services in psychosis will be invited to participate in a series of co-design workshops. Data will be collected in various forms, including expressive forms (eg, art and spoken word) and traditional methods (interview transcription and surveys), with phenomenographic and thematic analyses being used to understand these data. Furthermore, the co-design process will draw upon indigenous (Māori) knowledge and the lived experience of mental health services from the perspectives of the members of the research team. The co-design process will be evaluated in terms of acceptability from the perspective of service users via rating scales and interviews. The study will be conducted within the Lower North Island in Aotearoa New Zealand. Results: Data collection will be performed between August 2022 and February 2023. Drawing from extended consultations with service users and service providers, we have developed a robust co-design process with which we intend to collect rich qualitative and quantitative data. The results of this process will be used to create a system of support that can be immediately applied and as preliminary evidence for funding and resource applications to deliver and evaluate a “full” version of the co-designed system of support. Conclusions: The co-designed system of support and accompanying set of principles will offer a potentially impactful health and well-being intervention for young people experiencing FEP in Aotearoa New Zealand. Furthermore, making the co-design process transparent will further the field in terms of providing a blueprint for this form of participant-focused research. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12622001323718; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=384775&isReview=true International Registered Report Identifier (IRRID): DERR1-10.2196/44980 %M 37129953 %R 10.2196/44980 %U https://www.researchprotocols.org/2023/1/e44980 %U https://doi.org/10.2196/44980 %U http://www.ncbi.nlm.nih.gov/pubmed/37129953 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e39740 %T Improving Cognitive Function Through High-Intensity Interval Training in Breast Cancer Patients Undergoing Chemotherapy: Protocol for a Randomized Controlled Trial %A Wilson,Rebekah %A Kang,Dong-Woo %A Tahbaz,Meghan %A Norris,Mary %A Uno,Hajime %A Ligibel,Jennifer %A Guenette,Jeffrey %A Christopher,Cameron %A Dieli-Conwright,Christina %+ Division of Population Sciences, Department of Medical Oncology, Dana-Farber Cancer Institute, 375 Longwood Avenue, Boston, MA, 02215, United States, 1 (617) 582 8321, christinam_dieli-conwright@dfci.harvard.edu %K cognitive function %K high-intensity interval training %K exercise %K breast cancer %K chemotherapy %K magnetic resonance imaging %K MRI %D 2023 %7 7.4.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: More than 75% of patients with breast cancer treated with chemotherapy experience cognitive impairments (eg, memory and attention problems), commonly known as chemo-brain. Exercise, especially aerobic high-intensity interval training (HIIT), is associated with better cognitive function in healthy populations. However, clinical trials testing the impact of exercise interventions on chemotherapy-induced cognitive decline in patients with cancer are lacking, and the mechanisms through which exercise could improve cognitive function are unclear. Objective: The objective of the Improving Cognitive Function Through High-Intensity Interval Training in Breast Cancer Patients Undergoing Chemotherapy trial is to examine the effects of HIIT on cognitive function in patients with breast cancer undergoing chemotherapy. Methods: This 2-arm, single-center, pilot randomized controlled trial will randomize 50 patients with breast cancer undergoing chemotherapy to HIIT or attention control. The HIIT group will perform a supervised 16-week, thrice-weekly intervention, with each session including a 5-minute warm-up at 10% maximal power output (POmax), 10 sets of alternating 1-minute high-intensity (90% POmax) and 1-minute recovery (10% POmax) intervals, and a 5-minute cooldown (10% POmax). The attention control group will receive a stretching program with no exercise components and be asked to maintain their exercise levels for 16 weeks. The primary outcomes of the study are executive function and memory measured using the National Institutes of Health toolbox and resting-state connectivity and diffusion tensor imaging microstructure evaluated using magnetic resonance imaging. The secondary and tertiary outcomes include cardiorespiratory fitness, body composition, physical fitness, and psychosocial health. The study has been approved by the institutional review board of the Dana-Farber Cancer Institute (20-222). Results: The trial was funded in January 2019, with recruitment started in June 2021. As of May 2022, a total of 4 patients have consented and been randomized (n=2, 50% to exercise; n=1, 25% to control; and n=1, 25% nonrandomized). Trial completion is expected in January 2024. Conclusions: This first-of-its-kind study incorporates a novel exercise intervention (ie, HIIT) and comprehensive cognitive measures. If positive, our findings will establish the pilot efficacy of HIIT on chemotherapy-induced cognitive function in patients with breast cancer, providing the foundation for future larger phase-II and phase-III trials to confirm the findings and potentially establish HIIT as a standard of care for women undergoing chemotherapy for breast cancer. Trial Registration: ClinicalTrials.gov NCT04724499; https://clinicaltrials.gov/ct2/show/NCT04724499 International Registered Report Identifier (IRRID): DERR1-10.2196/39740 %M 37027186 %R 10.2196/39740 %U https://www.researchprotocols.org/2023/1/e39740 %U https://doi.org/10.2196/39740 %U http://www.ncbi.nlm.nih.gov/pubmed/37027186 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e41146 %T Management of Hypertension Using a Plant-Based Diet Among Farmers: Protocol for a Mixed Methods Study %A Susanto,Tantut %A Rasny,Hanny %A Kurdi,Fahruddin %A Yunanto,Rismawan Adi %A Rahmawati,Ira %+ Department of Community, Family, and Geriatric Nursing, Faculty of Nursing, Universitas Jember, Jalan Kalimantan No 37 Kampus Tegalboto Jember, Jember, 68121, Indonesia, 62 81336932902, tantut_s.psik@unej.ac.id %K hypertension %K farming %K plant-based diet %K nursing %D 2023 %7 3.4.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Farmers in Indonesia have a high risk for hypertension owing to their lifestyle and working environment. Diet management is a solution to reduce hypertension, and Indonesia has natural resources in the agricultural sector that could help manage hypertension. Optimizing vegetable and fruit intake in a plant-based diet (PBD) could help maintain blood pressure among farmers in Indonesia. Objective: This study aims to explore the health problem of hypertension and the characteristics of local food sources to formulate a PBD menu for treating hypertension, as well as assess the prevalence of hypertension, level of acceptability of a PBD, and associated sociodemographic factors. Further, we want to examine the effectiveness of a community-based nursing program for managing hypertension using a PBD. Methods: We will use the exploratory sequential mixed methods approach. There will be a qualitative study (phase I) in 2022 and a quantitative study (phase II) in 2023. We will analyze data using a thematic framework in phase I. In phase II, the study will involve (1) questionnaire development and validation; (2) examination of the prevalence of hypertension, the level of acceptability of a PBD, and the associated factors; and (3) a randomized controlled trial. We will recruit farmers with hypertension who meet the study criteria. Moreover, in phase II, we will invite expert nurses and nutritionists to assess the face and content validity of the questionnaire. We will use multiple logistic regression models to estimate the associated sociodemographic factors and the level of acceptability of a PBD. Furthermore, a linear generalized estimating equation will be used to estimate the parameters of a generalized linear model with a possible unmeasured correlation between observations from different time points for systolic and diastolic blood pressure. Results: A model PBD for hypertension management is expected to be developed. In 2022, we will collect information on hypertension and the characteristics of local food sources for managing hypertension, and will formulate a PBD menu to treat hypertension among farmers. In 2023, we will develop a questionnaire to assess the acceptability of a PBD to manage hypertension among farmers, the prevalence of hypertension, and the sociodemographic factors associated with hypertension among farmers. We will implement a community-based nursing program for managing hypertension using a PBD among farmers. Conclusions: The PBD model will not be readily available for other agricultural areas since validation of local food variation is required to design the menu. We expect contributions from the local government to implement the intervention as one of the policies in the management of hypertension for farmers in the agricultural plantation areas of Jember. This program may also be implemented in other agricultural countries with similar problems, so that hypertension can be optimally treated among farmers. International Registered Report Identifier (IRRID): PRR1-10.2196/41146 %M 37010908 %R 10.2196/41146 %U https://www.researchprotocols.org/2023/1/e41146 %U https://doi.org/10.2196/41146 %U http://www.ncbi.nlm.nih.gov/pubmed/37010908 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e44629 %T Motivational Interviewing for Enhancing Self-care in Patients With Heart Failure: Protocol for a Randomized Controlled Trial %A Dellafiore,Federica %A Ghizzardi,Greta %A Vellone,Ercole %A Magon,Arianna %A Conte,Gianluca %A Baroni,Irene %A De Angeli,Giada %A Vangone,Ida %A Russo,Sara %A Arrigoni,Cristina %A Caruso,Rosario %+ Department of Biomedicine and Prevention, University of Rome Tor Vergata, Via Cracovia, 50, Rome, 00133, Italy, 39 0371376565, greta.ghizza91@gmail.com %K cardiology %K cardiovascular %K clinical trial %K heart failure %K motivational interviewing %K randomized %K heart %K self-care %K randomized controlled trial %D 2023 %7 28.3.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Heart failure (HF) is characterized by an increasing prevalence, representing a public health problem and a significant cause of morbidity and mortality. Self-care is a cornerstone approach for optimizing therapy for patients with HF. Patients play a crucial role in managing their condition, given that several adverse health outcomes might be avoided with adequate self-care. In this regard, the literature describes motivational interviewing (MI) as highly favorable for treating chronic diseases, with promising results supporting its efficacy in enhancing self-care. Moreover, caregivers’ availability constitutes a fundamental supporting factor among the strategies to improve self-care behaviors in people with HF. Objective: The primary study aim is to test the efficacy of a structured program, including scheduled MI interventions, in improving self-care maintenance in the 3-month follow-up from the enrollment. Secondary aims comprehend the assessment of the effectiveness of the above intervention on secondary outcomes (eg, self-care monitoring, quality of life, sleep disturbance) and the corroboration of the superiority of caregivers’ participation to the intervention over the program administrated only to individual patients in enhancing self-care behaviors and other outcomes at 3, 6, 9, and 12 months from the enrollment. Methods: This study protocol designed a prospective, parallel-arm, open-label, 3-arm, controlled trial. The MI intervention will be administered by nurses trained in HF self-care and MI; the education program will be provided to nurses by an expert psychologist. Analyses will be performed within the framework of intention-to-treat analysis. Comparisons between groups will be based on an alpha of 5% and 2-tailed null hypotheses. In the case of missingness, analyzing the extent of the missingness and identifying underlying mechanisms and patterns will guide imputation methods. Results: The data collection was started in May 2017. We completed the data collection with the last follow-up in May 2021. We plan to perform data analysis by December 2022. We plan to publish the study results within March 2023. Conclusions: MI enhances potential self-care practices in patients with HF and their caregivers. Although MI is effectively largely employed either alone or combined with other treatments and is administered in different settings and ways, face-to-face interventions seem to be more effective. Dyads with higher shared HF knowledge are more efficient in promoting self-care adherence behaviors. Moreover, patients and caregivers may perceive proximity with health care professionals, resulting in a better ability to follow the received health professionals’ directions. The scheduled in-person meetings with patients and caregivers will be exploited to administer MI, respecting all the safety regulations for infection containment. The conduction of this study may support changes in clinical practice to include MI to improve self-care for patients with HF. Trial Registration: ClinicalTrials.gov NCT05595655; https://clinicaltrials.gov/ct2/show/NCT05595655 International Registered Report Identifier (IRRID): DERR1-10.2196/44629 %M 36976630 %R 10.2196/44629 %U https://www.researchprotocols.org/2023/1/e44629 %U https://doi.org/10.2196/44629 %U http://www.ncbi.nlm.nih.gov/pubmed/36976630 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e41421 %T Exercise Training to Improve Brain Health in Older People Living With HIV: Study Protocol for a Randomized Controlled Trial %A Cooley,Sarah %A Nelson,Brittany M %A Rosenow,Alexander %A Westerhaus,Elizabeth %A Cade,W Todd %A Reeds,Dominic N %A Vaida,Florin %A Yarasheski,Kevin E %A Paul,Robert H %A Ances,Beau M %+ Department of Neurology, School of Medicine, Washington University in St. Louis, 660 S. Euclid, Campus Box 8111, Saint Louis, MO, 63110, United States, 1 3147476453, scooley22@wustl.edu %K cardiorespiratory fitness %K cognition %K exercise %K HIV %K magnetic resonance imaging %K resistance training %D 2023 %7 21.3.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: With the advent of antiretrovirals, people living with HIV are living near-normal lifespans. However, people living with HIV are at greater risk of experiencing cognitive impairment and reduced brain integrity despite well-controlled viremia. A robust literature supports exercise interventions as a method of improving cognition and structural brain integrity in older individuals without HIV. The effects of exercise on cardiometabolic, neurocognitive, and neural structures in middle-aged to older people living with HIV are less well known, with few prospective studies examining these measures. Objective: This prospective randomized clinical trial will examine the effects of a 6-month exercise training intervention compared to a 6-month stretching intervention (control) on cardiorespiratory fitness, physical function and strength, cognition, and neuroimaging measures of brain volumes and cerebral blood flow in people living with HIV. Methods: Sedentary middle-aged to older people living with HIV (ages≥40; n=150) with undetectable HIV viral load (<20 copies/mL) will be enrolled in the study. At the baseline and final visit, fasting plasma lipid, insulin, glucose, and brain neurotrophic factor concentrations; cardiorespiratory fitness; cognitive performance; brain volumes; and cerebral blood flow via a magnetic resonance imaging scan will be measured. Participants will be randomized in a 2:1 ratio to either the exercise or control stretching intervention. All participants will complete their assigned programs at a community fitness center 3 times a week for 6 months. A professional fitness trainer will provide personal training guidance at all sessions for individuals enrolled in both arms. Individuals randomized to the exercise intervention will perform endurance and strength training exercises, while those randomized to the control intervention will perform stretches to increase flexibility. A midpoint visit (at 3 months) will assess cognitive performance, and at the end point visit, subjects will undergo cardiorespiratory fitness and cognition testing, and a magnetic resonance imaging scan. Physical activity throughout the duration of the trial will be recorded using an actigraph. Results: Recruitment and data collection are complete as of December 2020. Data processing, cleaning, and organization are complete as of December 2021. Data analysis began in January 2022, with the publication of study results for primary aims 1 and 2 expected by early 2023. Conclusions: This study will investigate the effects of a 6-month aerobic and resistance exercise training intervention to improve cardiometabolic risk factors, cognitive performance, cerebral structure, and blood flow in sedentary people living with HIV. Results will inform clinicians and patients of the potential benefits of a structured aerobic exercise training program on the cognitive, functional, and cardiometabolic health status of older people living with HIV. Assessment of compliance will inform the development and implementation of future exercise programs for people living with HIV. Trial Registration: ClinicalTrials.gov NCT02663934; https://clinicaltrials.gov/ct2/show/NCT02663934 International Registered Report Identifier (IRRID): DERR1-10.2196/41421 %M 36943345 %R 10.2196/41421 %U https://www.researchprotocols.org/2023/1/e41421 %U https://doi.org/10.2196/41421 %U http://www.ncbi.nlm.nih.gov/pubmed/36943345 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e41197 %T Repeat Ivermectin Mass Drug Administrations for Malaria Control II: Protocol for a Double-blind, Cluster-Randomized, Placebo-Controlled Trial for the Integrated Control of Malaria %A Foy,Brian D %A Some,Anthony %A Magalhaes,Tereza %A Gray,Lyndsey %A Rao,Sangeeta %A Sougue,Emmanuel %A Jackson,Conner L %A Kittelson,John %A Slater,Hannah C %A Bousema,Teun %A Da,Ollo %A Coulidiaty,A Gafar V %A Colt,McKenzie %A Wade,Martina %A Richards,Kacey %A Some,A Fabrice %A Dabire,Roch K %A Parikh,Sunil %+ Department of Epidemiology of Microbial Diseases, Yale School of Public Health, 60 College Street, Room 724, New Haven, CT, 06520, United States, 1 2037377906, sunil.parikh@yale.edu %K malaria %K ivermectin %K mass drug administration %K mosquito %K Anopheles %K endectocide %K cluster-randomized %K clinical trial %K seasonal malaria chemoprevention %K transmission %D 2023 %7 20.3.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: The gains made against malaria have stagnated since 2015, threatened further by increasing resistance to insecticides and antimalarials. Improvement in malaria control necessitates a multipronged strategy, which includes the development of novel tools. One such tool is mass drug administration (MDA) with endectocides, primarily ivermectin, which has shown promise in reducing malaria transmission through lethal and sublethal impacts on the mosquito vector. Objective: The primary objective of the study is to assess the impact of repeated ivermectin MDA on malaria incidence in children aged ≤10 years. Methods: Repeat Ivermectin MDA for Malaria Control II is a double-blind, placebo-controlled, cluster-randomized, and parallel-group trial conducted in a setting with intense seasonal malaria transmission in Southwest Burkina Faso. The study included 14 discrete villages: 7 (50%) randomized to receive standard measures (seasonal malaria chemoprevention [SMC] and bed net use for children aged 3 to 59 months) and placebo, and 7 (50%) randomized to receive standard measures and monthly ivermectin MDA at 300 μg/kg for 3 consecutive days, provided under supervision to all eligible village inhabitants, over 2 successive rainy seasons. Nonpregnant individuals >90 cm in height were eligible for ivermectin MDA, and cotreatment with ivermectin and SMC was not permitted. The primary outcome is malaria incidence in children aged ≤10 years, as assessed by active case surveillance. The secondary safety outcome of repeated ivermectin MDA was assessed through active and passive adverse event monitoring. Results: The trial intervention was conducted from July to November in 2019 and 2020, with additional sampling of humans and mosquitoes occurring through February 2022 to assess postintervention changes in transmission patterns. Additional human and entomological assessments were performed over the 2 years in a subset of households from 6 cross-sectional villages. A subset of individuals underwent additional sampling in 2020 to characterize ivermectin pharmacokinetics and pharmacodynamics. Analysis and unblinding will commence once the database has been completed, cleaned, and locked. Conclusions: Our trial represents the first study to directly assess the impact of a novel approach for malaria control, ivermectin MDA as a mosquitocidal agent, layered into existing standard-of-care interventions. The study was designed to leverage the current SMC deployment infrastructure and will provide evidence regarding the additional benefit of ivermectin MDA in reducing malaria incidence in children. Trial Registrations: ClinicalTrials.gov NCT03967054; https://clinicaltrials.gov/ct2/show/NCT03967054 and Pan African Clinical Trials Registry PACT201907479787308; https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=8219 International Registered Report Identifier (IRRID): DERR1-10.2196/41197 %M 36939832 %R 10.2196/41197 %U https://www.researchprotocols.org/2023/1/e41197 %U https://doi.org/10.2196/41197 %U http://www.ncbi.nlm.nih.gov/pubmed/36939832 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e43760 %T Nitric Oxide on Extracorporeal Membrane Oxygenation in Neonates and Children (NECTAR Trial): Protocol for a Randomized Controlled Trial %A Mattke,Adrian C %A Johnson,Kerry %A Gibbons,Kristen %A Long,Debbie %A Robertson,Jeremy %A Venugopal,Prem S %A Blumenthal,Antje %A Schibler,Andreas %A Schlapbach,Luregn %+ Paediatric Intensive Care Unit, Children's Health Queensland, Queensland Children's Hospital, 501 Stanley Street, South Brisbane, 4101, Australia, 61 401698994, adrian.mattke@health.qld.gov.au %K extracorporeal membrane oxygenation %K randomized controlled trial %K children %K nitric oxide %K child %K RCT %K ECMO %K neonate %K neonatal %K infant %K baby %K babies %K life support %K mortality %K pulmonary %K cardiovascular %K heart %K lung %D 2023 %7 15.3.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Extracorporeal membrane oxygenation (ECMO) provides support for the pulmonary or cardiovascular function of children in whom the predicted mortality risk remains very high. The inevitable host inflammatory response and activation of the coagulation cascade due to the extracorporeal circuit contribute to additional morbidity and mortality in these patients. Mixing nitric oxide (NO) into the sweep gas of ECMO circuits may reduce the inflammatory and coagulation cascade activation during ECMO support. Objective: The purpose of this study is to test the feasibility and safety of mixing NO into the sweep gas of ECMO systems and assess its effect on inflammation and coagulation system activation through a pilot randomized controlled trial. Methods: The Nitric Oxide on Extracorporeal Membrane Oxygenation in Neonates and Children (NECTAR) trial is an open-label, parallel-group, pilot randomized controlled trial to be conducted at a single center. Fifty patients who require ECMO support will be randomly assigned to receive either NO mixed into the sweep gas of the ECMO system at 20 ppm for the duration of ECMO or standard care (no NO) in a 1:1 ratio, with stratification by support type (veno-venous vs veno-arterial ECMO). Results: Outcome measures will focus on feasibility (recruitment rate and consent rate, and successful inflammatory marker measurements), the safety of the intervention (oxygenation and carbon dioxide control within defined parameters and methemoglobin levels), and proxy markers of efficacy (assessment of cytokines, chemokines, and coagulation factors to assess the impact of NO on host inflammation and coagulation cascade activation, clotting of ECMO components, including computer tomography scanning of oxygenators for clot assessments), bleeding complications, as well as total blood product use. Survival without ECMO and the length of stay in the pediatric intensive care unit (PICU) are clinically relevant efficacy outcomes. Long-term outcomes include neurodevelopmental assessments (Ages and Stages Questionnaire, Strength and Difficulties Questionnaire, and others) and quality of life (Pediatric Quality of Life Inventory and others) measured at 6 and 12 months post ECMO cannulation. Analyses will be conducted on an intention-to-treat basis. Conclusions: The NECTAR study investigates the safety and feasibility of NO as a drug intervention during extracorporeal life support and explores its efficacy. The study will investigate whether morbidity and mortality in patients treated with ECMO can be improved with NO. The intervention targets adverse outcomes in patients who are supported by ECMO and who have high expected mortality and morbidity. The study will be one of the largest randomized controlled trials performed among pediatric patients supported by ECMO. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12619001518156; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376869 International Registered Report Identifier (IRRID): DERR1-10.2196/43760 %M 36920455 %R 10.2196/43760 %U https://www.researchprotocols.org/2023/1/e43760 %U https://doi.org/10.2196/43760 %U http://www.ncbi.nlm.nih.gov/pubmed/36920455 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e42846 %T Dietary Temperature’s Influence on Energy Balance in Humans: Protocol for a Randomized Controlled Trial and Crossover Design %A Rastmanesh,Reza %A Flack,Kyle D %+ American Physical Society, College Park, Maryland, MD, United States, 98 22750414, r.rastmanesh@gmail.com %K dietary temperature %K energy intake %K energy conservation %K heat shock proteins %K clinical trial %K design of study %D 2023 %7 3.3.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: According to the first law of thermodynamics, energy cannot be created or destroyed in an isolated system. Water has a characteristically high heat capacity, indicating that the temperature of ingested fluids and meals could contribute to energy homeostasis. Citing the underlying molecular mechanisms, we present a novel hypothesis that states that the temperature of one’s food and drink contributes to energy balance and plays a role in the development of obesity. We provide strong associations with certain molecular mechanisms that are activated by heat and correlate them with obesity and a hypothetical trial that could test this hypothesis. We conclude that if meal or drink temperature proves to contribute to energy homeostasis, then depending on its contribution and scale, future clinical trials should attempt to adjust this effect when analyzing data. In addition, previous research and established relationships of disease states with dietary patterns, energy intake, and food component intakes should be revisited. We understand the common assumption that thermal energy in food is absorbed by the body during digestion and dissipated as heat into the environment, not contributing to the energy balance. We challenge this assumption herein, including a proposed study design that would test our hypothesis. Objective: This paper hypothesizes that the temperature of ingested foods or fluids influences energy homeostasis through the expression of heat shock proteins (HSPs), especially HSP-70 and HSP-90, which are expressed to a greater extent in obesity and are known to cause deficits in glucose metabolism. Methods: We provide preliminary evidence supporting our hypothesis that greater dietary temperatures disproportionally induce activation of both intracellular and extracellular HSPs and that these HSPs influence energy balance and contribute to obesity. Results: This trial protocol has not been initiated and funding has not been sought at the time of this publication. Conclusions: To date, no clinical trials are available regarding the potential effects of meal and fluid temperature on weight status or its confounding effects in data analysis. A potential mechanism is proposed as a basis by which higher temperatures of foods and beverages might influence energy balance via HSP expression. On the basis of the evidence supporting our hypothesis, we propose a clinical trial that will further elucidate these mechanisms. International Registered Report Identifier (IRRID): PRR1-10.2196/42846 %M 36867437 %R 10.2196/42846 %U https://www.researchprotocols.org/2023/1/e42846 %U https://doi.org/10.2196/42846 %U http://www.ncbi.nlm.nih.gov/pubmed/36867437 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e41839 %T Physiological and Psychological Effects of Parent-Delivered Traditional Thai Massage in Children With Autism: Protocol for a Randomized Controlled Trial %A Ruan,Hui %A Eungpinichpong,Wichai %A Wu,Hua %A Aonsri,Chanada %+ Research Center in Back, Neck, Other Joint Pain and Human Performance, Division of Physical Therapy, Khon Kaen University, 123 Faculty of Associated Medical Sciences, Khon Kaen, 4000, Thailand, 66 817494748, wiceun@gmail.com %K autism %K massage %K randomized controlled trial %K protocol %D 2023 %7 8.2.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Although many autistic children receive massage as a complementary therapy, it is not included in evidence-based practice for autism because evidence of its efficacy is lacking. Further, prior studies have failed to identify objective indicators of core symptoms or elucidate their mechanisms. Objective: We developed a parent-delivered traditional Thai massage (TTM) intervention for children with autism, aiming to experimentally determine whether children with autism truly experience positive effects from parent-delivered TTM and determine possible mechanisms of the observed effects. Methods: A 2-armed, parallel randomized controlled trial was conducted between February 2022 and June 2022. Forty-eight children with autism (aged 7-12 years) were recruited from the Hainan Special Education School and randomly assigned to either a parental TTM or control group at a ratio of 1:1 based on random numbers generated with Online Research Randomizer. The generated sequences were concealed in an opaque envelope. Individuals in the parental TTM group received 16 parent-delivered TTM sessions over 8 weeks at the school’s health room after school, and the control group maintained a normal daily routine. Outcomes were assessed on admission, after 8 weeks, and at a 2-month follow-up and included the effect of massage treatment on autism symptoms, measured with the Autism Treatment Evaluation Checklist score (evaluated by parents and a blinded teacher), physiological parameters (ie, heart rate variability and gait), and the Parenting Stress Index, Fourth Edition–Short Form. Results: We finished all data collection on June 20, 2022. Data analysis will be started, and we expect to publish results in 2023. Conclusions: This study will provide further evidence for massage treatment of autism and provide support for family-based care. Trial Registration: Chinese Clinical Trial Registry ChiCTR2100051355; https://tinyurl.com/3dwjxsw5 International Registered Report Identifier (IRRID): DERR1-10.2196/41839 %M 36753320 %R 10.2196/41839 %U https://www.researchprotocols.org/2023/1/e41839 %U https://doi.org/10.2196/41839 %U http://www.ncbi.nlm.nih.gov/pubmed/36753320 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e41173 %T Effectiveness of an Individualized Exergame-Based Motor-Cognitive Training Concept Targeted to Improve Cognitive Functioning in Older Adults With Mild Neurocognitive Disorder: Study Protocol for a Randomized Controlled Trial %A Manser,Patrick %A Michels,Lars %A Schmidt,André %A Barinka,Filip %A de Bruin,Eling D %+ Motor Control and Learning Group – Institute of Human Movement Sciences and Sport, Department of Health Sciences and Technology, ETH Zurich, Leopold-Ruzicka-Weg 4, Zurich, 8093, Switzerland, 41 79 519 96 46, patrick.manser@hest.ethz.ch %K cognition %K cognitive impairment %K effectiveness %K exercise %K exergame %K neuroplasticity %K neurosciences %K technology %K training %D 2023 %7 6.2.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Simultaneous motor-cognitive training is considered promising for preventing the decline in cognitive functioning in older adults with mild neurocognitive disorder (mNCD) and can be highly motivating when applied in the form of exergaming. The literature points to opportunities for improvement in the application of exergames in individuals with mNCD by developing novel exergames and exergame-based training concepts that are specifically tailored to patients with mNCD and ensuring the implementation of effective training components. Objective: This study systematically explores the effectiveness of a newly developed exergame-based motor-cognitive training concept (called “Brain-IT”) targeted to improve cognitive functioning in older adults with mNCD. Methods: A 2-arm, parallel-group, single-blinded randomized controlled trial with a 1:1 allocation ratio (ie, intervention: control), including 34 to 40 older adults with mNCD will be conducted between May 2022 and December 2023. The control group will proceed with the usual care provided by the (memory) clinics where the patients are recruited. The intervention group will perform a 12-week training intervention according to the “Brain-IT” training concept, in addition to usual care. Global cognitive functioning will be assessed as the primary outcome. As secondary outcomes, domain-specific cognitive functioning, brain structure and function, spatiotemporal parameters of gait, instrumental activities of daily living, psychosocial factors, and resting cardiac vagal modulation will be assessed. Pre- and postintervention measurements will take place within 2 weeks before starting and after completing the intervention. A 2-way analysis of covariance or the Quade nonparametric analysis of covariance will be computed for all primary and secondary outcomes, with the premeasurement value as a covariate for the predicting group factor and the postmeasurement value as the outcome variable. To determine whether the effects are substantive, partial eta-squared (η2p) effect sizes will be calculated for all primary and secondary outcomes. Results: Upon the initial submission of this study protocol, 13 patients were contacted by the study team. Four patients were included in the study, 2 were excluded because they were not eligible, and 7 were being informed about the study in detail. Of the 4 included patients, 2 already completed all premeasurements and were in week 2 of the intervention period. Data collection is expected to be completed by December 2023. A manuscript of the results will be submitted for publication in a peer-reviewed open-access journal in 2024. Conclusions: This study contributes to the evidence base in the highly relevant area of preventing disability because of cognitive impairment, which has been declared a public health priority by the World Health Organization. Trial Registration: ClinicalTrials.gov NCT05387057; https://clinicaltrials.gov/ct2/show/NCT05387057 International Registered Report Identifier (IRRID): DERR1-10.2196/41173 %M 36745483 %R 10.2196/41173 %U https://www.researchprotocols.org/2023/1/e41173 %U https://doi.org/10.2196/41173 %U http://www.ncbi.nlm.nih.gov/pubmed/36745483 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e41170 %T A Text Messaging–Based Support Intervention to Enhance Pre-exposure Prophylaxis for HIV Prevention Adherence During Pregnancy and Breastfeeding: Protocol for a Randomized Controlled Trial %A Mogaka,Jerusha Nyabiage %A Otieno,Felix Abuna %A Akim,Eunita %A Beima-Sofie,Kristin %A Dettinger,Julia %A Gomez,Lauren %A Marwa,Mary %A Odhiambo,Ben %A Ngure,Kenneth %A Ronen,Keshet %A Sharma,Monisha %A John-Stewart,Grace %A Richardson,Barbra %A Stern,Joshua %A Unger,Jennifer %A Udren,Jenna %A Watoyi,Salphine %A Pintye,Jillian %A Kinuthia,John %+ School of Nursing, University of Washington, 1959 NE Pacific Street, Seattle, WA, 98195, United States, 1 206 543 4278, jpintye@uw.edu %K pre-exposure prophylaxis %K text messaging %K text message %K mobile technology %K PrEP adherence %K adherence %K prevention %K pregnancy %K pregnant %K breastfeeding %K maternal %K randomized %K RCT %K peripartum %K patient-provider %K postpartum %K HIV prevention %K SMS %K HIV %K mHealth %K mobile health %D 2023 %7 30.1.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Cisgender women in Kenya are at elevated risk of HIV acquisition during pregnancy and post partum. Acute HIV infection during pregnancy and breastfeeding accounts for approximately one-third of all vertical HIV transmissions. The World Health Organization recommends offering oral tenofovir-based pre-exposure prophylaxis (PrEP) to pregnant and postpartum women who are HIV negative but at substantial and ongoing risk for HIV acquisition. PrEP delivery for pregnant and postpartum women is expanding within routine maternal child health clinics in Kenya. However, approximately half of pregnant women discontinue PrEP within 30 days of initiation. Therefore, it is crucial to develop PrEP adherence strategies that enhance support for adherence when peripartum events and health issues pose challenges to sustaining PrEP adherence. Objective: We are conducting a randomized controlled trial to determine the effect of a bidirectional communication platform named Mobile Solutions for Women’s and Children’s Health (mWACh), which utilizes two-way SMS text messaging between patients and remote nurses to support PrEP adherence and address maternal health concerns in real time during the peripartum period. Methods: The mWACh-PrEP study is a randomized trial designed to support PrEP adherence during the peripartum period by comparing mWACh-PrEP to the standard of care (ie, in-clinic adherence counseling) among women who are HIV negative and initiating PrEP. Purposive sampling was used to select 5 facilities offering PrEP in antenatal clinics in Kisumu and Siaya Counties, and block randomization will be used to divide participants into groups. Participants in the intervention arm will receive a customized messaging curriculum via SMS text messages targeted toward their particular perinatal stage. The primary outcome, PrEP adherence at 6 months post partum, will be evaluated using a log-binomial regression model, adjusting for imbalanced baseline characteristics. Based on a previous study of directly observed dosing conditions, we will use a hair tenofovir concentration cutoff of 0.038 ng/mg (corresponding to 7 doses/week) as the primary adherence outcome measured at 6 months post partum (binary outcome). Qualitative interviews and cost-effective analyses will be conducted to understand the feasibility, acceptability, and economic impact of the intervention. Results: Enrollment began in March 2022 and is projected to continue until July 2023, with follow-up through March 2024. The study results are expected to be reported in 2025. Conclusions: This trial will provide insights into using mobile health to enhance PrEP adherence among pregnant and postpartum mothers. Additionally, the findings will have implications for the use of mobile health technology to improve adherence to other daily medications during the peripartum period. Trial Registration: ClinicalTrials.gov NCT04472884; https://clinicaltrials.gov/ct2/show/NCT04472884 International Registered Report Identifier (IRRID): DERR1-10.2196/41170 %M 36716092 %R 10.2196/41170 %U https://www.researchprotocols.org/2023/1/e41170 %U https://doi.org/10.2196/41170 %U http://www.ncbi.nlm.nih.gov/pubmed/36716092 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e40115 %T The Effect of Prophylactic Intravenous Amiodarone Administration on Reperfusion Ventricular Fibrillation in Patients With Left Ventricular Hypertrophy Undergoing Cardiopulmonary Bypass Surgery: Protocol for a Randomized Double-Blind Clinical Trial %A Zhou,Xiaokai %A Zhang,Zhenfeng %A Gong,Chanjuan %A Fang,Yin %+ Department of Anesthesia and Perioperative Medicine, The First Affiliated Hospital of Nanjing Medical University, 300 GuangZhou road, Nanjing, 210029, China, 86 13002500363, yitianfang@sina.cn %K amiodarone %K cardiopulmonary bypass %K left ventricular hypertrophy %K ventricular fibrillation %D 2023 %7 27.1.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Ventricular fibrillation (VF) is a common arrhythmia that occurs after the release of aortic cross-clamp (ACC) in patients undergoing cardiopulmonary bypass (CPB) surgery. Repeated defibrillation and long duration of VF could increase myocardial injuries. In patients with left ventricular hypertrophy (LVH), VF is easier to occur and more difficult to be terminated. Amiodarone, known as class III antiarrhythmic agent, has the prominent properties of converting VF and restoring the sinus rhythm. Before ACC release, administration of amiodarone has been confirmed useful to reduce occurrence of VF. However, few studies are focused on the effect of amiodarone before ACC release on reducing VF in patients with LVH. Objective: This study aimed at determining the efficacy of prophylactic intravenous amiodarone administration on reperfusion VF after release of ACC in patients with LVH undergoing CPB surgery. Methods: This will be a prospective, randomized, double-blind, placebo-controlled trial. The trial will enroll 54 patients with LVH aged 18-75 years who will undergo CPB surgery. All eligible participants will be randomly allocated to either the amiodarone or placebo group by using the block randomization in a 1:1 ratio. The primary end point will be the incidence rate of VF 30 minutes after ACC release and be assessed using the Fisher exact test. All data will be analyzed in accordance with the intention-to-treat principle. Results: The study began in August 2022, and the data collection will take place for the next 2 academic years. As of this writing, 21 participants have already been recruited for the study. Conclusions: With this trial, we are hoping to demonstrate that prophylactic infusion of amiodarone before ACC release could reduce the occurrence of reperfusion VF in patients with LVH. Trial Registration: ClinicalTrials.gov ChiCTR2000035057; https://www.chictr.org.cn/showprojen.aspx?proj=57145 International Registered Report Identifier (IRRID): DERR1-10.2196/40115 %M 36705966 %R 10.2196/40115 %U https://www.researchprotocols.org/2023/1/e40115 %U https://doi.org/10.2196/40115 %U http://www.ncbi.nlm.nih.gov/pubmed/36705966 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e41013 %T Neural Correlates of the DEEPP (Anti-suicidal Response to Ketamine in Treatment-Resistant Bipolar Depression) Study: Protocol for a Pilot, Open-Label Clinical Trial %A Knyahnytska,Yuliya %A Zomorrodi,Reza %A Kaster,Tyler %A Voineskos,Daphne %A Trevizol,Alisson %A Blumberger,Daniel %+ Centre for Addiction and Mental Health, 1025 Queen Street West, Toronto, ON, Canada, 1 4165358501, Yuliya.Knyahnytska@camh.ca %K bipolar depression %K suicidality %K ketamine intervention %K neurophysiological markers of response %D 2023 %7 27.1.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: Suicide is among the top 10 leading causes of death worldwide. Of people who died by suicide, the majority are diagnosed with depression. It is estimated that 25%-60% of people with bipolar depression (BD) will attempt suicide at least once, and 10%-15% will die by suicide. Several treatments, such as lithium, clozapine, electroconvulsive therapy, and cognitive behavioral therapy, have been shown to be effective in treating suicidality. However, these treatments can be difficult to tolerate or may take months to take effect. Ketamine, a glutamate N-methyl-D-aspartate antagonist, has been shown to have rapid antisuicidal effect and antidepressant qualities, and is thus a promising intervention to target acute suicidality in patients with BD. However, the biological mechanism underlying its therapeutic action remains poorly understood. Enhancing our understanding of underlying mechanisms of action for ketamine’s effectiveness in reducing suicidality is critical to establishing biological markers of treatment response and developing tailored, personalized interventions for patients with BD. Objective: This is an open-label clinical trial to test the safety and feasibility of repeated ketamine infusions to treat acute suicidality. The primary objective is to test the safety and feasibility of ketamine intervention. The secondary objective is to examine ketamine’s potential neurophysiological mechanisms of action by assessing cortical excitation and inhibition to determine potential biomarkers of clinical response. Other objectives are to evaluate the effect of ketamine on acute suicidality and other clinical outcomes, such as depressive symptoms and quality of life, to inform a future larger trial. Methods: This open-label clinical trial aims to test the safety and feasibility of repeated ketamine infusions in patients with BD for suicidality and to assess ketamine’s neurophysiological effects. A sterile form of racemic ketamine hydrochloride will be administered over a 40-minute intravenous infusion 2 times per week on nonconsecutive days for 4 weeks (8 sessions). We will recruit 30 adults (24-65 year olds) over 2 years from an academic psychiatric hospital in Toronto, Canada. Results: This study is currently ongoing and actively recruiting participants. So far, 5 participants have completed the trial, 1 is currently in active treatment, and 8 participants are on the waitlist to be screened. We anticipate initial results being available in the fall of 2023. This proposal was presented as a poster presentation at the Research to Reality Global Summit on Psychedelic-Assisted Therapies and Medicine, held in May 2022 in Toronto, Canada. Conclusions: Developing effective interventions for acute suicidality in high-risk populations such as those with BD remains a major therapeutic challenge. Ketamine is a promising treatment due to its rapid antidepressant and antisuicidal effects, but its underlying neurophysiological mechanisms of action remain unknown. Trial Registration: ClinicalTrials.gov NCT05177146; https://clinicaltrials.gov/ct2/show/NCT05177146 International Registered Report Identifier (IRRID): DERR1-10.2196/41013 %M 36573651 %R 10.2196/41013 %U https://www.researchprotocols.org/2023/1/e41013 %U https://doi.org/10.2196/41013 %U http://www.ncbi.nlm.nih.gov/pubmed/36573651 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 12 %N %P e41812 %T FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases (FAST-01): Protocol for the First Prospective Feasibility Study %A Daugherty,Emily C %A Mascia,Anthony %A Zhang,Yong %A Lee,Eunsin %A Xiao,Zhiyan %A Sertorio,Mathieu %A Woo,Jennifer %A McCann,Claire %A Russell,Kenneth %A Levine,Lisa %A Sharma,Ricky %A Khuntia,Deepak %A Bradley,Jeffrey %A Simone II,Charles B %A Perentesis,John %A Breneman,John %+ Department of Radiation Oncology, University of Cincinnati, 234 Goodman Avenue ML0757, Cincinnati, OH, 45219, United States, 1 513 584 5327, brenemjc@ucmail.uc.edu %K bone metastases %K FLASH %K proton therapy %K external beam radiotherapy %K palliative radiotherapy %K extremities %K pain relief %K ultra-high dose rate %K radiation therapy %K cancer treatment %K toxicity %K oncology %K radiotherapy %D 2023 %7 5.1.2023 %9 Protocol %J JMIR Res Protoc %G English %X Background: In preclinical studies, FLASH therapy, in which radiation delivered at ultrahigh dose rates of ≥40 Gy per second, has been shown to cause less injury to normal tissues than radiotherapy delivered at conventional dose rates. This paper describes the protocol for the first-in-human clinical investigation of proton FLASH therapy. Objective: FAST-01 is a prospective, single-center trial designed to assess the workflow feasibility, toxicity, and efficacy of FLASH therapy for the treatment of painful bone metastases in the extremities. Methods: Following informed consent, 10 subjects aged ≥18 years with up to 3 painful bone metastases in the extremities (excluding the feet, hands, and wrists) will be enrolled. A treatment field selected from a predefined library of plans with fixed field sizes (from 7.5 cm × 7.5 cm up to 7.5 cm × 20 cm) will be used for treatment. Subjects will receive 8 Gy of radiation in a single fraction—a well-established palliative regimen evaluated in prior investigations using conventional dose rate photon radiotherapy. A FLASH-enabled Varian ProBeam proton therapy unit will be used to deliver treatment to the target volume at a dose rate of ≥40 Gy per second, using the plateau (transmission) portion of the proton beam. After treatment, subjects will be assessed for pain response as well as any adverse effects of FLASH radiation. The primary end points include assessing the workflow feasibility and toxicity of FLASH treatment. The secondary end point is pain response at the treated site(s), as measured by patient-reported pain scores, the use of pain medication, and any flare in bone pain after treatment. The results will be compared to those reported historically for conventional dose rate photon radiotherapy, using the same radiation dose and fractionation. Results: FAST-01 opened to enrollment on November 3, 2020. Initial results are expected to be published in 2022. Conclusions: The results of this investigation will contribute to further developing and optimizing the FLASH-enabled ProBeam proton therapy system workflow. The pain response and toxicity data acquired in our study will provide a greater understanding of FLASH treatment effects on tumor responses and normal tissue toxicities, and they will inform future FLASH trial designs. Trial Registration: : ClinicalTrials.gov NCT04592887; http://clinicaltrials.gov/ct2/show/NCT04592887 International Registered Report Identifier (IRRID): DERR1-10.2196/41812 %M 36206189 %R 10.2196/41812 %U https://www.researchprotocols.org/2023/1/e41812 %U https://doi.org/10.2196/41812 %U http://www.ncbi.nlm.nih.gov/pubmed/36206189 %0 Journal Article %@ 2563-6316 %I JMIR Publications %V 3 %N 4 %P e40747 %T Exercise-Induced Hypoalgesia Following Proprioceptive Neuromuscular Facilitation and Resistance Training Among Individuals With Shoulder Myofascial Pain: Randomized Controlled Trial %A Xu,Zi-Han %A An,Nan %A Wang,Zi-Ru %+ School of Sport Medicine and Rehabilitation, Beijing Sport University, 48 Xinxi Road, Haidian district, Beijing, 100084, China, 86 17888837585, 2290259311@qq.com %K exercise induced hypoalgesia %K proprioceptive neuromuscular facilitation %K PNF %K resistance exercise %K conditioned pain modulation %K myofascial pain syndrome %K resistance training %K hypoalgesia %K exercise-induced hypoalgesia %K shoulder myofascial pain %K myofascial pain %K pain management %K chronic pain %K musculoskeletal pain %K physical therapy %K physiotherapy %K shoulder pain %K upper back pain %K exercise %K pain %D 2022 %7 27.12.2022 %9 Original Paper %J JMIRx Med %G English %X Background: Various exercises can attenuate pain perception in healthy individuals and may interact with the descending pain modulation in the central nervous system. However, the analgesic effects of exercise in patients with myofascial pain can be disrupted by the pathological changes during chronic pain conditions. Thus, the exercises targeted on the facilitation of the sensory-motor interaction may have a positive impact on the restoration of the descending pain modulation and the analgesia effects. Objective: This paper estimates the effect of proprioceptive neuromuscular facilitation (PNF) and resistance training on exercise-induced hypoalgesia (EIH) and conditioned pain modulation (CPM) among patients with myofascial pain syndrome. Methods: A total of 76 female patients with myofascial pain syndrome (aged 18-30 years), with the pain in the upper trapezius and a visual analog scale score of greater than 30/100 mm, were enrolled in the study. Participants were randomly assigned into 3 intervention groups, including isometric (n=18, 24%), isotonic (n=19, 25%), and PNF (n=20, 26%) exercises, as well as 1 control group (n=19, 25%) with no intervention. Pressure pain threshold and the CPM responses at the myofascial trigger point, arm, and leg sites were assessed before and after the exercise session. The effective EIH response was reflected in the improvement of pressure pain thresholds. Results: There was an increase in pressure pain thresholds and CPM responses at trigger point (P<.001 and P<.001), arm (P<.001 and P<.001), and leg sites (P<.001 and P=.03) in participants who performed PNF and isotonic exercise, while the isometric exercise only increased pressure pain thresholds at leg sites (P=.03). Compared with the control group, both the isotonic (P=.02) and PNF (P<.001) groups showed greater EIH responses at the trigger points. In comparison to the control group, only the PNF exercise (P=.01) significantly improved pressure pain thresholds and CPM responses at arm and leg sites compared to the control group. Conclusions: PNF, isotonic, and isometric exercises could lead to local and global EIH effects. The improvement in CPM response following PNF and isotonic exercises suggested that the EIH mechanisms of different resistance exercises may be attributed to the enhancement of the endogenous pain modulation via the motor-sensory interaction from the additional eccentric and dynamic muscle contraction. Trial Registration: Chinese Clinical Trial Registry ChiCtr202111090819166165; https://tinyurl.com/2ab93p7n %M 37725522 %R 10.2196/40747 %U https://med.jmirx.org/2022/4/e40747 %U https://doi.org/10.2196/40747 %U http://www.ncbi.nlm.nih.gov/pubmed/37725522 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 11 %P e40969 %T Physical Activity Program for the Survival of Elderly Patients With Lymphoma: Study Protocol for Randomized Phase 3 Trial %A Dubu,Jonas %A Boyas,Sébastien %A Roland,Virginie %A Landry,Sébastien %A Septans,Anne-Lise %A Balavoine,Magali %A Bourgeois,Hugues %A Pointreau,Yoann %A Denis,Fabrice %A Letellier,Christophe %A Le Dû,Katell %+ ELSAN, Institut inter-regional de Cancerologie Jean Bernard, 9 rue Beauverger, Le Mans, 72000, France, 33 769510938, j.dubu@ilcgroupe.fr %K diffuse large B-cell lymphoma %K adapted physical activity %K survival %K sarcopenia %D 2022 %7 25.11.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: The practice of regular physical activity can reduce the incidence of certain cancers (colon, breast, and prostate) and improve overall survival after treatment by reducing fatigue and the risk of relapse. This impact on survival has only been demonstrated in active patients with lymphoma before and after treatment. As poor general health status reduces the chances of survival and these patients are most likely to also have sarcopenia, it is important to be able to improve their physical function through adapted physical activity (APA) as part of supportive care management. Unfortunately, APA is often saved for patients with advanced blood cancer. As a result, there is a lack of data regarding the impact of standardized regular practice of APA and concomitant chemotherapy as first-line treatment on lymphoma survival. Objective: This study aimed to assess the impact of a new and open rehabilitation program suitable for a frail population of patients treated for diffuse large B-cell lymphoma (DLBCL). Methods: PHARAOM (Physical Activity Program for the Survival of Elderly Patients with Lymphoma) is a phase 3 randomized (1:1) study focusing on a frail population of patients treated for DLBCL. The study will include 186 older adult patients with DLBCL (aged >65 years) receiving rituximab and chemotherapy. Overall, 50% (93/186) of patients (investigational group) will receive APA along with chemotherapy, and they will be supervised by a dedicated qualified kinesiologist. The APA program will include endurance and resistance training at moderate intensity 3 times a week during the 6 months of chemotherapy. The primary end point of this study will be event-free survival of the patients. The secondary end points will include the overall survival, progression-free survival, prevalence of sarcopenia and undernutrition, and patients’ quality of life. This study will be conducted in accordance with the principles of the Declaration of Helsinki. Results: Recruitment, enrollment, and data collection began in February 2021, and 4 participants have been enrolled in the study as of July 2022. Data analysis will begin after the completion of data collection. Future outcomes will be published in peer-reviewed health-related research journals and presented at national congress, and state professional meetings. This publication is based on protocol version 1.1, August 3, 2020. Conclusions: The PHARAOM study focuses on highlighting the benefits of APA intervention on survival during the period of first-line treatment of patients with DLBCL. This study could also contribute to our understanding of how an APA program can reduce complications such as sarcopenia in patients with lymphoma and improve their quality of life. By documenting the prevalence and relationship between sarcopenia and exercise load, we might be able to help physicians plan better interventions in the care of patients with DLBCL. Trial Registration: ClinicalTrials.gov NCT04670029; https://clinicaltrials.gov/ct2/show/NCT04670029 International Registered Report Identifier (IRRID): DERR1-10.2196/40969 %M 36427234 %R 10.2196/40969 %U https://www.researchprotocols.org/2022/11/e40969 %U https://doi.org/10.2196/40969 %U http://www.ncbi.nlm.nih.gov/pubmed/36427234 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 11 %P e40894 %T Percutaneous Bioelectric Current Stimulation in the Treatment of Chronic Achilles Tendinopathy: Protocol for a Double-Blind, Placebo-Controlled Randomized Multicenter Trial %A Schröder,Philipp %A Molsberger,Albrecht %A Drabik,Attyla %A Karst,Matthias %A Merk,Harry %+ Columbus Health Products GmbH, Kasernenstr 1b, Duesseldorf, 40213, Germany, 49 0211866880, ph.schroeder@mac.com %K Achilles tendinopathy %K pain %K PBCS %K conservative treatment %D 2022 %7 11.11.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: The consensus for the optimal treatment strategy for chronic Achilles tendinopathy (AT) is still debated and treatment options are limited. This results in a significant medical need for more effective treatment options. Objective: The aim of this study is to investigate the therapeutic effects of percutaneous bioelectric current stimulation (PBCS) on AT. Methods: A multicenter, randomized, double-blind, placebo-controlled clinical trial will be conducted. A total of 72 participants with chronic (ie, >3 months) midpoint AT will be randomized and receive four PBCS sessions—either verum or placebo—over 3 weeks. Both groups will complete daily Achilles tendon loading exercises in addition to the intervention. Evaluation sessions will be completed at baseline and during the intervention (weeks 0-3). Self-reported outcome measures will be completed at follow-up at weeks 4, 12, 26, and 52. The primary outcomes are the Victorian Institute of Sports Assessment–Achilles questionnaire scores and statistical evaluation of intraindividual differences between baseline and 12-week evaluations after initial treatment of verum therapy compared to control. Secondary outcomes will assess Pain Disability Index scores; average pain, using the 11-point Numeric Rating Scale; return to sports; and use of emergency medication. Results: The study began in May 2021. As of October 2022, we randomized 66 out of 72 participants. We anticipate completing recruitment by the end of 2022 and completing primary data analysis by March 2023. Conclusions: The study will evaluate the effects of PBCS on pain, physical function, and clinical outcomes. Trial Registration: German Clinical Trials Register DRKS00017293; https://tinyurl.com/mvz7s98k International Registered Report Identifier (IRRID): DERR1-10.2196/40894 %M 36325808 %R 10.2196/40894 %U https://www.researchprotocols.org/2022/11/e40894 %U https://doi.org/10.2196/40894 %U http://www.ncbi.nlm.nih.gov/pubmed/36325808 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 11 %P e37496 %T A Psychosocial Intervention for Supporting Informal Caregivers of Older People With Alzheimer Disease: Protocol for the InnFamiglia Randomized Controlled Trial %A Pasquini,Sara %A Margaritini,Arianna %A Gambella,Elena %A Di Rosa,Mirko %A Maranesi,Elvira %A Bevilacqua,Roberta %A Civerchia,Patrizia %A Pelliccioni,Giuseppe %+ IRCCS INRCA, Via Santa Margherita 5, Ancona, 60124, Italy, 39 0718004767, r.bevilacqua@inrca.it %K Alzheimer disease %K caregiver burden %K psychosocial intervention %K self-help %K emotional support %K randomized controlled trial %K dementia %D 2022 %7 11.11.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Dementia is a neurodegenerative syndrome characterized by impaired cognitive functions associated with psychological and behavioral disorders. The informal caregiver has a central role in the life of the person with dementia. Committing a large part of the day to caring for the assisted person inevitably has an effect on the caregiver’s life. Objective: The aim of this study is to analyze the impact of a psychosocial intervention dedicated to a group of informal caregivers of patients with Alzheimer disease. The intervention will be guided by a trained psychologist who will facilitate the participants’ expression of their emotional states, as compared to a traditional self-help group. Methods: The intervention described in this paper was designed and developed for the project INNovazione sociale e tecnologica per le FAMIGLIE che assistono malati affetti da Alzheimer (InnFamiglia). The study is designed as a randomized controlled trial (RCT). The RCT includes an experimental group, in which the participants will undertake the psychosocial intervention, and a control group, where participants will receive support according to traditional self-help methodology. Interventions for both groups will last 4 months and will be comprised of 16 sessions. Results: Participant recruitment, enrollment, and data collection began in 2021. Enrollment continued until September 2022, at which time the last group began the intervention. Data collection will be completed by December 2022, and data analysis will be completed by March 2023. The study findings will be published in peer-reviewed scientific journals and will be presented at scientific meetings. Summaries of the results will also be made available to investigators for dissemination within their clinics. Conclusions: We hypothesize that the experimental group will be more effective in managing caregiver burden and coping strategies and that this will improve the perception of well-being, anxiety, and depression among caregivers. Our study aims to compare two groups receiving different interventions: a self-help group and a psychosocial group with elements of emotional support. This study may also give us more information about the most appropriate ways to support and help caregivers of people with dementia. International Registered Report Identifier (IRRID): DERR1-10.2196/37496 %M 36367770 %R 10.2196/37496 %U https://www.researchprotocols.org/2022/11/e37496 %U https://doi.org/10.2196/37496 %U http://www.ncbi.nlm.nih.gov/pubmed/36367770 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 10 %P e31345 %T A Rehabilitation Program for Individuals With Chronic Low Back Pain: Protocol for a Randomized Clinical Trial %A Junkes-Cunha,Maíra %A Sieczkowska,Sofia Mendes %A Vilarino,Guilherme Torres %A Bevilacqua,Guilherme %A Andrade,Alexandro %+ Federal University of Pelotas (UFPel), School of Physical Education (ESEF), R. Luís de Camões, 625 - Tres Vendas, Rio Grande do Sul., Pelotas, 96055-630, Brazil, 55 48999099897, mairajunkes@gmail.com %K low back pain %K chronic pain %K therapeutic exercise %K pain education %D 2022 %7 31.10.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Low back pain (LBP) is the leading cause of disability worldwide. Physical exercise, as a treatment, is beneficial for the improvement of quality of life in patients with LBP, and it is widely accepted. Objective: We aimed to develop a protocol for a feasibility study that is designed to compare the effectiveness of different interventions in reducing pain, functional, and psychosocial factors among patients with chronic LBP after 8 weeks of randomization. Methods: This is a study protocol for a randomized controlled trial that will consist of individuals with chronic LBP who are aged between 18 and 65 years. Participants will be allocated, through block randomization, to one of the following groups: the motor control exercises (MCEs), pain education, MCEs+pain education, and usual care groups. The primary outcome will be pain intensity, and the secondary outcomes will be the pressure pain threshold, which will be measured with a digital algometer; LBP-related disability; fears and beliefs; the fear of movement; quality of life; mood states; and levels of depression and anxiety. The trial was approved by the ethics committee for research involving human beings of the Federal University of Pelotas (reference number: 5.717.390) in September 2022, and it will be conducted until August 2023. Results: The researchers are being trained to apply the questionnaires and carry out the interventions. Patient recruitment will begin at the end of 2022 and results are expected to be achieved by August 2023. Conclusions: Our trial will provide preliminary data regarding the feasibility and safety of MCEs and pain education for patients with LBP. It will also provide preliminary outcome data that can be used to identify the most efficient intervention and the level of health care that should be implemented in public health services. Trial Registration: Brazilian Registry of Clinical Trials U1111-1221-4106; https://ensaiosclinicos.gov.br/rg/RBR-2xx2r2/ International Registered Report Identifier (IRRID): PRR1-10.2196/31345 %M 36315232 %R 10.2196/31345 %U https://www.researchprotocols.org/2022/10/e31345 %U https://doi.org/10.2196/31345 %U http://www.ncbi.nlm.nih.gov/pubmed/36315232 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 10 %P e42373 %T The PharmNet Harm Reduction Intervention for Community Pharmacies: Protocol for a Pilot Randomized Controlled Trial %A Eldridge,Lori Ann %A Agley,Jon %A Meyerson,Beth E %A Golzarri-Arroyo,Lilian %+ Prevention Insights, Department of Applied Health Science, School of Public Health Bloomington, Indiana University Bloomington, 809 E 9th St, Bloomington, IN, 47405, United States, 1 812 855 3123, jagley@indiana.edu %K naloxone %K opioid %K overdose %K pharmacy %K randomized controlled trial %K RCT %K opioid use %K digital health intervention %K community health %K drug use %K prevention %K PharmNet %K health resources %K health outcome %D 2022 %7 24.10.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: The overdose epidemic in the United States has continued to worsen despite substantial efforts to mitigate its harms. The opioid antagonist naloxone has been identified as a key means of reducing the prevalence of fatal overdoses. An important evidence-based approach to optimizing naloxone’s impact is to seed it throughout the community, because bystanders are often able to reverse overdoses more quickly than first responders and sometimes are the only possible means of overdose reversal. As part of a multipronged approach to distributing naloxone nationwide, community pharmacies have been identified as ideal venues for naloxone dispensing, especially under standing orders. However, dispensing rates remain surprisingly low, and there is a need to understand how best to engage community pharmacies in naloxone-based harm reduction services. Objective: The objective of this trial is to determine whether a tailored, pragmatic pharmacy intervention (PharmNet) results in greater naloxone dispensing relative to baseline (the prior 3 months) compared to a control condition. This pilot trial is intended to determine whether it is appropriate to invest the substantial resources that would be required to conduct a full-scale, randomized controlled study of PharmNet. Methods: We will conduct a 3-month randomized controlled pilot trial consisting of 2 parallel groups with a 4:3 allocation ratio. A group of 7 independent pharmacies from rural areas in Indiana will be randomly assigned to either the PharmNet intervention arm (n=4) or the control arm (n=3). The primary outcome will be overall naloxone dispensing (both at cost and free), and secondary outcomes will include the distribution of referral cards and multiple variables at the level of individual staff members. Dispensing data will be collected for the 3 months prior to the intervention and the 3 months of the intervention, and all other data will be collected using a pretest-posttest design. The primary analysis will be a generalized linear mixed model with a Poisson distribution with fixed effects for group, time, and their interaction and a random effect for pharmacy ID to account for repeated measures within pharmacies. Results: This study was approved by the Indiana University institutional review board in 2 phases (August 2, 2021, and April 26, 2022) and was funded by the Indiana University Grand Challenge: Responding to the Addictions Crisis. Conclusions: If this study produces evidence that the PharmNet intervention results in increased naloxone dispensing relative to control pharmacies, it will be both appropriate and important to study it in a large, full-scale randomized controlled trial. International Registered Report Identifier (IRRID): PRR1-10.2196/42373 %M 36279161 %R 10.2196/42373 %U https://www.researchprotocols.org/2022/10/e42373 %U https://doi.org/10.2196/42373 %U http://www.ncbi.nlm.nih.gov/pubmed/36279161 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 10 %P e38715 %T Providing Accessible ReCreation Outdoors–User-Driven Research on Standards: Protocol for Mobile and Web-Based Interviews for Winter Assessments %A Prescott,Mike %A Gamache,Stéphanie %A Mortenson,W Ben %A Best,Krista L %A Grandisson,Marie %A Mostafavi,Mir Abolfazl %A Labbé,Delphine %A Morales,Ernesto %A Mahmood,Atiya %A Borisoff,Jaimie %A Sawatzky,Bonita %A Miller,William C %A Bulk,Laura Yvonne %A Robillard,Julie M %A Routhier,François %+ Center for Interdisciplinary Research in Rehabilitation and Social Integration, Centre Intégré Universitaire de Santé et de Services Sociaux de la Capitale-Nationale, 525, boulevard Hamel, Québec, QC, G1M 2S8, Canada, 1 418 529 9141 ext 6256, francois.routhier@rea.ulaval.ca %K parks %K accessibility %K standards %K user-oriented research %K winter %K disability %K access %K participatory %K national parks %K barriers %K participation %K Canada %K national park %K participation %K outdoor %K activity %K standard %K interview %K safe %K virtual %K summer %K data %K mix-method %K development %D 2022 %7 7.10.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Although there have been recent efforts to improve access to Canadian national parks, many remain not fully accessible to people with disabilities. Winter conditions, in particular, present challenges that limit their participation in outdoor activities. Objective: This study aimed to develop a novel method to assess park access during winter, which will inform recommendations for national park standards to meet the needs of all park visitors (regardless of ability) during winter conditions. Methods: A larger participatory mixed methods research project exploring park access was adapted. A 3-phase approach has already been proposed to achieve the study objectives. In the first phase, a scoping review of the existing accessibility standards will be conducted. In the second phase, objective audits of trails and features in 6 parks, 3 in western Canada and 3 in eastern Canada, will be conducted, as well as mobile interviews with 24 various participants in each region regarding their experiences of and recommendations for improving the park’s accessibility. In the final phase, a Delphi participatory consensus development process will be used, based on the data gathered in the first 2 phases, to prioritize recommendations for standards. This paper will focus on the second phase of the study, specifically on whether the in-person winter mobile interviews (ie, walking and wheeling interviews) with people who have a wide range of disabilities while visiting 3 parks in 2 provinces were modified. Changes were made to accommodate the extreme winter weather conditions in Quebec while using safe and informative data collection methods. Results: In Quebec, one park, where winter conditions are safer, has been assessed in person (n=4). Web-based interviews were used to facilitate the assessment of other winter and summer conditions in two other parks (n=8). Winter and web-based interviews were completed in April 2022. Data are currently being collected and analyzed, and results will be completed by December 2022. Conclusions: We expect that adapting the protocol to gather further information on winter conditions and access to parks will provide high-quality and rich data to better inform park access standards. This participatory mixed methods research will inform the development of park standards that consider the accessibility needs of all people. International Registered Report Identifier (IRRID): DERR1-10.2196/38715 %M 36206037 %R 10.2196/38715 %U https://www.researchprotocols.org/2022/10/e38715 %U https://doi.org/10.2196/38715 %U http://www.ncbi.nlm.nih.gov/pubmed/36206037 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 10 %P e39856 %T A Positive Emotion–Focused Intervention to Increase Physical Activity After Bariatric Surgery: Protocol for a Pilot Randomized Controlled Trial %A Feig,Emily H %A Harnedy,Lauren E %A Thorndike,Anne N %A Psaros,Christina %A Healy,Brian C %A Huffman,Jeff C %+ Department of Psychiatry, Massachusetts General Hospital, 55 Fruit St, Boston, MA, 02114, United States, 1 617 724 9140, efeig@mgh.harvard.edu %K behavioral intervention %K physical activity %K positive psychology %K design %K bariatric surgery %K positive %K psychological %K well-being %K weight loss %K intervention %K feasibility %K acceptability %K efficacy %K effect %K obesity %K weight %D 2022 %7 6.10.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Physical activity levels after bariatric surgery are usually low, despite the significant protective health benefits of physical activity in this population. Positive psychological well-being is associated with improved adherence to health behaviors, but bariatric surgery patients often have negative associations with physical activity that prevent sustained engagement. Objective: The Gaining Optimism After weight Loss Surgery (GOALS) pilot randomized controlled trial is aimed at testing a novel intervention to increase physical activity after bariatric surgery, which incorporates positive psychological skill-building with motivational interviewing and goal-setting. Methods: The GOALS trial is a 2-arm, 24-week pilot randomized controlled trial that aims to enroll 58 adults who report less than 200 minutes per week of moderate to vigorous physical activity and a desire to become more active 6-12 months after bariatric surgery. GOALS is testing the feasibility, acceptability, and preliminary efficacy of a positive psychology–motivational interviewing telephone intervention targeting to increase physical activity and associated positive affect. Intervention components include positive psychology, goal-setting, self-monitoring via provided Fitbits, and motivational interviewing to overcome barriers and increase motivation. The intervention is compared to a physical activity education control that includes mailings with psychoeducation around physical activity and provision of a Fitbit. The primary outcomes of the pilot trial are feasibility and acceptability, measured as session completion rates and participant ratings of ease and helpfulness of each session. The main secondary outcome is change in accelerometer-measured moderate to vigorous physical activity post intervention and at 24-week follow-up. Additional outcomes include changes in attitudes related to physical activity, psychological well-being, and physical health measures. Results: This multiphase project was funded in 2020 and institutional review board approval was obtained for the proposed trial in 2021. Recruitment for the randomized controlled trial began in July 2022. Upon completion of the pilot trial, we will examine the feasibility, acceptability, and preliminary efficacy of the intervention. Conclusions: Although bariatric surgery is the most effective treatment available for severe obesity, weight regain occurs, often in the context of low psychological well-being. Many individuals would benefit from learning strategies to increase positive psychological well-being after bariatric surgery, which could help them maintain lifestyle changes. Positive psychology is a novel approach to improve adherence by increasing positive associations with health behaviors including physical activity. The GOALS pilot trial will determine whether this type of intervention is feasible and acceptable to this population and will provide a foundation for a future full-scale randomized controlled efficacy trial. Trial Registration: ClinicalTrials.gov NCT04868032; https://clinicaltrials.gov/ct2/show/NCT04868032 International Registered Report Identifier (IRRID): PRR1-10.2196/39856 %M 36201380 %R 10.2196/39856 %U https://www.researchprotocols.org/2022/10/e39856 %U https://doi.org/10.2196/39856 %U http://www.ncbi.nlm.nih.gov/pubmed/36201380 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 9 %P e39843 %T Optimized Informed Consent for Psychotherapy: Protocol for a Randomized Controlled Trial %A Gerke,Leonie %A Ladwig,Sönke %A Pauls,Franz %A Trachsel,Manuel %A Härter,Martin %A Nestoriuc,Yvonne %+ Clinical Psychology, Helmut-Schmidt-University/University of the Federal Armed Forces Hamburg, Holstenhofweg 85, Hamburg, 22043, Germany, 49 40 6541 2461, gerkel@hsu-hh.de %K expectation management %K psychiatry %K risks and side effects of psychotherapy %K risk %K counseling %K consent %K shared decision-making %K decision-making %K ethics %K nocebo effect %K side effect %K adverse effect %K psychotherapy %K mental health %K nocebo %D 2022 %7 30.9.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Informed consent is a legal and ethical prerequisite for psychotherapy. However, in clinical practice, consistent strategies to obtain informed consent are scarce. Inconsistencies exist regarding the overall validity of informed consent for psychotherapy as well as the disclosure of potential mechanisms and negative effects, the latter posing a moral dilemma between patient autonomy and nonmaleficence. Objective: This protocol describes a randomized controlled web-based trial aiming to investigate the efficacy of a one-session optimized informed consent consultation. Methods: The optimized informed consent consultation was developed to provide information on the setting, efficacy, mechanisms, and negative effects via expectation management and shared decision-making techniques. A total of 122 participants with an indication for psychotherapy will be recruited. Participants will take part in a baseline assessment, including a structured clinical interview for Diagnostic and Statistical Manual of Mental Disorders-fifth edition (DSM-5) disorders. Eligible participants will be randomly assigned either to a control group receiving an information brochure about psychotherapy as treatment as usual (n=61) or to an intervention group receiving treatment as usual and the optimized informed consent consultation (n=61). Potential treatment effects will be measured after the treatment via interview and patient self-report and at 2 weeks and 3 months follow-up via web-based questionnaires. Treatment expectation is the primary outcome. Secondary outcomes include the capacity to consent, decisional conflict, autonomous treatment motivation, adherence intention, and side-effect expectations. Results: This trial received a positive ethics vote by the local ethics committee of the Center for Psychosocial Medicine, University-Medical Center Hamburg-Eppendorf, Hamburg, Germany on April 1, 2021, and was prospectively registered on June 17, 2021. The first participant was enrolled in the study on August 5, 2021. We expect to complete data collection in December 2022. After data analysis within the first quarter of 2023, the results will be submitted for publication in peer-reviewed journals in summer 2023. Conclusions: If effective, the optimized informed consent consultation might not only constitute an innovative clinical tool to meet the ethical and legal obligations of informed consent but also strengthen the contributing factors of psychotherapy outcome, while minimizing nocebo effects and fostering shared decision-making. Trial Registration: PsychArchives; http://dx.doi.org/10.23668/psycharchives.4929 International Registered Report Identifier (IRRID): DERR1-10.2196/39843 %M 36178713 %R 10.2196/39843 %U https://www.researchprotocols.org/2022/9/e39843 %U https://doi.org/10.2196/39843 %U http://www.ncbi.nlm.nih.gov/pubmed/36178713 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 9 %P e40025 %T Melatonin for Neuropathic Pain: Protocol for a Double-blind, Randomized Controlled Trial %A Gilron,Ian %A Tu,Dongsheng %A Holden,Ronald R %A Moulin,Dwight E %A Duggan,Scott %A Milev,Roumen %+ Department of Anesthesiology & Perioperative Medicine, Queen's University, 76 Stuart Street, Victory 2 Pavillion, Kingston, ON, K7L2V7, Canada, 1 613 549 6666 ext 3963, gilroni@queensu.ca %K melatonin %K neuropathic pain %K chronic pain %K sleep %K analgesic therapy %K placebo %K clinical trials %K neuropathic %K pain %K nonopioid %K treatment %K efficacy %K insomnia %K placebo %K preclinical %K clinical %D 2022 %7 28.9.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Neuropathic pain (NP), a complication of several conditions (eg, diabetic neuropathy and varicella zoster), is a common challenging problem, and there is a growing need to develop safe and effective nonopioid treatments. Sleep disturbance is commonly associated with NP because pain intensity in NP conditions is often worse at night. The pineal hormone melatonin has been shown to reduce pain in both preclinical and clinical settings, in addition to multiple trials demonstrating efficacy for primary insomnia and delayed sleep phase syndrome. Objective: We propose to conduct a clinical trial to evaluate the efficacy and safety of melatonin for NP. Methods: Using a double-blind, placebo-controlled, crossover design, 30 adults with NP will be randomly allocated to one of two sequences of treatment with melatonin and placebo. During each of the two treatment periods, participants will take capsules containing melatonin or placebo for 4 weeks, followed by a 7-day washout period. The primary outcome will be mean daily pain intensity (scored 0-10) at maximally tolerated doses (MTDs) during each period. Secondary outcomes, assessed at MTDs, will include global improvement, adverse events, mood, and quality of life. Results: This trial was registered in the International Standard Randomized Controlled Trial registry May 4, 2022 (ISRCTN #16215617), attained conditional ethics approval May 9, 2022 (Queen’s University Health Sciences & Affiliated Teaching Hospitals Research Ethics Board protocol number ANAE-387-22), and recruitment is set to start August 2022. Conclusions: This trial will provide rigorous evidence comparing the efficacy of melatonin to that of placebo in the treatment of NP. Trial Registration: ISRCTN Registry 16215617; https://www.isrctn.com/ISRCTN16215617 International Registered Report Identifier (IRRID): PRR1-10.2196/40025 %M 36170003 %R 10.2196/40025 %U https://www.researchprotocols.org/2022/9/e40025 %U https://doi.org/10.2196/40025 %U http://www.ncbi.nlm.nih.gov/pubmed/36170003 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 9 %P e37965 %T A Care Concept of Community Health Nursing Interventions for Adults With Chronic Health Conditions in an Urban Area: Protocol for a Randomized Controlled Field Trial (CoSta Study) %A Nock,Annike Morgane %A Iversen,Linda %A Waidhas,Lukas %A Zapf,Antonia %A Seifert,Caroline %A Petersen-Ewert,Corinna %+ Department of Nursing and Management, Hamburg University of Applied Sciences, Campus Alexanderstraße, Alexanderstraße 1, Hamburg, 20099, Germany, 49 40 428 757128, Annike.Nock@haw-hamburg.de %K community health nursing %K chronic health conditions %K randomized controlled trial %K community-based program %K health-related quality of life %K nurse-led consultation %K nursing %K nurse %K intervention %K urban %K protocol %K Germany %K adults %D 2022 %7 28.9.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Implementing community health nursing programs is a new field of application in the primary health sector of Germany. Hence, there is limited evidence of effective community-based and nurse-led interventions with regard to the German health care system. International research findings are mostly not transferable. The Community Health Nursing in der Stadt (CoSta; ie, “Community Health Nursing in the City”) project is the first study that examines a community health nurse–led intervention for adults with chronic health conditions. Objective: This study protocol describes the design and methods of a randomized controlled field trial that will investigate if a community health nurse–based intervention has an impact on health-related quality of life in adults with chronic conditions. Methods: The study was designed as a randomized controlled trial that will be conducted under real-life conditions in the field. In a 4-month period, patients with at least 1 chronic International Classification of Diseases, Tenth Revision, diagnosis will be enrolled. Participants will be randomly allocated to an intervention group or a control group. The sample size was assumed based on an effect size of 0.50 with a significance level of .05, using a 2-sided (2-tailed), 2-sample unequal variance t test. The control group will be treated as usual. The intervention group will receive—in addition to the usual treatment—preventive home visits; consultations; and educative training, which will be offered by 2 community health nurses for up to 12 months. Both groups will be followed up at baseline, after 6 months, and after 12 months. The primary outcome measure is the mental component summary score from the 36-Item Short Form Health Survey after 12-months. Secondary patient outcomes will be included. The study received ethics approval from the Competence Health Center’s institutional review board at the University of Applied Sciences Hamburg (procedure number: 2020-14). Results: The CoSta project was funded by the Federal Ministry of Education and Research Germany (contract number: 13FH019SX8). In total, 187 participants were recruited at the beginning of August 2021. Further, 92 were excluded and 94 were randomized. Data collection will be conducted until the end of 2022. Conclusions: Our study will provide data with regard to the effectiveness of community nurse–led interventions that focus on the treatment of vulnerable adults with chronic health conditions in a community health center. In secondary analyses, the associations among influencing social factors (education, income, and employment) will be examined. We expect results that will help reduce the research-to-practice gap. Trial Registration: German Clinical Trials Register DRKS00026164; https://tinyurl.com/yckxc5ut International Registered Report Identifier (IRRID): DERR1-10.2196/37965 %M 36170005 %R 10.2196/37965 %U https://www.researchprotocols.org/2022/9/e37965 %U https://doi.org/10.2196/37965 %U http://www.ncbi.nlm.nih.gov/pubmed/36170005 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 9 %P e38950 %T Therapist-Delivered Versus Care Ally–Assisted Massage for Veterans With Chronic Neck Pain: Protocol for a Randomized Controlled Trial %A Munk,Niki %A Daggy,Joanne K %A Evans,Erica %A Kline,Matthew %A Slaven,James E %A Laws,Brian %A Foote,Trevor %A Matthias,Marianne S %A Bair,Matthew J %+ Department of Health Sciences, School of Health and Human Sciences, Indiana University, 901 W. New York Street, Indianapolis, IN, 46202, United States, 1 317 278 8658, nmunk@iu.edu %K Veterans %K chronic neck pain %K integrative medicine %K whole health %K modified trial design %K therapist-delivered versus care ally–assisted massage for Veterans with chronic neck pain %K TOMCATT %D 2022 %7 27.9.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Chronic neck pain (CNP) is prevalent, and it reduces functional status and quality of life and is associated with deleterious psychological outcomes in affected individuals. Despite the desirability of massage and its demonstrated effectiveness in CNP treatment, multiple accessibility barriers exist. Caregiver-applied massage has demonstrated feasibility in various populations but has not been examined in Veterans with CNP or compared in parallel to therapist-delivered massage. Objective: This manuscript described the original study design, lessons learned, and resultant design modifications for the Trial Outcomes for Massage: Care Ally–Assisted Versus Therapist-Treated (TOMCATT) study. Methods: TOMCATT began as a 3-arm, randomized controlled trial of 2 massage delivery approaches for Veterans with CNP with measures collected at baseline, 1 and 3 months after intervention, and 6 months (follow-up). Arm I, care ally–assisted massage, consisted of an in-person, 3.5-hour training workshop, an instructional DVD, a printed treatment manual, and three 30-minute at-home care ally–assisted massage sessions weekly for 3 months. Arm II, therapist-treated massage, consisted of two 60-minute sessions tailored to individual pain experiences and treatments per week for 3 months. The treatments followed a standardized Swedish massage approach. Arm III consisted of wait-list control. Results: Retention and engagement challenges in the first 30 months were significant in the care ally–assisted massage study arm (63% attrition between randomization and treatment initiation) and prompted modification to a 2-arm trial, that is, removing arm I. Conclusions: The modified TOMCATT study successfully launched and exceeded recruitment goals 2.5 months before the necessary COVID-19 pause and is expected to be completed by early 2023. Trial Registration: ClinicalTrials.gov NCT03100539; https://clinicaltrials.gov/ct2/show/NCT03100539 International Registered Report Identifier (IRRID): DERR1-10.2196/38950 %M 36166287 %R 10.2196/38950 %U https://www.researchprotocols.org/2022/9/e38950 %U https://doi.org/10.2196/38950 %U http://www.ncbi.nlm.nih.gov/pubmed/36166287 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 9 %P e37823 %T Mindfulness-Based Stress Reduction, Cognitive Behavioral Therapy, and Acupuncture in Chronic Low Back Pain: Protocol for Two Linked Randomized Controlled Trials %A Mackey,Sean %A Gilam,Gadi %A Darnall,Beth %A Goldin,Philippe %A Kong,Jiang-Ti %A Law,Christine %A Heirich,Marissa %A Karayannis,Nicholas %A Kao,Ming-Chih %A Tian,Lu %A Manber,Rachel %A Gross,James %+ Division of Pain Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University, 1070 Arastradero Road, Suite 200, Palo Alto, CA, 94304, United States, 1 650 498 6477, smackey@stanford.edu %K mind-body therapies %K chronic low back pain %K nonpharmacologic treatments %K neuroimaging %D 2022 %7 27.9.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Nonpharmacologic mind-body therapies have demonstrated efficacy in low back pain. However, the mechanisms underlying these therapies remain to be fully elucidated. Objective: In response to these knowledge gaps, the Stanford Center for Low Back Pain—a collaborative, National Institutes of Health P01–funded, multidisciplinary research center—was established to investigate the common and distinct biobehavioral mechanisms of three mind-body therapies for chronic low back pain: cognitive behavioral therapy (CBT) that is used to treat pain, mindfulness-based stress reduction (MBSR), and electroacupuncture. Here, we describe the design and implementation of the center structure and the associated randomized controlled trials for characterizing the mechanisms of chronic low back pain treatments. Methods: The multidisciplinary center is running two randomized controlled trials that share common resources for recruitment, enrollment, study execution, and data acquisition. We expect to recruit over 300 chronic low back pain participants across two projects and across different treatment arms within each project. The first project will examine pain-CBT compared with MBSR and a wait-list control group. The second project will examine real versus sham electroacupuncture. We will use behavioral, psychophysical, physical measure, and neuroimaging techniques to characterize the central pain modulatory and emotion regulatory systems in chronic low back pain at baseline and longitudinally. We will characterize how these interventions impact these systems, characterize the longitudinal treatment effects, and identify predictors of treatment efficacy. Results: Participant recruitment began on March 17, 2015, and will end in March 2023. Recruitment was halted in March 2020 due to COVID-19 and resumed in December 2021. Conclusions: This center uses a comprehensive approach to study chronic low back pain. Findings are expected to significantly advance our understanding in (1) the baseline and longitudinal mechanisms of chronic low back pain, (2) the common and distinctive mechanisms of three mind-body therapies, and (3) predictors of treatment response, thereby informing future delivery of nonpharmacologic chronic low back pain treatments. Trial Registration: ClinicalTrials.gov NCT02503475; https://clinicaltrials.gov/ct2/show/NCT02503475 International Registered Report Identifier (IRRID): PRR1-10.2196/37823 %M 36166279 %R 10.2196/37823 %U https://www.researchprotocols.org/2022/9/e37823 %U https://doi.org/10.2196/37823 %U http://www.ncbi.nlm.nih.gov/pubmed/36166279 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 9 %P e36403 %T Feasibility, Acceptability, and Protective Efficacy of Seasonal Malaria Chemoprevention Implementation in Nampula Province, Mozambique: Protocol for a Hybrid Effectiveness-Implementation Study %A Baker,Kevin %A Aide,Pedro %A Bonnington,Craig A %A Rassi,Christian %A Richardson,Sol %A Roca-Feltrer,Arantxa %A Rodrigues,Maria %A Sitoe,Mercia %A Pulido Tarquino,Ivan Alejandro %A Enosse,Sonia %A McGugan,Caitlin %A de Carvalho,Eva Amelia %A Saute,Francisco %A Mayor Aparicio,Alfredo Gabriel %A Candrinho,Baltazar %+ Department of Public Health Sciences, Karolinska Institute, Tomtebodavagen 18A, Stockholm, 17177, Sweden, 44 7811266539, kevin.baker@ki.se %K malaria %K chemoprevention %K children %K protocol %K Nampula %K Mozambique %K feasibility %K effectiveness %K mixed methods %K SMC %K SP+AQ %K hybrid effectiveness %K cRCT %D 2022 %7 23.9.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Seasonal malaria chemoprevention (SMC) is a highly effective community-based intervention to prevent malaria infections in areas where the malaria burden is high and transmission occurs mainly during the rainy season. In Africa, so far, SMC has been implemented in the Sahel region. Mozambique contributes 4% of the global malaria cases, and malaria is responsible for one-quarter of all deaths in the country. Based on recommendations in the Malaria Strategic Plan, the Malaria Consortium, in partnership with the National Malaria Control Programme in Mozambique, initiated a phased SMC implementation study in the northern province of Nampula. The first phase of this 2-year implementation study was conducted in 2020-2021 and focused on the feasibility and acceptability of SMC. The second phase will focus on demonstrating impact. This paper describes phase 2 of the implementation study. Objective: Specific objectives include the following: (1) to determine the effectiveness of SMC in terms of its reduction in incidence of malaria infection among children aged 3 to 59 months; (2) to determine the chemoprevention efficacy of sulfadoxine-pyrimethamine plus amodiaquine (SP+AQ) when used for SMC in Nampula Province, Mozambique, and the extent to which efficacy is impacted by drug resistance and drug concentrations; (3) to investigate the presence and change in SP+AQ– and piperaquine-resistance markers over time as a result of SMC implementation; and (4) to understand the impact of the SMC implementation model, determining the process and acceptability outcomes for the intervention. Methods: This type 2, hybrid, effectiveness-implementation study uses a convergent mixed methods approach. SMC will be implemented in four monthly cycles between December 2021 and March 2022 in four districts of Nampula Province. Phase 2 will include four components: (1) a cluster randomized controlled trial to establish confirmed malaria cases, (2) a prospective cohort to determine the chemoprevention efficacy of the antimalarials used for SMC and whether drug concentrations or resistance influence the duration of protection, (3) a resistance marker study in children aged 3 to 59 months to describe changes in resistance marker prevalence over time, and (4) a process evaluation to determine feasibility and acceptability of SMC. Results: Data collection began in mid-January 2022, and data analysis is expected to be completed by October 2022. Conclusions: This is the first effectiveness trial of SMC implemented in Mozambique. The findings from this trial will be crucial to policy change and program expansion to other suitable geographies outside of the Sahel. The chemoprevention efficacy cohort study is a unique opportunity to better understand SMC drug efficacy in this new SMC environment. Trial Registration: ClinicalTrials.gov NCT05186363; https://clinicaltrials.gov/ct2/show/NCT05186363 International Registered Report Identifier (IRRID): DERR1-10.2196/36403 %M 36149743 %R 10.2196/36403 %U https://www.researchprotocols.org/2022/9/e36403 %U https://doi.org/10.2196/36403 %U http://www.ncbi.nlm.nih.gov/pubmed/36149743 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 9 %P e38866 %T The Impact of the COVID-19 Pandemic on Perinatal Loss Experienced by the Parental Couple: Protocol for a Mixed Methods Study %A Cena,Loredana %A Trainini,Alice %A Tralli,Nella %A Nodari,Luisa Silvia %A Iacona,Erika %A Ronconi,Lucia %A Testoni,Ines %+ Observatory of Perinatal Clinical Psychology, Department of Clinical and Experimental Science, University of Brescia, Viale Europa 11, Brescia, 25123, Italy, 39 0303717274, loredana.cena@unibs.it %K COVID-19 pandemic %K perinatal loss %K bereavement care %K mourning %K anxiety %K depression %K posttraumatic stress disorder %K COVID-19 %K pandemic %K psychological %K bereavement %K miscarriage %K stillbirth %K neonatal death %K parent %K experience %K coping %K grief %D 2022 %7 12.9.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: At the beginning of 2020, mothers and fathers who experienced perinatal events (from conception to pregnancy and postpartum period) found themselves facing problems related to the emergency caused by the COVID-19 pandemic and the associated difficulties for health care centers in providing care. In the unexpected and negative event of perinatal loss (ie, miscarriage, stillbirth, and neonatal death) more complications occurred. Perinatal loss is a painful and traumatic life experience that causes grief and can cause affective disorders in the parental couple—the baby dies and the couple’s plans for a family are abruptly interrupted. During the COVID-19 pandemic, limited access to perinatal bereavement care, due to the lockdown measures imposed on medical health care centers and the social distancing rules to prevent contagion, was an additional risk factor for parental mental health, such as facing a prolonged and complicated grief. Objective: The main aims of this study are as follows: to investigate the impact of COVID-19 on mothers and fathers who experienced perinatal loss during the pandemic, comparing their perceptions; to evaluate their change over time between the first survey administration after bereavement and the second survey after 6 months; to examine the correlations between bereavement and anxiety, depression, couple satisfaction, spirituality, and sociodemographic variables; to investigate which psychosocial factors may negatively affect the mourning process; and to identify the potential predictors of the development of complicated grief. Methods: This longitudinal observational multicenter study is structured according to a mixed methods design, with a quantitative and qualitative section. It will include a sample of parents (mothers and fathers) who experienced perinatal loss during the COVID-19 pandemic from March 2020. There are two phases—a baseline and a follow-up after 6 months. Results: This protocol was approved by the Ethics Committee of Psychological Research, University of Padova, and by the Institutional Ethics Board of the Spedali Civili of Brescia, Italy. We expect to collect data from 34 or more couples, as determined by our sample size calculation. Conclusions: This study will contribute to the understanding of the psychological processes related to perinatal loss and bereavement care during the COVID-19 pandemic. It will provide information useful to prevent the risk of complicated grief and psychopathologies among bereaved parents and to promote perinatal mental health. International Registered Report Identifier (IRRID): DERR1-10.2196/38866 %M 36044641 %R 10.2196/38866 %U https://www.researchprotocols.org/2022/9/e38866 %U https://doi.org/10.2196/38866 %U http://www.ncbi.nlm.nih.gov/pubmed/36044641 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 9 %P e41747 %T Using Normative Language When Describing Scientific Findings: Protocol for a Randomized Controlled Trial of Effects on Trust and Credibility %A Agley,Jon %A Xiao,Yunyu %A Thompson,Esi E %A Golzarri-Arroyo,Lilian %+ Prevention Insights, Department of Applied Health Science, School of Public Health Bloomington, Indiana University Bloomington, 809 E 9th St, Bloomington, IN, 47405, United States, 1 812 855 3123, jagley@indiana.edu %K trust %K trust in science %K scientific communication %K meta-science %K RCT %K randomized controlled trial %K infodemic %K COVID-19 %K misinformation %K normative language %K meta-cognitive %K cognitive %K scientific information %K credible %K credibility %D 2022 %7 9.9.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Trust in science and scientists has received renewed attention because of the “infodemic” occurring alongside COVID-19. A robust evidence basis shows that such trust is associated with belief in misinformation and willingness to engage in public and personal health behaviors. At the same time, trust and the associated construct of credibility are complex meta-cognitive concepts that often are oversimplified in quantitative research. The discussion of research often includes both normative language (what one ought to do based on a study’s findings) and cognitive language (what a study found), but these types of claims are very different, since normative claims make assumptions about people’s interests. Thus, this paper presents a protocol for a large randomized controlled trial to experimentally test whether some of the variability in trust in science and scientists and perceived message credibility is attributable to the use of normative language when sharing study findings in contrast to the use of cognitive language alone. Objective: The objective of this trial will be to examine if reading normative and cognitive claims about a scientific study, compared to cognitive claims alone, results in lower trust in science and scientists as well as lower perceived credibility of the scientist who conducted the study, perceived credibility of the research, trust in the scientific information on the post, and trust in scientific information coming from the author of the post. Methods: We will conduct a randomized controlled trial consisting of 2 parallel groups and a 1:1 allocation ratio. A sample of 1500 adults aged ≥18 years who represent the overall US population distribution by gender, race/ethnicity, and age will randomly be assigned to either an “intervention” arm (normative and cognitive claims) or a control arm (cognitive claims alone). In each arm, participants will view and verify their understanding of an ecologically valid claim or set of claims (ie, from a highly cited, published research study) designed to look like a social media post. Outcomes will be trust in science and scientists, the perceived credibility of the scientist who conducted the study, the perceived credibility of the research, trust in the scientific information on the post, and trust in scientific information coming from the author of the post. Analyses will incorporate 9 covariates. Results: This study will be conducted without using any external funding mechanisms. Conclusions: If there is a measurable effect attributable to the inclusion of normative language when writing about scientific findings, it should generate discussion about how such findings are presented and disseminated. Trial Registration: Open Science Framework n7yfc; https://osf.io/n7yfc International Registered Report Identifier (IRRID): PRR1-10.2196/41747 %M 36044639 %R 10.2196/41747 %U https://www.researchprotocols.org/2022/9/e41747 %U https://doi.org/10.2196/41747 %U http://www.ncbi.nlm.nih.gov/pubmed/36044639 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 8 %P e35729 %T Reducing New Chlamydia Infection Among Young Men by Promoting Correct and Consistent Condom Use: Protocol for a Randomized Controlled Trial %A Stone,Nicole %A Bedford,Rowena %A Newby,Katie %A Brown,Katherine %A Jackson,Louise %A Bremner,Stephen %A Morrison,Leanne %A McGrath,Nuala %A Nadarzynski,Tom %A Bayley,Jake %A Perry,Nicky %A Graham,Cynthia %+ Department of Psychology, Faculty of Environmental and Life Sciences, University of Southampton, University Road, Highfield, Southampton, SO17 1BJ, United Kingdom, 44 07871310526, C.A.Graham@soton.ac.uk %K condom fit and feel %K condom use %K pleasure %K digital intervention %K sexual behavior %K health psychology %K behavior intervention %K chlamydia %K sexual health %K randomized controlled trial %D 2022 %7 10.8.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: The health, social, and economic costs of sexually transmitted infections (STIs) represent a major public health concern. Young people are considered one of the groups most at risk for acquiring and transmitting STIs. Correct and consistent condom use has been shown to be the most effective method for reducing STIs; however, condoms are often not used properly. Evidence shows that brief behavior change interventions that focus on skills, communication, and motivation to acquire safe sex practices should be adopted into routine care to reduce STIs. Funding for sexual health services in England has declined dramatically, so novel ways of reducing clinic attendance are being sought. The home-based intervention strategy (HIS-UK) to promote condom use among young men has shown promise in feasibility and pilot studies by demonstrating high acceptability of the intervention in participant and health professional feedback, including aiding men to find condoms they like and feel more confident when using condoms. Objective: The aim of this study is to determine the effectiveness and cost-effectiveness of HIS-UK when compared to usual condom distribution care among young men. Methods: The 3 trial arms consisting of “e-HIS” (HIS-UK delivered digitally), “ProHIS” (HIS-UK delivered face-to-face), and control condition (usual National Health Service [NHS] care) will be compared against the following 3 primary outcomes: the extent to which correct and consistent condom use is increased; improvement of condom use experiences (pleasure as well as fit and feel); and decrease in chlamydia test positivity. Eligibility criteria include men aged 16-25 years at risk of STIs through reporting of condom use errors (ie, breakage or slippage) or condomless penile-vaginal or penile-anal intercourse with casual or new sexual partners during the previous 3 months. Prospective participants will be recruited through targeted advertisements and an opportunistic direct approach at selected sexual health and genitourinary medicine services and university-associated health centers and general practitioner practices. Community and educational establishments will be used to further advertise the study and signpost men to recruitment sites. Participants will be randomly allocated to 1 of 3 trial arms. A repeated measures design will assess the parallel arms with baseline and 12 monthly follow-up questionnaires after intervention and 3 chlamydia screening points (baseline, 6, and 12 months). Results: Recruitment commenced in March 2020. Due to the COVID-19 pandemic, the study was halted and has since reopened for recruitment in Summer 2021. A 30-month recruitment period is planned. Conclusions: If effective and cost-effective, HIS-UK can be scaled up into routine NHS usual care to reduce both STI transmission in young people and pressure on NHS resources. This intervention may further encourage sexual health services to adopt digital technologies, allowing for them to become more widely available to young people while decreasing health inequalities and fear of stigmatization. Trial Registration: ISRCTN Registry ISRCTN11400820; https://www.isrctn.com/ISRCTN11400820 %M 35947422 %R 10.2196/35729 %U https://www.researchprotocols.org/2022/8/e35729 %U https://doi.org/10.2196/35729 %U http://www.ncbi.nlm.nih.gov/pubmed/35947422 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 8 %P e35051 %T Magnetic Resonance Imaging Angiography of Physiological and Pathological Pregnancy Placentas Ex Vivo: Protocol for a Prospective Pilot Study %A Dap,Matthieu %A Chen,Bailiang %A Banasiak,Claire %A Hossu,Gabriela %A Morel,Olivier %A Beaumont,Marine %A Bertholdt,Charline %+ Obstetric and Fetal Medicine Unit, Centre Hospitalier Régional Universitaire of Nancy, 10, rue du docteur Heydenreich, Nancy, 54000, France, 33 630736896, m.dap@chru-nancy.fr %K MRI %K magnetic resonance imaging %K placenta %K IUGR %K intrauterine growth restriction %K preeclampsia %K PE %K uterine %K intrauterine %K pregnancy %K vasculogenesis %K pathology %K physiology %D 2022 %7 10.8.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Preeclampsia (PE) and intrauterine growth restriction (IUGR) are 2 major pregnancy complications due to abnormal placental vasculogenesis. Data on whole fetoplacental vasculature are still missing; hence, these pathologies are not well understood. Ex vivo magnetic resonance imaging (MRI) angiography has been developed to characterize the human placental vasculature by injecting a contrast agent within the umbilical cord. Objective: The primary objective of this study is to compare the placental vascular architecture between normal and pathological pregnancies. This study’s secondary objectives are to (1) compare texture features on MRI between groups (normal and pathological), (2) quantitatively compare the vascular architecture between both pathological groups (pathological IUGR, and pathological PE), (3) evaluate the quality of the histological examination in injected placentas, and (4) compare vascularization indices to histological characteristics. Methods: This is a prospective controlled study. We expect to include 100 placentas: 40 from normal pregnancies and 60 from pathological pregnancies (30 for IUGR and 30 for PE). Ex vivo MR image acquisition will be performed shortly after delivery and with preparation by injection of a contrast agent in the umbilical cord. The vascular architecture will be quantitatively described by vascularization indices measured from ex vivo MRI angiography data. Comparisons of vascularization indices and texture features in accordance with the group and within comparable gestational age will be also performed. After MR image acquisition, placental histopathological analysis will be performed. Results: The enrollment of women began in November 2019. In view of the recruitment capacity of our institution and the availability of the MRI, recruitment should be completed by March 2022. As of November 2021, we enrolled 70% of the intended study population. Conclusions: This study protocol aims to provide information about the fetal side of placental vascular architecture in normal and pathological placenta through MRI. Trial Registration: Clinicaltrials.gov NCT04389099; https://clinicaltrials.gov/ct2/show/NCT04389099 International Registered Report Identifier (IRRID): DERR1-10.2196/35051 %M 35947435 %R 10.2196/35051 %U https://www.researchprotocols.org/2022/8/e35051 %U https://doi.org/10.2196/35051 %U http://www.ncbi.nlm.nih.gov/pubmed/35947435 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 7 %P e30611 %T The Impact of an Evidence-Informed Spinal Cord Injury Activities of Daily Living Education Manual (SADL-eM): Protocol for a Randomized Controlled Trial %A Abu Mostafa,Moussa %A Plastow,Nicola Ann %A Savin-Baden,Maggi %A Ayele,Birhanu %+ Occupational Therapy Department, Hamad Rehabilitation Hospital, The Sea St, Opposite to Mobaraq Hospital, Block N 199/34, Khanyouniss, Occupied Palestinian Territory, 970 597401091, moussaabumostafa@gmail.com %K occupational therapy %K educational intervention %K activities of daily living %K spinal cord injury %K clinical trials %D 2022 %7 22.7.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Spinal cord injury (SCI) is a catastrophic injury associated with functional loss and life-threatening complications. Many people with SCI in the Gaza Strip of Palestine are discharged from inpatient rehabilitation to the community while still lacking many daily life skills. This randomized controlled trial (RCT) seeks to test the impact of the Spinal Cord Injury Activities of Daily Living Education Manual (SADL-eM)—an evidence-based occupational therapy patient educational intervention—on rehabilitation outcomes. Objective: The proposed trial aims to evaluate the SADL-eM intervention compared with standard treatment among people with SCI. Methods: This is a parallel RCT with two study arms: intervention and control. A total of 90 patients treated in inpatient rehabilitation settings will be randomly allocated to two study groups. Both groups will receive standard care. The intervention group will also use the SADL-eM with their treating occupational therapist during rehabilitation. The SADL-eM is a comprehensive activities of daily living (ADL) educational tool that was codeveloped with people with SCI and stakeholders across Gaza. The self-report version of the Spinal Cord Independence Measure will be used on admission (ie, baseline measure) and after 6 weeks as the primary outcome measure. Secondary outcomes include the third version of the Spinal Cord Independence Measure, the Private Religiousness Practices Scale, the Organizational Religiousness Short-Form, additional ADL domains covered by the education manual, and adherence to the intervention. The effect of the intervention will be determined using repeated-measures analysis of variance. Results: This study will be conducted from April 2021 through December 2022, with results expected to be available in January 2023. Conclusions: If the SADL-eM is demonstrated as clinically effective, this will have significant implications for occupational therapy interventions in low- and middle-income countries. Trial Registration: ClinicalTrials.gov NCT04735887; https://clinicaltrials.gov/ct2/show/NCT04735887 %M 35867399 %R 10.2196/30611 %U https://www.researchprotocols.org/2022/7/e30611 %U https://doi.org/10.2196/30611 %U http://www.ncbi.nlm.nih.gov/pubmed/35867399 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 7 %P e38365 %T An Intervention to Increase Outdoor Play in Early Childhood Education Centers (PROmoting Early Childhood Outside): Protocol for a Pilot Wait-list Control Cluster Randomized Trial %A Ramsden,Rachel %A Han,Christina S %A Mount,Dawn %A Loebach,Janet %A Cox,Adina %A Herrington,Susan %A Bundy,Anita %A Fyfe-Johnson,Amber %A Sandseter,Ellen Beate Hansen %A Stone,Michelle %A Tremblay,Mark S %A Brussoni,Mariana %+ Department of Pediatrics, University of British Columbia, F511, 4480 Oak Street, Vancouver, BC, V6H 3V4, Canada, 1 6048753712, mbrussoni@bcchr.ubc.ca %K early childhood education and care %K preschool %K randomized controlled trial %K RCT %K intervention studies %K outdoor play %K built environment %K pedagogy %K behavior mapping %D 2022 %7 12.7.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Participation in outdoor play has been extensively documented as beneficial for the health, well-being, and development of children. Canadian early childhood education centers (ECECs) are important settings in young children’s lives and provide opportunities to participate in outdoor play. However, there are barriers to the provision of outdoor play opportunities at ECECs, such as adverse weather conditions, poorly designed outdoor spaces, outdoor time policies, and early childhood educator comfort levels. Objective: The PROmoting Early Childhood Outside (PRO-ECO) study is a wait-list control cluster randomized trial that evaluates the impact of the PRO-ECO intervention, an innovative outdoor play intervention, on children’s outdoor play behavior. The purpose of this paper was to provide a detailed overview of the pilot study protocol and the methods that will be used to develop, implement, and evaluate the PRO-ECO intervention. Methods: A total of 8 ECECs delivering licensed care to children aged 2.5 to 6 years in the Greater Vancouver region of British Columbia, Canada, and operated by the YMCA of Greater Vancouver (YMCA GV) are included in this study. Using a wait-list control cluster randomized trial design, we randomly allocated ECECs to either the PRO-ECO intervention arm (n=4) or the wait-list control arm (n=4). The primary outcome measures include changes in the proportion and diversity of observed outdoor play behavior during dedicated outdoor times at the ECECs as measured through observational behavior mapping. Secondary outcome measures include changes in educator attitudes; quality of ECECs’ outdoor play space; and children’s psychosocial strengths, physical activity levels, and social behaviors. A process evaluation of the acceptability of the PRO-ECO intervention in the 8 YMCA GV ECECs will also be assessed. Outcome data will be collected at baseline, 6-month follow-up, and 12-month follow-up. Mixed effect models will test the effect of the PRO-ECO intervention on quantitative outcomes. Baseline and postintervention data will be included in the analysis, controlling for the cluster design. Qualitative data will support quantitative findings and provide evidence for the acceptability of implementation. Results: Participant recruitment for this study began in August 2021, and baseline data collection was completed at all 8 ECECs in November 2021. As of April 2022, a total of 130 children have been recruited to participate in this study. Conclusions: The PRO-ECO pilot study will develop, implement, and evaluate the PRO-ECO intervention within 8 YMCA GV ECECs in the Vancouver region of British Columbia, Canada. The findings of this study will be useful for early childhood educators, ECEC providers, and policy makers to consider means for enhancing outdoor play provision and assessing the sustainability of the intervention in ECEC settings. Trial Registration: ClinicalTrials.gov NCT05075580; https://clinicaltrials.gov/ct2/show/NCT05073380 International Registered Report Identifier (IRRID): DERR1-10.2196/38365 %M 35819829 %R 10.2196/38365 %U https://www.researchprotocols.org/2022/7/e38365 %U https://doi.org/10.2196/38365 %U http://www.ncbi.nlm.nih.gov/pubmed/35819829 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 7 %P e36925 %T The Role of Mealtimes in Fostering Language Development and Aligning Home and School Learning: Protocol for a Multi-Method Study of Preschool Children in Rural Kenya and Zambia %A Zeidler,Henriette %A Farrow,Claire %A Jarman,Megan %A Koteng,Grace %A Simatende,Barnabas %A Matthews,Danielle %A Mooya,Haatembo %A Shapiro,Laura R %A Wadende,Pamela %+ School of Psychology, College of Health and Life Sciences, Aston University, Aston Triangle, Birmingham, B4 7ET, United Kingdom, 44 702349027, h.zeidler1@aston.ac.uk %K language development %K nutrition %K preschool education %K school %K education %K home %K environment %K academic %K children %K student %K language learning %K language %K caregiving %K responsive caregiving %K speech %K child-directed speech %K nutritional level %D 2022 %7 5.7.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: The association between school and home is fundamental to sustainable education: parents’ understanding of the school’s priorities and teachers’ understanding of their pupils’ home environment are both vital for children to remain in school and succeed academically. The relationship between parents and teachers is closest in preschool settings, providing a valuable opportunity to build bridges between home and school. In this protocol paper, we outline our planned methods for identifying beneficial home and school behaviors. Objective: Our project aims to identify culture-specific structures and behaviors in home and school settings, which influence the quantity and quality of child-directed speech and identify positive experiences that can help improve children’s linguistic development and nutrition. Methods: Using a mixed methods approach and focusing on early language learning, nutrition, and responsive caregiving, we will video-record and analyze mealtime language and eating behaviors at home and in school, targeting 80 preschool children and their families in rural Kenya and Zambia. In addition, we will assess children’s language skills through audio recordings and use questionnaire-based interviews to collect extensive sociodemographic and dietary data. Results: Between the start of our project in January 2020 and the end of December 2021, we had collected complete sets of sociodemographic, observational, and food recall data for 40 children in Kenya and 16 children in Zambia. By the end of May 2022, we had started data collection for an additional 24 children in Zambia and transcribed and coded approximately 85% of the data. By the end of September, 2022, we plan to complete data collection, transcription, and coding for the entire sample of 80 children across both countries. From September 2022 onwards, we will focus on analyzing our language data, and we hope to have results ready for publication in early 2023. By relating children’s language outcomes and nutritional intake to the observed mealtime behaviors, we hope to identify practices that increase the quantity and quality of child-directed speech and improve children’s nutritional intake. Conclusions: Good nutrition and the promotion of language learning are key issues in early childhood development. By using a cross-cultural approach, combining a variety of methods, and working closely with stakeholders and policy makers throughout the project, we hope to find and share best practices for improving children’s linguistic outcomes and nutrition and lay the foundation for the development of practitioner networks and parent outreach programs. International Registered Report Identifier (IRRID): DERR1-10.2196/36925 %M 35788473 %R 10.2196/36925 %U https://www.researchprotocols.org/2022/7/e36925 %U https://doi.org/10.2196/36925 %U http://www.ncbi.nlm.nih.gov/pubmed/35788473 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 7 %P e36037 %T Examining the International Palliative Care Systems in Rural Areas: Protocol for a Comparative Case Study %A Mondejar-Pont,Meritxell %A Abbott-Anderson,Kristen %A Ramon-Aribau,Anna %A Kumpula,Renee %A Neiman,Tammy %A De Ruiter,Hans-Peter %+ School of Nursing, Minnesota State University, 360 Wissink Hall, Mankato, MN, 56001-6071, United States, 1 5073896821, kristen.abbott-anderson@mnsu.edu %K palliative care %K palliative care systems %K integrated palliative care %K global health comparison %K hospice %K rural health %K ethical dilemmas %K COVID-19 %K coronavirus %K complementary therapy %D 2022 %7 1.7.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: The aging population in the Global North is associated with an increased prevalence of multiple chronic diseases that would benefit from integrated palliative care. In this context, it is vital to consider the effectiveness of health care systems’ response to the needs of the older population residing in rural areas, including access to palliative care services. Understanding palliative care program availability and palliative care system characteristics is important in creating useful health interventions in rural areas. Objective: This study aims to provide an international view on palliative care in rural areas. A study exploring palliative care services offered in Southern Minnesota will be carried out, building on a previous study conducted in Osona, Spain. Findings from both studies will be compared, providing insights into the strengths of each system and identifying areas for growth. Methods: This study will be performed using qualitative case study methodology. Using a similar methodology to the one used in the Spanish study, palliative care services will be explored in a similarly sized rural area in Southern Minnesota. This will be accomplished by (1) reviewing available literature related to the Southern Minnesota palliative care system and (2) identifying key providers in this US palliative care system who will be invited to participate in semistructured interviews. The study participants will be asked about the gaps between ideal integrated palliative care system services and the existing complementary palliative care services, and the ethical issues and dilemmas that evolved during the COVID-19 pandemic. Results: Following ethical approval for this protocol, data collection is anticipated to begin in spring or summer 2022 and is expected to take 6 months. Data collection will be followed by data analysis in fall 2022. Finally, the researchers plan to disseminate the findings in spring 2023. Conclusions: Comparing 2 similarly sized but culturally different rural palliative care systems in Minnesota and Osona will provide insights into how integrated palliative care systems impact the older population and those with chronic illnesses. Study findings will contribute to enhanced patient care, organizational improvements, policy change, and an understanding of the impact of different health care system models. International Registered Report Identifier (IRRID): PRR1-10.2196/36037 %M 35776505 %R 10.2196/36037 %U https://www.researchprotocols.org/2022/7/e36037 %U https://doi.org/10.2196/36037 %U http://www.ncbi.nlm.nih.gov/pubmed/35776505 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 6 %P e34430 %T A Comparison of the Effects of Stochastic Resonance Therapy, Whole-Body Vibration, and Balance Training on Pain Perception and Sensorimotor Function in Patients With Chronic Nonspecific Neck Pain: Protocol for a Randomized Controlled Trial %A Igbokwe,Emmanuel Osinachi %A Taube,Wolfgang %A Beinert,Konstantin %+ Reha Center Michaeliskarree, Jahnstr. 42, Hof, 95030, Germany, 49 92869190853, emmanuel.igbokwe@unifr.ch %K neck pain %K stochastic resonance therapy %K whole-body vibration %K cervical joint position sense %K pressure pain threshold %K balance training %K chronic neck pain %K sensorimotor function %K rehabilitation %K pain %K therapy %K chronic pain %K rehabilitative technology %K chronic nonspecific neck pain %D 2022 %7 24.6.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Neck pain is a prevalent pathological condition, and together with low back pain, it presents as the leading cause of years lived with disability worldwide in 2015 and continues to contribute substantially to the global burden of disease. Objective: This study will investigate and compare the effects of stochastic resonance therapy (SRT), whole-body vibration (WBV), and balance training (BLT) in the management of chronic nonspecific neck pain. Methods: In total, 45 participants with chronic neck pain will be randomly allocated into SRT, WBV, and BLT groups. Pain intensity, pressure pain threshold, neck disability, and cervical joint position sense will be measured before, immediately after, and 15 minutes after the first intervention session and after 4 weeks of intervention. A follow-up postintervention measurement would be taken after 4 weeks. The SRT group will train on an SRT device (SRT Zeptor Medical plus noise, Zeptoring). The WBV group will train on a Galileo vibration device (Novotec Medical), while the BLT group will perform balance exercises. All participants shall train 3 times a week for a period of 4 weeks. Mixed ANOVA will be used to determine the main and effects of interactions within (before intervention, post intervention 1, post intervention 2, post intervention 3, and follow-up) and between (SRT, WBV, and BLT) factors on the study outcome variables. Results: Recruitment of participants started in May 2021, and as of May 2022, a total of 20 patients have been enrolled in the study. All participants are expected to have completed the trial by the end of 2022, and data analysis will commence thereafter. Conclusions: The outcome of this study will shed closer light on the effects of SRT, WBV, and BLT on pain and function in patients with chronic neck pain. Trial Registration: German Clinical Trials Register DRKS00023881; https://tinyurl.com/ycxuhj37 International Registered Report Identifier (IRRID): DERR1-10.2196/34430 %M 35656706 %R 10.2196/34430 %U https://www.researchprotocols.org/2022/6/e34430 %U https://doi.org/10.2196/34430 %U http://www.ncbi.nlm.nih.gov/pubmed/35656706 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 6 %P e36229 %T Continuous Versus Intermittent Nutrition in Pediatric Intensive Care Patients: Protocol for a Randomized Controlled Trial %A Veldscholte,Karlien %A Cramer,Arnout B G %A de Jonge,Rogier C J %A Eveleens,Renate D %A Joosten,Koenraad F M %A Verbruggen,Sascha C A T %+ Intensive Care Unit, Department of Pediatrics and Pediatric Surgery, Erasmus MC - Sophia Children's Hospital, University Medical Center Rotterdam, Postbus 2060, Rotterdam, 3000 CB, Netherlands, 31 107032770, s.verbruggen@erasmusmc.nl %K pediatric intensive care unit %K PICU %K pediatric critical illness %K time-restricted feeding %K intermittent fasting %K feeding intolerance %K ketones %K circadian rhythm %D 2022 %7 23.6.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Intermittent fasting is a time-restricted feeding strategy with proven health benefits, which is based on multiple metabolic and endocrine changes, in several patient populations and healthy participants. In the pediatric intensive care unit (PICU), artificial feeding is usually administered 24 hours a day, although solid evidence supporting this practice is lacking. This discards the potential benefits of fasting in this population. We hypothesize that intermittent nutrition with a focus on an overnight feeding interruption (intermittent fasting), as compared with 24-hour continuous nutrition, is a feasible and safe strategy, with potential benefits, for critically ill children. Objective: The aim of the Continuous versus Intermittent Nutrition in Pediatric Intensive Care randomized controlled trial (RCT) is to investigate a strategy of intermittent nutrition with a focus on an overnight feeding interruption period versus 24-hour nutrition during the first 14 days in the PICU. Methods: The Continuous versus Intermittent Nutrition in Pediatric Intensive Care study is an investigator-initiated RCT in a tertiary referral PICU. Critically ill children (term newborn to 18 years), expected to stay in the PICU for ≥48 hours, and dependent on artificial nutrition, are eligible for inclusion. This study will randomize critically ill children (n=140) to a continuous versus intermittent nutrition strategy. In both groups, similar daily caloric targets will be prescribed. In the continuous group (control), nutrition will be administered 24 hours a day, with a maximum interruption period of 2 hours. In the intermittent group (intervention), nutrition will be interrupted during an age-dependent overnight fasting period. The study intervention will last until admission day 14, initiation of oral intake, or discharge from the PICU, whichever comes first. The primary outcome is the difference in ketosis between the groups under the condition of noninferiority regarding caloric intake. Secondary outcomes are feeding intolerance; the proportion of severe and resistant hypoglycemic events and severe gastrointestinal complications; and additional observed effects on nutritional intake, circadian rhythm, and clinically relevant outcome measures of the intermittent feeding strategy compared with continuous nutrition. Results: The study was approved by the Dutch national ethical review board in February 2020. The first patient was enrolled on May 19, 2020. By May 2022, a total of 132 patients had been included in the study. Recruitment of the last patient is expected in Q3 2022. Conclusions: Although intermittent fasting has been proven to have many health benefits in both animal and human studies, the feasibility and safety of this strategy in a PICU setting must be investigated. This RCT will help physicians gain more insight into the feasibility, safety, and potential clinical effects of intermittent feeding with overnight fasting in critically ill children. Trial Registration: Netherlands Trial Register NL7877; https://trialsearch.who.int/Trial2.aspx?TrialID=NL7877 International Registered Report Identifier (IRRID): DERR1-10.2196/36229 %M 35737448 %R 10.2196/36229 %U https://www.researchprotocols.org/2022/6/e36229 %U https://doi.org/10.2196/36229 %U http://www.ncbi.nlm.nih.gov/pubmed/35737448 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 6 %P e36012 %T Effectiveness and Cost-effectiveness of Online Brief Mindfulness-based Cognitive Therapy for the Improvement of Productivity in the Workplace: Study Protocol for a Randomized Controlled Trial %A Sado,Mitsuhiro %A Yamada,Masashi %A Ninomiya,Akira %A Nagaoka,Maki %A Goto,Naho %A Koreki,Akihiro %A Nakagawa,Atsuo %A Segal,Zindel %A Mimura,Masaru %+ Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 1608582, Japan, 81 0333531211 ext 62454, mitsusado@keio.jp %K mindfulness-based cognitive therapy %K mindfulness %K cognitive therapy %K occupational health %K workplace %K randomized controlled trial %K cost-effectiveness %K cost %K online %K internet-based %K eHealth %K mental health %K heath outcome %K work %K stress %K burnout %K productivity %K employee %D 2022 %7 13.6.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Numerous studies have demonstrated the effectiveness of mindfulness-based programs (MBPs) among both clinical and nonclinical populations. These data document positive impacts in the workplace, including reducing perceived stress and burnout and increasing well-being. However, the effectiveness for productivity, which is of most interest to managers and administrators, is still unclear. In addition, MBPs in the workplace tend to be modified by reducing the number of the program sessions or delivering content online to improve accessibility. To date, however, the impact of MBPs that feature these modifications on productivity in the workplace has not been investigated. Objective: The study aims to investigate the effectiveness and cost-effectiveness of online-delivered brief mindfulness-based cognitive therapy (bMBCT) for improving productivity and other work-related outcomes among healthy workers compared to the waitlist control. Methods: We will conduct a 4-week randomized controlled trial (RCT) with a 6-month follow-up. Employees are included in the study if they (1) are between the ages of 20 and 65 years and (2) work longer than 30 hours weekly. Employees are randomly allocated to either the bMBCT group or the waitlist control group. The primary outcome of the study is the mean difference of productivity measured by the World Health Organization Health and Work Performance Questionnaire (WHO-HPQ) between the groups at 4, 16, and 28 weeks. Secondary outcomes include several clinical outcomes and health economics evaluation. Results: We started recruiting participants in August 2021, and the intervention began in October 2021. A total of 104 participants have been enrolled in the study as of October 2021. The intervention is scheduled to be completed in December 2023. Data collection will be completed by the end of January 2024. Conclusions: The novelty of the study is that (1) it will investigate bMBCT’s effectiveness on productivity, which is still unclear, and (2) samples are recruited from 3 companies in different industries. The limitations of the study are that (1) all measures assessed are in self-report format and (2) we lack an active control group. This study has the potential to provide new data on the relationship between MBPs and occupational health and productivity. Trial Registration: University Hospital Medical Information Network Clinical Trials Registry UMIN000044721; https://tinyurl.com/4e2fh873 International Registered Report Identifier (IRRID): DERR1-10.2196/36012 %M 35387762 %R 10.2196/36012 %U https://www.researchprotocols.org/2022/6/e36012 %U https://doi.org/10.2196/36012 %U http://www.ncbi.nlm.nih.gov/pubmed/35387762 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 6 %P e35695 %T Impact of a Papillomavirus Vaccination Promotion Program in Middle School: Study Protocol for a Cluster Controlled Trial %A Tran,Phuong Lien %A Chirpaz,Emmanuel %A Boukerrou,Malik %A Bertolotti,Antoine %+ Department of Gynecology and Obstetrics, University Hospital of St Pierre, 97 Avenue du Président Mitterrand, Saint Pierre, Réunion, 97410, France, 33 262262359135, phuong.tran@chu-reunion.fr %K HPV vaccine %K vaccination program %K middle school %K school %K student %K women's health %K sexual health %K cervical cancer %K vaccination %K papillomavirus %K vaccine %K public education %K patient education %K community education %K promotion %K program %K youth %K children %K protocol %K mortality %K uterine cervical cancer %K cancer %K HPV %K health promotion %K girls %K school %K intervention %K parent %K training %D 2022 %7 13.6.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: On Reunion Island, incidence and mortality for uterine cervical cancer is high, yet coverage rate for human papillomavirus (HPV) vaccination is low. Objective: The main objective of the study is to evaluate the impact of a health promotion program promoting HPV vaccination on the proportion of middle school girls who complete the full HPV vaccination schedule (2 or 3 doses) by the end of school year. Methods: This study is a cluster controlled intervention study using a superiority design. A combined health promotion program will be offered containing information to students and parents, training of general practitioners, and free school-based vaccination (in a “health bus”). Children who attend this program will constitute the intervention group and will be compared to children from another middle school who will not attend the program constituting the control group. Results: Recruitment began in October 2020. In the intervention school, of 780 students, 245 were randomly selected in the 12 classes. In the control school, 259 students out of 834 were randomly selected. Conclusions: In this study, we explore the impact of a health promotion program combining information toward students, parents, and general practitioners with free school-based vaccination. We expect a significantly higher HPV vaccination coverage in the intervention school as compared to the control school, whether it be among girls or boys. The final implication would be an extension of this program in all middle schools on the Island and thus an increase in HPV vaccination coverage. Trial Registration: ClinicalTrials.gov NCT04459221; https://clinicaltrials.gov/ct2/show/NCT04459221 International Registered Report Identifier (IRRID): DERR1-10.2196/35695 %M 35700023 %R 10.2196/35695 %U https://www.researchprotocols.org/2022/6/e35695 %U https://doi.org/10.2196/35695 %U http://www.ncbi.nlm.nih.gov/pubmed/35700023 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 6 %P e30616 %T The Efficacy of Virtual Reality Game Preparation for Children Scheduled for Magnetic Resonance Imaging Procedures (IMAGINE): Protocol for a Randomized Controlled Trial %A Le May,Sylvie %A Genest,Christine %A Hung,Nicole %A Francoeur,Maxime %A Guingo,Estelle %A Paquette,Julie %A Fortin,Olivier %A Guay,Stéphane %+ Research Center, Centre Hospitalier Universitaire Sainte-Justine, 3175 Chemin de la Côte-Sainte-Catherine, Montreal, QC, H3T 1C5, Canada, 1 514 345 4931, sylvie.lemay@umontreal.ca %K virtual reality %K children %K video games %K magnetic resonance imaging %K anxiety %K pediatrics %K patient collaboration %K patient preparation %K biofeedback %D 2022 %7 13.6.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: It is known that magnetic resonance imaging (MRI) procedures generate fear and anxiety. Children may become restless during scanning, which results in movement artifacts requiring the MRI procedure to be repeated with sedation. Few studies seem to have looked at the effect of immersive virtual reality (IVR) on anxiety in children scheduled for MRI scans and how to identify which children are more responsive. Objective: The aims of this study are 3-fold: develop an algorithm of predictability based on biofeedback, address feasibility and acceptability of preprocedural IVR game preparation for anxiety management during MRI procedures, and examine the efficacy of IVR game preparation compared with usual care for the management of procedural anxiety during MRI scans. Methods: This study will have 2 phases. We will first conduct a field test with 10 participants aged 7 to 17 years to develop a predictive algorithm for biofeedback solution and to address the feasibility and acceptability of the research. After the field test, a randomized controlled trial will be completed using a parallel design with 2 groups: an experimental group (preprocedural IVR game preparation) and a usual care group (standard care as per the radiology department’s protocol) in an equal ratio of 49 participants per group for 98 participants. Recruitment will be carried out at a hospital in Quebec, Canada. The experimental group will receive a preprocedural IVR game preparation (IMAGINE) that offers an immersive simulation of the MRI scan. Participants will complete a questionnaire to assess the acceptability, feasibility, and incidence of side effects related to the intervention and the biofeedback device. Data collected will include sociodemographic and clinical characteristics as well as measures of procedure-related anxiety with the French-Canadian version of the State-Trait Anxiety Inventory for Children (score 1-3) and the Children’s Fear Scale (score 0-4). Physiological signs will be noted and include heart rate, skin conductance, hand temperature, and muscle tension. Measures of the level of satisfaction of health care professionals, parents, and participants will also be collected. Analyses will be carried out according to the intention-to-treat principle, with a Cronbach α significance level of .05. Results: As of May 10, 2022, no participant was enrolled in the clinical trial. The data collection time frame is projected to be between April 1, 2022, and March 31, 2023. Findings will be disseminated through peer-reviewed publications. Conclusions: Our study provides an alternative method for anxiety management to better prepare patients for an awake MRI procedure. The biofeedback will help predict which children are more responsive to this type of intervention. This study will guide future medical practice by providing evidence-based knowledge on a nonpharmacological therapeutic modality for anxiety management in children scheduled for an MRI scan. Trial Registration: ClinicalTrials.gov NCT04988516; https://clinicaltrials.gov/ct2/show/NCT04988516 International Registered Report Identifier (IRRID): PRR1-10.2196/30616 %M 35700000 %R 10.2196/30616 %U https://www.researchprotocols.org/2022/6/e30616 %U https://doi.org/10.2196/30616 %U http://www.ncbi.nlm.nih.gov/pubmed/35700000 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 6 %P e33625 %T OptimalMe Intervention for Healthy Preconception, Pregnancy, and Postpartum Lifestyles: Protocol for a Randomized Controlled Implementation Effectiveness Feasibility Trial %A Harrison,Cheryce L %A Brammall,Bonnie R %A Garad,Rhonda %A Teede,Helena %+ Monash Centre for Health Research and Implementation, School of Public Health and Preventive Medicine, 43-51 Kanooka Grove, Clayton, 3168, Australia, 61 8572 2662, cheryce.harrison@monash.edu %K preconception %K pregnancy %K postpartum %K weight %K obesity prevention %K womens health %K intervention %K implementation %D 2022 %7 9.6.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Reproductive-aged women are a high-risk population group for accelerated weight gain and obesity development, with pregnancy recognized as a critical contributory life-phase. Healthy lifestyle interventions during the antenatal period improve maternal and infant health outcomes, yet translation and implementation of such interventions into real-world health care settings remains limited. Objective: We aim to generate key implementation learnings to inform the feasibility of future scale up and determine the effectiveness of intervention delivery methods on engagement, experience, acceptability, knowledge, risk perception, health literacy, and modifiable weight-related health behaviors in women during preconception, pregnancy, and postpartum periods. Methods: This randomized hybrid implementation effectiveness study will evaluate the penetration, reach, feasibility, acceptability, adoption, and fidelity of a healthy lifestyle intervention (OptimalMe) implemented into, and in partnership with, private health care. Individual health outcomes associated with implementation delivery mode, including knowledge, risk perception, health literacy, self-management, and health behaviors, are secondary outcomes. A total of 300 women aged 18 to 44 years, who are not pregnant but wish to conceive within the next 12 months, and with access to the internet will be recruited. All participants will receive the same digital lifestyle intervention, OptimalMe, which is supported by health coaching and text messages during preconception, pregnancy, and postpartum periods. We will use a parallel 2-arm design to compare telephone with videoconference remote delivery methods for health coaching. Methods are theoretically underpinned by the Consolidated Framework for Implementation Research and outcomes based on the Reach, Engagement, Adaptation, Implementation and Maintenance framework. Results: The study was approved on August 16, 2019 and has been registered. Recruitment commenced in July 2020, and data collection is ongoing. Results are expected to be published in 2022. Conclusions: The study’s design aligns with best practice implementation research. Results will inform translation of evidence from randomized controlled trials on healthy lifestyle interventions into practice targeting women across preconception, pregnancy, and postpartum periods. Learnings will target consumers, program facilitators, health professionals, services, and policy makers to inform future scale up to ultimately benefit the health of women across these life-phases. Trial Registration: Australian and New Zealand Clinical Trial Registry ACTRN12620001053910; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378243&isReview=true International Registered Report Identifier (IRRID): DERR1-10.2196/33625 %M 35679115 %R 10.2196/33625 %U https://www.researchprotocols.org/2022/6/e33625 %U https://doi.org/10.2196/33625 %U http://www.ncbi.nlm.nih.gov/pubmed/35679115 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 5 %P e29389 %T Dyadic Intervention for Sexually Transmitted Infection Prevention in Urban Adolescents and Young Adults (The SEXPERIENCE Study): Protocol for a Randomized Controlled Trial %A Trent,Maria %A Yusuf,Hasiya Eihuri %A Rowell,Julia %A Toppins,Jacquelin %A Woods,Colin %A Huettner,Steven %A Robinson,Camille %A Fields,Errol L %A Marcell,Arik V %A DiClemente,Ralph %A Matson,Pamela %+ Department of Pediatrics, Division of Adolescent/Young Adult Medicine, Johns Hopkins University School of Medicine, 200 N Wolfe Street, Baltimore, MD, 21287, United States, 1 410 955 2910, mtrent2@jhmi.edu %K STI %K adolescent %K young adult %K youth %K dyadic %K sexual risk %K heterosexual %K health education %K sexually transmitted disease %K disease %K adolescent %K education %D 2022 %7 25.5.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Adolescents and young adults (AYA) aged younger than 25 years have the highest rates of sexually transmitted infections (STIs) in the United States. Current STI prevention strategies for AYA rely primarily on individual approaches, leaving sexual partners with significant unmet sexual and reproductive health care and health education needs. Dyadic interventions may hold promise for harnessing the power of communal coping within relationship dynamics to enhance sexual decision making, communication, and behavior changes that reduce the future risk of STIs. Objective: This paper describes the protocol and research methods of a dyad-based behavioral intervention that augments individual evidence-based interventions with joint health education counseling for heterosexual AYA dyads within a primary care setting. The trial aims to improve partner communication and collaborative sexual decision making and promote the adoption of sexual behaviors such as consistent condom use. The primary objective of this study is to assess the feasibility, acceptability, and effectiveness of a dyadic intervention targeted at preventing STIs in heterosexual couples in an urban setting. Methods: A total of 100 AYA (50 dyads) aged 16 to 25 years, engaged in heterosexual intercourse, who reside in the city and are willing to recruit their main sexual partner for the study will be recruited and randomized into 2 groups, an intervention arm and a control arm. Participants will be recruited from an AYA medicine clinic and by using social media (Facebook and Instagram). The index participant and partner will complete a single individual session separately (Sister to Sister or Focus on the Future) with a gender-matched health educator. Dyads will then be randomized to receive an additional joint debriefing session together to discuss relationship dynamics, condom negotiation, etc. Participants will separately complete a telephone interview 6 weeks postintervention to determine the feasibility, acceptability, and impact of the intervention on mutual sexual negotiation, consistency of condom use, and communal coping skills, etc. Results: So far, 25.4% (44/173) of eligible participants have been enrolled and randomized. Participants are mostly female (20/22, 91%), with at least a high school diploma (19/22, 86%), and 9 average lifetime sexual partners. Acceptability is high, with 98% (43/44) of participants expressing satisfaction with their study experience; 100% of dyads recruited were still together at 6-week follow-up. Conclusions: Findings from this study will add to the current literature on the approaches to STI prevention, and its success will inform its application in risk reduction counseling for youth who are most at risk. Trial Registration: Clinical Trials.gov NCT03275168; https://www.clinicaltrials.gov/ct2/history/NCT03275168 International Registered Report Identifier (IRRID): DERR1-10.2196/29389 %M 35612881 %R 10.2196/29389 %U https://www.researchprotocols.org/2022/5/e29389 %U https://doi.org/10.2196/29389 %U http://www.ncbi.nlm.nih.gov/pubmed/35612881 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 5 %P e35145 %T Effectiveness of Silver Diamine Fluoride for Preventing Occlusal Caries in the Primary Teeth of Preschool Children: Protocol for a Randomized Controlled Trial %A Duangthip,Duangporn %A He,Shuyang %A Gao,Sherry Shiqian %A Chu,Chun Hung %A Lo,Edward Chin Man %+ Applied Oral Sciences & Community Dental Care, Faculty of Dentistry, The University of Hong Kong, 34 Hospital Rd, Sai Wan, Hong Kong, China, 86 2859 0292, hrdplcm@hku.hk %K silver diamine fluoride %K sodium fluoride %K children %K early childhood caries %K prevention %D 2022 %7 23.5.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Tooth decay is a significant public health problem globally. The caries-arrest effectiveness of 38% silver diamine fluoride (SDF) has been well documented. However, information on the caries-preventive effect of SDF on primary teeth is insufficient. Objective: The aim of this trial is to investigate the effectiveness of semiannual application of 38% SDF and that of 5% sodium fluoride (NaF) varnish when compared with placebo control for preventing occlusal caries in the primary molars of preschool children over 30 months. Methods: This 3-arm, parallel design, double-blind, randomized controlled trial involves 791 preschool children. Children are randomly allocated to receive 1 of 3 interventions as follows: Group 1, 38% SDF; Group 2, 5% NaF varnish; and Group 3, placebo control (tonic water). The intervention and dental examination will be carried out every 6 months. A parent-administered questionnaire, including the children’s demographic background and oral health–related behaviors, has been collected at baseline. Follow-up examinations to detect new caries development will be conducted every 6 months by a masked examiner. Caries development will be diagnosed at the cavitation level. Chi-square tests and logistic regression analyses will be adopted. A 2-level logistic regression analysis will be performed to investigate the effects of the study interventions and other potential confounding factors on the development of occlusal caries. Results: This study was started on September 1, 2020, and the recruitment process ended on September 30, 2021. At present, a total of 791 children are participating in the study. This 30-month clinical trial is expected to be completed in March 2024. Conclusions: If SDF application is more effective than NaF varnish for preventing caries on occlusal surfaces of primary teeth, it can be a preferred choice for caries prevention in a kindergarten-based program. Results of this trial will provide valuable clinical evidence for the development of oral health strategies and policies on the promotion of child oral health. Trial Registration: HKU Clinical Registry HKUCTR-2844, https://tinyurl.com/bdhz9yuk; ClinicalTrials.gov NCT05084001, https://clinicaltrials.gov/ct2/show/NCT05084001 International Registered Report Identifier (IRRID): DERR1-10.2196/35145 %M 35604758 %R 10.2196/35145 %U https://www.researchprotocols.org/2022/5/e35145 %U https://doi.org/10.2196/35145 %U http://www.ncbi.nlm.nih.gov/pubmed/35604758 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 5 %P e35533 %T Efficacy of Ibuprofen Gargle for Postoperative Pain After Mandibular Third Molar Extraction: Protocol for a Phase II, Placebo-Controlled, Double-Blind, Randomized Crossover Trial %A Kakei,Yasumasa %A Ioroi,Takeshi %A Ito,Takahiro %A Okazaki,Yutaro %A Hasegawa,Takumi %A Yano,Ikuko %A Akashi,Masaya %+ Department of Oral and Maxillofacial Surgery, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, 6500017, Japan, 81 78 382 6213, ykakei@med.kobe-u.ac.jp %K protocol %K phase II %K placebo-controlled %K double-blind %K randomized crossover trial %K mandibular third molar extraction %K pain management %K ibuprofen %K gargle %D 2022 %7 16.5.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Extraction of mandibular third molars is one of the most commonly performed oral surgical procedures, and nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used for pain management. Oral NSAIDs are associated with adverse events such as gastrointestinal disorders, renal and hepatic dysfunction, and platelet dysfunction. Topical analgesics have been proposed as alternatives to oral and injectable medications to safely improve postoperative pain relief. We will conduct a single-center, placebo-controlled, double-blind, randomized crossover trial to assess the pain-relieving effect of an ibuprofen-containing gargle in patients undergoing extraction of mandibular third molars when compared with a placebo gargle. Objective: This will be the first clinical study to compare the efficacy of an ibuprofen gargle with that of a placebo for relieving postoperative pain in addition to loxoprofen after mandibular third molar extraction. Methods: This study will be performed at Kobe University Hospital. Participants (N=40) will be randomized equally to 1 of 2 groups. The ibuprofen-placebo group will receive an ibuprofen gargle on postoperative day (POD) 1 and a placebo gargle on POD 2. The placebo-ibuprofen group will receive a placebo gargle on POD 1 and an ibuprofen gargle on POD 2. Both groups will receive ibuprofen gargles on PODs 3-5 at least once daily. The primary objective is to estimate the within-subject difference on a visual analog scale (VAS) before and 5 minutes after using the ibuprofen or placebo gargle on PODs 1 and 2. The secondary objectives are to estimate the within-subject differences in ΔVAS before and 15 minutes after using the ibuprofen or placebo gargle on PODs 1 and 2, ΔVAS before and 5 or 15 minutes after using the ibuprofen gargle on PODs 3-5, overall efficacy (self-completion, 5 scales) on PODs 1-5, daily frequency of use (ibuprofen or placebo gargle and analgesics) on PODs 1-7, and the occurrence of adverse events. Results: The Certified Review Board of Kobe University approved the study. The intervention was implemented in May 2021. For the primary analysis, we will calculate the mean and SD of ΔVAS5 on PODs 1 and 2 and the within-study difference in ΔVAS5. The treatment effect will be estimated by dividing the mean ΔVAS5 in the within-subject difference by 2 and calculating the P value using an unpaired t test. For the secondary analysis, we will calculate the mean and SD of ΔVAS15 on PODs 1 and 2 and the within-study difference in ΔVAS15. The treatment effect will be estimated as in the primary analysis. Conclusions: This trial will provide exploratory evidence of the efficacy and safety of an ibuprofen gargle for pain reduction after mandibular third molar extraction. Trial Registration: Japan Registry of Clinical Trials jRCTs051210022; https://tinyurl.com/39ej23zu International Registered Report Identifier (IRRID): DERR1-10.2196/35533 %M 35459640 %R 10.2196/35533 %U https://www.researchprotocols.org/2022/5/e35533 %U https://doi.org/10.2196/35533 %U http://www.ncbi.nlm.nih.gov/pubmed/35459640 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 5 %P e34292 %T Effect of the Nutraceutical Micodigest 2.0 on the Complication Rate of Colorectal Cancer Surgery With Curative Intent: Protocol for a Placebo-Controlled Double-blind Randomized Clinical Trial %A Regueiro,Cristina %A Codesido,Laura %A García-Nimo,Laura %A Zarraquiños,Sara %A Remedios,David %A Rodríguez-Blanco,Arturo %A Sinde,Esteban %A Fernández-de-Ana,Catalina %A Cubiella,Joaquín %+ Department of Gastroenterology, Complexo Hospitalario Universitario de Ourense, Instituto de Investigación Sanitaria Galicia Sur, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Ramón Puga 52-54, Ourense, 32002, Spain, 34 988385824, cristinaregueiroexposito@gmail.com %K colorectal cancer %K surgery complications %K gut microbiota %K inflammatory pattern %K nutritional status %K nutraceutical %K postsurgery %K colorectal %K cancer %K colon %D 2022 %7 16.5.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Most colorectal cancer patients diagnosed are candidates for surgical resection with curative intent, although colorectal surgery is associated with some complications that could be life-threatening. Antibiotic prophylaxis is commonly used for the prevention of infectious postoperative complications. However, this intervention can change the composition of intestinal microbiota and promote adverse inflammatory outcomes in colorectal cancer patients. The combination of different fungal extracts could be beneficial because of their role in gut microbiota modulation and their anti-inflammatory activity. Objective: Based on this hypothesis, we have designed a double-bind, randomized clinical trial to evaluate the effect of the nutraceutical fungal extract Micodigest 2.0 on complications of surgery for colorectal cancer resection. Methods: Colorectal cancer candidates for surgery will be considered for inclusion in the study. After evaluation by the multidisciplinary tumor board, patients who meet selection criteria will be screened, stratified according to tumor location, and randomly allocated to be treated with Micodigest 2.0 or placebo. Treatment will be continued until admission for surgery (4-6 weeks). Participants will undergo a medical and clinical evaluation including baseline and preadmission quality of life, microbiome composition, inflammatory and nutritional status, adverse events, and adherence assessments. The main end point of the study is the surgery complication rate. We will evaluate complications using the Clavien-Dindo classification. It will be necessary to recruit 144 patients to find a relevant clinical difference. We will also evaluate the effect of the nutraceutical on microbiome composition, inflammatory response, nutritional status, and quality of life, as well as the effect of these variables on surgical complications. Results: This study was funded in 2020 by the Center for Industrial Technology Development. Recruitment began in September 2021 and is expected to be completed in September 2022. Data will be analyzed and the results will be disseminated in 2023. Conclusions: The results of this protocol study could help to reduce surgery complications in patients with colorectal cancer using the new treatment Micodigest. This study could also identify new features associated with colorectal surgery complications. In summary, this study trial could improve the management of colorectal cancer patients. Trial Registration: Clinical Trials.gov NCT04821258; https://clinicaltrials.gov/ct2/show/NCT04821258 International Registered Report Identifier (IRRID): DERR1-10.2196/34292 %M 35576566 %R 10.2196/34292 %U https://www.researchprotocols.org/2022/5/e34292 %U https://doi.org/10.2196/34292 %U http://www.ncbi.nlm.nih.gov/pubmed/35576566 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 5 %P e34480 %T Implementing Infection Control and Quality of Life Best Practices in Nursing Homes With Project ECHO: Protocol for a Patient-Centered Randomized Controlled Trial %A Calo,William A %A Francis,Erica %A Kong,Lan %A Hogentogler,Ruth %A Heilbrunn,Emily %A Fisher,Abbey %A Hood,Nancy %A Kraschnewski,Jennifer %+ Department of Medicine, College of Medicine, Penn State University, 90 Hope Dr, Hershey, PA, 17033, United States, 1 202 329 1973, efrancis@pennstatehealth.psu.edu %K infection control %K COVID-19 %K nursing home %K telementoring %K Project ECHO %K case-based learning %K patient-centered outcome %K RE-AIM %K randomized controlled trial %K implementation %K quality of life %K best practice %K guideline %K comparison %K effectiveness %K intervention %D 2022 %7 13.5.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Nursing homes in the United States were devastated by COVID-19, with 710,000 cases and 138,000 deaths nationally through October 2021. Although facilities are required to have infection control staff, only 3% of designated infection preventionists have taken a basic infection control course prior to the COVID-19 pandemic. Most research has focused on infection control in the acute care setting. However, little is known about the implementation of infection control practices and effective interventions in nursing homes. This study utilizes Project ECHO (Extension for Community Health Outcomes), an evidence-based telementoring model, to connect Penn State University subject matter experts with nursing home staff and administrators to proactively support evidence-based infection control guideline implementation. Objective: Our study seeks to answer the research question of how evidence-based infection control guidelines can be implemented effectively in nursing homes, including comparing the effectiveness of two ECHO-delivered training interventions on key patient-centered outcomes such as reducing the number of residents with a COVID-19 diagnosis. Methods: A stratified cluster randomized design was utilized. Using a 1:1 ratio, we randomly assigned 136 nursing homes to ECHO or ECHO Plus arms. Randomization was stratified by geographic location, baseline COVID-19 infection rate, and facility capacity. The study had two phases. In phase one, completed in July 2021, nursing homes in both study arms received a 16-week infectious disease and quality improvement training intervention via real-time, interactive videoconferencing and the ECHO learning model. Phase one sessions were up to 90 minutes in duration. In phase two, completed in November 2021, the ECHO group was offered optional 60-minute office hours for 9 weeks and the ECHO Plus group received 9 weeks of 60-minute sessions on emerging topics and an additional 8-session refresher series on infection control. Results: A total of 290 nursing home facilities were assessed for eligibility, with 136 nursing homes recruited and randomly assigned to ECHO or ECHO Plus. Guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, we will simultaneously evaluate the study’s effectiveness and implementation outcomes at baseline (intervention start date), and at 4, 6, 12, and 18 months. The primary outcome is the COVID-19 infection rate in nursing homes. Secondary outcomes include COVID-19 hospitalizations and deaths, flu-like illness, and quality of life. Surveys and interviews with participants will also provide data as to the adoption, implementation, and maintenance of best practices taught throughout ECHO sessions. Conclusions: A multipronged approach to improving infection control and emergency preparedness in nursing homes is important, given the toll that the COVID-19 pandemic has taken on residents and staff. The ECHO model has significant strengths when compared to traditional training, as it allows for remote learning delivered by a multidisciplinary team of experts, and utilizes case discussions that match the context and capacity of nursing homes. Trial Registration: ClinicalTrials.gov NCT04499391; https://clinicaltrials.gov/ct2/show/NCT04499391 %M 35476823 %R 10.2196/34480 %U https://www.researchprotocols.org/2022/5/e34480 %U https://doi.org/10.2196/34480 %U http://www.ncbi.nlm.nih.gov/pubmed/35476823 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 5 %P e36673 %T Long COVID Optimal Health Program (LC-OHP) to Enhance Psychological and Physical Health: Protocol for a Feasibility Randomized Controlled Trial %A Al-Jabr,Hiyam %A Windle,Karen %A Thompson,David R %A Jenkins,Zoe M %A Castle,David J %A Ski,Chantal F %+ Integrated Care Academy, University of Suffolk, Waterfront Building, 19 Neptune Quay, Ipswich, IP4 1QJ, United Kingdom, 44 01473 338845, h.al-jabr@uos.ac.uk %K long COVID %K COVID-19 %K optimal health program %K telemedicine %K integrated care %K telehealth %K patient care %K health intervention %K mental health %K physical health %K psychological health %K pandemic %K patient support %D 2022 %7 12.5.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Long COVID is a collection of symptoms that develop during or following a confirmed or suspected case of COVID-19, which continue for more than 12 weeks. Despite the negative impact of long COVID on people’s lives and functioning, there is no validated treatment or even rehabilitation guidance. What has been recommended thus far is the adoption of holistic management approaches. The Optimal Health Program (OHP) is a brief 5-session, plus booster, psychosocial program designed to support mental and physical well-being that has been used effectively for a range of chronic conditions. Objective: This study examines the feasibility and acceptability of employing an especially customized version of OHP (long COVID OHP [LC-OHP]) to improve psychological and physical health of people with long COVID. Methods: This is a feasibility randomized controlled trial that will be running from November 2021 to February 2023. Eligible participants aged 18 years or older who are experiencing symptoms of long COVID will be identified through their secondary practitioners with recruitment to be undertaken by the research team. A total of 60 participants will be randomized into a control (usual care) or an intervention (LC-OHP) group. Outcomes will be feasibility and acceptability of the program (primary); and efficacy of the LC-OHP in improving anxiety, depression, fatigue, self-efficacy, and quality of life (secondary). Up to 20 participants will be interviewed at the end of the trial to explore their experience with the program. Quantitative data will be analyzed using SPSS, and differences between groups will be compared using inferential tests where appropriate. Qualitative data will be transcribed and thematically analyzed to identify common emerging themes. Results: This is an ongoing study, which began in November 2021. Conclusions: Long COVID has a significant impact on an individual’s mental and physical functioning. The LC-OHP has a potential to provide people living with long COVID with additional support and to improve self-efficacy. The findings of this study would identify the feasibility of delivering this program to this population and will provide an indication for the program’s effectiveness. Trial Registration: ISRCTN Registry ISRCTN38746119; https://www.isrctn.com/ISRCTN38746119 International Registered Report Identifier (IRRID): DERR1-10.2196/36673 %M 35468586 %R 10.2196/36673 %U https://www.researchprotocols.org/2022/5/e36673 %U https://doi.org/10.2196/36673 %U http://www.ncbi.nlm.nih.gov/pubmed/35468586 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 4 %P e31464 %T Overcoming Decisional Gaps in High-Risk Prescribing by Junior Physicians Using Simulation-Based Training: Protocol for a Randomized Controlled Trial %A Lauffenburger,Julie C %A DiFrancesco,Matthew F %A Barlev,Renee A %A Robertson,Ted %A Kim,Erin %A Coll,Maxwell D %A Haff,Nancy %A Fontanet,Constance P %A Hanken,Kaitlin %A Oran,Rebecca %A Avorn,Jerry %A Choudhry,Niteesh K %+ Brigham and Women's Hospital, Harvard Medical School, 1620 Tremont Street Suite 3030, Boston, MA, 02120, United States, 1 6175258865, jlauffenburger@bwh.harvard.edu %K pragmatic trial %K behavioral science %K prescribing %K benzodiazepines %K antipsychotics %K impact evaluation %D 2022 %7 27.4.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Gaps between rational thought and actual decisions are increasingly recognized as a reason why people make suboptimal choices in states of heightened emotion, such as stress. These observations may help explain why high-risk medications continue to be prescribed to acutely ill hospitalized older adults despite widely accepted recommendations against these practices. Role playing and other efforts, such as simulation training, have demonstrated benefits to help people avoid decisional gaps but have not been tested to reduce overprescribing of high-risk medications. Objective: This study aims to evaluate the impact of a simulation-based training program designed to address decisional gaps on prescribing of high-risk medications compared with control. Methods: In this 2-arm pragmatic trial, we are randomizing at least 36 first-year medical resident physicians (ie, interns) who provide care on inpatient general medicine services at a large academic medical center to either intervention (simulation-based training) or control (online educational training). The intervention comprises a 40-minute immersive individual simulation training consisting of a reality-based patient care scenario in a simulated environment at the beginning of their inpatient service rotation. The simulation focuses on 3 types of high-risk medications, including benzodiazepines, antipsychotics, and sedative hypnotics (Z-drugs), in older adults, and is specifically designed to help the physicians identify their reactions and prescribing decisions in stressful situations that are common in the inpatient setting. The simulation scenario is followed by a semistructured debriefing with an expert facilitator. The trial’s primary outcome is the number of medication doses for any of the high-risk medications prescribed by the interns to patients aged 65 years or older who were not taking one of the medications upon admission. Secondary outcomes include prescribing by all providers on the care team, being discharged on 1 of the medications, and prescribing of related medications (eg, melatonin, trazodone), or the medications of interest for the control intervention. These outcomes will be measured using electronic health record data. Results: Recruitment of interns began on March 29, 2021. Recruitment for the trial ended in Q42021, with follow-up completed by Q12022. Conclusions: This trial will evaluate the impact of a simulation-based training program designed using behavioral science principles on prescribing of high-risk medications by junior physicians. If the intervention is shown to be effective, this approach could potentially be reproducible by others and for a broader set of behaviors. Trial Registration: ClinicalTrials.gov NCT04668248; https://clinicaltrials.gov/ct2/show/NCT04668248 International Registered Report Identifier (IRRID): PRR1-10.2196/31464 %M 35475982 %R 10.2196/31464 %U https://www.researchprotocols.org/2022/4/e31464 %U https://doi.org/10.2196/31464 %U http://www.ncbi.nlm.nih.gov/pubmed/35475982 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 4 %P e31887 %T Early Detection of Cardiotoxicity From Systemic and Radiation Therapy in Patients With Breast Cancer: Protocol for a Multi-Institutional Prospective Study %A Borgonovo,Giulia %A Vettus,Elen %A Greco,Alessandra %A Leo,Laura Anna %A Faletra,Francesco Fulvio %A Klersy,Catherine %A Curti,Moreno %A Valli,Mariacarla %+ Clinic of Radiation Oncology, Oncology Institute of Southern Switzerland, Via Gallino, Bellinzona, 6500, Switzerland, 41 918119430, Mariacarla.Valli@eoc.ch %K breast cancer %K cardiotoxicity %K cardiac diagnostic imaging %K radiotherapy %K chemotherapy %D 2022 %7 21.4.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: The incidence of breast cancer is rising worldwide. Recent advances in systemic and local treatments have significantly improved survival rates of patients having early breast cancer. In the last decade, great attention has been paid to the prevention and early detection of cardiotoxicity induced by breast cancer treatments. Systemic therapy-related cardiac toxicities have been extensively studied. Radiotherapy, an essential component of breast cancer treatment, can also increase the risk of heart diseases. Consequently, it is important to balance the expected benefits of cancer treatment with cardiovascular risk and to identify strategies to prevent cardiotoxicity and improve long-term outcomes and quality of life for these patients. Objective: This CardioTox Breast study aims to investigate the use of cardiac imaging, based on cardiac magnetic resonance and echocardiography, and to identify associated circulating biomarkers to assess early tissue changes in chemo-induced and radiation-induced cardiotoxicity in the time window of 12 months after the end of radiotherapy in patients with breast cancer. Methods: The CardioTox Breast trial is a multicenter observational prospective longitudinal study. We aim to enroll 150 women with stage I-III unilateral breast cancer, treated with breast conserving surgery, who planned to receive radiotherapy with or without systemic therapy. Baseline and follow-up data include cardiac measurements based on cardiac magnetic resonance imaging, echocardiography, and circulating biomarkers of cardiac toxicity. Results: This study details the protocol of the CardioTox Breast trial. Recruitment started in September 2020. The results of this study will not be published until data are mature for the final analysis of the primary study end point. Conclusions: The CardioTox Breast study is designed to investigate the effects of systemic and radiation therapy on myocardial function and structure, thus providing additional evidence on whether cardiac magnetic resonance is the optimal screening imaging for cardiotoxicity. Trial Registration: ClinicalTrials.gov NCT04790266; https://clinicaltrials.gov/ct2/show/NCT04790266 International Registered Report Identifier (IRRID): DERR1-10.2196/31887 %M 35451989 %R 10.2196/31887 %U https://www.researchprotocols.org/2022/4/e31887 %U https://doi.org/10.2196/31887 %U http://www.ncbi.nlm.nih.gov/pubmed/35451989 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 4 %P e32693 %T The Effectiveness and Cost-effectiveness of Well Parent Japan for Japanese Mothers of Children With ADHD: Protocol for a Randomized Controlled Trial %A Shimabukuro,Shizuka %A Daley,David %A Endo,Takahiro %A Harada,Satoshi %A Tomoda,Akemi %A Yamashita,Yushiro %A Oshio,Takashi %A Guo,Boliang %A Ishii,Atsuko %A Izumi,Mio %A Nakahara,Yukiko %A Yamamoto,Kazushi %A Yao,Akiko %A Tripp,Gail %+ Human Developmental Neurobiology Unit, Okinawa Institute of Science and Technology Graduate University, 1919-1 Tancha, Onna-son, Okinawa, 904-0495, Japan, 81 98 966 8802, shizuka.shimabukuro@oist.jp %K ADHD %K parent training %K Japan %K New Forest Parent Programme %K parent stress management %D 2022 %7 19.4.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental disorder associated with numerous functional deficits and poor long-term outcomes. Internationally, behavioral interventions are recommended as part of a multimodal treatment approach for children with ADHD. Currently, in Japan, there are limited interventions available to target ADHD. Well Parent Japan (WPJ), a new hybrid parent-training program, provides a culturally acceptable and effective way to help support Japanese children with ADHD and their parents. Objective: This pragmatic multicenter randomized controlled trial aims to provide preliminary evidence about the effectiveness and cost-effectiveness of WPJ evaluated against treatment as usual (TAU) within routine Japanese mental health services. Methods: Mothers of children (aged 6-12 years) diagnosed with ADHD were recruited from child and adolescent mental health care services at three hospital sites across Japan (Fukui, Fukuoka, and Okinawa). The mothers were randomized to receive immediate treatment or TAU. The effectiveness and cost-effectiveness of WPJ over TAU at the end of the intervention and at 3-month follow-up will be evaluated. The primary outcome is maternal parent domain stress in the parenting role. The following secondary outcomes will be explored: child behavior, including severity of ADHD symptoms; parenting practices; emotional well-being; and the parent-child relationship and maternal child domain parenting stress. Data analysis will follow intention-to-treat principles with treatment effects quantified through analysis of covariance using multilevel modeling. An incremental cost-effectiveness ratio will be used to analyze the cost-effectiveness of the WPJ intervention. Results: Study funding was secured through a proof-of-concept grant in July 2018. Approval by the institutional review board for the data collection sites was obtained between 2017 and 2019. Data collection began in August 2019 and was completed in April 2022. Participant recruitment (N=124) was completed in May 2021. Effectiveness and cost-effectiveness analyses are expected to be completed by July 2022 and December 2022, respectively. These timelines are subject to change owing to the COVID-19 pandemic. Conclusions: This is the first multisite pragmatic trial of WPJ based on the recruitment of children referred directly to routine clinical services in Japan. This multisite randomized trial tests the effectiveness of WPJ in children and families by comparing WPJ directly with the usual clinical care offered for children diagnosed with ADHD in Japan. We also seek to assess and compare the cost-effectiveness of WPJ with TAU in Japan. Trial Registration: International Standard Randomised Controlled Trial Number ISRCTN66978270; https://www.isrctn.com/ISRCTN66978270 International Registered Report Identifier (IRRID): DERR1-10.2196/32693 %M 35438647 %R 10.2196/32693 %U https://www.researchprotocols.org/2022/4/e32693 %U https://doi.org/10.2196/32693 %U http://www.ncbi.nlm.nih.gov/pubmed/35438647 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 4 %P e34576 %T Casting Without Reduction Versus Closed Reduction With or Without Fixation in the Treatment of Distal Radius Fractures in Children: Protocol for a Randomized Noninferiority Trial %A Garcia-Rueda,Maria Fernanda %A Bohorquez-Penaranda,Adriana Patricia %A Gil-Laverde,Jacky Fabian Armando %A Aguilar-Sierra,Francisco Javier %A Mendoza-Pulido,Camilo %+ Department of Orthopedics, Instituto Roosevelt, Carrera 4 Este No. 17-50, Bogotá, 110321, Colombia, 57 353 40 00 ext 6252, m-garciar@javeriana.edu.co %K radius fractures %K distal radius %K pediatric %K remodeling %K surgical reduction %K cast immobilization %K outcome measure %D 2022 %7 14.4.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Acute treatment for distal radius fractures, the most frequent fractures in the pediatric population, represents a challenge to the orthopedic surgeon. Deciding on surgical restoration of the alignment or cast immobilization without reducing the fracture is a complex concern given the remodeling potential of bones in children. In addition, the lack of evidence-based safe boundaries of shortening and angulation, that will not jeopardize upper-extremity functionality in the future, further complicates this decision. Objective: The authors aim to measure functional outcomes, assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Physical Function v2.0 instrument. The authors hypothesize that outcomes will not be worse in children treated with cast immobilization in situ compared with those treated with closed reduction with or without percutaneous fixation. The authors also aim to compare the following as secondary outcomes: ulnar variance and fracture alignment in the sagittal and coronal planes, range of motion, pressure ulcers, pain control, radius osteotomy due to deformity, pseudoarthrosis cure, and remanipulation. Methods: This is the protocol of a randomized noninferiority trial comparing upper-extremity functionality in children aged 5 to 10 years, after sustaining a distal radius fracture, treated with either cast immobilization in situ or closed reduction with or without fixation in a single orthopedic hospital. Functional follow-up is projected at 6 months, while clinical and radiographic follow-up will occur at 2 weeks, 3 months, and 9 months. Results: Recruitment commenced in July 2021. As of January 2022, 23 children have been randomized. Authors expect an average of 5 patients to be recruited monthly; therefore, recruitment and analysis should be complete by October 2024. Conclusions: This experimental design that addresses upper-extremity functionality after cast immobilization in situ in children who have sustained a distal fracture of the radius may yield compelling information that could aid the clinician in deciding on the most suitable orthopedic treatment. Trial Registration: ClinicalTrials.gov NCT05008029; https://clinicaltrials.gov/ct2/show/NCT05008029 International Registered Report Identifier (IRRID): DERR1-10.2196/34576 %M 35436224 %R 10.2196/34576 %U https://www.researchprotocols.org/2022/4/e34576 %U https://doi.org/10.2196/34576 %U http://www.ncbi.nlm.nih.gov/pubmed/35436224 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 4 %P e36166 %T Comparing the New Interdisciplinary Health in Work Intervention With Conventional Monodisciplinary Welfare Interventions at Norwegian Workplaces: Protocol for a Pragmatic Cluster Randomized Trial %A Höper,Anje Christina %A Terjesen,Christoffer Lilja %A Fleten,Nils %+ Occupational Health in the North, Department of Community Medicine, UiT The Arctic University of Norway, Postboks 6050 Langnes, Tromsø, 9037, Norway, 47 98022451, anje.hoeper@uit.no %K sickness absence %K work environment %K work environment intervention %K health related quality of life %K cluster randomized trial %K cost-effectiveness-analysis %K cost-benefit-analysis %K health in work %D 2022 %7 7.4.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Musculoskeletal and mental health complaints are the dominant diagnostic categories in long-term sick leave and disability pensions in Norway. Continuing to work despite health complaints is often beneficial, and a good work environment can improve work inclusion for people affected. In 2001, the Norwegian Labour and Welfare Administration began to offer inclusive work measures to improve the psychosocial work environment and work inclusion of people with health complaints. In 2018, the Norwegian Labour and Welfare Administration and specialist health services started offering the new collaborative Health in work program. Its workplace intervention presents health and welfare information that may improve employees’ coping ability regarding common health complaints. It encourages understanding of coworkers’ health complaints and appropriate work adjustments to increase work participation. Objective: This protocol presents an ongoing, 2-arm, pragmatic cluster-randomized trial. Its aim is to compare the effect of monodisciplinary inclusive work measures (treatment as usual) and interdisciplinary Health in work in terms of changes in overall sickness absence, health care use, health-related quality of life, and costs. The secondary objectives are to compare changes in individual sickness absence, psychosocial work environment, job and life satisfaction, health, and health anxiety at both the individual and group levels. Methods: Data will be collected from national registers, trial-specific registrations, and questionnaires. Effects will be explored using difference-in-difference analysis and regression modeling. Multilevel analysis will visualize any cluster effects using intraclass correlation coefficients. Results: Inclusion was completed in July 2021 with 97 workplaces and 1383 individual consents. Data collection will be completed with the last questionnaires to be sent out in July 2023. Conclusions: This trial will contribute to filling knowledge gaps regarding the effectiveness and costs of workplace interventions, thereby benefiting health and welfare services, political decision makers, and the public and business sectors. The findings will be disseminated in reports, peer-reviewed journals, and conferences. Trial Registration: ClinicalTrials.gov NCT04000035; https://clinicaltrials.gov/ct2/show/NCT04000035 International Registered Report Identifier (IRRID): DERR1-10.2196/36166 %M 35388792 %R 10.2196/36166 %U https://www.researchprotocols.org/2022/4/e36166 %U https://doi.org/10.2196/36166 %U http://www.ncbi.nlm.nih.gov/pubmed/35388792 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 4 %P e35543 %T Effectiveness of Individual Feedback and Coaching on Shared Decision-making Consultations in Oncology Care: Protocol for a Randomized Clinical Trial %A van Veenendaal,Haske %A Peters,Loes J %A Ubbink,Dirk T %A Stubenrouch,Fabienne E %A Stiggelbout,Anne M %A Brand,Paul LP %A Vreugdenhil,Gerard %A Hilders,Carina GJM %+ Erasmus School of Health Policy and Management, Erasmus University Rotterdam, P.O. Box 1738, Rotterdam, 3000 DR, Netherlands, 31 651952029, haskevanveenendaal@gmail.com %K decision-making %K shared %K education %K professional %K feedback learning %K coaching %K medical consultation %K medical oncology %K palliative care %D 2022 %7 6.4.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Shared decision-making (SDM) is particularly important in oncology as many treatments involve serious side effects, and treatment decisions involve a trade-off between benefits and risks. However, the implementation of SDM in oncology care is challenging, and clinicians state that it is difficult to apply SDM in their actual workplace. Training clinicians is known to be an effective means of improving SDM but is considered time consuming. Objective: This study aims to address the effectiveness of an individual SDM training program using the concept of deliberate practice. Methods: This multicenter, single-blinded randomized clinical trial will be performed at 12 Dutch hospitals. Clinicians involved in decisions with oncology patients will be invited to participate in the study and allocated to the control or intervention group. All clinicians will record 3 decision-making processes with 3 different oncology patients. Clinicians in the intervention group will receive the following SDM intervention: completing e-learning, reflecting on feedback reports, performing a self-assessment and defining 1 to 3 personal learning questions, and participating in face-to-face coaching. Clinicians in the control group will not receive the SDM intervention until the end of the study. The primary outcome will be the extent to which clinicians involve their patients in the decision-making process, as scored using the Observing Patient Involvement–5 instrument. As secondary outcomes, patients will rate their perceived involvement in decision-making, and the duration of the consultations will be registered. All participating clinicians and their patients will receive information about the study and complete an informed consent form beforehand. Results: This trial was retrospectively registered on August 03, 2021. Approval for the study was obtained from the ethical review board (medical research ethics committee Delft and Leiden, the Netherlands [N20.170]). Recruitment and data collection procedures are ongoing and are expected to be completed by July 2022; we plan to complete data analyses by December 2022. As of February 2022, a total of 12 hospitals have been recruited to participate in the study, and 30 clinicians have started the SDM training program. Conclusions: This theory-based and blended approach will increase our knowledge of effective and feasible training methods for clinicians in the field of SDM. The intervention will be tailored to the context of individual clinicians and will target the knowledge, attitude, and skills of clinicians. The patients will also be involved in the design and implementation of the study. Trial Registration: Netherlands Trial Registry NL9647; https://www.trialregister.nl/trial/9647 International Registered Report Identifier (IRRID): DERR1-10.2196/35543 %M 35383572 %R 10.2196/35543 %U https://www.researchprotocols.org/2022/4/e35543 %U https://doi.org/10.2196/35543 %U http://www.ncbi.nlm.nih.gov/pubmed/35383572 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 4 %P e26827 %T Exercise and Creatine Supplementation to Augment the Adaptation of Exercise Training Among Breast Cancer Survivors Completing Chemotherapy: Protocol for an Open-label Randomized Controlled Trial (the THRIVE Study) %A Patel,Darpan I %A Gonzalez,Angela %A Moon,Crisann %A Serra,Monica %A Bridges,Preston Blake %A Hughes,Daniel %A Clarke,Geoffrey %A Kilpela,Lisa %A Jiwani,Rozmin %A Musi,Nicolas %+ Biobehavioral Research Laboratory, School of Nursing, University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Drive, San Antonio, TX, 78229, United States, 1 210 567 0362, pateld7@uthscsa.edu %K rehabilitation %K supplements %K resistant exercise %K oncology %K quality of life %K doxorubicin %D 2022 %7 1.4.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: In breast cancer survivors, chemotherapy-induced muscle loss has been shown to be attenuated with structured resistance exercise. Creatine supplementation can increase bioenergetics in skeletal muscle, which helps to improve overall strength and endurance and reduce muscular fatigue. Therefore, we hypothesize that adding creatinine supplementation to exercise training will accelerate improvements in strength, endurance, and bioenergetics in breast cancer survivors. Objective: The primary objective is to determine the effects of combining creatine supplementation with exercise on modulating strength and physical function in breast cancer survivors by comparing these effects to those of exercise alone. The secondary objectives are to determine if creatine supplementation and exercise can increase the intramuscular storage of creatine and improve body composition by comparing this intervention to exercise alone. Methods: We aim to test our hypothesis by conducting an open-label randomized controlled trial of 30 breast cancer survivors who have completed chemotherapy within 6 months of enrollment. Eligible participants will be equally randomized (1:1) to either a creatine and exercise group or an exercise-only group for this 12-week intervention. Individuals who are randomized to receive creatine will be initially dosed at 20 g per day for 7 days to boost the availability of creatine systemically. Thereafter, the dose will be reduced to 5 g per day for maintenance throughout the duration of the 12-week protocol. All participants will engage in 3 center-based exercise sessions, which will involve completing 3 sets of 8 to 12 repetitions on chest press, leg press, seated row, shoulder press, leg extension, and leg curl machines. The primary outcomes will include changes in strength, body composition, and physical function in breast cancer survivors. The secondary outcomes will be intramuscular concentrations of creatine and adenosine triphosphate in the vastus lateralis, midthigh cross-sectional area, and quality of life. Results: As of October 2021, a total of 9 patients have been enrolled into the study. No unexpected adverse events have been reported. Conclusions: Creatine is being studied as a potential agent for improving strength, endurance, and bioenergetics in breast cancer survivors following chemotherapy. The findings from our trial may have future implications for supporting breast cancer survivors in reversing the muscle loss experienced during chemotherapy and improving their physical function and quality of life. Trial Registration: ClinicalTrials.gov NCT04207359; https://clinicaltrials.gov/ct2/show/NCT04207359 International Registered Report Identifier (IRRID): PRR1-10.2196/26827 %M 35363152 %R 10.2196/26827 %U https://www.researchprotocols.org/2022/4/e26827 %U https://doi.org/10.2196/26827 %U http://www.ncbi.nlm.nih.gov/pubmed/35363152 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 3 %P e31308 %T Treatment of Persistent Postconcussion Syndrome With Repetitive Transcranial Magnetic Stimulation Using Functional Near-Infrared Spectroscopy as a Biomarker of Response: Protocol for a Randomized Controlled Clinical Trial %A du Plessis,Sané %A Oni,Ibukunoluwa K %A Lapointe,Andrew P %A Campbell,Christina %A Dunn,Jeff F %A Debert,Chantel T %+ Department of Clinical Neurosciences, Cumming School of Medicine, University of Calgary, 3330 Hospital Dr NW, Calgary, AB, T2N4N1, Canada, 1 9448643, sane.duplessis@ucalgary.ca %K concussion %K mild traumatic brain injury %K persistent postconcussion syndrome %K repetitive transcranial magnetic stimulation %K functional near-infrared spectroscopy %K traumatic brain injury %K TBI %K brain injury %K brain %K symptom burden %K mental health %K quality of life %K neuroscience %K neurology %D 2022 %7 22.3.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Approximately one-third of all concussions lead to persistent postconcussion syndrome (PPCS). Repetitive transcranial magnetic stimulation (rTMS) is a form of noninvasive brain stimulation that has been extensively used to treat refractory major depressive disorder and has a strong potential to be used as a treatment for patients with PPCS. Functional near-infrared spectroscopy (fNIRS) has already been used as a tool to assess patients with PPCS and may provide insight into the pathophysiology of rTMS treatment in patients with PPCS. Objective: The primary objective of this research is to determine whether rTMS treatment improves symptom burden in patients with PPCS compared to sham treatment using the Rivermead postconcussion symptom questionnaire. The secondary objective is to explore the neuropathophysiological changes that occur following rTMS in participants with PPCS using fNIRS. Exploratory objectives include determining whether rTMS treatment in participants with PPCS will also improve quality of life, anxiety, depressive symptoms, cognition, posttraumatic stress, and function secondary to headaches. Methods: A total of 44 adults (18-65 years old) with PPCS (>3 months to 5 years) will participate in a double-blind, sham-controlled, concealed allocation, randomized clinical trial. The participants will engage in either a 4-week rTMS treatment protocol or sham rTMS protocol (20 treatments). The left dorsolateral prefrontal cortex will be located through Montreal Neurologic Institute coordinates. The intensity of the rTMS treatment over the left dorsolateral prefrontal cortex will be 120% of resting motor threshold, with a frequency of 10 Hz, 10 trains of 60 pulses per train (total of 600 pulses), and intertrain interval of 45 seconds. Prior to starting the rTMS treatment, participant and injury characteristics, questionnaires (symptom burden, quality of life, depression, anxiety, cognition, and headache), and fNIRS assessment will be collected. Repeat questionnaires and fNIRS will occur immediately after rTMS treatment and at 1 month and 3 months post rTMS. Outcome parameters will be analyzed by a 2-way (treatment × time) mixed analysis of variance. Results: As of May 6, 2021, 5 participants have been recruited for the study, and 3 have completed the rTMS protocol. The estimated completion date of the trial is May 2022. Conclusions: This trial will expand our knowledge of how rTMS can be used as a treatment option of PPCS and will explore the neuropathophysiological response of rTMS through fNIRS analysis. Trial Registration: ClinicalTrials.gov NCT04568369; https://clinicaltrials.gov/ct2/show/NCT04568369 International Registered Report Identifier (IRRID): DERR1-10.2196/31308 %M 35315783 %R 10.2196/31308 %U https://www.researchprotocols.org/2022/3/e31308 %U https://doi.org/10.2196/31308 %U http://www.ncbi.nlm.nih.gov/pubmed/35315783 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 1 %P e29230 %T Aerobic Exercise in HIV-Associated Neurocognitive Disorders: Protocol for a Randomized Controlled Trial %A Nweke,Martins %A Mshunqane,Nombeko %A Govender,Nalini %A Akinpelu,Aderonke %A Ogunniyi,Adesola %+ Department of Physiotherapy, Faculty of Health Sciences, University of Pretoria, 15 4th Avenue Trans-Ekulu, Enugu, 400281, Nigeria, 234 07038734685, martins.nweke@gmail.com %K HIV %K neurocognitive disorder %K exercise %K rehabilitation %K quality of life %K activity limitation %D 2022 %7 31.1.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Since the introduction of antiretroviral therapy (ART), the incidence of HIV-associated dementia has drastically fallen. Despite using ART, people living with HIV continue to experience less severe but limiting forms of HIV-associated neurocognitive disorder (HAND). People living with HIV who are on ART and experiencing symptoms of HAND may benefit from aerobic exercise. Objective: This protocol describes a randomized controlled trial designed to determine the effects of a 12-week aerobic exercise program on HAND in Southeastern Nigeria. Methods: At least 68 patients diagnosed with HAND will be randomly placed into either an aerobic exercise group or control group. Patients in the aerobic exercise group will perform a moderate intensity workout on a stationary bicycle ergometer, 3 times a week for 12 weeks. We will measure the primary outcomes including neurocognitive performance, prevalence of HAND, viral load, and CD4 count. We will evaluate postexercise neurocognitive performance using reliable neuropsychological tests relevant to people living with HIV, in line with the Frascati criteria. We will assess secondary outcomes such as quality of life, activity limitation, and social participation using the World Health Organization Quality of Life (WHOQOL)-Brief, and the Oxford Participation and Activities questionnaire. We will use exploratory statistics to test the data for normality and homogeneity. We will analyze the effect of the exercise program on HAND using relative risk (RR) and absolute risk reduction (number needed to treat). Analysis of covariance will be run to estimate the effect of exercise on quality of life and activity and participation level. Results: This funded trial was approved by the Institutional Review Board in May 2020. The protocol was approved on June 15, 2020. Enrollment commenced in January 2021 and was completed in May 2021. Over 60% of the participants were recruited at the time of first submission to JMIR Mental Health. Data curation is still ongoing; hence, data analysis is yet to be executed. Study outcomes are expected to be published in March 2022. Conclusions: This is a protocol for a randomized controlled trial that aims to evaluate the effect of a 12-week aerobic exercise program on HAND in Southeastern Nigeria. Trial Registration: Pan African Clinical Trials Registry PACTR202009483415745; https://tinyurl.com/2p97zpu9 International Registered Report Identifier (IRRID): PRR1-10.2196/29230 %M 35099405 %R 10.2196/29230 %U https://www.researchprotocols.org/2022/1/e29230 %U https://doi.org/10.2196/29230 %U http://www.ncbi.nlm.nih.gov/pubmed/35099405 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 1 %P e27935 %T Comparing Neuroplasticity Changes Between High and Low Frequency Gait Training in Subacute Stroke: Protocol for a Randomized, Single-Blinded, Controlled Study %A Ahmedy,Fatimah %A Mohamad Hashim,Natiara %A Lago,Herwansyah %A Plijoly,Leonard Protasius %A Ahmedy,Ismail %A Idna Idris,Mohd Yamani %A Gani,Abdullah %A Sybil Shah,Syahiskandar %A Chia,Yuen Kang %+ Faculty of Medicine and Health Sciences, Universiti Malaysia Sabah, Jalan UMS, Kota Kinabalu, 88400, Malaysia, 60 138805513, fatimahmedy@ums.edu.my %K neuroplasticity %K gait training %K stroke rehabilitation %K electroencephalogram signals %D 2022 %7 28.1.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Walking recovery post stroke can be slow and incomplete. Determining effective stroke rehabilitation frequency requires the assessment of neuroplasticity changes. Neurobiological signals from electroencephalogram (EEG) can measure neuroplasticity through incremental changes of these signals after rehabilitation. However, changes seen with a different frequency of rehabilitation require further investigation. It is hypothesized that the association between the incremental changes from EEG signals and the improved functional outcome measure scores are greater in higher rehabilitation frequency, implying enhanced neuroplasticity changes. Objective: The purpose of this study is to identify the changes in the neurobiological signals from EEG, to associate these with functional outcome measures scores, and to compare their associations in different therapy frequency for gait rehabilitation among subacute stroke individuals. Methods: A randomized, single-blinded, controlled study among patients with subacute stroke will be conducted with two groups: an intervention group (IG) and a control group (CG). Each participant in the IG and CG will receive therapy sessions three times a week (high frequency) and once a week (low frequency), respectively, for a total of 12 consecutive weeks. Each session will last for an hour with strengthening, balance, and gait training. The main variables to be assessed are the 6-Minute Walk Test (6MWT), Motor Assessment Scale (MAS), Berg Balance Scale (BBS), Modified Barthel Index (MBI), and quantitative EEG indices in the form of delta to alpha ratio (DAR) and delta-plus-theta to alpha-plus-beta ratio (DTABR). These will be measured at preintervention (R0) and postintervention (R1). Key analyses are to determine the changes in the 6MWT, MAS, BBS, MBI, DAR, and DTABR at R0 and R1 for the CG and IG. The changes in the DAR and DTABR will be analyzed for association with the changes in the 6MWT, MAS, BBS, and MBI to measure neuroplasticity changes for both the CG and IG. Results: We have recruited 18 participants so far. We expect to publish our results in early 2023. Conclusions: These associations are expected to be positive in both groups, with a higher correlation in the IG compared to the CG, reflecting enhanced neuroplasticity changes and objective evaluation on the dose-response relationship. International Registered Report Identifier (IRRID): DERR1-10.2196/27935 %M 35089146 %R 10.2196/27935 %U https://www.researchprotocols.org/2022/1/e27935 %U https://doi.org/10.2196/27935 %U http://www.ncbi.nlm.nih.gov/pubmed/35089146 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 1 %P e33776 %T Effectiveness of Mindfulness-Based Cognitive Therapy With Follow-Up Sessions for Pharmacotherapy-Refractory Anxiety Disorders: Protocol for a Feasibility Randomized Controlled Trial %A Sado,Mitsuhiro %A Ninomiya,Akira %A Nagaoka,Maki %A Koreki,Akihiro %A Goto,Naho %A Sasaki,Yohei %A Takamori,Chie %A Kosugi,Teppei %A Yamada,Masashi %A Park,Sunre %A Sato,Yasunori %A Fujisawa,Daisuke %A Nakagawa,Atsuo %A Mimura,Masaru %+ Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan, 1 0333531211 ext 62454, mitsusado@keio.jp %K mindfulness-based cognitive therapy %K anxiety disorders %K long-term effects %K randomized controlled trial %K cost-effectiveness %D 2022 %7 21.1.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Augmented mindfulness-based cognitive therapy (MBCT) with treatment as usual (mainly pharmacotherapy) is reported to be effective after treatment for anxiety disorders. However, whether its effectiveness persists in the long term is unclear. Objective: This study aims to examine the feasibility, acceptability, and effectiveness of a follow-up program by conducting a feasibility randomized controlled trial (RCT) that compares augmented MBCT with follow-up sessions and that without follow-up sessions in preparation for a definitive RCT. Methods: The study involves an 8-week MBCT with a 10-month follow-up. Patients aged 20 to 65 years who meet the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for panic disorder, agoraphobia, or social anxiety disorder, which is not remitted with usual treatment for at least 4 weeks, will be included in the study and randomly allocated to receive augmented MBCT with follow-up sessions or augmented MBCT without follow-up sessions. For this feasibility RCT, the primary outcomes are (1) study inclusion rate, (2) dropout rate, (3) attendance rate, and (4) mean and standard deviation of several clinical measures at 8 weeks and 5, 8, and 12 months. Results: We started recruiting participants in January 2020, and 43 participants have been enrolled up to January 2021. The study is ongoing, and data collection will be completed by May 2022. Conclusions: This study is novel in terms of its design, which compares augmented MBCT with and without follow-up sessions. The limitations of the trial are as follows: (1) mixed participants in terms of the delivery mode of the intervention, and (2) lack of a pharmacotherapy-alone arm. Owing to its novelty and significance, this study will provide fruitful knowledge for future definitive RCTs. Trial Registration: UMIN Clinical Trials Registry UMIN000038626; https://tinyurl.com/2p9dtxzh International Registered Report Identifier (IRRID): DERR1-10.2196/33776 %M 34787573 %R 10.2196/33776 %U https://www.researchprotocols.org/2022/1/e33776 %U https://doi.org/10.2196/33776 %U http://www.ncbi.nlm.nih.gov/pubmed/34787573 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 1 %P e31413 %T The Role of Carbohydrates in Irritable Bowel Syndrome: Protocol for a Randomized Controlled Trial Comparing Three Different Treatment Options %A Nybacka,Sanna %A Törnblom,Hans %A Simren,Magnus %A Störsrud,Stine %+ Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Medicinaregatan 13, Gothenburg, 413 46, Sweden, 46 031 7860000, sanna.nybacka@gu.se %K irritable bowel syndrome %K low FODMAP %K LCHF %K pharmacological treatment %K diet %K NICE diet %D 2022 %7 17.1.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Although it is widely acknowledged that food intake can worsen symptoms in patients with irritable bowel syndrome (IBS), there is a lack of efficient treatments that can apply to all patients and subtypes of IBS. As IBS can manifest in different ways, it is likely that the most successful treatment option will differ among patients; therefore, this large, randomized controlled trial comparing 3 different treatment options for patients with IBS is highly warranted. Objective: This study aims to conduct a randomized controlled trial to evaluate the effectiveness of 3 different treatment options for patients with IBS. Methods: A total of 300 patients with IBS will be randomized (1:1:1) to receive one of the following three treatment options: a diet with low total carbohydrate content; a diet combining low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols and traditional dietary advice in IBS; and optimized medical treatment. The study will comprise a 10-day screening period, 28 days of intervention, and a 6-month follow-up for patients receiving dietary treatment. Questionnaires assessing both gastrointestinal and extraintestinal symptoms will be used as end points, as well as metabolomics, microbiota profiling, and immunological markers. Furthermore, qualitative methods will be used to evaluate the patients’ experiences regarding diet treatments. Results: Recruitment for this study began in January 2017. By May 2021, of the proposed 300 participants, 270 (90%) had been randomized, and 244 (81.3%) participants had finished the 4-week intervention. The study is still in progress, and the results are expected to be published in 2022. Conclusions: By collecting a wide range of data before, during, and after treatment in a large group of patients with IBS and diverse bowel habits, we will gain new insights into the predictors of response to treatment. That information can, in the future, be used to personalize treatment for the patient, based on the individual’s phenotype and IBS symptoms. In addition, the long-term effects of 2 different dietary treatments will be evaluated regarding their impact on gut microbiota and clinical laboratory tests and to ensure that they are safe, effective, and applicable for patients with IBS. Trial Registration: ClinicalTrials.gov NCT02970591; https://clinicaltrials.gov/ct2/show/NCT02970591 International Registered Report Identifier (IRRID): DERR1-10.2196/31413 %M 35037893 %R 10.2196/31413 %U https://www.researchprotocols.org/2022/1/e31413 %U https://doi.org/10.2196/31413 %U http://www.ncbi.nlm.nih.gov/pubmed/35037893 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 1 %P e30163 %T The Safety, Clinical, and Neurophysiological Effects of Intranasal Ketamine in Patients Who Do Not Respond to Electroconvulsive Therapy: Protocol for a Pilot, Open-Label Clinical Trial %A Knyahnytska,Yuliya %A Zomorrodi,Reza %A Kaster,Tyler %A Voineskos,Daphne %A Trevizol,Alisson %A Blumberger,Daniel %+ Centre for Addiction and Mental Health, 1025 Queen Str West, B1-2104, Toronto, ON, M6J 1H4, Canada, 1 4165358501 ext 34648, Yuliya.Knyahnytska@camh.ca %K intranasal %K racemic ketamine %K NMDA antagonist %K treatment resistant depression %K electroconvulsive therapy nonresponders %K drug %K treatment %K ketamine %K depression %K mental health %K safety %K neurophysiological %K side effect %K biomarker %K clinical trial %K alternative %D 2022 %7 17.1.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: Major depressive disorder is among the most disabling illnesses worldwide, with a lifetime prevalence of 16.2%. Research suggests that 20% to 40% of patients with depression do not respond to pharmacotherapy, developing treatment-resistant depression. Electroconvulsive therapy is the gold standard for treating individuals with treatment-resistant depression, with remission rates of approximately 75% to 90%. However, 10% to 25% of patients do not respond to electroconvulsive therapy, and many are unable to tolerate it due to the side effects. Both groups are considered to be patients who do not respond to electroconvulsive therapy, because both groups continue to exhibit symptoms of severe depression, have a limited number of treatment options available, and are in need of rapid treatment. Ketamine, an N-methyl-D-aspartate receptor antagonist, has been shown to exert rapid antidepressant effects in patients with treatment-resistant depression when administered in subanesthetic doses through 40-minute intravenous infusions. Recently, a ketamine compound, esketamine (Spravato), that is administered through the intranasal route received regulatory approval by the US Food and Drug Administration and Health Canada to treat depression. However, esketamine is challenging to access due to high costs and limited availability. Racemic ketamine (rketamine) is cheap and easy to access; however, the effects in patients who have not responded to electroconvulsive therapy have yet to be understood or tested. This study will use transcranial magnetic stimulation to study mechanisms of human brain cortical physiology at the systemic level to identify neurobiomarkers of response. Objective: The objective of this open-label pilot clinical trial is to test the feasibility and safety of intranasal ketamine in patients who have not responded to electroconvulsive therapy. The primary outcome is to determine the feasibility of a larger randomized controlled trial to test the efficacy of intranasal ketamine for patients who have not responded to electroconvulsive therapy for clinical indicators in unipolar depression. The secondary outcome is to determine the preliminary effects of an intervention on clinical outcomes, such as depressive symptoms, suicidal ideation, and quality of living. The third outcome is to explore neurophysiological changes as measured by transcranial magnetic stimulation electromyography and electroencephalography to measure changes in cortical excitability as potential predictors of clinical response. Methods: A sterile solution of racemic ketamine hydrochloride will be administered twice per week for 4 weeks (8 sessions) intranasally to patients with treatment-resistant depression who did not respond to or could not tolerate an acute course of electroconvulsive therapy. We will recruit 25 adults (24-65 years old) over the course of 2 years from an academic psychiatric hospital in Toronto, Canada. Results: This study has received ethics approval, and funding has been secured. The study is currently active. Conclusions: This is the first study to test repeated doses of intranasal rketamine in patients who have not responded to electroconvulsive therapy for depression. Results from this study will (1) inform the development of a larger adequately powered randomized controlled trial to test the efficacy of intranasal ketamine for depression and (2) determine potential neurophysiological markers of clinical response. Trial Registration: Clinical Trials.gov NCT05137938; http://clinicaltrials.gov/ct2/show/NCT05137938 International Registered Report Identifier (IRRID): PRR1-10.2196/30163 %M 34882570 %R 10.2196/30163 %U https://www.researchprotocols.org/2022/1/e30163 %U https://doi.org/10.2196/30163 %U http://www.ncbi.nlm.nih.gov/pubmed/34882570 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 11 %N 1 %P e27843 %T Sensitivity Treatments for Teeth with Molar Incisor Hypomineralization: Protocol for a Randomized Controlled Trial %A Mendonça,Fernanda L %A Regnault,Fabiana Giuseppina Di Campli %A Di Leone,Camilla C L %A Grizzo,Isabella C %A Bisaia,Aliny %A Fragelli,Camila %A Oliveira,Thais M %A Magalhães,Ana C %A Rios,Daniela %+ Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr Octávio Pinheiro Brisolla, 9-75, Bauru, 17012-101, Brazil, 55 14 3235 8346, danirios@usp.br %K sensitivity %K molar incisor hypomineralization %K fluoride %K dentistry %K pediatric dentistry %K dental care %D 2022 %7 6.1.2022 %9 Protocol %J JMIR Res Protoc %G English %X Background: The sensitivity of teeth with molar incisor hypomineralization (MIH) can affect children’s quality of life and is a challenging problem for dentists. Remineralizing agents such as sodium fluoride varnish seem to reduce the sensitivity of teeth with MIH, but long-term clinical trials with large samples are still needed for more evidence about its effectiveness as a desensitizing agent before its clinical recommendation. Objective: This randomized clinical trial aims to compare three treatment interventions for teeth with MIH and hypersensitivity. Methods: A total of 60 children aged 6-10 years presenting with at least one first permanent molar with sensitivity and no loss of enamel will be randomly assigned to three groups: the control group (sodium fluoride varnish; Duraphat, Colgate); experimental group I (4% titanium tetrafluoride varnish); and experimental group II (a coating resin containing surface prereacted glass-ionomer filler; PRG Barrier Coat, Shofu). The sodium fluoride varnish and 4% titanium tetrafluoride varnish will be applied once per week for 4 consecutive weeks and the PRG Barrier Coat resin will be applied in the first session and the application will be simulated the following 3 weeks to guarantee the blinding of the study. The primary outcome will be sensitivity level measured at different moments (before each material application, immediately after application or simulation, and 1, 2, 4, and 6 months after the last application/simulation) by one examiner using the Wong-Baker FACES Pain Rating Scale, the Schiff Cold Air Sensitivity Scale, and the FLACC (Face, Legs, Activity, Cry, Consolability) scale. As secondary outcomes, parental satisfaction and child self-reported discomfort after the treatment will be measured with a questionnaire prepared by the researcher. The data will undergo statistical analysis and the significance level will be set at 5%. Results: The project was funded in 2018, and enrollment was completed in November 2019. The recruitment of participants is currently underway and the first results are expected to be submitted for publication in 2022. Conclusions: If found effective in reducing the patient’s sensitivity long term, these agents can be considered as a treatment choice, and the findings will contribute to the development of a treatment protocol for teeth with sensitivity due to MIH. Trial Registration: Brazilian Registry of Clinical Trials Universal Trial Number U1111-1237-6720; https://tinyurl.com/mr4x82k9 International Registered Report Identifier (IRRID): DERR1-10.2196/27843 %M 34989687 %R 10.2196/27843 %U https://www.researchprotocols.org/2022/1/e27843 %U https://doi.org/10.2196/27843 %U http://www.ncbi.nlm.nih.gov/pubmed/34989687 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 12 %P e33104 %T Effects of Prosthetic Rehabilitation on Temporomandibular Disorders: Protocol for a Randomized Controlled Trial %A Sreekumar,Saranya %A Janakiram,Chandrashekar %A Mathew,Anil %+ Department of Prosthodontics and Implantology, Amrita School of Dentistry, Amrita Vishwa Vidyapeetham, Edapally, Kochi, Kerala, 682041, India, 91 9048020550, saranyask.manu@gmail.com %K orofacial pain %K joint pain %K prosthesis, edentulism %K TMD %K temporomandibular disorder %K prosthetic rehabilitation %D 2021 %7 24.12.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Loss of teeth or occlusal imbalance is one of the proposed dental risk factors for temporomandibular disorders (TMDs). Losing some non–free-end teeth cause the original occluding tooth/teeth to supraerupt from the original upright position and causes neighboring tooth/teeth to shift in an angle, causing biomechanical imbalance on the mandible. Based on these sequelae, rehabilitation of missing teeth is the first step in managing TMD in edentulous patients. Even though the prevalence of TMD in association with edentulism and in rehabilitated patients has been increasing, proper guidelines for the management of such cases have not been established. This study describes the protocol to analyze the effect of prosthetic rehabilitation on patients with TMD. Objective: This study aims to determine the effectiveness of prosthetic rehabilitation in the reduction of pain in edentulous patients with TMD and to determine the effect of the span of edentulism, the number of quadrants involved, pathological migration, the type of Kennedy classification, and the prosthetic status on temporomandibular joint dysfunction signs and symptoms. Methods: In this randomized controlled trial, 300 patients diagnosed with TMD will be grouped into one of the three interventional groups based on the type of their edentulous state. The interventional groups are (1) partially edentulous arch: Kennedy Class I and II (prosthetic rehabilitation without splint); (2) partially edentulous arch: Kennedy Class III and IV (prosthetic rehabilitation with a splint); and (3) completely edentulous arches (prosthetic rehabilitation without splint). All three of the mentioned interventional groups have corresponding control groups that will receive symptomatic treatment and comprehensive counseling. The measured primary outcomes are pain and electromyogram, and the secondary outcomes include pain drawing, Graded Chronic Pain Scale, Jaw Functional Limitation Scale, Oral Behaviours Checklist, depression, physical symptoms, and anxiety. The outcome measurements will be recorded at baseline and at the end of 24 hours, 7 days, 28 days, and 3 months. Results: Ethical approval was obtained from the Institutional Review Board of Amrita Institute of Medical Sciences, Kochi, India. Study participants’ recruitment began in May 2021 and is expected to conclude in March 2023. This clinical trial protocol was developed based on the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 Statement. Conclusions: The purpose of this study is to gather data on prosthetic rehabilitation as a treatment for TMD. Obtaining this goal will aid in the development of evidence-based therapy protocols for prosthetic rehabilitation in TMD management. Trial Registration: Clinical Trials Registry - India CTRI/2020/06/026169; http://ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=42381 International Registered Report Identifier (IRRID): DERR1-10.2196/33104 %M 34951603 %R 10.2196/33104 %U https://www.researchprotocols.org/2021/12/e33104 %U https://doi.org/10.2196/33104 %U http://www.ncbi.nlm.nih.gov/pubmed/34951603 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 12 %P e31128 %T A Venomics Approach to the Identification and Characterization of Bioactive Peptides From Animal Venoms for Colorectal Cancer Therapy: Protocol for a Proof-of-Concept Study %A Shahzadi,Syeda Kiran %A Karuvantevida,Noushad %A Banerjee,Yajnavalka %+ Department of Basic Medical Sciences, Mohammed Bin Rashid University of Medicine and Health Sciences, Building 14, Dubai Healthcare City, Dubai, 505055, United Arab Emirates, 971 568345125, yajnavalka.banerjee@mbru.ac.ae %K animal venoms %K colorectal cancer %K bioactive peptides %K high-throughput screening %K venom %K cancer %K colorectal %K peptide %K screening %K treatment %K conceptual %K characterize %K development %K therapy %D 2021 %7 21.12.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Cancer is the third leading cause of death in the United Arab Emirates (UAE), after cardiovascular diseases and accidents. In the UAE, colorectal cancer (CRC) is the first and fourth most common cancer in males and females, respectively. Several treatment modalities have been employed for cancer treatment, such as surgery, radiotherapy, chemotherapy, hormone replacement therapy, and immunotherapy. These treatment modalities often elicit adverse effects on normal cells, causing toxic side effects. To circumvent these toxicities, there has been an increased impetus towards the identification of alternate treatment strategies. Animal venoms are rich sources of pharmacologically active polypeptides and proteins. Objective: In this proof-of-concept study, we will apply a high-throughput venomics strategy to identify and characterize anticancer bioactive peptides (BAPs) from 20 different animal venoms, specifically targeting CRC. We chose to focus on CRC because it is one of the foremost health issues in the UAE. Methods: In the initial study, we will screen 2500 different peptides derived from 20 different animal venoms for anticancer activity specifically directed against 3 CRC cell lines and two control cell lines employing the 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) colorimetric assay for cytotoxicity. Of the 20 venoms, 3 that exhibit specific and potent anticancer activity directed against the 3 CRC cell lines will be selected; and from these 3 venoms, the specific peptides with anti-CRC activity will be isolated and characterized. Results: This study is at the protocol development stage only, and as such, no results are available. However, we have initiated the groundwork required to disseminate the proposed study, which includes culturing of colorectal cancer cell lines and preparation of venom screens. Conclusions: In summary, the proposed study will generate therapeutic leads to manage and treat one of the leading health issues in the UAE, namely, CRC. International Registered Report Identifier (IRRID): PRR1-10.2196/31128 %M 34932002 %R 10.2196/31128 %U https://www.researchprotocols.org/2021/12/e31128 %U https://doi.org/10.2196/31128 %U http://www.ncbi.nlm.nih.gov/pubmed/34932002 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 12 %P e30909 %T A Modern Flexitarian Dietary Intervention Incorporating Web-Based Nutrition Education in Healthy Young Adults: Protocol for a Randomized Controlled Trial %A Braakhuis,Andrea %A Gillies,Nicola %A Worthington,Anna %A Knowles,Scott %A Conner,Tamlin %A Roy,Rajshri %A Pham,Toan %A Bermingham,Emma %A Cameron-Smith,David %+ Discipline of Nutrition, Faculty of Medical and Health Science, The University of Auckland, 85 Park Road, Grafton, Auckland, 1100, New Zealand, 64 0223502926, a.braakhuis@auckland.ac.nz %K protein %K meat %K vegetarian %K eating patterns %K diet %K nutrition %K dietary restrictions %K biomarkers %K health %K well-being %K macronutrients %K micronutrients %D 2021 %7 21.12.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: The trend of flexitarian eating patterns is on the rise, with young adults among the biggest adopters claiming health and environmental reasons to reduce red meat intake. Nutrient-dense meat and animal products are often the lynchpin of these diets, even when consumed only occasionally and in moderate amounts. Red meat provides forms and concentrations of essential proteins, lipids, and micronutrients that are scarce in exclusively vegetarian regimens. Objective: The aim of this study is to consider the effects of moderate consumption of lean red meat as part of an otherwise vegetarian balanced diet and its impact on biomarkers of sustained health and well-being. Methods: A cohort of healthy, young (20-34 years old, n=80) male and female participants will take part in a 2-arm, parallel randomized controlled trial (RCT) for a duration of 12 weeks, with a 3-month posttrial follow-up. The trial will commence with a 2-week assessment period followed by allocation to the intervention arms. The intervention will include the consumption of red meat or meat alternatives 3 times per week for 10 weeks. Blood samples of the participants will be collected to measure changes in erythrocyte fatty acid distribution, circulating amino acids, neurotransmitters, markers of mineral status, and inflammatory markers. Questionnaires to assess well-being and mental health will be undertaken every 2 weeks. Body composition, physical function, and blood parameters will be assessed at allocation (t0), week 5 into the intervention (t5), and post intervention (t10). Results: The protocol has been developed using the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) checklist and the outcomes will be reported in accordance with the CONSORT (Consolidated Standards of Reporting Trials) guidelines. The trial was approved by the New Zealand Ministry of Health’s Health and Disability Ethics Committees (protocol 20/STH/157). The results of this study will be communicated via publication. Conclusions: To our knowledge, this is the first RCT investigating the overarching health consequences of consuming pasture-fed red meat or no meat as part of a healthy diet. Trial Registration: ClinicalTrials.gov NCT04869163; https://clinicaltrials.gov/ct2/show/NCT04869163 International Registered Report Identifier (IRRID): PRR1-10.2196/30909 %M 34931994 %R 10.2196/30909 %U https://www.researchprotocols.org/2021/12/e30909 %U https://doi.org/10.2196/30909 %U http://www.ncbi.nlm.nih.gov/pubmed/34931994 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 11 %P e27054 %T A Parent Coach–Led Model of Well-Child Care for Young Children in Low-Income Communities: Protocol for a Cluster Randomized Controlled Trial %A Hurst,Rachel %A Liljenquist,Kendra %A Lowry,Sarah J %A Szilagyi,Peter G %A Fiscella,Kevin A %A Weaver,Marcia R %A Porras-Javier,Lorena %A Ortiz,Janette %A Sotelo Guerra,Laura J %A Coker,Tumaini R %+ School of Public Health, New York University, 70 Washington Square S, New York, NY, 10012, United States, 1 212 998 1212, rjh430@nyu.edu %K preventive care %K well-child care %K community health centers %D 2021 %7 25.11.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: The Parent-focused Redesign for Encounters, Newborns to Toddlers (PARENT) intervention was created as a team-based approach to well-child care (WCC) that relies on a health educator (Parent Coach) to provide the bulk of WCC services, address specific needs faced by families in low-income communities, and decrease reliance on the clinician as the primary provider of WCC services. Objective: This study aims to evaluate the impact of PARENT using a cluster randomized controlled trial. Methods: This study tested the effectiveness of PARENT at 10 clinical sites in 2 federally qualified health centers in Tacoma, Washington, and Los Angeles, California. We conducted a cluster randomized controlled trial that included 916 families with children aged ≤12 months at the time of the baseline survey. Parents will be followed up at 6 and 12 months after enrollment. The Parent Coach, the main element of PARENT, provides anticipatory guidance, psychosocial screening and referral, developmental and behavioral surveillance, screening, and guidance at each WCC visit. The coach is supported by parent-focused previsit screening and visit prioritization, a brief, problem-focused clinician encounter for a physical examination and any concerns that require a clinician’s attention, and an automated text message parent reminder and education service for periodic, age-specific messages to reinforce key health-related information recommended by Bright Futures national guidelines. We will examine parent-reported quality of care (receipt of nationally recommended WCC services, family-centeredness of care, and parental experiences of care), and health care use (WCC, urgent care, emergency department, and hospitalizations), conduct a cost analysis, and conduct a separate time-motion study of clinician time allocation to assess efficiency. We will also collect data on exploratory measures of parent-and parenting-focused outcomes. Our primary outcomes were receipt of anticipatory guidance and emergency department use. Results: Participant recruitment began in March 2019. After recruitment, 6- and 12-month follow-up surveys will be completed. As of August 30, 2021, we enrolled a total of 916 participants. Conclusions: This large pragmatic trial of PARENT in partnership with federally qualified health centers will assess its utility as an evidence-based and financially sustainable model for the delivery of preventive care services to children in low-income communities. Trial Registration: ClinicalTrials.gov: NCT03797898; https://clinicaltrials.gov/ct2/show/NCT03797898 International Registered Report Identifier (IRRID): DERR1-10.2196/27054 %M 34842563 %R 10.2196/27054 %U https://www.researchprotocols.org/2021/11/e27054 %U https://doi.org/10.2196/27054 %U http://www.ncbi.nlm.nih.gov/pubmed/34842563 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 11 %P e29467 %T Comparison of (Cost-)Effectiveness of Magnetic Resonance Image–Guided High-Intensity–Focused Ultrasound With Standard (Minimally) Invasive Fibroid Treatments: Protocol for a Multicenter Randomized Controlled Trial (MYCHOICE) %A Anneveldt,Kimberley J %A Nijholt,Ingrid M %A Schutte,Joke M %A Dijkstra,Jeroen R %A Frederix,Geert W J %A Ista,Erwin %A Verpalen,Inez M %A Veersema,Sebastiaan %A Huirne,Judith A F %A Hehenkamp,Wouter J K %A Boomsma,Martijn F %+ Department of Radiology, Isala Hospital, Dokter ven Heesweg 2, Zwolle, 8025 AB, Netherlands, 31 384242243, k.j.anneveldt@isala.nl %K high-intensity–focused ultrasound ablation %K magnetic resonance imaging, interventional %K leiomyoma %K randomized controlled trial %K cost-effectiveness analysis %K clinical trial protocol %D 2021 %7 24.11.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Magnetic resonance image–guided high-intensity–focused ultrasound (MR-HIFU) is a rather new, noninvasive option for the treatment of uterine fibroids. It is safe, effective, and has a very short recovery time. However, a lack of prospectively collected data on long-term (cost-)effectiveness of the MR-HIFU treatment compared with standard uterine fibroid care prevents the MR-HIFU treatment from being reimbursed for this indication. Therefore, at this point, when conservative treatment for uterine fibroid symptoms has failed or is not accepted by patients, standard care includes the more invasive treatments hysterectomy, myomectomy, and uterine artery embolization (UAE). Primary outcomes of currently available data on MR-HIFU treatment often consist of technical outcomes, instead of patient-centered outcomes such as quality of life (QoL), and do not include the use of the latest equipment or most up-to-date treatment strategies. Moreover, data on cost-effectiveness are rare and seldom include data on a societal level such as productivity loss or use of painkillers. Because of the lack of reimbursement, broad clinical implementation has not taken place, nor is the proper role of MR-HIFU in uterine fibroid care sufficiently clear. Objective: The objective of our study is to determine the long-term (cost-)effectiveness of MR-HIFU compared with standard (minimally) invasive fibroid treatments. Methods: The MYCHOICE study is a national, multicenter, open randomized controlled trial with randomization in a 2:1 ratio to MR-HIFU or standard care including hysterectomy, myomectomy, and UAE. The sample size is 240 patients in total. Women are included when they are 18 years or older, in premenopausal stage, diagnosed with symptomatic uterine fibroids, conservative treatment has failed or is not accepted, and eligible for MR-HIFU. Primary outcomes of the study are QoL 24 months after treatment and costs of treatment including direct health care costs, loss of productivity, and patient costs. Results: Inclusion for the MYCHOICE study started in November 2020 and enrollment will continue until 2024. Data collection is expected to be completed in 2026. Conclusions: By collecting data on the long-term (cost-)effectiveness of the MR-HIFU treatment in comparison to current standard fibroid care, we provide currently unavailable evidence about the proper place of MR-HIFU in the fibroid treatment spectrum. This will also facilitate reimbursement and inclusion of MR-HIFU in (inter)national uterine fibroid care guidelines. Trial Registration: Netherlands Trial Register NL8863; https://www.trialregister.nl/trial/8863 International Registered Report Identifier (IRRID): DERR1-10.2196/29467 %M 34821569 %R 10.2196/29467 %U https://www.researchprotocols.org/2021/11/e29467 %U https://doi.org/10.2196/29467 %U http://www.ncbi.nlm.nih.gov/pubmed/34821569 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 11 %P e26252 %T mHealth for Anemia Reduction: Protocol for an Entertainment Education–Based Dual Intervention %A Pant,Ichhya %A Rimal,Rajiv %A Yilma,Hagere %A Bingenheimer,Jeffrey %A Sedlander,Erica %A Behera,Sibabrata %+ Department of Prevention and Community Health, School of Public Health, George Washington University, 950 New Hampshire Ave NW #2, Washington, DC, 20052, United States, 1 4044619851, ipant@gwu.edu %K mHealth %K interactive %K voice response %K entertainment %K education %K rural %K anemia %K bystander %K violence against women %D 2021 %7 22.11.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: More than half of the women of reproductive age (aged 15-49 years) are anemic in India. The uptake of and adherence to iron folic acid (IFA) supplements remain low despite sustained efforts to increase their use. With India’s burgeoning digital environment, mobile phones offer a potential medium for increasing their uptake, especially when combined with interactive voice messages that deliver entertaining stories infused with norms-based educational messages. Objective: This study aims to investigate whether a norms-based entertainment education mobile health intervention can increase self-efficacy for IFA adherence among women of reproductive age in Odisha, India. Methods: Mobile reduction in anemia through normative innovations (mRANI) is a randomized 2-arm study that includes assessments before and after the intervention. All study participants will be recruited from the intervention arm of the parent reduction in anemia through normative innovations trial only. Although the usual practice is to randomize participants either to a treatment arm or a usual care control arm, we will assign the mRANI control group to another entertainment education–based treatment group that is designed to improve bystander intervention to reduce violence against women. Data collection for the mRANI study is embedded in the parent trial and will include baseline and end line assessments. The primary outcomes are self-efficacy for IFA adherence and violence against women–related bystander intervention. The inclusion criteria for the mRANI study are participation in the parent trial and phone ownership. Women (approximately n=400) who meet the mRANI inclusion criteria will be randomly assigned to the IFA arm or the bystander arm. Ordinary least squares regression with robust SEs will be conducted to assess between-group comparisons at the end line. A mediation analysis will be conducted to examine whether social norms and interactivity mediate the relationship between intervention exposure and primary outcomes in both arms. Real-time monitoring data will offer insights into intervention receptivity and audience engagement. Results: Data collection for the mRANI study is integrated within the parent trial. Household surveys were conducted between February and March of 2021. Responses on the mRANI study’s primary and secondary outcomes were collected from 381 participants. The data analysis is expected to be completed by October 2021. Conclusions: This study will provide evidence on whether a mobile health norms–based entertainment education intervention can increase self-efficacy for IFA adherence and violence against women–related bystander intervention. International Registered Report Identifier (IRRID): PRR1-10.2196/26252 %M 34812735 %R 10.2196/26252 %U https://www.researchprotocols.org/2021/11/e26252 %U https://doi.org/10.2196/26252 %U http://www.ncbi.nlm.nih.gov/pubmed/34812735 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 11 %P e31951 %T Effect of Door-to-Door Screening and Awareness Generation Activities in the Catchment Areas of Vision Centers on Service Use: Protocol for a Randomized Experimental Study %A Sabherwal,Shalinder %A Chinnakaran,Anand %A Sood,Ishaana %A Garg,Gaurav K %A Singh,Birendra P %A Shukla,Rajan %A Reddy,Priya A %A Gilbert,Suzanne %A Bassett,Ken %A Murthy,Gudlavalleti V S %A , %+ Department of Community Ophthalmology and Public Health Research, Dr Shroff’s Charity Eye Hospital, 5027, Kedarnath Lane, Daryaganj, New Delhi, 110002, India, 91 9910305208, Shalinder.sabherwal@sceh.net %K study protocol %K randomized intervention study %K vision centers %K door-to-door screening %K cost-effectiveness %K sustainability %K screening %K awareness %K vision %K eye %K utilization %K usage %K India %K rural %K intervention %K engagement %K scalability %D 2021 %7 4.11.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: A vision center (VC) is a significant eye care service model to strengthen primary eye care services. VCs have been set up at the block level, covering a population of 150,000-250,000 in rural areas in North India. Inadequate use by rural communities is a major challenge to sustainability of these VCs. This not only reduces the community’s vision improvement potential but also impacts self-sustainability and limits expansion of services in rural areas. The current literature reports a lack of awareness regarding eye diseases and the need for care, social stigmas, low priority being given to eye problems, prevailing gender discrimination, cost, and dependence on caregivers as factors preventing the use of primary eye care. Objective: Our organization is planning an awareness-cum-engagement intervention—door-to-door basic eye checkup and visual acuity screening in VCs coverage areas—to connect with the community and improve the rational use of VCs. Methods: In this randomized, parallel-group experimental study, we will select 2 VCs each for the intervention arm and the control arm from among poor, low-performing VCs (ie, walk-in of ≤10 patients/day) in our 2 operational regions (Vrindavan, Mathura District, and Mohammadi, Kheri District) of Uttar Pradesh. Intervention will include door-to-door screening and awareness generation in 8-12 villages surrounding the VCs, and control VCs will follow existing practices of awareness generation through community activities and health talks. Data will be collected from each VC for 4 months of intervention. Primary outcomes will be an increase in the number of walk-in patients, spectacle advise and uptake, referral and uptake for cataract and specialty surgery, and operational expenses. Secondary outcomes will be uptake of refraction correction and referrals for cataract and other eye conditions. Differences in the number of walk-in patients, referrals, uptake of services, and cost involved will be analyzed. Results: Background work involved planning of interventions and selection of VCs has been completed. Participant recruitment has begun and is currently in progress. Conclusions: Through this study, we will analyze whether our door-to-door intervention is effective in increasing the number of visits to a VC and, thus, overall sustainability. We will also study the cost-effectiveness of this intervention to recommend its scalability. Trial Registration: ClinicalTrials.gov NCT04800718; https://clinicaltrials.gov/ct2/show/NCT04800718 International Registered Report Identifier (IRRID): DERR1-10.2196/31951 %M 34734839 %R 10.2196/31951 %U https://www.researchprotocols.org/2021/11/e31951 %U https://doi.org/10.2196/31951 %U http://www.ncbi.nlm.nih.gov/pubmed/34734839 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 11 %P e28554 %T Effectiveness of a Walking Football Program for Middle-Aged and Older Men With Type 2 Diabetes: Protocol for a Randomized Controlled Trial %A Barbosa,Ana %A Brito,João %A Figueiredo,Pedro %A Seabra,André %A Mendes,Romeu %+ EPIUnit – Instituto de Saúde Pública, Universidade do Porto, Rua das Taipas, 135, Porto, 4050-600, Portugal, 351 222061820, romeuduartemendes@gmail.com %K type 2 diabetes %K cardiovascular risk factors %K physical activity %K exercise %K football %K soccer %K walking %K randomized controlled trial %D 2021 %7 3.11.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Studies on walking football have found positive effects on health; however, there are still several research gaps when applying walking football programs for patients with type 2 diabetes. Objective: This study aims to test the effectiveness of a walking football exercise program on glycemic control and cardiovascular risk factors in middle-aged and older men with type 2 diabetes. Methods: The study will be run as a randomized controlled trial with a 6-month duration in Portugal. Eligible participants will be randomized using a 1:1 ratio for intervention or control groups and compared using an intention-to-treat analysis. The intervention will consist of a walking football exercise program. The control group will continue with usual care in primary health care units. The primary outcome will be the mean difference in glycated hemoglobin between intervention and control groups after 6 months. Secondary outcomes include the mean differences in fasting blood glucose, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides, systolic and diastolic blood pressure, body mass index, waist circumference, fat-free mass, and fat mass. Additionally, secondary outcomes include the incidence of exercise-related injuries and adverse events and the walking football exercise program’s cost-utility. Results: The study protocol is being prepared to be submitted to the Health Ethics Committee of the Northern Regional Health Administration, Portugal. After approval, participant recruitment will start in primary health care units in Porto's metropolitan area by family medicine doctors. Conclusions: Walking football might have the potential to be effective in improving glycemic control and cardiovascular risk factors, with a low rate of exercise-related injuries and adverse events and a good cost-utility ratio. Therefore, walking football may be a sustainable intervention strategy for type 2 diabetes management. International Registered Report Identifier (IRRID): PRR1-10.2196/28554 %M 34730549 %R 10.2196/28554 %U https://www.researchprotocols.org/2021/11/e28554 %U https://doi.org/10.2196/28554 %U http://www.ncbi.nlm.nih.gov/pubmed/34730549 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 11 %P e25099 %T The Effects of Workplace-Based HIV Self-testing on Uptake of Testing and Linkage to HIV Care or Prevention by Men in Uganda (WISe-Men): Protocol for a Cluster Randomized Trial %A Muwanguzi,Patience A %A Ngabirano,Tom Denis %A Kiwanuka,Noah %A Nelson,LaRon E %A Nasuuna,Esther M %A Osingada,Charles Peter %A Nabunya,Racheal %A Nakanjako,Damalie %A Sewankambo,Nelson K %+ School of Health Sciences, College of Health Sciences, Makerere University, PO Box 7072, Kampala, Uganda, 256 392178085, pamuwanguzi@gmail.com %K Africa %K workplace HIV testing %K HIV self-testing %K linkage to care %K linkage to prevention %D 2021 %7 1.11.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: HIV testing uptake remains low among men in sub-Saharan Africa. HIV self-testing (HIVST) at the workplace is a novel approach to increase the availability of, and access to, testing among men. However, both access and linkage to posttest services remain a challenge. Objective: The aim of this protocol is to describe a cluster randomized trial (CRT)—Workplace-Based HIV Self-testing Among Men (WISe-Men)—to evaluate the effect of HIVST in workplace settings on the uptake of HIV testing services (HTS) and linkage to treatment and prevention services among men employed in private security services in Uganda. Methods: This is a two-arm CRT involving men employed in private security services in two Ugandan districts. The participants in the intervention clusters will undergo workplace-based HIVST using OraQuick test kits. Those in the control clusters will receive routine HTS at their work premises. In addition to HTS, participants in both the intervention and control arms will undergo other tests and assessments, which include blood pressure assessment, blood glucose and BMI measurement, and rapid diagnostic testing for syphilis. The primary outcome is the uptake of HIV testing. The secondary outcomes include HIV status reporting, linkage into HIV care and confirmatory testing following HIVST, initiation of antiretroviral therapy following a confirmatory HIV test, the uptake of voluntary medical male circumcision, consistent condom use, and the uptake of pre-exposure prophylaxis by the most at-risk populations. Results: Participant enrollment commenced in February 2020, and the trial is still recruiting study participants. Follow-up for currently enrolled participants is ongoing. Data collection and analysis is expected to be completed in December 2021. Conclusions: The WISe-Men trial will provide information regarding whether self-testing at worksites increases the uptake of HIV testing as well as the linkage to care and prevention services at male-dominated workplaces in Uganda. Additionally, the findings will help us propose strategies for improving men’s engagement in HTS and ways to improve linkage to further care following a reactive or nonreactive HIVST result. Trial Registration: ClinicalTrials.gov NCT04164433; https://clinicaltrials.gov/ct2/show/NCT04164433 International Registered Report Identifier (IRRID): DERR1-10.2196/25099 %M 34723826 %R 10.2196/25099 %U https://www.researchprotocols.org/2021/11/e25099 %U https://doi.org/10.2196/25099 %U http://www.ncbi.nlm.nih.gov/pubmed/34723826 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 10 %P e30131 %T Modulation of Bone and Joint Biomarkers, Gut Microbiota, and Inflammation Status by Synbiotic Supplementation and Weight-Bearing Exercise: Human Study Protocol for a Randomized Controlled Trial %A Ilesanmi-Oyelere,Bolaji Lilian %A Roy,Nicole C %A Kruger,Marlena C %+ College of Health, Massey University, Private Bag 11222, Palmerston North, 4442, New Zealand, 64 2108522308, b.ilesanmi-oyelere@massey.ac.nz %K synbiotic (prebiotic+probiotic) %K weight-bearing exercise %K gut microbiota %K inflammation %K BMD %K cytokines %K bone and joint biomarkers %D 2021 %7 26.10.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: There is strong evidence suggesting that prebiotics and probiotics regulate gut microbiota, reducing inflammation and thereby potentially improving bone health status. Similarly, mechanistic evidence suggests that either low-impact or high-impact weight-bearing exercises improve body composition and consequently increase bone mineral density in individuals with osteoporosis and osteoarthritis. Objective: This study aims to investigate the effects of a synbiotic (probiotic+prebiotic) supplementation, an exercise intervention, or a combination of both on gut microbiota, inflammation, and bone biomarkers in postmenopausal women. Methods: A total of 160 postmenopausal women from New Zealand will be recruited and randomized to one of four interventions or treatments for 12 weeks: control, synbiotic supplementation, exercise intervention, or synbiotic supplementation and exercise. The primary outcome measure is the bone and joint biomarkers at baseline and week 12, whereas the gut microbiota profile and inflammatory cytokine measurements will serve as the secondary outcome measures at baseline and week 12. Baseline data and exercise history will be used to assess, allocate, and stratify participants into treatment measures. Results: Recruitment of participants will begin in September 2021, and the anticipated completion date is June 2022. Conclusions: To the best of our knowledge, this will be the first randomized controlled trial to analyze the effects of both a synbiotic supplement and an exercise intervention in postmenopausal women. On the basis of the results obtained, a combination of synbiotic supplements and exercise might serve as a noninvasive approach to manage and/or improve body composition and bone health in postmenopausal women. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12620000998943p; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380336&isClinicalTrial=False %M 34698648 %R 10.2196/30131 %U https://www.researchprotocols.org/2021/10/e30131 %U https://doi.org/10.2196/30131 %U http://www.ncbi.nlm.nih.gov/pubmed/34698648 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 10 %P e29695 %T A New Tool for Safety Evaluation and a Combination of Measures for Efficacy Assessment of Cotransplanting Human Allogenic Neuronal Stem Cells and Mesenchymal Stem Cells for the Treatment of Parkinson Disease: Protocol for an Interventional Study %A Jamali,Fatima %A Aldughmi,Mayis %A Khasawneh,Mohammad W %A Dahbour,Said %A Salameh,Alaa A %A Awidi,Abdalla %+ Cell Therapy Center, University of Jordan, Queen Rania St, Amman, 11942, Jordan, 962 6 535 5000 ext 23960, ftmjamali@gmail.com %K Parkinson disease %K neurodegenerative disease %K regenerative medicine %K mesenchymal stem cells %K MSCs %K neuronal stem cells %K NSCs %K Unified Parkinson Disease Rating Scale %K UPDRS %K Mobility Lab %K α-synuclein %K PARK-7 %K stem cells %K stem cell therapy %K therapeutics %K Parkinson’s %K neurological diseases %D 2021 %7 22.10.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Parkinson disease (PD) is a neurodegenerative disorder associated with a broad spectrum of motor and nonmotor symptoms. Any proposed cure needs to address the many aspects of the disease. Stem cell therapy may have potential in this regard as indicated in recent preclinical and clinical studies. Objective: This protocol aims to examine the safety and therapeutic benefit of human Wharton jelly-derived mesenchymal stem cells (WJ-MScs) and their derivatives, neuronal stem cells (NSCs) in PD. Methods: This clinical trial is a double-arm, single-blinded, phase I-II interventional study. Participants have been allocated to 1 of 2 groups: one receiving allogeneic WJ-MSCs alone, the other receiving NSCs and WJ-MScs. Participants are being followed-up and assessed over a period of 6 months. To assess safety, an incidence of treatment-emergent adverse events (TEAEs) tool tailored for PD is being used immediately and up to 6 months after treatment. For efficacy assessment, a number of factors are being used, including the gold standard severity test and the Unified Parkinson Disease Rating Scale. In addition, the following standardized assessments for different common symptoms in PD are being included: motor (both subjectively and objectively assessed with wearable sensors), sensory, quality of life and psychological well-being, cognition, and sleep quality. Furthermore, immune-modulatory cytokines and neuronal damage versus regeneration markers in PD, including the neuronal protein linked to PD, α-synuclein, are being monitored. Results: Ten patients have been enrolled in this study and thus participant recruitment has been completed. The study status is active and beyond the recruiting stage. Study chart implementation, data collection, and analysis are ongoing. Conclusions: The combination of NSCs and MSCs in PD may be useful for harnessing the best of the immunomodulation and neural repair characteristics of these cell types. The tailored comprehensive and scaled TEAEs and the variety of evaluation tools used enables a comprehensive assessment of this cellular therapy treatment protocol. A consideration of this expanded tool set is important in the design of future clinical studies for PD. Trial Registration: ClinicalTrials.gov NCT03684122; https://clinicaltrials.gov/ct2/show/NCT03684122 International Registered Report Identifier (IRRID): DERR1-10.2196/29695 %M 34677138 %R 10.2196/29695 %U https://www.researchprotocols.org/2021/10/e29695 %U https://doi.org/10.2196/29695 %U http://www.ncbi.nlm.nih.gov/pubmed/34677138 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 10 %P e26898 %T Improving the Prognosis of Pancreatic Cancer Through Early Detection: Protocol for a Prospective Observational Study %A Yamada,Reiko %A Isaji,Shuji %A Fujii,Takehiro %A Mizuno,Shugo %A Kishiwada,Masashi %A Murata,Yasuhiro %A Hayasaki,Aoi %A Inoue,Hiroyuki %A Umeda,Yuhei %A Tanaka,Kyosuke %A Hamada,Yasuhiko %A Tsuboi,Junya %A Kato,Toshio %A Kondo,Yoshihiro %A Matsuda,Shinsuke %A Watanabe,Noriko %A Ogura,Toru %A Tamaru,Satoshi %+ Clinical Research Support Center, Mie University Hospital, 2-174, Edobashi, Tsu, Japan, 81 59 232 1111 ext 7606, reiko-t@clin.medic.mie-u.ac.jp %K pancreatic cancer %K prognosis %K early diagnosis %K risk factors %K scoring system %K referral %D 2021 %7 22.10.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Pancreatic cancer is associated with high mortality and its rates of detection are very low; as such, the disease is typically diagnosed at an advanced stage. A number of risk factors for pancreatic cancer have been reported and may be used to identify individuals at high risk for the development of this disease. Objective: The aim of this prospective, observational trial is to evaluate a scoring metric for systematic early detection of pancreatic cancer in Mie Prefecture, Japan. Methods: Eligible patients aged 20 years and older will be referred from participating clinics in the Tsu City area to the Faculty of Medicine, Gastroenterology, and Hepatology at Mie University Graduate School, until September 30, 2022. Participants will undergo a detailed examination for pancreatic cancer. Data collection will include diagnostic and follow-up imaging data and disease staging information. Results: The study was initiated in September 2020 and aims to recruit at least 150 patients in a 2-year period. Recruitment of patients is currently still underway. Final data analysis is expected to be complete by March 2025. Conclusions: This study will provide insights into the feasibility of using a scoring system for the early detection of pancreatic cancer, thus potentially improving the survival outcomes of diagnosed patients. Trial Registration: UMIN-CTR Clinical Trials Registry UMIN000041624; https://tinyurl.com/94tbbn3s International Registered Report Identifier (IRRID): DERR1-10.2196/26898 %M 34677132 %R 10.2196/26898 %U https://www.researchprotocols.org/2021/10/e26898 %U https://doi.org/10.2196/26898 %U http://www.ncbi.nlm.nih.gov/pubmed/34677132 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 9 %P e30499 %T Promoting Adolescent Healthy Relationships (The About Us Program): Protocol for a Randomized Clinical Trial %A Anderson,Pamela %A Coyle,Karin %A Guinosso,Stephanie %A Ferrand,John L %A Owora,Arthur %A Houghton,Rebecca F %A Walsh-Buhi,Eric %+ Department of Applied Health Science, School of Public Health, Indiana University, 1025 E. 7th Street, Room 116, Bloomington, IN, 47405, United States, 1 8128554867, erwals@iu.edu %K adolescents %K youth %K teens %K healthy relationships %K unintended pregnancy %K teen pregnancy %K sexually transmitted infections %K sexually transmitted diseases %K sexual health education %K school-based health center %K randomized controlled trial %D 2021 %7 1.9.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Romantic relationships play a critical role in adolescent development, and by middle adolescence, most young people have been involved in at least one romantic relationship, a context in which most sexual interactions occur. Research suggests adolescents lack positive models and skills related to building healthy relationships. Objective: This project aims to test the impact of an innovative healthy relationships intervention, called About Us, implemented in school-based health centers (SBHCs) in California in a randomized controlled trial. Methods: About Us is being tested using a 7-site, 2-group, parallel randomized controlled trial with a treatment versus control allocation ratio of 3:2 to assess the impact of the intervention relative to the standard of care among adolescents aged 14 to 18 years. Adolescents with active parental consent provide study assent at each of the 3 survey time points: baseline, 3 months postintervention, and 9 months postintervention. A stratified randomization procedure was used to ensure balance in key covariates and screening criteria across intervention groups. Through benchmark intent-to-treat analyses, we will examine the primary outcome of this study—the impact of About Us relative to the standard of care 9 months following the end of the intervention on the prevalence of vaginal or anal sex without condoms in the past 3 months. The secondary outcomes are four-fold: what is the impact of About Us relative to the standard of care 3 and 9 months following the end of the intervention, on (1) the prevalence of abstinence from vaginal or anal sex in the past 3 months, (2) composite scores of relationship communication and positive conflict resolution among participants involved in a relationship at baseline, (3) the prevalence of SBHC service use or information receipt in the past 3 months, and (4) composite scores of condom use intentions and attitudes regarding condoms and other birth control? Additionally, as part of our sensitivity analyses, two additional analyses will be implemented: modified intent-to-treat and complete case analysis. Results: This project (ClinicalTrials.gov #NCT03736876) was funded in 2016 through the Family Youth Services Bureau as part of the Personal Responsibility Education Innovative Strategies program. Baseline data collection took place between February 2018 and March 2020, yielding a total of 5 cohorts and 533 study participants: 316 assigned to treatment and 217 assigned to control. Ongoing follow-up data collection continued through May 2021. Conclusions: About Us draws on developmental science to create a contextually and developmentally relevant program that addresses motivation and emotional influences in sexual decision-making. The intervention was designed for implementation within SBHCs, an understudied venue for relationship and sexual health promotion interventions. Unfortunately, COVID-19 pandemic restrictions led to school closures, interrupting ongoing programming, and in-person follow-up data collection, which has affected study attrition. Trial Registration: ClinicalTrials.gov NCT03736876; https://clinicaltrials.gov/ct2/show/NCT03736876 International Registered Report Identifier (IRRID): DERR1-10.2196/30499 %M 34468330 %R 10.2196/30499 %U https://www.researchprotocols.org/2021/9/e30499 %U https://doi.org/10.2196/30499 %U http://www.ncbi.nlm.nih.gov/pubmed/34468330 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 8 %P e28156 %T Effect of Community-Based Kangaroo Mother Care Package on Neonatal Mortality Among Preterm and Low Birthweight Infants in Rural Pakistan: Protocol for a Cluster Randomized Controlled Trial %A Ariff,Shabina %A Habib,Atif %A Memon,Zahid %A Arshad,Tayyaba %A Samejo,Tariq %A Maznani,Ikram %A Umer,Muhammad %A Hussain,Amjad %A Rizvi,Arjumand %A Ahmed,Imran %A Soofi,Sajid Bashir %A Bhutta,Zulfiqar A %+ Center of Excellence in Women & Child Health, Aga Khan University, Stadium Road, P.O. Box 350​0, Karachi, 7480​0, Pakistan, 92 2134864798, zulfiqar.bhutta@aku.edu %K community kangaroo mother care %K low birth weight %K KMC champions %K neonatal mortality %K RCT protocol %K Pakistan %D 2021 %7 10.8.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Neonatal mortality due to preterm birth and low birthweight remains a significant challenge in Pakistan. Kangaroo mother care (KMC) is a unique, low-cost intervention proven to reduce neonatal mortality and morbidity and increase exclusive breastfeeding rates. However, KMC has not been attempted in community settings in Pakistan. We aim to implement and evaluate the effectiveness of a community-based KMC package to reduce neonatal morbidity and mortality among preterm and low birthweight (LBW) infants, which will provide evidence for policy development and the large-scale implementation of KMC across the country. Objective: The primary objective of this trial is to reduce neonatal mortality among preterm and LBW infants. The secondary objectives are growth (measured as weight gain), reduced incidence of possible serious bacterial infection, and increased exclusive breastfeeding and continued breastfeeding practices. Methods: We designed a community-based cluster randomized controlled trial in one rural district of Pakistan. Stable, LBW babies (weighing 1200 grams to 2500 grams) are included in the study. The community KMC package, consisting of the KMC kit, information and counseling material, and community mobilization through KMC champions (village volunteers), was designed after preliminary research in the same geographical location and implemented in intervention clusters. The standard essential newborn care is offered in the control clusters. Infants are recruited and followed up by independent teams of data collectors. Data are collected on the duration of skin-to-skin contact, growth, breastfeeding practices, morbidities, neonatal mortality, and neurodevelopment status. Data analysis will be conducted based on the intention to treat principle. The Cox regression model will be used to assess the primary outcome of neonatal mortality. The secondary outcomes will be evaluated using linear or logistic regression. Results: The Ethics Review Committee of Aga Khan University, Pakistan, approved the study protocol in February 2017. Data collection began in August 2019 and will be completed in December 2021. Data analyses are yet to be completed. Conclusions: This intervention may be effective in preventing sepsis and subsequently improve survival in LBW newborns in Pakistan and other low-income and middle-income countries worldwide. Trial Registration: clinicaltrials.gov NCT03545204; https://clinicaltrials.gov/ct2/show/NCT03545204 International Registered Report Identifier (IRRID): DERR1-10.2196/28156 %M 34170839 %R 10.2196/28156 %U https://www.researchprotocols.org/2021/8/e28156 %U https://doi.org/10.2196/28156 %U http://www.ncbi.nlm.nih.gov/pubmed/34170839 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 8 %P e24835 %T Implementing Exercise in Standard Cancer Care (Bizi Orain Hybrid Exercise Program): Protocol for a Randomized Controlled Trial %A Arietaleanizbeaskoa,Maria Soledad %A Gil Rey,Erreka %A Mendizabal Gallastegui,Nere %A García-Álvarez,Arturo %A De La Fuente,Ibon %A Domínguez-Martinez,Silvia %A Pablo,Susana %A Coca,Aitor %A Gutiérrez Santamaría,Borja %A Grandes,Gonzalo %+ Biocruces Health Research Institute, C/Plaza de Cruces, s/n., Barakaldo, 48903, Spain, 34 946006637, nere.mendizabalgallastegui@osakidetza.eus %K patients with cancer %K physical activity %K primary care %K behavioral change %K randomized controlled trial %K overall survival %D 2021 %7 9.8.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Despite the established benefits of regular exercise for patients with cancer to counteract the deleterious effects of the disease itself and treatment-related adverse effects, most of them do not engage in sufficient levels of physical activity and there is a paucity of data on the integration of efficacious exercise programs that are accessible and generalizable to a large proportion of patients with cancer into routine cancer care. Objective: We intend to examine the effects attributable to the implementation of a community-based exercise program on cardiorespiratory functional capacity and quality of life for patients with cancer. Methods: This will be a hybrid study. In the first experimental phase, patients diagnosed with any type of cancer will be randomized into two parallel groups. One group immediately performs Bizi Orain, a 3-month supervised exercise program (3 times a week), in addition to behavioral counseling in a primary health care setting; the other is a reference group that starts the exercise program 3 months later (delayed treatment). In the second observational phase, the entire cohort of participants will be followed-up for 5 years. Any person diagnosed with cancer in the previous 2 years is eligible for the program. The program evaluation involves the uptake, safety, adherence, and effectiveness assessed after completion of the program and with follow-ups at 3, 6, 12, 24, 36, 48, and 60 months. The primary outcomes of the experimental study, to be compared between groups, are improved physical function and quality of life, whereas overall survival is the main objective of the prospective study. To analyze the association between changes in physical activity levels and overall survival, longitudinal mixed-effects models will be used for repeated follow-up measures. Results: A total of 265 patients have been enrolled into the study since January 2019, with 42 patients from the hematology service and 223 from the oncology service. Conclusions: Bizi Orain is the first population-based exercise program in Spain that will offer more insight into the implementation of feasible, generalizable, and sustainable supportive care services involving structured exercise to extend survival of patients with cancer, improve their physical function and quality of life, and reverse the adverse effects of their disease and related treatments, thereby reducing the clinical burden. Trial Registration: ClinicalTrials.gov NCT03819595; http://clinicaltrials.gov/ct2/show/NCT03819595 International Registered Report Identifier (IRRID): DERR1-10.2196/24835 %M 34383676 %R 10.2196/24835 %U https://www.researchprotocols.org/2021/8/e24835 %U https://doi.org/10.2196/24835 %U http://www.ncbi.nlm.nih.gov/pubmed/34383676 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 7 %P e28273 %T Improving Physical Activity Levels in Prevocational Students by Student Participation: Protocol for a Cluster Randomized Controlled Trial %A Van de Kop,Huib %A Toussaint,Huub %A Janssen,Mirka %A Busch,Vincent %A Verhoeff,Arnoud %+ Faculty of Sports and Nutrition, Amsterdam University of Applied Sciences, Dr. Meurerlaan 8, Amsterdam, 1067 SM, Netherlands, 31 0 621158166, j.h.van.de.kop@hva.nl %K physical activity %K participatory %K adolescents %K protocol %K assets %K school-based %K students %K participation %K school-age children %K teenagers %K exercise %D 2021 %7 28.7.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: A consistent finding in the literature is the decline in physical activity during adolescence, resulting in activity levels below the recommended guidelines. Therefore, promotion of physical activity is recommended specifically for prevocational students. Objective: This protocol paper describes the background and design of a physical activity promotion intervention study in which prevocational students are invited to participate in the design and implementation of an intervention mix. The intervention is expected to prevent a decline in physical activity in the target group. Methods: The effectiveness of the intervention was evaluated in a two-group cluster randomized controlled trial with assessments at baseline and 2-year follow-up. A simple randomization was applied, allocating 11 schools to the intervention group and 11 schools to the control group, which followed the regular school curriculum. The research population consisted of 3003 prevocational students, aged 13-15 years. The primary outcome measures were self-reported physical activity levels (screen time, active commuting, and physical activity). As a secondary outcome, direct assessment of physical fitness (leg strength, arm strength, hip flexibility, hand speed, abdominal muscle strength, BMI, and body composition) was included. An intervention-control group comparison was presented for the baseline results. The 2-year interventions began by mapping the assets of the prevocational adolescents of each intervention school using motivational interviewing in the structured interview matrix and the photovoice method. In addition, during focus group sessions, students, school employees, and researchers cocreated and implemented an intervention plan that optimally met the students’ assets and opportunities in the school context. The degree of student participation was evaluated through interviews and questionnaires. Results: Data collection of the SALVO (stimulating an active lifestyle in prevocational students) study began in October 2015 and was completed in December 2017. Data analyses will be completed in 2021. Baseline comparisons between the intervention and control groups were not significant for age (P=.12), screen time behavior (P=.53), nonschool active commuting (P=.26), total time spent on sports activities (P=.32), total physical activities (P=.11), hip flexibility (P=.22), maximum handgrip (P=.47), BMI (P=.44), and sum of skinfolds (P=.29). Significant differences between the intervention and control groups were found in ethnicity, gender, active commuting to school (P=.03), standing broad jump (P=.02), bent arm hang (P=.01), 10× 5-m sprint (P=.01), plate tapping (P=.01), sit-ups (P=.01), and 20-m shuttle run (P=.01). Conclusions: The SALVO study assesses the effects of a participatory intervention on physical activity and fitness levels in prevocational students. The results of this study may lead to a new understanding of the effectiveness of school-based physical activity interventions when students are invited to participate and cocreate an intervention. This process would provide structured health promotion for future public health. Trial Registration: ISRCTN Registry ISRCTN35992636; http://www.isrctn.com/ISRCTN35992636 International Registered Report Identifier (IRRID): DERR1-10.2196/28273 %M 34121666 %R 10.2196/28273 %U https://www.researchprotocols.org/2021/7/e28273 %U https://doi.org/10.2196/28273 %U http://www.ncbi.nlm.nih.gov/pubmed/34121666 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 7 %P e28624 %T The Efficacy of the Dyson Air Purifier in Improving Asthma Control: Protocol for a Single-Center, Investigator-Led, Randomized, Double-Blind, Placebo-Controlled Trial %A Fong,Wei Chern Gavin %A Grevatt,Susan %A Potter,Stephen %A Tidbury,Tracey %A Kadalayil,Latha %A Bennett,Kaisha %A Larsson,Maria %A Nicolas,Frédéric %A Kurukulaaratchy,Ramesh %A Arshad,Syed Hasan %+ David Hide Asthma and Allergy Research Centre, Isle Of Wight NHS Trust, Newport, , United Kingdom, 44 (0) 1983 534373, S.H.Arshad@soton.ac.uk %K air purifier %K asthma %K clinical trial %K air pollution %K allergens %K respiratory function tests %K bronchial provocation tests %D 2021 %7 27.7.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Indoor air quality has been shown to influence asthma control and outcomes. Air purifiers and high-efficiency particulate air filtration devices can improve indoor air quality by reducing the indoor levels of air pollution and allergens. However, the influence of this improved indoor air quality on asthma control remains unclear; hence, randomized controlled trials are needed to further elucidate this phenomenon. Objective: This study aims to investigate the effect of reducing the levels of allergens and pollutants in the bedroom and living room through the use of Dyson air purifiers (Dyson Pure Cool) on asthma control. Methods: This is an 18-month long, investigator-led, randomized, double-blinded, placebo-controlled, single-center trial. Subjects will be randomized in a 1:1 ratio to active or placebo Dyson filters. The primary outcome is the change in the scores of Asthma Control Questionnaire 6 and Asthma-specific Quality of Life Questionnaire from baseline. Secondary outcomes include changes in lung function (forced expiratory volume in one second, forced expiratory volume in one second/forced vital capacity ratio, and midexpiratory flows), peak expiratory flow measurements, airway hyperresponsiveness (assessed by methacholine bronchial challenge), fractional exhaled nitric oxide, and indoor air pollutant levels. The sample size will be 50 subjects, and all subjects will have a confirmed diagnosis of mild persistent to moderate persistent asthma along with an Asthma Control Questionnaire 6 score of >1.5. Results: This study was approved by the West Midlands Research Ethics Committee (18/WM/0277). The study results will be published in peer-reviewed scientific journals; presented at relevant scientific conferences; and shared in plain English with participants in our newsletters, in our clinics, and via the David Hide Asthma and Allergy Research Centre website. Our trial began in September 2019 and is expected to end in August 2021. Conclusions: This is a double-blinded, placebo-controlled, randomized, investigator-led study to investigate the efficacy of a novel air purifier in improving asthma control in adults. The trial period of 18 months will facilitate the collection of robust data and will therefore generate clear signals. However, this extended trial duration may lead to patient withdrawal. Furthermore, this trial is conducted at a single center and in a location with a homogenous cohort of people, which may affect translatability. Nonetheless, it is hoped that the findings of this trial may help further inform clinicians regarding the utility of this novel device as an adjunct in asthma care. Trial Registration: ClinicalTrials.gov NCT04729530; https://clinicaltrials.gov/ct2/show/NCT04729530 International Registered Report Identifier (IRRID): DERR1-10.2196/28624 %M 34313599 %R 10.2196/28624 %U https://www.researchprotocols.org/2021/7/e28624 %U https://doi.org/10.2196/28624 %U http://www.ncbi.nlm.nih.gov/pubmed/34313599 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 7 %P e26053 %T Investigating the Mechanisms of Graded Sensorimotor Precision Training in Adults With Chronic Nonspecific Low Back Pain: Protocol for a Causal Mediation Analysis of the RESOLVE Trial %A Cashin,Aidan G %A Lee,Hopin %A Bagg,Matthew K %A Wand,Benedict M %A O'Hagan,Edel %A Rizzo,Rodrigo R N %A Stanton,Tasha R %A Moseley,G Lorimer %A McAuley,James H %+ Prince of Wales Clinical School, University of New South Wales, 61-63 Botany St, Randwick, 2031, Australia, 61 293991806, a.cashin@neura.edu.au %K chronic low back pain %K mediation analysis %K mechanism evaluation %K protocol %D 2021 %7 2.7.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Chronic low back pain (CLBP) is a global health problem associated with an increasing burden on individuals, health care systems, and society. Common treatments for people with CLBP produce, on average, small short-term improvements in pain and function compared with minimal care. The RESOLVE trial randomly allocated 276 people with CLBP to a new complex treatment strategy, pain education integrated with graded sensorimotor precision training (RESOLVE), or a sham control. The RESOLVE treatment was developed within a theoretical framework to target possible treatment mechanisms associated with CLBP development and persistence. Objective: This protocol describes the planned evaluation of these proposed treatment mechanisms. Improved understanding of the mechanisms underpinning the RESOLVE treatment may guide its refinement and implementation. Methods: We will use causal mediation analysis to evaluate the proposed treatment mechanisms, including pain self-efficacy, back beliefs, pain catastrophizing, kinesiophobia, back perception, tactile acuity, and movement coordination. The primary outcomes are pain intensity and function at 18 weeks following allocation. Data were collected blind to allocation and hypotheses at baseline (mediators, outcomes, confounders), end of treatment (mediators), and at 18 weeks following allocation (outcomes). We will test the robustness of our findings by conducting planned sensitivity analyses. Results: Ethical approval was granted by the University of New South Wales Human Research Ethics Committee (HC15357). A total of 276 participants have been recruited from primary care practices and the community in Sydney, Australia. Conclusions: The RESOLVE treatment constitutes a new paradigm for CLBP management with potentially wide-reaching implications. This mechanistic evaluation will provide evidence for the hypothesized treatment mechanisms and help explain why the treatment strategy did or did not have an effect on patient-reported outcomes. These results will help guide the treatment refinement and implementation. Trial Registration: Australian and New Zealand Clinical Trials Registry ACTRN12615000610538; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368619&isReview=true International Registered Report Identifier (IRRID): DERR1-10.2196/26053 %M 34255720 %R 10.2196/26053 %U https://www.researchprotocols.org/2021/7/e26053 %U https://doi.org/10.2196/26053 %U http://www.ncbi.nlm.nih.gov/pubmed/34255720 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 6 %P e29208 %T Assessing the Pregnancy Protective Impact of Scheduled Nonadherence to a Novel Progestin-Only Pill: Protocol for a Prospective, Multicenter, Randomized, Crossover Study %A Edelman,Alison %A Hemon,Agnes %A Creinin,Mitchell %A Borensztein,Pascale %A Scherrer,Bruno %A Glasier,Anna %+ Department of Obstetrics & Gynecology, Oregon Health & Science University, 3181 SW Sam Jackson, UHN 50, Portland, OR, 97239, United States, 1 503 418 2585, edelmana@ohsu.edu %K protocol %K missed pill %K progestin-only pills %K contraception %K pharmacokinetics %D 2021 %7 8.6.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Progestin-only contraceptive pills (POP) are commonly reserved for women with medical comorbidities but in actuality, POPs can be safely used by anyone wanting to prevent pregnancy. This wide safety profile makes them an ideal candidate for being available over the counter without a prescription, but adherence issues may be more common with over-the-counter use. We need a better understanding of the ability of POPs to prevent pregnancy when adherence issues occur in the form of a missed or delayed pill. Objective: This study aims to determine cervical mucus characteristics following a 6-hour delayed pill intake or after one missed pill as compared to typical daily use of norgestrel 75 mcg. Methods: This prospective, multicenter, randomized, crossover study assesses the effect of norgestrel 75 mcg (Opill) on cervical mucus and ovarian activity during reported compliant daily use, after a 6-hour delayed intake mid cycle, and after a mid-cycle missed pill. Subject participation will last approximately 4.5 months. We will recruit at 2 US sites: Oregon Health & Science University, Portland, Oregon and University of California Davis Health, Sacramento, California. Reproductive-aged subjects with regular menstrual cycles (21-35 days), BMI <32 kg/m2, and proven ovulation (screening luteal phase progesterone >3 ng/mL [>10 nmol/L]) are eligible to enroll. Participants cannot be at risk for pregnancy during the study period and not use other hormonal methods. Norgestrel 75 mcg will be taken at the same time daily except for one day in each of treatment periods 2 and 3, when the pill will be taken either 6 hours late (delayed pill) or omitted completely (missed pill). Every 3-4 days, we will monitor subjects for follicular activity with transvaginal ultrasound (TVUS) examination, cervical mucus, and blood sampling for ovarian hormones and gonadotropins. Subjects will undergo serial cervical mucus sampling on the days with missed and delayed pill intake at 8 hours after pill intake on the day before the delayed or missed pill, 3 hours following the scheduled time of pill intake if intake was delayed, 6 hours after the scheduled time if intake was omitted, and on the next day 30 minutes before the time of scheduled pill intake. The primary objective of the study is to determine the effect of a delayed or omitted pill intake on cervical mucus characteristics based on a modified Insler score compared to reported daily use. Results: Our protocol was successfully approved by a central institutional review board (Advarra, Columbia, MD), received ethical approval on March 23, 2018, and was registered with ClinicalTrials.gov (NCT03585712). As of January 2020, the study completed enrollment of 52 subjects. Analyses are pending. Conclusions: Our protocol was approved by a central review board, and study procedures were successfully executed with completed proposed enrollment. Trial Registration: ClinicalTrials.gov NCT03585712; https://clinicaltrials.gov/ct2/show/NCT03585712 International Registered Report Identifier (IRRID): DERR1-10.2196/29208 %M 33970869 %R 10.2196/29208 %U https://www.researchprotocols.org/2021/6/e29208 %U https://doi.org/10.2196/29208 %U http://www.ncbi.nlm.nih.gov/pubmed/33970869 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 5 %P e25343 %T Reactance to Social Authority in Entertainment-Education Media: Protocol for a Web-Based Randomized Controlled Trial %A Vandormael,Alain %A Adam,Maya %A Hachaturyan,Violetta %A Greuel,Merlin %A Favaretti,Caterina %A Gates,Jennifer %A Baernighausen,Till %+ Heidelberg Institute of Global Health, Heidelberg University, Im Neuenheimer Feld 130/3, Heidelberg, 69120, Germany, 49 6221 565344, alain.vandormael@uni-heidelberg.de %K entertainment-education %K sugar reduction %K reactance %K animated video %K list experiment %D 2021 %7 28.5.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Entertainment-education media can be an effective strategy for influencing health behaviors. To improve entertainment-education effectiveness, we seek to investigate whether the social authority of a person delivering a health message arouses the motivation to reject that message—a phenomenon known as reactance. Objective: In this study, using a short animated video, we aim to measure reactance to a sugar reduction message narrated by a child (low social authority), the child’s mother (equivalent social authority to the target audience), and a family physician (high social authority). The aims of the study are to determine the effect of the narrator’s perceived social authority on reactance to the sugar reduction message, establish the effectiveness of the video in improving behavioral intent to reduce the intake of added sugars, and quantify participants’ interest in watching the entertainment-education intervention video. Methods: This is a parallel group, randomized controlled trial comparing an intervention video narrated by a low, equivalent, or high social authority against a content placebo video and a placebo video. Using a web-based recruitment platform, we plan to enroll 4000 participants aged between 18 and 59 years who speak English and reside in the United Kingdom. The primary end points will include measures of the antecedents to reactance (proneness to reactance and threat level of the message), its components (anger and negative cognition), and attitudinal and behavioral intent toward sugar intake. We will measure behavioral intent using list experiments. Participants randomized to the placebo videos will be given a choice to watch one of the sugar-intervention videos at the end of the study to assess participant engagement with the entertainment-education video. Results: The study was approved by the ethics committee of Heidelberg University on March 18, 2020 (S-088/2020). Participant recruitment and data collection were completed in December 2020. The data analysis was completed in April 2021, and the final results are planned to be published by August 2021. Conclusions: In this trial, we will use several randomization procedures, list experimentation methods, and new web-based technologies to investigate the effect of perceived social authority on reactance to a message about reducing sugar intake. Our results will inform the design of future entertainment-education videos for public health promotion needs. Trial Registration: German Clinical Trials Registry DRKS00022340: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00022340. International Registered Report Identifier (IRRID): DERR1-10.2196/25343 %M 34047702 %R 10.2196/25343 %U https://www.researchprotocols.org/2021/5/e25343 %U https://doi.org/10.2196/25343 %U http://www.ncbi.nlm.nih.gov/pubmed/34047702 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 5 %P e16703 %T Effectiveness of a Two-Tier Family-Oriented Intervention in Enhancing the Family Functioning and Care Capacity of the Family Caregivers of Stroke Survivors: Protocol for a Randomized Controlled Trial %A Lou,Vivian Weiqun %A Tang,Jennifer Yee Man %A Lau,Gary Kui Kai %A Lum,Terry Yat Sang %A Fong,Kenneth %A Ko,Rachel Wai Tung %A Cheng,Clio Yuen Man %A Fu,Joyce Yinqi %A Chow,Eddie Siu Lun %A Chu,Angus Chun Kwok %A Hui,Elsie %A Ng,Winnie Wing Ling %A Chan,Felix Hon Wai %A Luk,C C %A Kwok,T K %+ Sau Po Centre on Ageing, The University of Hong Kong, 2/F, The Hong Kong Jockey Club Building for Interdisciplinary Research, 5 Sassoon Road, Pokfulam, Hong Kong, Hong Kong, 852 28315210, wlou@hku.hk %K two-tier family-oriented intervention %K family functioning %K family caregivers %K stroke survivors %K randomized controlled trial %D 2021 %7 28.5.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Stroke has profound impacts on families. Often, family members, including stroke survivors and the person who takes up the role of the primary caregiver, would encounter demands on finances, rehabilitation arrangement, and even conflicts. Hence, a family-oriented intervention is expected to enable families to rebuild internal and external resources to achieve optimal rehabilitation and community reintegration. Objective: This study aims to describe a design of a two-tier family-oriented care management intervention for enhancing the family functioning and care capacity of the caregivers of stroke survivors. Methods: The two-tier care management intervention was guided by a standardized protocol conducted by trained professional care managers (first tier) with the support of trained volunteers (second tier), which lasted for 8-12 weeks. Participants were recruited through collaborating hospitals according to inclusion and exclusion criteria. In order to examine the effectiveness and cost-effectiveness of the two-tier care management intervention, a two-arm randomization multicenter study was designed, including an active comparison group, which was guided by a standardized protocol conducted by trained volunteers. Dyadic participants, including both stroke survivors and their primary caregivers for both groups, were invited to participate in a questionnaire survey using standardized and purposefully developed measures 3 times: before the intervention, immediately after the intervention, and 2 months after the intervention. The primary outcome was family functioning measured by the Family Role Performance Scale and Family Assessment Device-General Functioning Scale. The secondary outcomes included caregiving burden, depressive symptoms, care management strategies, and the incremental cost-effectiveness ratio. Results: Recruitment began in January 2017 and was completed at the end of April 2019. Data collection was completed at the end of March 2020. As of March 2020, enrollment has been completed (n=264 stroke caregivers). A total of 200 participants completed the baseline questionnaires. We aim to publish the results by mid-2021. Conclusions: This study successfully developed a two-tier care management protocol that aims to enhance the family functioning of the caregivers of stroke survivors. Guided by a standardized protocol, this family-oriented two-tier intervention protocol was found to be feasible among Chinese families. Trial Registration: ClinicalTrials.gov NCT03034330; https://ichgcp.net/clinical-trials-registry/NCT03034330 International Registered Report Identifier (IRRID): RR1-10.2196/16703 %M 34047707 %R 10.2196/16703 %U https://www.researchprotocols.org/2021/5/e16703 %U https://doi.org/10.2196/16703 %U http://www.ncbi.nlm.nih.gov/pubmed/34047707 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 5 %P e25556 %T COVID-19 Rehabilitation With Herbal Medicine and Cardiorespiratory Exercise: Protocol for a Clinical Study %A Gao,Yang %A Zhong,Linda L D %A Quach,Binh %A Davies,Bruce %A Ash,Garrett I %A Lin,Zhi-Xiu %A Feng,Yibin %A Lau,Benson W M %A Wagner,Peter D %A Yang,Xian %A Guo,Yike %A Jia,Wei %A Bian,Zhaoxiang %A Baker,Julien S %+ Centre for Health and Exercise Science Research, Hong Kong Baptist University, Room AAB 926, 9/F, Academic and Administration Building, Baptist University Road Campus, Kowloon, Hong Kong, 852 34118032, jsbaker@hkbu.edu.hk %K COVID-19 %K rehabilitation %K cardiorespiratory exercise %K Chinese medicine %D 2021 %7 26.5.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Recent studies have revealed that many discharged patients with COVID-19 experience ongoing symptoms months later. Rehabilitation interventions can help address the consequences of COVID-19, including medical, physical, cognitive, and psychological problems. To our knowledge, no studies have investigated the effects of rehabilitation following discharge from hospital for patients with COVID-19. Objective: The specific aims of this project are to investigate the effects of a 12-week exercise program on pulmonary fibrosis in patients recovering from COVID-19. A further aim will be to examine how Chinese herbal medicines as well as the gut microbiome and its metabolites regulate immune function and possibly autoimmune deficiency in the rehabilitation process. Methods: In this triple-blinded, randomized, parallel-group, controlled clinical trial, we will recruit adult patients with COVID-19 who have been discharged from hospital in Hong Kong and are experiencing impaired lung function and pulmonary function. A total of 172 eligible patients will be randomized into four equal groups: (1) cardiorespiratory exercise plus Chinese herbal medicines group, (2) cardiorespiratory exercise only group, (3) Chinese herbal medicines only group, and (4) waiting list group (in which participants will receive Chinese herbal medicines after 24 weeks). These treatments will be administered for 12 weeks, with a 12-week follow-up period. Primary outcomes include dyspnea, fatigue, lung function, pulmonary function, blood oxygen levels, immune function, blood coagulation, and related blood biochemistry. Measurements will be recorded prior to initiating the above treatments and repeated at the 13th and 25th weeks of the study. The primary analysis is aimed at comparing the outcomes between groups throughout the study period with an α level of .05 (two-tailed). Results: The trial has been approved by the university ethics committee following the Declaration of Helsinki (approval number: REC/19-20/0504) in 2020. The trial has been recruiting patients. The data collection will be completed in 24 months, from January 1, 2021, to December 31, 2022. Conclusions: Given that COVID-19 and its sequelae would persist in human populations, important findings from this study would provide valuable insights into the mechanisms and processes of COVID-19 rehabilitation. Trial Registration: ClinicalTrials.gov NCT04572360; https://clinicaltrials.gov/ct2/show/NCT04572360 International Registered Report Identifier (IRRID): PRR1-10.2196/25556 %M 33970864 %R 10.2196/25556 %U https://www.researchprotocols.org/2021/5/e25556 %U https://doi.org/10.2196/25556 %U http://www.ncbi.nlm.nih.gov/pubmed/33970864 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 5 %P e23115 %T Impact of Nutrition Education on the Nutrition Capacity of Caregivers and Nutrition Outcomes of Indigenous Mbororo Children in the West Region of Cameroon: Protocol for a Cluster Randomized Controlled Trial %A Manjong,Florence Titu %A Verla,Vincent Siysi %A Egbe,Thomas Obinchemti %A Nsagha,Dickson Shey %+ Department of Public Health and Hygiene, Faculty of Health Sciences, University of Buea, PO Box 63, Buea, 237, Cameroon, 237 677 499 429, nsaghads@hotmail.com %K nutrition education %K caregivers %K nutrition outcomes %K indigenous children %D 2021 %7 20.5.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Inadequate diets and life-threatening infections have profound adverse implications for child growth, development, and survival, particularly among indigenous peoples. Evidence of the effectiveness of community-based nutrition education interventions in improving child feeding and nutrition outcomes among indigenous Mbororo population in Cameroon is scarce. Objective: This study aims to investigate the impact of culturally tailored community-based nutrition education intervention on caregivers’ knowledge, attitude, and practice regarding complementary feeding and on nutrition outcomes of indigenous Mbororo children (aged 3-59 months) in the Foumban and Galim health districts of the West Region of Cameroon. Methods: A two-arm cluster randomized controlled trial will be conducted in the Foumban Health District and Galim Health District. The intervention and control arms will each comprise 5 clusters with 121 child–caregiver pairs. Participants in the intervention arm will be organized into 5 caregivers’ peer-support platforms. A total of 12 educational sessions will be assigned to the intervention group by trained female Mbororo nutrition volunteers (n=6) and community health workers (n=6). The control arm will receive routine facility-based nutrition education. Data will be collected at 3-month and 6-month follow-up. Both descriptive statistics and multivariate logistic models will be used to estimate the effect of culturally tailored community-based nutrition education intervention (independent variable) on outcome variables (caregivers’ knowledge, attitude, and practice), child growth (weight, height/length, weight for age), and morbidity status (diarrhea, cough, and fever) between both arms. Data assessors will be blinded to the group allocation. Ethical approval (reference no. 2019/1002-07/UB/SG/IRB/FHS) was obtained from the Faculty of Health Sciences Institutional Review Board at the University of Buea. Results: Baseline data were collected in September 2019. In February 2020, 10 Mbororo communities (clusters) with 242 child–caregiver pairs were selected and allocated to the experimental and control arm in a 1:1 ratio. Community nutrition volunteers (n=6) and community health workers (n=6) were selected and trained. Data collection and analysis are ongoing, and results are not available for this manuscript. Conclusions: The findings of this study will provide evidence on the impact of culturally tailored and health belief model–based nutrition education on behavior change as a complementary strategy for strengthening health facility–based approaches in the reduction of malnutrition burden among the study population International Registered Report Identifier (IRRID): DERR1-10.2196/23115 %M 34014173 %R 10.2196/23115 %U https://www.researchprotocols.org/2021/5/e23115 %U https://doi.org/10.2196/23115 %U http://www.ncbi.nlm.nih.gov/pubmed/34014173 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 5 %P e24407 %T Norms and Social Network–Centric Behavior Change Intervention (Nam Nalavazhvu) for Improved Toilet Usage in Peri-Urban Communities of Tamil Nadu: Protocol for a Cluster-Randomized Controlled Trial %A Ashraf,Sania %A Bicchieri,Cristina %A Delea,Maryann G %A Das,Upasak %A Chauhan,Kavita %A Kuang,Jinyi %A Shpenev,Alex %A Thulin,Erik %+ Center for Social Norms and Behavioral Dynamics, University of Pennsylvania, 3718 Locust Walk, McNeil Building, Philadelphia, PA, 19104, United States, 1 215 898 3023, cb36@sas.upenn.edu %K sanitation %K behavior change %K social norms %K toilet %D 2021 %7 3.5.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Inconsistent toilet usage is a continuing challenge in India. Despite the impact of social expectations on toilet usage, few programs and studies have developed theoretically grounded norm-centric behavior change interventions to increase toilet use in low-income settings. Objective: The objective of this paper is to detail the rationale and design of an ex ante, parallel cluster-randomized trial evaluating the impact of a demand-side, norm-centric behavior change intervention on exclusive toilet use and maintenance in peri-urban Tamil Nadu, India. Methods: Following formative research, we developed an evidence-based norm-centric behavior change intervention called Nam Nalavazhvu (Tamil for “our well-being”). The multilevel intervention aims to improve toilet usage by shifting empirical expectations or beliefs about other relevant people’s sanitation practices. It also provides action-oriented information to aid individuals to set goals and overcome barriers to own, consistently use, and maintain their toilets. This trial includes 76 wards in the Pudukkottai and Karur districts, where half were randomly assigned to receive the intervention and the remaining served as counterfactuals. Results: We enrolled wards and conducted a baseline survey among randomly selected individuals in all 76 wards. The 1-year behavior change intervention is currently ongoing. At the endline, we will collect relevant data and compare results between study arms to determine the impacts of the Nam Nalavazhvu intervention on sanitation-related behavioral, health, and well-being outcomes and potential moderators. This study is powered to detect differences in the prevalence of exclusive toilet use between study arms. We are also conducting a process evaluation to understand the extent to which the intervention was implemented as designed, given the special pandemic context. Conclusions: Findings from this trial will inform norm-centric behavior change strategies to improve exclusive toilet usage. Trial Registration: ClinicalTrials.gov NCT04269824; https://www.clinicaltrials.gov/ct2/show/NCT04269824 International Registered Report Identifier (IRRID): DERR1-10.2196/24407 %M 33938805 %R 10.2196/24407 %U https://www.researchprotocols.org/2021/5/e24407 %U https://doi.org/10.2196/24407 %U http://www.ncbi.nlm.nih.gov/pubmed/33938805 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 4 %P e24884 %T User-Centered Counseling and Male Involvement in Contraceptive Decision Making: Protocol for a Randomized Controlled Trial %A Karra,Mahesh %A Zhang,Kexin %+ Frederick S Pardee School of Global Studies, Boston University, 152 Bay State Road, Room G04C, Boston, MA, 02215, United States, 1 617 358 0197, mvkarra@bu.edu %K user-centered counseling %K male involvement %K contraceptive use %K family planning %K randomized controlled trial %K Malawi %K Sub-Saharan Africa %D 2021 %7 5.4.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: To achieve informed choice within the framework of reproductive autonomy, family planning programs have begun to adopt user-centered approaches to service provision, which highlight the individual client as the focal point of interaction and key decision maker. However, little is known about how user-centered approaches to family planning, particularly family planning counseling, shape contraceptive preferences and choices. Objective: We conducted a multiarmed randomized controlled trial to identify the causal impact of user-centered approaches to family planning counseling on women’s contraceptive decision making in urban Malawi. This study aims to determine how a tailored, preference-driven approach to family planning counseling and the involvement of male partners during the counseling process may contribute to shaping women’s contraceptive preferences and choices. Methods: Married women aged 18-35 years were recruited and randomly assigned to 1 of the 3 intervention arms or a control arm characterized by the following two interventions: an intervention arm in which women were encouraged to invite their husbands to family planning counseling (husband invitation arm) and an intervention arm in which women received targeted, tailored counseling on up to five contraceptive methods (as opposed to up to 13 contraceptive methods) that reflected women’s stated preferences for contraceptive methods. Women were randomized into a control arm, T0 (no husband invitation, standard counseling); T1 (husband invitation, standard counseling); T2 (no husband invitation, targeted counseling); and T3 (husband invitation, targeted counseling). Following counseling, all women received a package of family planning services, which included free transportation to a local family planning clinic and financial reimbursement for family planning services. Follow-up surveys were conducted with women 1 month after counseling. Results: A total of 785 women completed the baseline survey, and 782 eligible respondents were randomized to 1 of the 3 intervention groups or the control group (T1, n=223; T2, n=225; T3, n=228; T0, n=108). Furthermore, 98.1% (767/782) of women were contacted for follow-up. Among the 767 women who were contacted, 95.3% (731/767) completed the follow-up survey. The analysis of the primary outcomes is ongoing and is expected to be completed by the end of 2021. Conclusions: The results from this trial will fill knowledge gaps on the effectiveness of tailored family planning counseling and male involvement in family planning on women’s stated and realized contraceptive preferences. More generally, the study will provide evidence on how user-centered counseling may affect women’s willingness to use and continue contraception to realize their contraceptive preferences. Trial Registration: American Economics Association’s Registry for Randomized Controlled Trials AEARCTR-0004194; https://www.socialscienceregistry.org/trials/4194/history/46808. Registry for International Development Impact Evaluations RIDIE-STUDY-ID-5ce4f42bbc2bf; https://ridie.3ieimpact.org/index.php?r=search/detailView&id=823. International Registered Report Identifier (IRRID): DERR1-10.2196/24884 %M 33818398 %R 10.2196/24884 %U https://www.researchprotocols.org/2021/4/e24884 %U https://doi.org/10.2196/24884 %U http://www.ncbi.nlm.nih.gov/pubmed/33818398 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 3 %P e20196 %T Community-Integrated Intermediary Care (CIIC) Service Model to Enhance Family-Based, Long-Term Care for Older People: Protocol for a Cluster Randomized Controlled Trial in Thailand %A Aung,Myo Nyein %A Moolphate,Saiyud %A Yuasa,Motoyuki %A Aung,Thin Nyein Nyein %A Koyanagi,Yuka %A Supakankunti,Siripen %A Ahmad,Ishtiaq %A Kayano,Ryoma %A Ong,Paul %+ Advanced Research Institute for Health Sciences and Faculty of International Liberal Arts, Juntendo University, 2-1-1, Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan, 81 3 3813 3111, dr.myonyeinaung@gmail.com %K aging %K Asia %K care prevention %K health promotion %K long-term care %K implementation research %D 2021 %7 24.3.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Thailand is one of the most rapidly aging countries in Asia. Traditional family-based care, which has been the basis of most care for older people, is becoming unsustainable as families become smaller. In addition, women tend to be adversely affected as they still form the bulk of caregivers for older people, and many are likely to exit the labor market in order to provide care. Many family caregivers also have no or minimal training, and they may be called upon to provide quite complex care, increasing the proportion of older people receiving suboptimal care if they rely only on informal care that is provided by families and friends. Facing the increasing burden of noncommunicable diseases and age-related morbidity, Thai communities are increasingly in need of community-integrated care models for older persons that can link existing health systems and reduce the burden upon caring families. This need is common to many countries in the Association of Southeast Asian Nations (ASEAN). Objective: In this study, we aimed to assess the effectiveness of a community-integrated intermediary care (CIIC) model to enhance family-based care for older people. Methods: This paper describes a cluster randomized controlled trial comprised of 6 intervention clusters and 6 control clusters that aim to recruit 2000 participants in each arm. This research protocol has been approved by the World Health Organization Ethics Review Committee. The intervention clusters will receive an integrated model of care structured around (1) a community respite service, (2) the strengthening of family care capacity, and (3) an exercise program that aims to prevent entry into long-term care for older people. Control group clusters receive usual care (ie, the current system of long-term care common to all provinces in Thailand), consisting principally of a volunteer-assisted home care service. The trial will be conducted over a period of 2 years. The primary outcome is family caregiver burden measured at a 6-month follow-up, as measured by the Caregiver Burden Inventory. Secondary outcomes consist of biopsychosocial indicators including functional ability, as measured using an activity of daily living scale; depression, as measured by the Geriatric Depression Scale; and quality of life of older people, as measured by the EuroQol 5-dimensions 5-levels scale. Intention-to-treat analysis will be followed. Results: The CIIC facility has been established. Community care prevention programs have been launched at the intervention clusters. Family caregivers are receiving training and assistance. However, the COVID-19 pandemic delayed the intervention. Conclusions: Since ASEAN and many Asian countries share similar traditional family-based, long-term care systems, the proposed CIIC model and the protocol for its implementation and evaluation may benefit other countries wishing to adopt similar community-integrated care models for older people at risk of needing long-term care. Trial Registration: Thai Clinical Trials Registry TCTR20190412004; http://www.thaiclinicaltrials.org/# International Registered Report Identifier (IRRID): DERR1-10.2196/20196 %M 33759787 %R 10.2196/20196 %U https://www.researchprotocols.org/2021/3/e20196 %U https://doi.org/10.2196/20196 %U http://www.ncbi.nlm.nih.gov/pubmed/33759787 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 3 %P e25838 %T Effects of a School-Based Physical Activity Intervention for Obesity and Health-Related Physical Fitness in Adolescents With Intellectual Disability: Protocol for a Randomized Controlled Trial %A Wang,Aiwei %A Gao,Yang %A Wang,Jingjing %A Tong,Tomas K %A Sun,Yan %A Yu,Siyue %A Zhao,Hong %A Zou,Daozhi %A Zhang,Ziheng %A Qi,Yuling %A Zuo,Nan %A Bu,Danran %A Zhang,Dexing %A Xie,Yaojie %A Baker,Julien S %+ Department of Sport, Physical Education and Health, Hong Kong Baptist University, AAB 927 Academic and Administration Building, 15 Baptist University Road, Hong Kong, China, 852 34113082, gaoyang@hkbu.edu.hk %K children %K intellectual disability %K physical activity %K overweight %K obesity %K intervention %D 2021 %7 22.3.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Childhood obesity accompanied by lower levels of health-related physical fitness (HRPF) is a major threat to public health both internationally and locally. Children with intellectual disability, especially adolescents, have a higher risk of being overweight/obese and having poor HRPF levels. Therefore, more interventions are needed to help this population attain their optimal health levels. However, there has been relatively limited research on this population compared with on their typically developing peers. Objective: The proposed study aims to fill this knowledge gap by developing and examining the success of a physical activity (PA) intervention for the target population. Methods: The proposed study will be a 12-week, school-based randomized controlled trial. The participants (N=48) will be recruited from special schools for students with mild intellectual disability and then randomly allocated to either the intervention group (IG) or the wait-list control group (CG). During the intervention period, the participants in the IG will receive a fun game–based moderate-to-vigorous PA (MVPA) training program (2 sessions/week, 60 minutes/session, for a total of 24 sessions). The intensity of the activities will increase in a progressive manner. Participants in the CG will receive no program during the study period, but the same PA program will be provided to them after the completion of the study. To observe and evaluate the sustaining effects of the intervention, follow-up testing will be scheduled for the participants 12 weeks after the intervention concludes. The study outcomes will include primary outcomes (obesity- and fitness-related outcomes) and a secondary outcome (blood pressure). All of the measurements will be taken at 3 time points. After the follow-up tests, the same PA training program will be provided to the participants in the CG. Results: This study is ongoing. The participants were recruited from October 2020 to November 2020. The total duration of the study is 13 months. Study results are expected at the end of 2021. Conclusions: The proposed study is expected to reduce obesity and improve HRPF levels in children with intellectual disability. If proven effective, the intervention will be made accessible to more special schools and mainstream schools with students with intellectual disability. Furthermore, the study can serve as an example for international researchers, policy makers, and members of the public who are seeking to tackle the problem of obesity and poor HRPF among children with intellectual disability. Trial Registration: ClinicalTrials.gov NCT04554355; https://www.clinicaltrials.gov/ct2/show/NCT04554355 International Registered Report Identifier (IRRID): PRR1-10.2196/25838 %M 33749611 %R 10.2196/25838 %U https://www.researchprotocols.org/2021/3/e25838 %U https://doi.org/10.2196/25838 %U http://www.ncbi.nlm.nih.gov/pubmed/33749611 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 3 %P e25966 %T Interprofessional Medication Adherence Program for Patients With Diabetic Kidney Disease: Protocol for a Randomized Controlled and Qualitative Study (PANDIA-IRIS) %A Bandiera,Carole %A Dotta-Celio,Jennifer %A Locatelli,Isabella %A Nobre,Dina %A Wuerzner,Grégoire %A Pruijm,Menno %A Lamine,Faiza %A Burnier,Michel %A Zanchi,Anne %A Schneider,Marie Paule %+ School of Pharmaceutical Sciences, University of Geneva, Rue Michel Servet 1, Geneva, 1211, Switzerland, 41 22 379 53 16, Marie.Schneider@unige.ch %K medication adherence %K patient compliance %K diabetes mellitus %K diabetes complications %K diabetic nephropathies %K chronic kidney disease %K kidney failure %K renal insufficiency %K electronic monitoring %K interprofessional program %D 2021 %7 19.3.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Despite effective treatments, more than 30% of patients with diabetes will present with diabetic kidney disease (DKD) at some point. Patients with DKD are among the most complex as their care is multifactorial and involves different groups of health care providers. Suboptimal adherence to polypharmacy is frequent and contributes to poor outcomes. As self-management is one of the keys to clinical success, structured medication adherence programs are crucial. The PANDIA-IRIS (patients diabétiques et insuffisants rénaux: un programme interdisciplinaire de soutien à l’adhésion thérapeutique) study is based on a routine medication adherence program led by pharmacists. Objective: The aim of this study is to define the impact of the duration of this medication adherence program on long-term adherence and clinical outcomes in patients with DKD. Methods: This monocentric adherence program consists of short, repeated motivational interviews focused on patients’ medication behaviors combined with the use of electronic monitors containing patients’ medications. When patients open the electronic monitor cap to take their medication, the date and hour at each opening are registered. In total, 73 patients are randomized as 1:1 in 2 parallel groups; the adherence program will last 6 months in the first group versus 12 months in the second group. After the intervention phases, patients continue using their electronic monitors for a total of 24 months but without receiving feedback. Electronic monitors and pill counts are used to assess medication adherence. Persistence and implementation will be described using Kaplan-Meier curves and generalized estimating equation multimodeling, respectively. Longitudinal adherence will be presented as the product of persistence and implementation and modelized by generalized estimating equation multimodeling. The evolution of the ADVANCE (Action in Diabetes and Vascular disease: Preterax and Diamicron Modified-Release Controlled Evaluation) and UKPDS (United Kingdom Prospective Diabetes Study) clinical scores based on medication adherence will be analyzed with generalized estimating equation multimodeling. Patients’ satisfaction with this study will be assessed through qualitative interviews, which will be transcribed verbatim, coded, and analyzed for the main themes. Results: This study was approved by the local ethics committee (Vaud, Switzerland) in November 2015. Since then, 2 amendments to the protocol have been approved in June 2017 and October 2019. Patients’ recruitment began in April 2016 and ended in October 2020. This study was introduced to all consecutive eligible patients (n=275). Among them, 73 accepted to participate (26.5%) and 202 (73.5%) refused. Data collection is ongoing and data analysis is planned for 2022. Conclusions: The PANDIA-IRIS study will provide crucial information about the impact of the medication adherence program on the adherence and clinical outcomes of patients with DKD. Monitoring medication adherence during the postintervention phase is innovative and will shed light on the duration of the intervention on medication adherence. Trial Registration: Clinicaltrials.gov NCT04190251_PANDIA IRIS; https://clinicaltrials.gov/ct2/show/NCT04190251 International Registered Report Identifier (IRRID): DERR1-10.2196/25966 %M 33739292 %R 10.2196/25966 %U https://www.researchprotocols.org/2021/3/e25966 %U https://doi.org/10.2196/25966 %U http://www.ncbi.nlm.nih.gov/pubmed/33739292 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 3 %P e22805 %T The Neurostimulation of the Brain in Depression Trial: Protocol for a Randomized Controlled Trial of Transcranial Direct Current Stimulation in Treatment-Resistant Depression %A Suleman,Raheem %A Tucker,Benjamin V %A Dursun,Serdar M %A Demas,Michael L %+ Department of Psychiatry, Faculty of Medicine and Dentistry, University of Alberta, 1E1 Walter Mackenzie Health Sciences Centre, University of Alberta, 8440-112 St NW, Edmonton, AB, T6G 2B7, Canada, 1 7804076504, rsuleman@ualberta.ca %K neuromodulation %K neurostimulation %K transcranial direct current stimulation %K electrical stimulation therapy %K psychiatric somatic therapies %K depression %K depressive disorder %K major depressive disorder %K depressive disorder, treatment resistant %K randomized controlled trial %K therapeutics %K clinical trial protocol %D 2021 %7 17.3.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Major depressive disorder (MDD) is the second highest cause of disability worldwide. Standard treatments for MDD include medicine and talk therapy; however, approximately 1 in 5 Canadians fail to respond to these approaches and must consider alternatives. Transcranial direct current stimulation (tDCS) is a safe, noninvasive method that uses electrical stimulation to change the activation pattern of different brain regions. By targeting those regions known to be affected in MDD, tDCS may be useful in ameliorating treatment-resistant depression. Objective: The objective of the Neurostimulation of the Brain in Depression trial is to compare the effectiveness of active versus sham tDCS in treating patients with ultraresistant MDD. The primary outcome will be the improvement in depressive symptoms, as measured by the change on the Mongtomery-Asberg Depression Rating Scale. Secondary outcomes will include changes in the Quick Inventory of Depressive Symptomatology Scale (subjective assessment), the World Health Organization Disability Assessment Schedule 2.0 (functional assessment), and the Screen for Cognitive Impairment in Psychiatry (cognitive assessment). Adverse events will be captured using the Young Mania Rating Scale; tDCS Adverse Events Questionnaire; Frequency, Intensity, and Burden of Side Effects Rating Scale; and Patient-Rated Inventory of Side Effects Scale. A parallel component of the study will involve assaying for baseline language function and the effect of treatment on language using an exploratory acoustic and semantic corpus analysis on recorded interviews. Participant accuracy and response latency on an auditory lexical decision task will also be evaluated. Methods: We will recruit inpatients and outpatients in the city of Edmonton, Alberta, and will deliver the study interventions at the Grey Nuns and University of Alberta Hospitals. Written informed consent will be obtained from all participants before enrollment. Eligible participants will be randomly assigned, in a double-blinded fashion, to receive active or sham tDCS, and they will continue receiving their usual pharmacotherapy and psychotherapy throughout the trial. In both groups, participants will receive 30 weekday stimulation sessions, each session being 30 minutes in length, with the anode over the left dorsolateral prefrontal cortex and the cathode over the right. Participants in the active group will be stimulated at 2 mA throughout, whereas the sham group will receive only a brief period of stimulation to mimic skin sensations felt in the active group. Measurements will be conducted at regular points throughout the trial and 30 days after trial completion. Results: The trial has been approved by the University of Alberta Research Ethics Board and is scheduled to commence in June 2021. The target sample size is 60 participants. Conclusions: This is a protocol for a multicenter, double-blinded, randomized controlled superiority trial comparing active versus sham tDCS in patients with treatment-resistant MDD. Trial Registration: ClinicalTrials.gov NCT04159012; http://clinicaltrials.gov/ct2/show/NCT04159012. International Registered Report Identifier (IRRID): PRR1-10.2196/22805 %M 33729165 %R 10.2196/22805 %U https://www.researchprotocols.org/2021/3/e22805 %U https://doi.org/10.2196/22805 %U http://www.ncbi.nlm.nih.gov/pubmed/33729165 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 3 %P e19633 %T Home-Based Intervention for the Prevention and Treatment of Malaria Among Children Younger Than 5 Years in the West Region of Cameroon: Protocol for a Randomized Controlled Trial %A Dongmo Kenfack,Esther %A Tendongfor,Nicholas %A Nsagha,Dickson Shey %+ Department of Public Health and Hygiene, Faculty of Health Sciences, University of Buea, P.O. Box 63, Molyko, Buea, Cameroon, 237 677499429 ext 699674201, nsaghads@hotmail.com %K home-based management %K malaria %K children younger than 5 years %K home caregivers %K West Region %K Cameroon %D 2021 %7 12.3.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Although malaria is preventable and curable, 1 child dies of this disease every 2 minutes in Africa. Home-based management of malaria reduces the progression of severe malaria by more than 50%. Scalable, efficacious, and cost-effective strategies are needed to empower the capacities of home caregivers of children younger than 5 years of age in health education, diagnosis, and treatment of malaria at home. Objective: The main objective of this trial is to assess the impact of the management provided by home caregivers on the prevention, diagnosis, and treatment of malaria in children younger than 5 years as compared to the home-based malaria management component of the integrated community-directed intervention (CDI) strategy of community health workers (CHWs). Methods: A randomized controlled trial will be conducted. CHWs have conducted a census of all households where there is at least one child younger than 5 years with their home caregivers. These children and their home caregivers have been randomly placed into the intervention or control groups among the households identified. The trial will allow malaria home-based prevention, diagnosis, and treatment of 350 children younger than 5 years old by home caregivers in the Fombap area (intervention group) where the integrated CDI strategy will not implemented. This group will be compared to the home-based malaria management component of the integrated CDI strategy in which 350 children in the same age group will be followed up by CHWs in the Baneghang area (control group). The primary outcomes will be the prevention, diagnosis, and treatment of malaria in children younger than 5 years of age by home caregivers at home. The secondary outcomes comprise the malaria follow-up indicators produced by home caregivers in the intervention group and those produced by CHWs in the control group. Both descriptive and one-way analysis of variance estimation techniques will be used to compare the mean difference in the 2 strategies. Results: From September 2019 to October 2019, all home caregivers with children younger than 5 years of age were identified in the intervention and control group by CHWs. Following this, 203 home caregivers with their 350 children younger than 5 years were randomly selected and enrolled in the intervention group, while 225 home caregivers with their 350 children younger than 5 years were enrolled in the control group. In the intervention group, 203 home caregivers were trained in November 2019. This home treatment effectively started in December 2019 and will continue until May 2020. Conclusions: Findings from this randomized controlled trial will contribute to resolving the challenges of severe malaria and to limiting the death due to malaria of children younger than 5 years. This will bring benefits to home caregivers who will know how to promptly diagnose and properly treat malaria in their children at home. Trial Registration: Pan African Clinical Trial Registry (PACTR) 202003487018009; https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=9788 International Registered Report Identifier (IRRID): DERR1-10.2196/19633 %M 33709938 %R 10.2196/19633 %U https://www.researchprotocols.org/2021/3/e19633 %U https://doi.org/10.2196/19633 %U http://www.ncbi.nlm.nih.gov/pubmed/33709938 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 3 %P e23994 %T Bovine Lactoferrin to Prevent Neonatal Infections in Low-Birth-Weight Newborns in Pakistan: Protocol for a Three-Arm Double-Blind Randomized Controlled Trial %A Ariff,Shabina %A Soofi,Sajid %A Aamir,Almas %A D'Almeida,Michelle %A Aziz Ali,Arzina %A Alam,Ashraful %A Dibley,Michael %+ School of Public Health, Faculty of Medicine and Health, The University of Sydney, Rm 328, Edward Ford Building A27, New South Wales, Sydney, 2006, Australia, 61 407616500, michael.dibley@sydney.edu.au %K bovine lactoferrin %K low birth weight %K sepsis %K human milk %K premature %K mortality %D 2021 %7 11.3.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Sepsis is a common and severe complication in premature neonates, particularly those born with low birth weights (<2500 g). Neonatal sepsis is steadily emerging as a leading cause of neonatal mortality in Pakistan. Lactoferrin is a natural product with broad-spectrum antimicrobial properties and glycoprotein that is actively involved in innate immune host responses. Clinical trials have revealed its protective effect on sepsis, but lactoferrin dosage, duration, and role in the prevention of sepsis are still uncertain. Objective: We aimed to establish the efficacy of bovine lactoferrin in the prevention of late-onset sepsis and to determine the optimal dose and method of administering bovine lactoferrin that may contribute to improvement in overall survival of low birth weight infants. Methods: We will implement the study in 2 phases at the Aga Khan University Hospital. The first phase, which we have completed, was formative research. This phase mainly focused on a qualitative exploration of perceptions about feeding and caring practices of low birth weight newborns and a trial of improved practices for the preparation and administration of bovine lactoferrin to newborns. The second phase is a 3-arm double-blind randomized controlled trial. In this phase, we randomly allocated 2 different daily oral prophylactic doses of bovine lactoferrin (150 mg or 300 mg) and placebo to 300 low–birth weight neonates starting within the first 72 hours of birth and continuing for the first 28 days of life. Results: The study protocol was approved by the Ethics Review Committee of Aga Khan University on August 16, 2017. Data collection began in April 2018 and was completed in September 2020. Data analyses are yet to be completed. We expect the results to be published in peer-reviewed journals by autumn of 2021. Conclusions: This intervention, if effective, has the potential to be translated into a safe, affordable, and widely utilized treatment to prevent sepsis and, subsequently, may improve the survival outcomes of low birth weight neonates in Pakistan and other low- and middle-income countries. Trial Registration: ClinicalTrials.gov NCT03431558; https://clinicaltrials.gov/ct2/show/NCT03431558 International Registered Report Identifier (IRRID): PRR1-10.2196/23994 %M 33704071 %R 10.2196/23994 %U https://www.researchprotocols.org/2021/3/e23994 %U https://doi.org/10.2196/23994 %U http://www.ncbi.nlm.nih.gov/pubmed/33704071 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 2 %P e22511 %T Valproic Acid as an Adjuvant Treatment for Generalized Convulsive Status Epilepticus in Adults Admitted to Intensive Care Units: Protocol for a Double-Blind, Multicenter Randomized Controlled Trial %A Sharshar,Tarek %A Ben Hadj Salem,Omar %A Porcher,Raphaël %A Grimaldi-Bensouda,Lamiae %A Heming,Nicholas %A Clair,Bernard %A Azabou,Eric %A Mazeraud,Aurélien %A Rohaut,Benjamin %A Outin,Hervé %+ Groupement Hospitalo-Universitaire Paris Psychiatrie et Neurosciences, 1, rue cabanis, Paris, 75014, France, 33 145658209, tsharhshar@gmail.com %K generalized convulsive status epilepticus %K intensive care unit %K seizure %K valproic acid %D 2021 %7 24.2.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Generalized convulsive status epilepticus (GCSE) is a frequent medical emergency. GCSE treatment focuses on the administration of benzodiazepines followed by a second-line antiepileptic drug (AED). Despite this stepwise strategy, GCSE is not controlled in one-quarter of patients and is associated with protracted hospitalization, high mortality, and long-term disability. Valproic acid (VPA) is an AED with good tolerability and neuroprotective properties. Objective: This study aims to demonstrate that administration of VPA as an adjuvant for first- and second-line treatment in GCSE can improve outcomes. Methods: A multicenter, double-blind, randomized controlled trial was conducted, comparing VPA with a placebo in adults admitted to intensive care units (ICUs) for GCSE in France. GCSE was diagnosed by specifically trained ICU physicians according to standard criteria. All patients received standard of care, including a benzodiazepine and a second-line AED (not VPA), at the discretion of the treating medical team. In the intervention arm, VPA was administered intravenously at a loading dose of 30 mg/kg over 15 minutes, followed by a continuous infusion of 1 mg/kg/hour over the next 12 hours. In the placebo group, an identical intravenous administration of 0.9% saline was used. The primary outcome was the proportion of patients discharged alive from the hospital by day 15. Secondary outcomes were frequency of refractory and super refractory GCSE, ICU-related morbidity, adverse events related to VPA, and cognitive dysfunction at 3 months. Statistical analyses will be performed according to the intent-to-treat principle. Results: The first patient was randomized on February 18, 2013, and the last patient was randomized on July 7, 2018. Of 248 planned patients, 98.7% (245/248) were enrolled across 20 ICUs. At present, data management is still ongoing, and all parties involved in the trial remain blinded. Conclusions: The Valproic Acid as an Adjuvant Treatment for Generalized Convulsive Status Epilepticus (VALSE) trial will evaluate whether the use of VPA as an adjuvant for first- and second-line treatment in GCSE improves outcomes. Trial Registration: ClinicalTrials.gov NCT01791868; https://clinicaltrials.gov/ct2/show/NCT01791868. International Registered Report Identifier (IRRID): DERR1-10.2196/22511 %M 33625371 %R 10.2196/22511 %U https://www.researchprotocols.org/2021/2/e22511 %U https://doi.org/10.2196/22511 %U http://www.ncbi.nlm.nih.gov/pubmed/33625371 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 2 %P e21911 %T Effects of the Active Choices Program on Self-Managed Physical Activity and Social Connectedness in Australian Defence Force Veterans: Protocol for a Cluster-Randomized Trial %A Gilson,Nicholas D %A Papinczak,Zoe E %A Mielke,Gregore Iven %A Haslam,Catherine %A Fooken,Jonas %A McKenna,Jim %A Brown,Wendy J %+ School of Human Movement and Nutrition Sciences, The University of Queensland, St Lucia, Brisbane, 4072, Australia, 61 (07) 3365 6114, n.gilson1@uq.edu.au %K military service veterans %K self-managed physical activity %K behavioral support program %K psychological well-being %K social connectedness %K health service utilization %K health service costs %K physical activity %K well-being %K health professional %K veterans %K behavioral %K support program %D 2021 %7 24.2.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: A stepped-down program is one in which clients transition from the care of a health professional to self-managed care. Very little is known about the effectiveness of stepped-down physical activity (PA) programs for military service veterans. Objective: This study will test Active Choices, a stepped-down behavioral support program designed to help Australian Defence Force veterans and their dependents who are clients of the Department of Veterans’ Affairs, transition from treatment by an exercise physiologist or physiotherapist to self-managed PA. Methods: The study is a parallel-group, randomized trial, with city-based exercise physiology or physiotherapy practices that recruit eligible Department of Veterans’ Affairs clients assigned to Active Choices or a comparison program. The study aims to recruit 52 participants (26 in each group). The Active Choices program will consist of 2 face-to-face (Weeks 1, 12) and 2 telephone (Weeks 4 and 8) consultations. During these sessions, the participant and Active Choices consultant will utilize an evidence-based resource booklet to review the key benefits of an active lifestyle, build an action plan for PA preferences, set and review goals, self-monitor progress relative to set goals, and discuss strategies to overcome PA barriers. Linking participants to local PA communities to overcome social isolation will be a program priority. The comparison program will consist of 2 consultations (Weeks 1 and 12) and use fewer behavioral support strategies (education, self-monitoring, and action planning only) than Active Choices. Outcome measures will be administered at baseline, end-intervention (12 weeks), and follow-up (24 weeks) to assess changes in moderate intensity self-managed PA, psychological well-being, and social connectedness. We will also measure health service utilization and costs as well as PA choices across the intervention period. End-intervention interviews will capture participant experiences. Results: Due to the impacts of the COVID-19 pandemic on human research activities in Australia, participant recruitment will commence when it is safe and feasible to do so. Conclusions: Findings will provide valuable pilot data to support up-scaling of the program and larger effectiveness trials with regional and rural as well as city-based Australian Defence Force veterans and their dependents. Trial Registration: Australian and New Zealand Clinical Trials Registry (ANZCTR): ACTRN12620000559910; https://www.anzctr.org.au/ACTRN12620000559910.aspx International Registered Report Identifier (IRRID): PRR1-10.2196/21911 %M 33625365 %R 10.2196/21911 %U https://www.researchprotocols.org/2021/2/e21911 %U https://doi.org/10.2196/21911 %U http://www.ncbi.nlm.nih.gov/pubmed/33625365 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 2 %P e21734 %T Tracking Demographic Movements and Immunization Status to Improve Children's Access to Immunization (TDM-IAI): Protocol for a Field-Based Randomized Controlled Trial %A Ateudjieu,Jérôme %A Yakum,Ndinakie Martin %A Goura,André Pascal %A Guenou,Etienne %A Beyala,Landry Bita’a %A Amada,Lapia %A Ngoche,Isabelle %A Kiadjieu,Frank Forex %A Nangue,Charlette %A Djosseu,Elvis Briand Soukep %A Kenfack,Bruno %+ Meilleur Accès aux soins de Santé (MA SANTE), Mvolye Street, Yaoundé, 33490, Cameroon, 237 679336464, pgoura@masante-cam.org %K immunization status %K coverage: completeness %K timeliness %K EPI vaccines %K children under five %K Foumban %K Cameroon %K vaccines %K infectious %K immunization %D 2021 %7 8.2.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: In Cameroon, the coverage, completeness, and timeliness of the Expanded Programme on Immunization (EPI) vaccines administration in children have remained heterogeneous and below the national and districts targets in several districts. In an effort to solve this problem, many interventions have been tested but none has shown significant improvement of the situation. Objective: This trial aims to test whether involving Community Volunteers to assess children vaccination status and demographic movements and using recorded data to plan catch-up immunization sessions can improve children vaccination timeliness, completeness and coverage. Methods: Communities of the Foumban Health district, West region of Cameroon will be selected and assigned to either intervention or control groups using a restricted randomization of 2. In the intervention group, one Community Volunteer per community will be trained to visit households and record EPI-targeted children in a register, record their demographic movements, and assess their immunization status monthly for a year. The information recorded will be snapped and sent to the competent health center immunization team through WhatsApp. These will be used to plan and implement monthly community catch up immunization sessions in collaboration with the community volunteer. In the control group, the routine immunization sessions will be conducted with health centers organizing either weekly vaccination sessions for communities situated not farther than 5 kilometers away from the health facility or monthly vaccination sessions in communities situated more than 5 kilometers away from the health center. Baseline, mid-term and end-line surveys will be conducted to assess and compare immunization coverage, timeliness, and completeness. Results: Funded in 2018, data collection started in 2018 and has been completed. Data analysis and reporting are ongoing. Conclusions: This trial is expecting to test an innovative approach to improving children’s immunization timeliness, completeness and coverage of immunization by tracking EPI targeted population vaccination status and denominator at household level and building collaboration between the community and health facilities vaccination teams to organize monthly community-based response vaccination sessions. This intervention is expected to improve children sustainable access to EPI vaccination as it offers assessing and responding to their immunization needs at monthly basis using low cost local human resources. Trial Registration: Pan African Clinical Trials Registry ID PACTR201808527428720; tinyurl.com/u058qnse International Registered Report Identifier (IRRID): DERR1-10.2196/21734 %M 33555269 %R 10.2196/21734 %U https://www.researchprotocols.org/2021/2/e21734 %U https://doi.org/10.2196/21734 %U http://www.ncbi.nlm.nih.gov/pubmed/33555269 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 2 %P e18837 %T Comparison of Endoscopy First and Laparoscopic Cholecystectomy First Strategies for Patients With Gallstone Disease and Intermediate Risk of Choledocholithiasis: Protocol for a Clinical Randomized Controlled Trial %A Aleknaite,Ausra %A Simutis,Gintaras %A Stanaitis,Juozas %A Jucaitis,Tomas %A Drungilas,Mantas %A Valantinas,Jonas %A Strupas,Kestutis %+ Center of Hepatology, Gastroenterology and Dietetics, Vilnius University Hospital Santaros Klinikos, Santariskiu 2, Vilnius, 08406, Lithuania, 370 61818076, ausra.aleknaite@santa.lt %K choledocholithiasis %K endoscopic ultrasound %K intraoperative cholangiography %K common bile duct stone %K endoscopic retrograde cholangiopancreatography %K laparoscopic cholecystectomy %D 2021 %7 4.2.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: The optimal approach for patients with gallbladder stones and intermediate risk of choledocholithiasis remains undetermined. The use of endoscopic retrograde cholangiopancreatography for diagnosis should be minimized as it carries considerable risk of postprocedural complications, and nowadays, less invasive and safer techniques are available. Objective: This study compares the two management strategies of endoscopic ultrasound before laparoscopic cholecystectomy and intraoperative cholangiography for patients with symptomatic cholecystolithiasis and intermediate risk of choledocholithiasis. Methods: This is a randomized, active-controlled, single-center clinical trial enrolling adult patients undergoing laparoscopic cholecystectomy for symptomatic gallbladder stones with intermediate risk of choledocholithiasis. The risk of choledocholithiasis is calculated using an original prognostic score (the Vilnius University Hospital Index). This index in a retrospective evaluation showed better prognostic performance than the score proposed by the American Society for Gastrointestinal Endoscopy in 2010. A total of 106 participants will be included and randomized into two groups. Evaluation of bile ducts using endoscopic ultrasound and endoscopic retrograde cholangiography on demand will be performed before laparoscopic cholecystectomy for one arm (“endoscopy first”). Intraoperative cholangiography during laparoscopic cholecystectomy and postoperative endoscopic retrograde cholangiopancreatography on demand will be performed in another arm (“cholecystectomy first”). Postoperative follow-up is 6 months. The primary endpoint is the length of hospital stay. The secondary endpoints are accuracy of the different management strategies, adverse events of the interventions, duct clearance and technical success of the interventions (intraoperative cholangiography, endoscopic ultrasound, and endoscopic retrograde cholangiography), and cost of treatment. Results: The trial protocol was approved by the Vilnius Regional Biomedical Research Ethics Committee in December 2017. Enrollment of patients was started in January 2018. As of June 2020, 66 patients have been enrolled. Conclusions: This trial is planned to determine the superior strategy for patients with intermediate risk of common bile duct stones and to define a simple and safe algorithm for managing choledocholithiasis. Trial Registration: ClinicalTrials.gov NCT03658863; https://clinicaltrials.gov/ct2/show/NCT03658863. International Registered Report Identifier (IRRID): DERR1-10.2196/18837 %M 33538700 %R 10.2196/18837 %U https://www.researchprotocols.org/2021/2/e18837 %U https://doi.org/10.2196/18837 %U http://www.ncbi.nlm.nih.gov/pubmed/33538700 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e18154 %T He Korowai Manaaki (Pregnancy Wraparound Care): Protocol for a Cluster Randomized Clinical Trial %A Lawton,Beverley %A Storey,Francesca %A Sibanda,Nokuthaba %A Bennett,Matthew %A Lambert,Charles %A Geller,Stacie %A Edmonds,Liza %A Cram,Fiona %+ Centre for Women's Health Research, Victoria University of Wellington, 44 Kelburn Parade, Wellington, 6140, New Zealand, 64 021463762, bev.lawton@vuw.ac.nz %K maternity %K inequity %K Indigenous health %K Māori %K pregnancy %K Kaupapa Māori %K socioeconomic %K primary health care %K methodology %D 2021 %7 29.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Maternal and infant health inequities between Māori (the Indigenous peoples of Aotearoa New Zealand) and New Zealand European women are well documented and cannot be explained solely by socioeconomic status. A research center-iwi (tribal group) partnership aims to address these disparities and improve maternal and infant health outcomes by implementing an augmented maternity care pathway (He Korowai Manaaki) to improve access to services and evidence-informed care. Objective: The objective of this study is to test whether an augmented maternity care pathway improves Māori infant health outcomes. Methods: This is a Kaupapa Māori (by, with, and for Māori) cluster randomized clinical trial involving 8 primary care practices allocated to either an intervention arm or control arm. The intervention arm comprises an augmented maternity care pathway (He Korowai Manaaki) offering clinical care through additional paid health care appointments and improved access to social support (eg, housing, transport). The control arm is usual care. The primary outcome is increased timely vaccination for Māori infants, defined as all age-appropriate vaccinations completed by 6 months of age. Results: Recruitment commenced in November 2018 and was completed in June 2020, with 251 enrolled women recruited in intervention primary care practices before 20 weeks of pregnancy. Publication of results is anticipated in late 2023. Conclusions: The results will inform primary health care policy including whether the provision of augmented maternal care pathways reduces disparities in the structural determinants of health. If effective, He Korowai Manaaki will strengthen the health and well-being of pregnant Māori women and their babies and improve their health outcomes, laying a strong foundation for lifelong health and well-being. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12619001155189; https://tinyurl.com/yypbef8q International Registered Report Identifier (IRRID): DERR1-10.2196/18154 %M 33512321 %R 10.2196/18154 %U http://www.researchprotocols.org/2021/1/e18154/ %U https://doi.org/10.2196/18154 %U http://www.ncbi.nlm.nih.gov/pubmed/33512321 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 10 %N 1 %P e15350 %T Effect of Switching to the Tobacco Heating System Versus Continued Cigarette Smoking on Chronic Generalized Periodontitis Treatment Outcome: Protocol for a Randomized Controlled Multicenter Study %A Pouly,Sandrine %A Ng,Wee Teck %A Benzimra,Muriel %A Soulan,Alexandre %A Blanc,Nicolas %A Zanetti,Filippo %A Picavet,Patrick %A Baker,Gizelle %A Haziza,Christelle %+ Philip Morris Products SA, Quai Jeanrenaud 5, Neuchâtel, 2000, Switzerland, 41 582421111, sandrine.pouly@pmi.com %K smoking %K tobacco %K periodontitis %K oral health %K Tobacco Heating System %K modified risk tobacco product %K clinical attachment level %K probing depth %K periodontal pocket %D 2021 %7 18.1.2021 %9 Protocol %J JMIR Res Protoc %G English %X Background: Smoking is a significant risk factor for periodontal disease and tooth loss, as shown in several clinical studies comparing smokers and nonsmokers. Although only a few longitudinal studies have assessed the outcome of periodontal disease after smoking cessation, they indicated that recovery after nonsurgical treatment was more successful in those who had quit smoking. As part of tobacco harm reduction strategies, substituting cigarettes with alternative, less harmful tobacco products is an approach complementary to cessation for smokers who would otherwise continue to smoke. The Tobacco Heating System (THS), developed by Philip Morris International (commercialized as IQOS), is part of the heat-not-burn product category. The IQOS device electrically heats tobacco instead of burning it, at much lower temperatures than cigarettes, thereby producing substantially lower levels of harmful and potentially harmful constituents, while providing the nicotine, taste, ritual, and a sensory experience that closely parallel those of cigarettes. Phillip Morris International has published the results from a broad clinical assessment program, which was established to scientifically substantiate the harm reduction potential of the THS among adult healthy smokers switching to the THS. The program is now progressing toward including adult smokers with smoking-related diseases. Objective: The goal of this study is to demonstrate favorable changes of periodontal endpoints in response to mechanical periodontal therapy in patients with generalized chronic periodontitis who completely switched to THS use compared with continued cigarette smoking. Methods: This is a randomized controlled two-arm parallel-group multicenter Japanese study conducted in patients with chronic generalized periodontitis who switch from cigarettes to THS compared with smokers continuing to smoke cigarettes for 6 months. The patients were treated with mechanical periodontal therapy as per standard of care in Japan. The primary objective of the study is to demonstrate the beneficial effect of switching to THS use compared with continued cigarette smoking on pocket depth (PD) reduction in all sites with an initial PD≥4 mm. The secondary objectives include evaluation of other periodontal parameters (eg, clinical attachment level or gingival inflammation) and overall oral health status upon switching to THS. Safety was monitored throughout the study. Results: In total, 172 subjects were randomized to the cigarette (n=86) or THS (n=86) groups, and all 172 completed the study. The conduct phase of the study is completed, while data cleaning and analyses are ongoing. Conclusions: This study is the first to test a heat-not-burn tobacco product in smokers with an already established disease. The results should further strengthen the evidence that switching to THS can significantly reduce the risk of smoking-related diseases if favorable changes in the evolution of chronic generalized periodontitis after mechanical therapy are found when compared with continued cigarette smoking. Trial Registration: ClinicalTrials.gov NCT03364751; https://clinicaltrials.gov/ct2/show/NCT03364751 International Registered Report Identifier (IRRID): DERR1-10.2196/15350 %M 33459599 %R 10.2196/15350 %U http://www.researchprotocols.org/2021/1/e15350/ %U https://doi.org/10.2196/15350 %U http://www.ncbi.nlm.nih.gov/pubmed/33459599 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 12 %P e23830 %T Efficacy and Safety of Inhaled Ciclesonide in Treating Patients With Asymptomatic or Mild COVID-19 in the RACCO Trial: Protocol for a Multicenter, Open-label, Randomized Controlled Trial %A Terada-Hirashima,Junko %A Suzuki,Manabu %A Uemura,Yukari %A Hojo,Masayuki %A Mikami,Ayako %A Sugiura,Wataru %A Ohmagari,Norio %A Sugiyama,Haruhito %+ Department of Pulmonary Medicine, Center Hospital of the National Center for Global Health and Medicine, 1-21-1 Toyama Shinjuku-ku, Tokyo, Japan, 81 332027181, jterada@hosp.ncgm.go.jp %K COVID-19 %K SARS-CoV-2 %K proposed therapy %K therapy %K drug %K treatment %K protocol %K randomized controlled trial %K intervention %D 2020 %7 31.12.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Currently, there are no specific effective treatments for SARS-CoV-2 infection; however, various COVID-19 treatment options are under investigation. It is vital to continue investigating the landscape of SARS-CoV-2–induced pneumonia and therapeutic interventions. Objective: This paper presents the protocol for a randomized controlled trial that aims to compare the pneumonia exacerbation rate between ciclesonide (ALVESCO; Teijin Pharma Limited) administration and symptomatic treatment in patients with COVID-19 and to determine the efficacy of ciclesonide. The secondary objectives are to investigate the safety of ciclesonide administration, changes in clinical and laboratory findings, and the number of viral genome copies of SARS-CoV-2 over time between the 2 groups. Methods: In this investigator-initiated, exploratory, prospective, multicenter, parallel-group, open-label, randomized controlled trial, a total of 90 patients diagnosed with COVID-19 will be recruited from 21 hospitals in Japan based on specific inclusion and exclusion criteria. Participants will be randomized either to the ciclesonide group, which will receive a 400-µg dose of ciclesonide 3 times per day over a 7-day period, or to the symptomatic treatment group. Both groups will receive antitussives and antipyretics as required. Data collection for various parameters will be conducted on days 1, 2, 4, 8, 22, and 29 to record baseline assessments and the findings over an extended period. Computed tomography images taken prior to drug administration and 1 week following treatment will be compared, and efficacy will be confirmed by checking for pneumonia exacerbation. Primary endpoint analysis will be performed using the Fisher exact test to determine statistically significant differences in the pneumonia exacerbation rate between the ciclesonide and symptomatic treatment groups. Results: The first trial participant was enrolled on April 3, 2020. Recruitment is expected to be completed on September 30, 2020, while follow-up assessments of all participants are expected to be completed by October 31, 2020. The study results will be published in a peer-reviewed scientific journal. Conclusions: The RACCO (Randomized Ciclesonid COVID-19) study will provide definitive comparative effectiveness data and important clinical outcomes data between the ciclesonide and symptomatic treatment groups. If the hypotheses that pneumonia exacerbation rate reduction is more significant in the ciclesonide treatment group than in the symptomatic treatment group and that ciclesonide is safe for use are valid, ciclesonide will serve as an important therapeutic option for patients with COVID-19. Trial Registration: Japan Registry of Clinical Trials jRCTs031190269; https://jrct.niph.go.jp/en-latest-detail/jRCTs031190269 International Registered Report Identifier (IRRID): DERR1-10.2196/23830 %M 33206053 %R 10.2196/23830 %U http://www.researchprotocols.org/2020/12/e23830/ %U https://doi.org/10.2196/23830 %U http://www.ncbi.nlm.nih.gov/pubmed/33206053 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 12 %P e23071 %T An Intervention to Enhance Social, Emotional, and Identity Learning for Very Young Adolescents and Support Gender Equity: Protocol for a Pragmatic Randomized Controlled Trial %A Cherewick,Megan %A Lebu,Sarah %A Su,Christine %A Dahl,Ronald E %+ Department of Health Sciences, California State University East Bay, 25800 Carlos Bee Blvd, Hayward, CA, 94542, United States, 1 734 645 5545, megan.cherewick@csueastbay.edu %K developmental science %K adolescence %K adolescence interventions %K gender norms %K developmental evaluation %K gender %K social learning %K emotional learning %K identity learning %K adolescents %D 2020 %7 31.12.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: The onset of puberty is a pivotal period of human development that is associated with significant changes in cognitive, social, emotional, psychological, and behavioral processes that shape identity formation. Very early adolescence provides a critical opportunity to shape identity formation around gender norms, attitudes, and beliefs before inequitable gender norms are amplified during and after puberty. Objective: The aim of the Discover Learning Project is to integrate strategic insights from developmental science to promote positive transformation in social, emotional, and gender identity learning among 10- to 11-year-olds in Tanzania. Through a pragmatic randomized controlled trial, the intervention scaffolds the development of critical social and emotional mindsets and skills (curiosity, generosity, persistence, purpose, growth mindset, and teamwork) delivered by conducting 18 after-school, technology-driven, experiential learning sessions in small, mixed-gender groups. Methods: The Discover Learning Intervention is a 3-arm randomized controlled trial that will be delivered to 579 participants selected from four public primary schools in Temeke District, Dar es Salaam, Tanzania. Randomization will be done at the individual level into 3 treatment groups receiving incremental intervention components. The treatment components include Discover Learning content curated into child-friendly videos, facilitated discussions, and a parent-child workbook, to be implemented over two phases, each 6 weeks long. A baseline survey will be administered to participants and their parents prior to the intervention. The process will be observed systematically, and data will be collected using surveys, in-depth interviews, observations, and focus group discussions with adolescents, parents, teachers, and facilitators conducted prior, during, and after each implementation phase. Results: This study builds on formative and pilot studies conducted with the target population to inform the design of the intervention. The results will generate new evidence that will inform strategies for achieving scale in Tanzania and provide insights for replication of similar programs that are invested in gender-transformative interventions in peri-urban, low-resource settings. Conclusions: The Discover Learning Intervention makes an important contribution to the field of adolescent developmental science as an intervention designed for very young adolescents in a low-resource setting. Trial Registration: ClinicalTrials.gov NCT04458077; https://clinicaltrials.gov/ct2/show/NCT04458077 International Registered Report Identifier (IRRID): DERR1-10.2196/23071 %M 33206624 %R 10.2196/23071 %U http://www.researchprotocols.org/2020/12/e23071/ %U https://doi.org/10.2196/23071 %U http://www.ncbi.nlm.nih.gov/pubmed/33206624 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 12 %P e19748 %T An Intervention With Dance and Yoga for Girls With Functional Abdominal Pain Disorders (Just in TIME): Protocol for a Randomized Controlled Trial %A Philipson,Anna %A Särnblad,Stefan %A Ekstav,Lars %A Eriksson,Mats %A Fagerberg,Ulrika L %A Möller,Margareta %A Mörelius,Evalotte %A Duberg,Anna %+ University Health Care Research Center, Faculty of Medicine and Health, Örebro University, Universitetssjukhuset Örebro, S-huset, vån 2, Örebro, SE-70185, Sweden, 46 196027491, anna.philipson@regionorebrolan.se %K dance %K functional abdominal pain %K functional abdominal pain disorders %K irritable bowel syndrome %K physical activity %K randomized trial %K study protocol %K yoga %D 2020 %7 15.12.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Functional abdominal pain disorders (FAPDs) affect many children worldwide, predominantly girls, and cause considerable long-term negative consequences for individuals and society. Evidence-based and cost-effective treatments are therefore strongly needed. Physical activity has shown promising effects in the practical management of FAPDs. Dance and yoga are both popular activities that have been shown to provide significant psychological and pain-related benefits with minimal risk. The activities complement each other, in that dance involves dynamic, rhythmic physical activity, while yoga enhances relaxation and focus. Objective: This study aims to evaluate the effects of a dance and yoga intervention among girls aged 9 to 13 years with FAPDs. Methods: The study is a prospective randomized controlled trial among girls aged 9 to 13 years with functional abdominal pain, irritable bowel syndrome, or both. The target sample size was 150 girls randomized into 2 arms: an intervention arm that receives dance and yoga sessions twice weekly for 8 months and a control arm that receives standard care. Outcomes will be measured at baseline and after 4, 8, 12, and 24 months, and long-term follow-up will be conducted 5 years from baseline. Questionnaires, interviews, and biomarker measures, such as cortisol in saliva and fecal microbiota, will be used. The primary outcome is the proportion of girls in each group with reduced pain, as measured by the faces pain scale-revised in a pain diary, immediately after the intervention. Secondary outcomes are gastrointestinal symptoms, general health, mental health, stress, and physical activity. The study also includes qualitative evaluations and health economic analyses. This study was approved by the Regional Ethical Review Board in Uppsala (No. 2016/082 1-2). Results: Data collection began in October 2016. The intervention has been performed in 3 periods from 2016 through 2019. The final 5-year follow-up is anticipated to be completed by fall 2023. Conclusions: Cost-effective and easily accessible interventions are warranted to reduce the negative consequences arising from FAPDs in young girls. Physical activity is an effective strategy, but intervention studies are needed to better understand what types of activities facilitate regular participation in this target group. The Just in TIME (Try, Identify, Move, and Enjoy) study will provide insights regarding the effectiveness of dance and yoga and is anticipated to contribute to the challenging work of reducing the burden of FAPDs for young girls. Trial Registration: ClinicalTrials.gov (NCT02920268); https://clinicaltrials.gov/ct2/show/NCT02920268 International Registered Report Identifier (IRRID): DERR1-10.2196/19748 %M 33320103 %R 10.2196/19748 %U http://www.researchprotocols.org/2020/12/e19748/ %U https://doi.org/10.2196/19748 %U http://www.ncbi.nlm.nih.gov/pubmed/33320103 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 12 %P e21273 %T An Educational Network for Surgical Education Supported by Gamification Elements: Protocol for a Randomized Controlled Trial %A Guérard-Poirier,Natasha %A Beniey,Michèle %A Meloche-Dumas,Léamarie %A Lebel-Guay,Florence %A Misheva,Bojana %A Abbas,Myriam %A Dhane,Malek %A Elraheb,Myriam %A Dubrowski,Adam %A Patocskai,Erica %+ Department of General Surgery, Université de Montréal, Pavillon Roger-Gaudry, Local: S-749, CP 6128, succursale Centre-ville, Montreal, QC, H3C 3J7, Canada, 1 514 343 6111, michele.beniey@umontreal.ca %K distance learning %K COVID-19 %K surgical pedagogy %K learning platform %K subcuticular sutures %K advanced sutures %K medical education %K peer learning %K surgery %K medical student %K web-based learning %K web-based tool %K gamification %K video %D 2020 %7 14.12.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Traditionally, medical students have learned surgical skills by observing a resident physician or surgeon who is performing the technique. Due to inconsistent practice opportunities in the clinical setting, a disparity of skill levels among students has been observed. In addition, the poor availability of faculty professors is a limiting factor in teaching and adequately preparing medical students for their clerkship years. With the ongoing COVID-19 pandemic, medical students do not have access to traditional suturing learning opportunities. Didactic courses are available on videoconferencing platforms; however, these courses do not include technical training. Objective: Our overarching goal is to evaluate the efficacy and usability of web-based peer-learning for advanced suturing techniques (ie, running subcuticular sutures). We will use the Gamified Educational Network (GEN), a newly developed web-based learning tool. We will assess students’ ability to identify and perform the correct technique. We will also assess the students’ satisfaction with regard to GEN. Methods: We will conduct a prospective randomized controlled trial with blinding of expert examiners. First-year medical students in the Faculty of Medicine of Université de Montréal will be randomized into four groups: (1) control, (2) self-learning, (3) peer-learning, and (4) peer-learning with expert feedback. Each arm will have 15 participants who will learn how to perform running subcuticular sutures through videos on GEN. For our primary outcome, the students’ ability to identify the correct technique will be evaluated before and after the intervention on GEN. The students will view eight videos and rate the surgical techniques using the Objective Structured Assessment of Technical Skills Global Rating Scale and the Subcuticular Suture Checklist as evaluation criteria. For our secondary outcomes, students will anonymously record themselves performing a running subcuticular suture and will be evaluated using the same scales. Then, a survey will be sent to assess the students’ acceptance of the intervention. Results: The study will be conducted in accordance with the Declaration of Helsinki and has been approved by our institutional review board (CERSES 20-068-D). No participants have been recruited yet. Conclusions: Peer learning through GEN has the potential to overcome significant limitations related to the COVID-19 pandemic and the lack of availability of faculty professors. Further, a decrease of the anxiety related to traditional suturing classes can be expected. We aim to create an innovative and sustainable method of teaching surgical skills to improve the efficiency and quality of surgical training in medical faculties. In the context of the COVID-19 pandemic, the need for such tools is imperative. Trial Registration: ClinicalTrials.gov NCT04425499; https://clinicaltrials.gov/ct2/show/NCT04425499 International Registered Report Identifier (IRRID): PRR1-10.2196/21273 %M 33284780 %R 10.2196/21273 %U http://www.researchprotocols.org/2020/12/e21273/ %U https://doi.org/10.2196/21273 %U http://www.ncbi.nlm.nih.gov/pubmed/33284780 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 11 %P e20904 %T Mass Drug Administration With High-Dose Ivermectin and Dihydroartemisinin-Piperaquine for Malaria Elimination in an Area of Low Transmission With High Coverage of Malaria Control Interventions: Protocol for the MASSIV Cluster Randomized Clinical Trial %A Dabira,Edgard Diniba %A Soumare,Harouna M %A Lindsay,Steven W %A Conteh,Bakary %A Ceesay,Fatima %A Bradley,John %A Kositz,Christian %A Broekhuizen,Henk %A Kandeh,Balla %A Fehr,Alexandra E %A Nieto-Sanchez,Claudia %A Ribera,Joan Muela %A Peeters Grietens,Koen %A Smit,Menno Roderick %A Drakeley,Chris %A Bousema,Teun %A Achan,Jane %A D’Alessandro,Umberto %+ Medical Research Council Unit Gambia, London School of Hygiene and Tropical Medicine, PO Box 273 Fajara The Gambia, Banjul, Gambia, 220 2040284, edabira@mrc.gm %K ivermectin %K dihydroartemisinin-piperaquine %K mass drug administration %K malaria %K cluster randomized trial %K The Gambia %D 2020 %7 19.11.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: With a decline in malaria burden, innovative interventions and tools are required to reduce malaria transmission further. Mass drug administration (MDA) of artemisinin-based combination therapy (ACT) has been identified as a potential tool to further reduce malaria transmission, where coverage of vector control interventions is already high. However, the impact is limited in time. Combining an ACT with an endectocide treatment that is able to reduce vector survival, such as ivermectin (IVM), could increase the impact of MDA and offer a new tool to reduce malaria transmission. Objective: The study objective is to evaluate the impact of MDA with IVM plus dihydroartemisinin-piperaquine (DP) on malaria transmission in an area with high coverage of malaria control interventions. Methods: The study is a cluster randomized trial in the Upper River Region of The Gambia and included 32 villages (16 control and 16 intervention). A buffer zone of ~2 km was created around all intervention clusters. MDA with IVM plus DP was implemented in all intervention villages and the buffer zones; control villages received standard malaria interventions according to the Gambian National Malaria Control Program plans. Results: The MDA campaigns were carried out from August to October 2018 for the first year and from July to September 2019 for the second year. Statistical analysis will commence once the database is completed, cleaned, and locked. Conclusions: This is the first cluster randomized clinical trial of MDA with IVM plus DP. The results will provide evidence on the impact of MDA with IVM plus DP on malaria transmission. Trial Registration: ClinicalTrials.gov NCT03576313; https://clinicaltrials.gov/ct2/show/NCT03576313 International Registered Report Identifier (IRRID): DERR1-10.2196/20904 %M 33211022 %R 10.2196/20904 %U https://www.researchprotocols.org/2020/11/e20904 %U https://doi.org/10.2196/20904 %U http://www.ncbi.nlm.nih.gov/pubmed/33211022 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 11 %P e19162 %T Posttraumatic Stress Disorder and Neuroprogression in Women Following Sexual Assault: Protocol for a Randomized Clinical Trial Evaluating Allostatic Load and Aging Process Acceleration %A Coimbra,Bruno Messina %A Yeh,Mary %A D'Elia,Ana Teresa %A Maciel,Mariana Rangel %A Carvalho,Carolina Muniz %A Milani,Ana Carolina %A Mozzambani,Adriana %A Juruena,Mario %A Belangero,Sintia Iole %A Jackowski,Andrea Parolin %A Poyares,Dalva %A Mello,Andrea Feijo %A Mello,Marcelo Feijo %+ Program for Research and Care on Violence and PTSD, Universidade Federal de São Paulo, Rua Major Maragliano 241, São Paulo, 04017030, Brazil, 55 1155764990 ext 1064, feijomellom@me.com %K PTSD %K neuroprogression %K allostatic load %K sexual assault %K trauma %K thematic research %K randomized clinical trial %K aging %D 2020 %7 18.11.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Posttraumatic stress disorder (PTSD) is a prevalent, chronic, and severe disorder related to traumatic events. Women are disproportionately affected by PTSD than men and are more at risk in the occurrence of sexual assault victimization. Estimates suggest that 50% of women develop PTSD following sexual assault and successful clinical management can be challenging. Growing evidence has implicated neural, immune, and endocrine alterations underpinning PTSD, but only few studies have assessed the evolution of acute PTSD in women. Objective: This study aims to measure whether the onset of PTSD is associated with accelerated aging in women following sexual assault. We hypothesize that the increase of allostatic load caused by PTSD leads to neuroprogression. We will implement a randomized clinical trial to compare responses to treatment with either interpersonal psychotherapy adapted for PTSD (IPT-PTSD) or the selective serotonin reuptake inhibitor sertraline. Methods: We will include women between 18 and 45 years of age, who experienced sexual assault from 1 to 6 months before the initial evaluation, and present with a Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) diagnosis of PTSD. Baseline evaluation will comprise clinical and psychometric assessments, structural and functional magnetic resonance imaging, neuropsychological testing, polysomnography, evaluation of immune and endocrine parameters, and genetic analyses. Age-matched female healthy controls will be included and subjected to the same evaluation. Patients will be randomized for treatment in 1 of the 2 arms of the study for 14 weeks; follow-up will continue until 1 year after inclusion via treatment as usual. The researchers will collect clinical and laboratory data during periodic clinical assessments up to 1-year follow-up. Results: Data collection started in early 2016 and will be completed by the end of the first semester of 2020. Analyses will be performed soon afterward, followed by the elaboration of several articles. Articles will be submitted in early 2021. This research project has obtained a grant from the Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP 2014/12559-5). Conclusions: We expect to provide insight into the consequences of recent sexual assault exposure in women by investigating the degree of neuroprogression developing from an early stage of PTSD. We also expect to provide important evidence on the efficacy of a non-exposure psychotherapy (IPT-PTSD) to mitigate PTSD symptoms in recently sexually assaulted women. Further, we aim to obtain evidence on how treatment outcomes are associated with neuroprogression measures. Trial Registration: Brazilian Clinical Trials Registry RBR-3z474z; http://www.ensaiosclinicos.gov.br/rg/RBR-3z474z/ International Registered Report Identifier (IRRID): DERR1-10.2196/19162 %M 33206061 %R 10.2196/19162 %U http://www.researchprotocols.org/2020/11/e19162/ %U https://doi.org/10.2196/19162 %U http://www.ncbi.nlm.nih.gov/pubmed/33206061 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 10 %P e21100 %T Tobacco-Free Duo Adult-Child Contract for Prevention of Tobacco Use Among Adolescents and Parents: Protocol for a Mixed-Design Evaluation %A Galanti,Maria Rosaria %A Pulkki-Brännström,Anni-Maria %A Nilsson,Maria %+ Centre for Epidemiology and Community Health, Solnavägen 1E, Stockholm , Sweden, 46 704718984, rosaria.galanti@ki.se %K tobacco use %K prevention %K school %K social influence %K public commitment %K cluster randomized trial %K observational study %D 2020 %7 29.10.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Universal tobacco-prevention programs targeting youths usually involve significant adults, who are assumed to be important social influences. Commitment not to use tobacco, or to quit use, as a formal contract between an adolescent and a significant adult is a preventive model that has not been widely practiced or explored and has been formally evaluated even less. In this paper, we present the rationale and protocol for the evaluation of the Swedish Tobacco-free Duo program, a multicomponent school-based program the core of which rests on a formal agreement between an adolescent and an adult. The adolescent’s commitment mainly concerns avoiding the onset of any tobacco use while the adult commits to support the adolescent in staying tobacco free, being a role model by not using tobacco themselves. Objective: To assess (1) whether Tobacco-free Duo is superior to an education-only program in preventing smoking onset among adolescents and promoting cessation among their parents, (2) whether exposure to core components (adult-child agreement) entails more positive effects than exposure to other components, (3) the impact of the program on whole school tobacco use, (4) potential negative side effects, and (5) school-level factors related to fidelity of the program’s implementation. Methods: A mixed-design approach was developed. First, a cluster randomized controlled trial was designed with schools randomly assigned to either the comprehensive multicomponent program or its educational component only. Primary outcome at the adolescent level was identified as not having tried tobacco during the 3-year junior high school compulsory grades (12-15 years of age). An intention-to-treat cohort-wise approach and an as-treated approach complemented with a whole school repeated cross-sectional approach was devised as analytical methods of the trial data. Second, an observational study was added in order to compare smoking incidence in the schools participating in the experiment with that of a convenience sample of schools that were not part of the experimental study. Diverse secondary outcomes at both adolescent and adult levels were also included. Results: The study was approved by the Umeå Regional Ethics Review Board (registration number 2017/255-31) in 2017. Recruitment of schools started in fall 2017 and continued until June 2018. In total, 43 schools were recruited to the experimental study, and 16 schools were recruited to the observational study. Data collection started in the fall 2018, is ongoing, and is planned to be finished in spring 2021. Conclusions: Methodological, ethical, and practical implications of the evaluation protocol were discussed, especially the advantage of combining several sources of data, to triangulate the study questions. The results of these studies will help revise the agenda of this program as well as those of similar programs. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN) 52858080; https://doi.org/10.1186/ISRCTN52858080 International Registered Report Identifier (IRRID): DERR1-10.2196/21100 %M 33000762 %R 10.2196/21100 %U http://www.researchprotocols.org/2020/10/e21100/ %U https://doi.org/10.2196/21100 %U http://www.ncbi.nlm.nih.gov/pubmed/33000762 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 10 %P e22989 %T High-Intensity Interval Aerobic Resistance Training to Counteract Low Relative Appendicular Lean Soft Tissue Mass in Middle Age: Study Protocol for a Randomized Controlled Trial %A Vlietstra,Lara %A Waters,Debra L %A Jones,Lynnette M %A Meredith-Jones,Kim %+ Department of Medicine, Otago Medical School, Dunedin Campus, University of Otago, 201 Great King Street, Dunedin, New Zealand, 64 34740999, lara.vlietstra@otago.ac.nz %K sarcopenia %K high-intensity interval training %K randomized controlled trial %D 2020 %7 16.10.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Sarcopenia is the age-related loss of skeletal muscle mass and function and may exist in early middle age. Previous research in this area has focused on resistance training in older individuals; however, there is a lack of intervention trials in middle-aged adults with low relative appendicular lean soft tissue mass who may be at risk for sarcopenia in older age. Objective: This randomized controlled trial aims to determine the effects of a high-intensity interval aerobic resistance training intervention on appendicular lean soft tissue mass in middle-aged adults with low relative appendicular lean soft tissue mass. Methods: We will conduct a 40-week, single-blinded randomized controlled trial in 84 middle-aged adults with low appendicular lean soft tissue mass in the wider Dunedin area, New Zealand. We will randomly allocate participants to receive either a group-based, 20-week high-intensity interval aerobic resistance training intervention program or a single, 60-minute education session on current exercise recommendations. After the first 20 weeks, both groups will be given a 20-week home program. The study will assess primary and secondary outcome measures, including body composition (regional and whole-body lean soft tissue mass, fat mass, percentage body fat, measured by dual x-ray absorptiometry), blood biomarkers (cortisol, creatinine, C-reactive protein, lipid profile, hemoglobin), physical fitness (maximum oxygen consumption, blood pressure), physical activity (accelerometry), physical function (handgrip strength, sit-to-stand, gait speed, quadriceps strength), and self-reported questionnaires (health outcomes, self-efficacy, perceived enjoyment of physical activity, and multifactorial lifestyle), at baseline, 20 weeks, and 40 weeks. Physical function and self-reported questionnaires will also be measured at 10 weeks. We will assess the primary outcome measure, total body lean soft tissue mass, at baseline, 20 weeks, and 40 weeks. Analyses will be performed using intention-to-treat principles, comparing the outcomes resulting from the intervention, using linear mixed models. Results: We obtained ethical approval for this study from The University of Otago Human Ethics Committee on December 10, 2018. Participant recruitment started on February 11, 2019 and was completed on May 14, 2019. Data collection started on February 25, 2019 and was completed on February 28, 2020. We expect to publish the results in January 2021. Conclusions: High-intensity interval aerobic resistance training is a time-efficient form of exercise, enabling busy middle-aged adults to meet physical activity recommendations while maximizing training results. The findings can inform the development of future prevention-focused interventions aimed at counteracting the high prevalence of sarcopenia in the aging population. Trial Registration: Australian New Zealand Clinical Trials Registry (ACTRN12618001778279); https://tinyurl.com/y555z6fz. International Registered Report Identifier (IRRID): DERR1-10.2196/22989 %M 33064101 %R 10.2196/22989 %U http://www.researchprotocols.org/2020/10/e22989/ %U https://doi.org/10.2196/22989 %U http://www.ncbi.nlm.nih.gov/pubmed/33064101 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 10 %P e18553 %T Effects of Acute Exercise on Drug Craving, Self-Esteem, Mood, and Affect in Adults with Polysubstance Use Disorder: Protocol for a Multicenter Randomized Controlled Trial %A Ellingsen,Maren Mikkelsen %A Johannesen,Sunniva Launes %A Martinsen,Egil Wilhelm %A Dahl,Sandra Rinne %A Hallgren,Mats %+ Department for Inpatient Treatment of Substance Misuse, Division of Mental Health and Addiction, Oslo University Hospital, Postbox 4959 Nydalen, Oslo, 0424, Norway, 47 23020800, mamiel@ous-hf.no %K exercise %K acute %K substance abuse %K physical activity %K drug addiction %D 2020 %7 13.10.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Novel treatments for substance use disorders are needed. Acute bouts of exercise can improve mood states and craving in nonclinical populations. Exercise effects in those with polysubstance dependence are understudied; controlled trials are needed. Objective: This protocol describes a clinical study examining the short-term psychological effects of 2 types of physical activity, soccer and circuit training, in patients with substance use disorders. Effects will be compared with a nonexercise control group. Specific aims are to investigate whether there are differences between the activities and the duration of changes. Methods: This study is a short-term multicenter randomized control trial with a crossover design. Patients consecutively admitted to 4 inpatient treatment centers were invited to participate in 3 conditions, each lasting 45 minutes, within one week. The order of the conditions was randomized. There were a total of 5 assessments, taken at baseline, immediately before each condition, immediately after each condition, and 1, 2, and 4 hours postintervention, enabling patterns of change over time to be observed. Psychological effects were assessed with self-report questionnaires, which included scales for craving, state anxiety, positive and negative affect, self-esteem, and mood. Exercise intensity was assessed with the Borg Rating of Perceived Exertion scale and a heart rate monitor (Polar M200; Polar Electro Ltd). Cortisol was assessed in saliva before and 4 hours after the intervention. Results: A total of 39 patients were included in the study. Data collection was completed in 2019. Conclusions: We anticipate larger improvements in the intervention groups than among controls, indicating positive psychological effects during and after exercise. The study will add clinically relevant information about the short-term psychological effects of exercise in the treatment of substance use disorders, using activities that are easily accessible in different clinical settings. Trial Registration: German Clinical Trials Register DRKS00018869; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00018869 International Registered Report Identifier (IRRID): DERR1-10.2196/18553 %M 33048056 %R 10.2196/18553 %U http://www.researchprotocols.org/2020/10/e18553/ %U https://doi.org/10.2196/18553 %U http://www.ncbi.nlm.nih.gov/pubmed/33048056 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 10 %P e15677 %T Intravital Microscopy (IVM) in Human Solid Tumors: Novel Protocol to Examine Tumor-Associated Vessels %A Trumbull,Denslow Allerton %A Lemini,Riccardo %A Bagaria,Sanjay P %A Elli,Enrique F %A Colibaseanu,Dorin T %A Wallace,Michael B %A Gabriel,Emmanuel %+ Division of Surgical Oncology, Department of Surgery, Mayo Clinic, 4500 San Pablo Rd, Jacksonville, FL, 32224, United States, 1 904 953 2523, Gabriel.Emmanuel@mayo.edu %K intravital microscopy %K solid tumors %K microvasculature %D 2020 %7 9.10.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Intravital microscopy (IVM) allows the real-time, direct visualization of microscopic blood vessels. This pilot clinical trial will elucidate the physical and functional characteristics of vessels associated with solid tumors. Objective: The main objective of this study is to determine the feasibility of performing IVM in patients with solid tumors during the standard course of surgical resection. IVM will also be performed when vasopressors or fluid boluses are administered during the standard course of the operation. Methods: This is an open-label, nonrandomized, single-center, pilot study of IVM observation in subjects with solid tumors undergoing surgical resection. Results: This study was active on January 1, 2019 (NCT03823144) and funded by the Mayo Clinic Florida Cancer Focused Research Team Award. As of September 27, 2020, we had enrolled 20 patients. Accrual period is expected to end by December 31, 2021. Conclusions: This trial will support the development of interventions to improve patient treatment by extending the application of IVM to the tumor microenvironment. IVM observations during volume and pressor management at the time of surgery may aid in the development of strategies to augment responses to systemic treatments. International Registered Report Identifier (IRRID): PRR1-10.2196/15677 %M 33034295 %R 10.2196/15677 %U http://www.researchprotocols.org/2020/10/e15677/ %U https://doi.org/10.2196/15677 %U http://www.ncbi.nlm.nih.gov/pubmed/33034295 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 10 %P e18432 %T Career Crafting Training Intervention for Physicians: Protocol for a Randomized Controlled Trial %A van Leeuwen,Evelien H %A van den Heuvel,Machteld %A Knies,Eva %A Taris,Toon W %+ University Medical Center Utrecht, Heidelberglaan 100, Utrecht, 3584 CX, Netherlands, 31 620561387, e.h.vanleeuwen@umcutrecht.nl %K career crafting %K job crafting %K career self-management %K intervention study %K employability %K physicians %K intervention mapping %D 2020 %7 8.10.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Physicians work in a highly demanding work setting where ongoing changes affect their work and challenge their employability (ie, their ability and willingness to continue working). In this high-pressure environment, physicians could benefit from proactively managing or crafting their careers; however, they tend not to show this behavior. The new concept of career crafting concerns proactively making choices and adapting behavior regarding both short-term job design (ie, job crafting) as well as longer-term career development (ie, career self-management). However, so far, no intervention studies have aimed at enhancing career crafting behavior among physicians. Given that proactive work and career behavior have been shown to be related to favorable outcomes, we designed an intervention to support career crafting behavior and employability of physicians. Objective: The objectives of this study were to describe (1) the development and (2) the design of the evaluation of a randomized controlled career crafting intervention to increase job crafting, career self-management, and employability. Methods: A randomized controlled intervention study was designed for 141 physicians in two Dutch hospitals. The study was designed and will be evaluated based on parts of the intervention mapping protocol. First, needs of physicians were assessed through 40 interviews held with physicians and managers. This pointed to a need to support physicians in becoming more proactive regarding their careers as well as in building awareness of proactive behaviors in order to craft their current work situation. Based on this, a training program was developed in line with their needs. A number of theoretical methods and practical applications were selected as the building blocks of the training. Next, participants were randomly assigned to either the waitlist-control group (ie, received no training) or the intervention group. The intervention group participated in a 4-hour training session and worked on four self-set goals. Then, a coaching conversation took place over the phone. Digital questionnaires distributed before and 8 weeks after the intervention assessed changes in job crafting, career self-management, employability, and changes in the following additional variables: job satisfaction, career satisfaction, work-home interference, work ability, and performance. In addition, a process evaluation was conducted to examine factors that may have promoted or hindered the effectiveness of the intervention. Results: Data collection was completed in March 2020. Evaluation of outcomes and the research process started in April 2020. Study results were submitted for publication in September 2020. Conclusions: This study protocol gives insight into the systematic development and design of a career crafting training intervention that is aimed to enhance job crafting, career self-management, and employability. This study will provide valuable information to physicians, managers, policy makers, and other researchers that aim to enhance career crafting. International Registered Report Identifier (IRRID): RR1-10.2196/18432 %M 33030151 %R 10.2196/18432 %U http://www.researchprotocols.org/2020/10/e18432/ %U https://doi.org/10.2196/18432 %U http://www.ncbi.nlm.nih.gov/pubmed/33030151 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 10 %P e23543 %T Safety and Efficacy of Convalescent Plasma to Treat Severe COVID-19: Protocol for the Saudi Collaborative Multicenter Phase II Study %A Albalawi,Mohammed %A Zaidi,Syed Ziauddin Ahmed %A AlShehry,Nawal %A AlAskar,Ahmed %A Zaidi,Abdul Rehman Zia %A Abdallah,Rania Nagib Mohammed %A Salam,Abdul %A AlSagheir,Ahmed %A AlMozain,Nour %A Elgohary,Ghada %A Batarfi,Khalid %A Alfaraedi,Alia %A Khojah,Osamah %A Al-Ansari,Rehab %A Alfaraj,Mona %A Dayel,Afra %A Al Bahrani,Ahmed %A Abdelhameed,Arwa Nabhan %A Alhumaidan,Hind %A Al-Otaibi,Jawaher M %A Radwi,Ghazala %A Raizah,Abdulrahman %A Shatry,Hind %A Alsaleh,Sara %A AlZahrani,Hazzaa %A Al-Hashmi,Hani %+ Adult Hematology & Stem Cell Transplantation Department, Oncology Centre, King Fahad Specialist Hospital, Amr Bin Thabet, P.O. Box 15373, Dammam, 31444, Saudi Arabia, 966 564773377, hashmih@yahoo.com %K coronaviruses %K SARS-CoV-2 %K COVID-19 %K antibodies %K convalescent plasma %K treatment %K immunology %K feasibility %K safety %K efficacy %K infectious disease %D 2020 %7 2.10.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: The COVID-19 pandemic is expected to cause significant morbidity and mortality. The development of an effective vaccine will take several months to become available, and its affordability is unpredictable. Transfusion of convalescent plasma (CP) may provide passive immunity. Based on initial data from China, a group of hematologists, infectious disease specialists, and intensivists drafted this protocol in March 2020. Objective: The aim of this study is to test the feasibility, safety, and efficacy of CP in treating patients with COVID-19 across Saudi Arabia. Methods: Eligible patients with COVID-19 will be recruited for CP infusion according to the inclusion criteria. As COVID-19 has proven to be a moving target as far as its management is concerned, we will use current definitions according to the Ministry of Health (MOH) guidelines for diagnosis, treatment, and recovery. All CP recipients will receive supportive management including all available recommended therapies according to the available MOH guidelines. Eligible CP donors will be patients with COVID-19 who have fully recovered from their disease according to MOH recovery criteria as detailed in the inclusion criteria. CP donors have to qualify as blood donors according to MOH regulations except for the history of COVID-19 in the recent past. We will also test the CP donors for the presence of SARS-CoV-2 antibodies by a rapid test, and aliquots will be archived for future antibody titration. Due to the perceived benefit of CP, randomization was not considered. However, we will compare the outcome of the cohort treated with CP with those who did not receive CP due to a lack of consent or lack of availability. In this national collaborative study, there is a likelihood of not finding exactly matched control group patients. Hence, we plan to perform a propensity score matching of the CP recipients with the comparator group patients for the major characteristics. We plan to collect demographic, clinical, and laboratory characteristics of both groups and compare the outcomes. A total sample size of 575 patients, 115 CP recipients and 460 matched controls (1:4 ratio), will be sufficient to detect a clinically important hospital stay and 30-day mortality difference between the two groups with 80% power and a 5% level of significance. Results: At present, patient recruitment is still ongoing, and the interim analysis of the first 40 patients will be shared soon. Conclusions: In this paper, we present a protocol for a national collaborative multicenter phase II study in Saudi Arabia for assessing the feasibility, safety, and potential efficacy of CP in treating patients with severe COVID-19. We plan to publish an interim report of the first 40 CP recipients and their matched comparators soon. Trial Registration: ClinicalTrials.gov NCT04347681; https://clinicaltrials.gov/ct2/show/NCT04347681 International Registered Report Identifier (IRRID): PRR1-10.2196/23543 %M 32903199 %R 10.2196/23543 %U https://www.researchprotocols.org/2020/10/e23543 %U https://doi.org/10.2196/23543 %U http://www.ncbi.nlm.nih.gov/pubmed/32903199 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 9 %P e16127 %T One-Way and Two-Way Mobile Phone Text Messages for Treatment Adherence Among Patients With HIV: Protocol for a Randomized Controlled Trial %A Nsagha,Dickson Shey %A Siysi,Vincent Verla %A Ekobo,Same %A Egbe,Thomas Obinchemti %A Kibu,Odette Dzemo %+ Department of Public Health and Hygiene, University of Buea, PO Box 63, Buea, Cameroon, 237 677499429, nsaghads@hotmail.com %K HIV %K antiretroviral therapy %K short message service %K adherence %D 2020 %7 30.9.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Incomplete adherence to antiretroviral therapy (ART) is one of the factors that contribute to HIV drug resistance, and it is a major problem for the public health system in controlling the HIV pandemic. There is emerging evidence that SMS can play an important role in health care delivery among patients with HIV on ART, especially in resource-limited settings. Objective: This paper aims to assess the impact of two-way and one-way SMS text messaging on adherence to HIV treatment. We hypothesized that sending weekly text messages through the one-way and two-way SMS text messaging approach will improve adherence to ART among patients with HIV and improve associated clinical outcomes (quality of life). Methods: A randomized controlled trial is being carried out among participants with HIV who have been on ART for at least one month from an accredited treatment center, namely the Buea Regional Hospital and Kumba District Hospital of South West Region, Cameroon. Participants with HIV, both male and female, aged 21 years and older make up a sample size of 207. The interventions involved the use of mobile phone text messages. Before commencing the intervention, a focus group discussion was carried out among the participants to understand their perception about the use of SMS-based interventions to improve adherence. A total of 246 participants were randomized to receive either a one-way text message (SMS sent to a recipient without recipient sending a reply) or two-way text message (SMS sent to a recipient and recipient sends a reply) or the control (no SMS, only standard care). Data on adherence and quality of life were collected at baseline and after 6 months and will be analyzed using SPSS version 21, while qualitative data will be analyzed using Atlas.ti 7.5. Results: Data collection began in September 2019 with focus group discussions and baseline data collection. After 1 month of baseline data collection, the intervention began in October 2019, and postintervention data were collected after 6 months (March 2020). At the end of the study, we will be able to understand the perception of patients toward SMS text messaging–based interventions and also assess the impact of one-way and two-way SMS text messages on treatment adherence among patients with HIV and on associated clinical outcomes (quality of life). Conclusions: The impact of SMS text messaging varies across different settings. The results from this study will determine the perception of patients toward an SMS text messaging–based intervention and its impact on adherence to ART. International Registered Report Identifier (IRRID): DERR1-10.2196/16127 %M 32996886 %R 10.2196/16127 %U http://www.researchprotocols.org/2020/9/e16127/ %U https://doi.org/10.2196/16127 %U http://www.ncbi.nlm.nih.gov/pubmed/32996886 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 9 %P e18521 %T Evaluation of a Package of Behaviour Change Interventions (Baduta Program) to Improve Maternal and Child Nutrition in East Java, Indonesia: Protocol for an Impact Study %A Dibley,Michael John %A Alam,Ashraful %A Fahmida,Umi %A Ariawan,Iwan %A Titaley,Christiana Rialine %A Htet,Min Kyaw %A Damayanti,Rita %A Li,Mu %A Sutrisna,Aang %A Ferguson,Elaine %+ Sydney School of Public Health, Room 328 Edward Ford Building, Fisher Road, The University of Sydney, 2006, Australia, 61 407616500, michael.dibley@sydney.edu.au %K infant %K feeding behavior %K diet, food, and nutrition %K growth disorders %K undernutrition %K nutrition during pregnancy %K water treatment %D 2020 %7 8.9.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Over the past decade, the prevalence of stunting has been close to 37% in children aged <5 years in Indonesia. The Baduta program, a multicomponent package of interventions developed by the Global Alliance for Improved Nutrition, aims to improve maternal and infant nutrition in Indonesia. Objective: This study aims to assess the impact of the Baduta program, a package of health system strengthening and behavior change interventions, compared with the standard village health services on maternal and child nutrition. Methods: The impact evaluation uses a cluster randomized controlled trial design with 2 outcome assessments. The first uses cross-sectional surveys of mothers of children aged 0-23 months and pregnant women before and after the interventions. The second is a cohort study of pregnant women followed until their child is 18 months from a subset of clusters. We will also conduct a process evaluation guided by the program impact pathway to assess coverage, fidelity, and acceptance. The study will be conducted in the Malang and Sidoarjo districts of East Java, Indonesia. The unit of randomization is the subdistricts. As random allocation of interventions to only 6 subdistricts is feasible, we will use constrained randomization to ensure balance of baseline covariates. The first intervention will be health system strengthening, including the Baby-Friendly Hospital Initiative, and training on counseling for appropriate infant and young child feeding (IYCF). The second intervention will be nutrition behavior change that includes Emo-Demos; a national television (TV) advertising campaign; local screening TV spots; a free, text message service; and promotion of low-cost water filters and hygiene practices. The primary study outcome is child stunting (low length-for-age), and secondary outcomes include length-for-age Z scores, wasting (low weight-for-length), anemia, child morbidity, IYCF indicators, and maternal and child nutrient intakes. The sample size for each cross-sectional survey is 1400 mothers and their children aged <2 years and 200 pregnant women in each treatment group. The cohort evaluation requires a sample size of 340 mother-infant pairs in each treatment group. We will seek Gatekeeper consent and written informed consent from the participants. The intention-to-treat principle will guide our data analysis, and we will apply Consolidated Standards of Reporting Trials guidelines for clustered randomized trials in the analysis. Results: In February 2015, we conducted a baseline cross-sectional survey on 2435 women with children aged <2 years and 409 pregnant women. In February 2017, we conducted an end-line survey on 2740 mothers with children aged <2 years and 642 pregnant women. The cohort evaluation began in February 2015, with 729 pregnant women, and was completed in December 2016. Conclusions: The results of the program evaluation will help guide policies to support effective packages of behavior change interventions to prevent child stunting in Indonesia. International Registered Report Identifier (IRRID): RR1-10.2196/18521 %M 32897234 %R 10.2196/18521 %U https://www.researchprotocols.org/2020/9/e18521 %U https://doi.org/10.2196/18521 %U http://www.ncbi.nlm.nih.gov/pubmed/32897234 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 9 %P e17840 %T Comparative Effectiveness of Two Nonsurgical Treatments to Reduce Oral Health Disparities From Untreated Tooth Decay in Older Adults: Protocol for a Cluster Randomized Trial %A Nelson,Suchitra %A Albert,Jeffrey M %A Milgrom,Peter %+ Case Western Reserve University, 10900 Euclid Avenue, Cleveland, OH, 44106, United States, 1 2163683469, suchitra.nelson@case.edu %K dental caries %K older adults %K atraumatic restorative treatment %K silver diamine fluoride %K fluoride varnish %D 2020 %7 8.9.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: The majority of dental caries lesions in older adults are at the gumline, at the edges of failed fillings and crowns, and in the surfaces of roots after gum recession. These lesions are difficult to restore with conventional surgical treatments using a dental drill and restorations often fail. Clinical guidelines are general and apply treatments that were designed for younger individuals in the dental care of older adults. Objective: This study will compare the effectiveness of 2 evidence-based nonsurgical strategies to manage dental caries lesions in adults aged 62 or older: (1) biannual topical application of silver diamine fluoride versus (2) atraumatic restorative treatment + biannual fluoride varnish. Methods: A cluster randomized clinical trial is being conducted in 22 publicly subsidized and other low-income housing facilities/sites (Arm 1: 11 sites, 275 participants; Arm 2: 11 sites, 275 participants). At baseline, participants will be screened for caries lesions. Those with nonurgent lesions will be treated according to the treatment arm to which the housing site was randomly assigned. The primary outcomes are caries lesion arrest, tooth sensitivity, and tooth pain at 52 weeks after treatment. Analytic methods for the primary aim include a generalized estimating equation approach to determine noninferiority of silver diamine fluoride relative to atraumatic restorative treatment + fluoride varnish treatment. Results: The trial was funded in April 2019. Enrollment began in September 2019 and results are expected in June 2023. Conclusions: This study will inform the standard of care for treating caries lesions in older adults. If effective, either of these interventions has broad applicability in clinical and community-based settings. Trial Registration: ClinicalTrials.gov NCT03916926; https://clinicaltrials.gov/ct2/show/NCT03916926 International Registered Report Identifier (IRRID): DERR1-10.2196/17840 %M 32897236 %R 10.2196/17840 %U http://www.researchprotocols.org/2020/9/e17840/ %U https://doi.org/10.2196/17840 %U http://www.ncbi.nlm.nih.gov/pubmed/32897236 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 8 %P e15997 %T Fluid Administration in Emergency Room Limited by Lung Ultrasound in Patients with Sepsis: Protocol for a Prospective Phase II Multicenter Randomized Controlled Trial %A Mohamed,Mouhand F H %A Malewicz,Nathalie M %A Zehry,Hanan Ibrahim %A Hussain,Dina A Monim %A Barouh,Judah Leão %A Cançado,Adriana V %A Silva,Jeancarllo Sousa %A Suwileh,Salah %A Carvajal,Jose Retamal %+ Department of General Internal Medicine, Hamad Medical Corporation, Department of General Internal Medicine, Hamad Medical Corporation, Al Rayyan road, PO Box 3050, Doha, Qatar, 974 33649384, dr.m.oraiby@hotmail.com %K sepsis %K fluid resuscitation %K PaO2/FiO2 %K B-Lines %K point-of-care ultrasound %K pulmonary edema %K oxygenation %K outcomes %K emergency department %K ultrasound %K lung %D 2020 %7 26.8.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Sepsis remains a major health challenge with high mortality. Adequate volume administration is fundamental for a successful outcome. However, individual fluid needs differ between patients due to varying degrees of systemic vasodilation, circulatory flow maldistribution, and increased vascular permeability. The current fluid resuscitation practice has been questioned. Fluid overload is associated with higher mortality in sepsis. A sign of fluid overload is extravascular lung water, seen as B lines in lung ultrasound. B lines correlate inversely with oxygenation (measured by a ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen ie, PaO2/FiO2). Thus, B lines seen by bedside ultrasound may have a role in guiding fluid therapy. Objective: We aim to evaluate if fluid administration guided by lung ultrasound in patients with sepsis in emergency departments will lead to better oxygenation and patient outcomes than those in the standard therapy. Methods: A phase II, multicenter, randomized, open-label, parallel-group, superiority trial will be performed. Patients will be recruited at emergency departments of the participating centers. A total of 340 patients will be randomly allocated to the intervention or standard-of-care group (30mL/kg). The intervention group will receive ultrasound-guided intravenous fluid until 3 B lines appear. The primary outcome will be oxygenation (measured as PaO2/FiO2 ratio) at 48 hours after starting intravenous fluid administration. Secondary outcomes will be patients’ outcome parameters, including oxygenation after 15 mL/kg fluid at 6, 12, 24, and 48 hours; sepsis progress through Sequential Organ Failure Assessment (SOFA) scores; pulmonary edema evaluation; and 30-day mortality. Results: The trial will be conducted in accordance with the Declaration of Helsinki. Institutional review board approval will be sought after the participating sites are selected. The protocol will be registered once the institutional review board approval is granted. The trial duration is expected to be 1.5-2.5 years. The study is planned to be performed from 2021 to 2022, with enrollment starting in 2021. First results are expected in 2022. Informed written consent will be obtained before the patient’s enrollment in the study. An interim analysis and data monitoring will ensure the patient safety. The results will be published in a peer-reviewed journal and discussed at international conferences. Conclusions: This is a protocol for a randomized control trial that aims to evaluate the role of bedside ultrasound in guiding fluid therapy in patients with sepsis via B lines evaluation. International Registered Report Identifier (IRRID): PRR1-10.2196/15997 %M 32657759 %R 10.2196/15997 %U http://www.researchprotocols.org/2020/8/e15997/ %U https://doi.org/10.2196/15997 %U http://www.ncbi.nlm.nih.gov/pubmed/32657759 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 8 %P e19001 %T Specialized Nutritious Food Combined With Cash Transfers and Social and Behavior Change Communication to Prevent Stunting Among Children Aged 6 to 23 Months in Pakistan: Protocol for a Cluster Randomized Controlled Trial %A Khan,Gul Nawaz %A Kureishy,Sumra %A Ariff,Shabina %A Habib,Muhammad Atif %A Usmani,Asra Abeer %A Mubarik,Areeba %A Hussain,Masawar %A Akbar,Naveed %A Rodriguez de Castro,Pablo %A Garzon,Alba Cecilia %A de Pee,Saskia %A Soofi,Sajid Bashir %+ Department of Paediatrics and Child Health, Aga Khan University, National Stadium Road, Karachi, , Pakistan, 92 3486 4798 ext 4798, sajid.soofi@aku.edu %K stunting %K cash transfers %K specialized nutritious food %K social and behavior change communication %K Pakistan %D 2020 %7 24.8.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: In Pakistan, the prevalence of stunting in children younger than 5 years has remained above global critical levels over the past two decades, with the stunting rate being 40.2% in 2018. Children living in rural areas and in the poorest households suffer the most from stunting across the country—43.2% in rural areas and 51.4% in the lowest wealth quintile. As a continuing public health concern, it is essential that stunting prevention is a national priority in order to ensure human capital development, especially among the poorest households. Objective: The primary objective of this study is to determine the effect of a medium quantity of a lipid-based nutrient supplement (LNS) combined with unconditional cash transfers and social and behavior change communication (SBCC) on reduction of stunting in children aged 6 to 23 months. Methods: A 5-arm cluster randomized controlled trial will be conducted in the district of Rahim Yar Khan in Punjab, Pakistan. The intervention packages will be (1) cash only, (2) cash with LNS, (3) cash with SBCC, and (4) cash with SBCC and LNS. The control arm will receive routine standard of care. We will enroll children at 6 months of age and follow up on a monthly basis up to 24 months of age. A total of 2000 children, 400 in each arm, will be enrolled to detect a 20% reduction in the prevalence of stunting among children aged 24 months. Length, weight, food intake, compliance to interventions, morbidities, and other relevant data will be collected at enrollment and on a monthly basis over the period of 18 months. The process evaluation will assess acceptability of the interventions and potential barriers to implementation through focus group discussions and in-depth interviews with the target population and relevant stakeholders. Furthermore, a cost analysis will be conducted to assess the cost-effectiveness of each intervention package. Results: The study protocol was approved by the Ethics Review Committee of Aga Khan University in Pakistan on January 4, 2017. Data collection began in May 2017 and was completed in July 2019. Data analyses are yet to be completed. This study will explore the effectiveness of intervention packages comprised of cash transfers from Benazir Income Support Programme with or without additional LNS and SBCC in preventing childhood stunting. We expect the results to be published in peer-reviewed journals by autumn of 2020. Conclusions: The findings of this trial will provide robust evidence as to which intervention packages can have significant effects on linear growth of children and design effective intervention packages to prevent stunting in children aged 6 to 23 months. Trial Registration: ClinicalTrials.gov NCT03299218; https://clinicaltrials.gov/ct2/show/NCT03299218 International Registered Report Identifier (IRRID): DERR1-10.2196/19001 %M 32831183 %R 10.2196/19001 %U http://www.researchprotocols.org/2020/8/e19001/ %U https://doi.org/10.2196/19001 %U http://www.ncbi.nlm.nih.gov/pubmed/32831183 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 8 %P e16697 %T The Effect of Improved Access to Family Planning on Postpartum Women: Protocol for a Randomized Controlled Trial %A Karra,Mahesh %A Canning,David %+ Frederick S Pardee School of Global Studies, Boston University, 152 Bay State Road, Room G04C, Boston, MA, 02215, United States, 1 617 358 0197, mvkarra@bu.edu %K postpartum family planning %K contraceptive use %K birth spacing %K women’s well-being %K randomized controlled trial %K Malawi %K Sub-Saharan Africa %D 2020 %7 14.8.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: The World Health Organization recommends that a woman waits at least 24 months after a live birth before getting pregnant again; however, an estimated 25% of birth intervals in low-income countries do not meet this recommendation for adequate birth spacing, and the unmet need for postpartum family planning (PPFP) services is high. Few randomized controlled trials have assessed the causal impact of access to PPFP services, and even fewer evaluations have investigated how such interventions may affect postpartum contraceptive use, birth spacing, and measures of health and well-being. Objective: This protocol paper aims to describe a randomized controlled trial that is being conducted to identify the causal impact of an intervention to improve access to PPFP services on contraceptive use, pregnancy, and birth spacing in urban Malawi. The causal effect of the intervention will be determined by comparing outcomes for respondents who are randomly assigned to an intervention arm against outcomes for respondents who are randomly assigned to a control arm. Methods: Married women aged 18-35 years who were either pregnant or had recently given birth were randomly assigned to either the intervention arm or control arm. Women assigned to the intervention arm received a package of services over a 2-year intervention period. Services included a brochure and up to 6 home visits from trained family planning counselors; free transportation to a high-quality family planning clinic; and financial reimbursement for family planning services, consultations, and referrals for services. Two follow-up surveys were conducted 1 and 2 years after the baseline survey. Results: A total of 2143 women were randomly assigned to either the intervention arm (n=1026) or the control arm (n=1117). Data collection for the first follow-up survey began in August 2017 and was completed in February 2018. A total of 1773 women, or 82.73% of women who were eligible for follow-up, were successfully contacted and reinterviewed at the first follow-up. Data collection for the second follow-up survey began in August 2018 and was completed in February 2019. A total of 1669 women, or 77.88% of women who were eligible for follow-up, were successfully contacted and reinterviewed at the second follow-up. The analysis of the primary outcomes is ongoing and is expected to be completed in 2021. Conclusions: The results of this trial seek to fill the current knowledge gaps in the effectiveness of family planning interventions on improving fertility and health outcomes. The findings also show that the benefits of improving access to family planning are likely to extend beyond the fertility and health domain by improving other measures of women’s well-being. Trial Registration: American Economics Association Registry Trial Number AEARCTR-0000697; https://www.socialscienceregistry.org/trials/697 Registry for International Development Impact Evaluations (RIDIE) Trial Number RIDIE-STUDY-ID-556784ed86956; https://ridie.3ieimpact.org/index.php?r=search/detailView&id=320 International Registered Report Identifier (IRRID): DERR1-10.2196/16697 %M 32795987 %R 10.2196/16697 %U http://www.researchprotocols.org/2020/8/e16697/ %U https://doi.org/10.2196/16697 %U http://www.ncbi.nlm.nih.gov/pubmed/32795987 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 8 %P e17145 %T Effectiveness of Combining Organizational Alcohol Policy and Skills Training for Managers to Reduce Hazardous Alcohol Consumption in Swedish Workplaces: Study Protocol for a Cluster Randomized Study %A Elling,Devy Lysandra %A Wilson,Martina %A Carlbring,Per %A Wennberg,Peter %A Sundqvist,Kristina %+ Department of Public Health Sciences, Stockholm University, Sveavagen 160, Stockholm, SE-106 91, Sweden, 46 8 16 20 00, devy.elling@su.se %K alcohol prevention %K health promotion %K workplace intervention %K hazardous alcohol use %K alcohol use %K intervention %K workplace %D 2020 %7 12.8.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: High alcohol consumption poses risks to individual health and society. Previous alcohol interventions have mainly focused on high-risk consumers or young adults in school-based settings. Since the majority of the adult population is in the workforce, the workplace can be considered a favorable arena for implementing interventions. Objective: This protocol describes a project aimed at increasing knowledge of the effectiveness of combining the implementation of an organizational alcohol policy with skills training for managers as a workplace alcohol prevention program, by evaluating the intervention and exploring managers’ perceptions of the intervention. Methods: Organizations with at least 100 employees were invited to take part in the project. A total of 11 organizations (744 managers and 11,761 employees) were included in the project. Data are collected through self-administered online surveys at baseline, 12 months, and 24 months. The primary outcome is managers’ inclination to initiate an early alcohol intervention (eg, by initiating a dialogue) when concern regarding employees’ hazardous alcohol consumption arises. The secondary outcomes of interest are managers’ and employees’ organizational alcohol policy knowledge and changes in alcohol consumption, as measured using the Alcohol Use Disorder Identification Test (AUDIT) score. A linear mixed-model framework will be used to model variability on different levels. Primary analysis will follow an intention-to-treat approach. Additionally, managers’ responses from semistructured interviews will be analyzed using thematic analysis to explore managers’ experiences regarding the prevention program. Results: This study is ongoing. The overall study start was on January 2018, and the study is planned to end in December 2020. Baseline and 12-month follow-up measurements have been collected. Conclusions: This project is designed to evaluate the effectiveness of an alcohol prevention program regarding higher inclination to initiate early alcohol interventions after policy implementation and skills training among managers, compared to the usual practices in the workplace. The results from this study can contribute to increased knowledge about alcohol interventions and future prevention programs in the workplace. Trial Registration: ISRCTN17250048; http://www.isrctn.com/ISRCTN17250048 International Registered Report Identifier (IRRID): DERR1-10.2196/17145 %M 32784185 %R 10.2196/17145 %U https://www.researchprotocols.org/2020/8/e17145 %U https://doi.org/10.2196/17145 %U http://www.ncbi.nlm.nih.gov/pubmed/32784185 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 8 %P e16198 %T A Novel HIV-1 RNA Testing Intervention to Detect Acute and Prevalent HIV Infection in Young Adults and Reduce HIV Transmission in Kenya: Protocol for a Randomized Controlled Trial %A Graham,Susan M %A Agutu,Clara %A van der Elst,Elise %A Hassan,Amin S %A Gichuru,Evanson %A Mugo,Peter M %A Farquhar,Carey %A Babigumira,Joseph B %A Goodreau,Steven M %A Hamilton,Deven T %A Ndung'u,Thumbi %A Sirengo,Martin %A Chege,Wairimu %A Sanders,Eduard J %+ Department of Global Health, University of Washington, Box 359909, 325 Ninth Avenue, Seattle, WA, 98104, United States, 1 2063510414, grahamsm@uw.edu %K diagnostic tests %K HIV infection %K viral burden %K contact tracing %K highly active antiretroviral therapy %K pre-exposure prophylaxis %D 2020 %7 7.8.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Detection and management of acute HIV infection (AHI) is a clinical and public health priority, and HIV infections diagnosed among young adults aged 18 to 39 years are usually recent. Young adults with recent HIV acquisition frequently seek care for symptoms and could potentially be diagnosed through the health care system. Early recognition of HIV infection provides considerable individual and public health benefits, including linkage to treatment as prevention, access to risk reduction counseling and treatment, and notification of partners in need of HIV testing. Objective: The Tambua Mapema Plus study aims to (1) test 1500 young adults (aged 18-39 years) identified by an AHI screening algorithm for acute and prevalent (ie, seropositive) HIV, linking all newly diagnosed HIV-infected patients to care and offering immediate treatment; (2) offer assisted HIV partner notification services to all patients with HIV, testing partners for acute and prevalent HIV infection and identifying local sexual networks; and (3) model the potential impact of these two interventions on the Kenyan HIV epidemic, estimating incremental costs per HIV infection averted, death averted, and disability-adjusted life year averted using data on study outcomes. Methods: A modified stepped-wedge design is evaluating the yield of this HIV testing intervention at 4 public and 2 private health facilities in coastal Kenya before and after intervention delivery. The intervention uses point-of-care HIV-1 RNA testing combined with standard rapid antibody tests to diagnose AHI and prevalent HIV among young adults presenting for care, employs HIV partner notification services to identify linked acute and prevalent infections, and follows all newly diagnosed patients and their partners for 12 months to ascertain clinical outcomes, including linkage to care, antiretroviral therapy (ART) initiation and virologic suppression in HIV-infected patients, and pre-exposure prophylaxis uptake in uninfected individuals in discordant partnerships. Results: Enrollment started in December 2017. As of April 2020, 1374 participants have been enrolled in the observation period and 1500 participants have been enrolled in the intervention period, with 13 new diagnoses (0.95%) in the observation period and 37 new diagnoses (2.47%), including 2 AHI diagnoses, in the intervention period. Analysis is ongoing and will include adjusted comparisons of the odds of the following outcomes in the observation and intervention periods: being tested for HIV infection, newly diagnosed with prevalent or acute HIV infection, linked to care, and starting ART by week 6 following HIV diagnosis. Participants newly diagnosed with acute or prevalent HIV infection in the intervention period are being followed for outcomes, including viral suppression by month 6 and month 12 following ART initiation and partner testing outcomes. Conclusions: The Tambua Mapema Plus study will provide foundational data on the potential of this novel combination HIV prevention intervention to reduce ongoing HIV transmission in Kenya and other high-prevalence African settings. Trial Registration: ClinicalTrials.gov NCT03508908; https://clinicaltrials.gov/ct2/show/NCT03508908 International Registered Report Identifier (IRRID): DERR1-10.2196/16198 %M 32763882 %R 10.2196/16198 %U https://www.researchprotocols.org/2020/8/e16198 %U https://doi.org/10.2196/16198 %U http://www.ncbi.nlm.nih.gov/pubmed/32763882 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 8 %P e17516 %T Effects of Alternative Offers of Screening Sigmoidoscopy and Colonoscopy on Utilization and Yield of Endoscopic Screening for Colorectal Neoplasms: Protocol of the DARIO Randomized Trial %A Schrotz-King,Petra %A Hoffmeister,Michael %A Sauer,Peter %A Schaible,Anja %A Brenner,Hermann %+ Division of Preventive Oncology, National Center for Tumor Diseases (NCT), German Cancer Research Center (DKFZ), Im Neuenheimer Feld 460, Heidelberg, 69120, Germany, 49 6221 56 35970 ext 56, petra.schrotz-king@nct-heidelberg.de %K cross-sectional study %K prospective randomized controlled two-arm intervention trial %K endoscopy %K screening colonoscopy %K screening sigmoidoscopy %K neoplasms %K liquid and tissue biobank %K human biosamples %K early detection markers %K blood %K stool %K urine %K saliva %K tissue %K prevention and early detection program %D 2020 %7 5.8.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Flexible sigmoidoscopy and colonoscopy are recommended screening options for colorectal cancer (CRC). Despite colonoscopy being offered for CRC screening in Germany, the uptake of this offer has been very limited. Objective: The objective of this study was to assess the potential for increasing use of endoscopic CRC screening and the detection of advanced colorectal neoplasms by offering the choice between use of flexible sigmoidoscopy and colonoscopy. Methods: The DARIO study includes a cross-sectional study (part I), followed by a prospective 2-arm randomized controlled intervention trial (part II) with an associated biobank study (part III). Participation is possible in part I of the DARIO study only, parts I and II, or all 3 study parts. After obtaining informed consent from the municipalities, 12,000 people, aged 50-54 years, from the Rhine-Neckar region in Germany were randomly selected from residential lists of the responsible population registries and invited to complete a standardized questionnaire to investigate the nature, frequency, timing, and results of previous CRC screening and eventual diagnostic colonoscopies. In study part II participants from study part I with no colonoscopy in the preceding 5 years are randomized into 2 arms: arm A offering screening colonoscopy only, and arm B offering both options, either screening colonoscopy or screening sigmoidoscopy. The primary endpoint is the proportion of participants in whom colorectal neoplasms >0.5 cm are detected and removed at screening endoscopy. The secondary endpoints are the detection rate of any neoplasm and use of any endoscopic screening. Part III of the study will use samples from participants in study part II to construct a liquid and tissue biobank for the evaluation of less invasive methods of early detection of colon cancer and for the more detailed characterization of the detected neoplasms. Blood, urine, stool, and saliva samples are taken before the endoscopy. Tissue samples are obtained from the neoplasms removed during endoscopy. Results: A total of 10,568 from 12,000 randomly selected women and men aged 50-54 years living in the Rhine-Neckar-Region of Germany have been invited for participation. The remaining 1432 (11.93%) could not be invited because they reached the age of 55 at the time of contact. Of those invited, 2785/10,568 (26.35%) participated in study part I; 53.60% (1493/2785) of these participants were female. Study parts II and III are ongoing. Conclusions: This study will answer the question if alternative offers of either screening sigmoidoscopy or screening colonoscopy will increase utilization and effectiveness of endoscopic CRC screening compared with an exclusive offer of screening colonoscopy. In addition, alternative noninvasive screening tests will be developed and validated. Trial Registration: German Clinical Trials Register DRKS00018932; https://www.drks.de/drks_web/navigate.do? navigationId=trial.HTML&TRIAL_ID=DRKS00018932 International Registered Report Identifier (IRRID): DERR1-10.2196/17516 %M 32755890 %R 10.2196/17516 %U https://www.researchprotocols.org/2020/8/e17516 %U https://doi.org/10.2196/17516 %U http://www.ncbi.nlm.nih.gov/pubmed/32755890 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 7 %P e15612 %T Self-Myofascial Release Intervention and Mobile App in Patients With Hemophilic Ankle Arthropathy: Protocol for a Randomized Controlled Trial %A Meroño-Gallut,Antonio Javier %A Cuesta-Barriuso,Rubén %A Pérez-Llanes,Raúl %A Donoso-Úbeda,Elena %A López-Pina,José-Antonio %+ Department of Physiotherapy, European University of Madrid, Tajo Street, Villaviciosa de Odón, Madrid, 28670, Spain, 34 912115369, ruben.cuestab@gmail.com %K Hemophilic arthropathy %K ankle %K self-myofascial release %K joint pain %K functionality %K randomized clinical trial %D 2020 %7 31.7.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Hemophilic ankle arthropathy is manifested by degenerative functional alterations and chronic pain. Myofascial release techniques are used to treat soft tissue adhesions, relieve pain, and reduce tissue sensitivity. Objective: This study aims to evaluate the safety and efficacy of a protocol using self-myofascial release with a foam roller to be applied in patients with hemophilic ankle arthropathy. Methods: Patients with ankle arthropathy (N=70) will be recruited, enrolled, and assigned to one of two groups—experimental or control—in a 1:1 allocation ratio. Patients will be recruited from 5 centers in different regions of Spain. Patient data will be collected at baseline, posttreatment, and follow-up. The primary outcome will be frequency of ankle joint bleeding (self-reported). The secondary outcomes will be ankle range of motion (measured with a digital goniometer); joint pain (measured with a visual analog scale and an algometer); joint status (measured using the Hemophilia Joint Health Score); muscle strength (measured with a dynamometer); functionality of lower limbs (measured using the 6-minute walking test); activity (self-reported); and muscle flexibility (measured using the fingertip-to-floor test). The treatment program includes 11 exercises that must be administered bilaterally. A mobile app will be developed where each patient will be able to observe the exercises to be carried out. Each session will last 15 minutes with 5 physiotherapy sessions per week for a period of 3 months. It is expected that patients with hemophilia who receive the foam roller intervention will show improvement in mobility, pain, and status of the ankle joint; muscle strength; and function in the lower extremities. Results: The study has been approved by the institutional review board of the University of Murcia. Patient recruitment will begin in September 2020, and the intervention period will last until June 2021. Data collection will take place between September 2020 and October 2021. Conclusions: This protocol describes a randomized clinical trial to examine the safety and efficacy of a self-myofascial release intervention using a foam roller in patients with hemophilic ankle arthropathy. Trial Registration: ClinicalTrials.gov NCT03914287; http://clinicaltrials.gov/ct2/show/NCT03914287. International Registered Report Identifier (IRRID): PRR1-10.2196/15612 %M 32734929 %R 10.2196/15612 %U https://www.researchprotocols.org/2020/7/e15612 %U https://doi.org/10.2196/15612 %U http://www.ncbi.nlm.nih.gov/pubmed/32734929 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 7 %P e17482 %T Evidence-Based Decision Aid for Patients With Parkinson Disease: Protocol for Interview Study, Online Survey, and Two Randomized Controlled Trials %A Bientzle,Martina %A Kimmerle,Joachim %A Eggeling,Marie %A Cebi,Idil %A Weiss,Daniel %A Gharabaghi,Alireza %+ Leibniz-Institut für Wissensmedien, Schleichstr 6, Tübingen, 72076, Germany, 49 7071979 ext 363, j.kimmerle@iwm-tuebingen.de %K decision aids %K Parkinson disease %K interview study %K online survey %K randomized controlled trial %K patients %D 2020 %7 14.7.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Shared decision making is particularly important in situations with different treatment alternatives. For the treatment of idiopathic Parkinson disease, both pharmacological and surgical approaches can be applied. Objective: In this research project, a series of studies will be conducted to investigate how decision aids for patients with idiopathic Parkinson disease should be designed in order to support the decision-making process. Methods: In Study 1a, qualitative interviews will be conducted to determine which needs frequently occur for patients with idiopathic Parkinson disease. In Study 1b, the identified needs will then be rated for personal relevance by an independent group of patients in an online survey. In Study 2, a randomized controlled trial will be used to pretest different decision aids in a sample group of people who do not have a medical background and who do not have Parkinson disease. In Study 3, a randomized controlled trial will be used to investigate the effect of the decision aids that had been evaluated as positive in Study 2 with patients who have idiopathic Parkinson disease. Results: This series of studies received ethical approval in January 2020. As of June 2020, data collection for Study 1a has started, and it is estimated that Studies 1a, 1b, 2, and 3 will take approximately 4, 4, 6, and 6 months to complete, respectively. It is planned to present the results and analyses at international conferences and to submit the results to peer-reviewed journals for publication, once the studies have been completed. The findings will also be shared with clinicians and patients through presentations at information events. Conclusions: This series of studies is intended to result in an evidence-based decision aid for patients with idiopathic Parkinson disease in order to support the informed and reflected shared decision-making process. We further intend to contribute to a deeper understanding of the individual preferences of patients with idiopathic Parkinson disease and the impact of those preferences on treatment decisions. %M 32673261 %R 10.2196/17482 %U https://www.researchprotocols.org/2020/7/e17482 %U https://doi.org/10.2196/17482 %U http://www.ncbi.nlm.nih.gov/pubmed/32673261 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 7 %P e17826 %T Del Nido Cardioplegia Versus Cold Blood Cardioplegia in Adult Cardiac Surgery: Protocol for a Randomized Controlled Trial %A Garcia-Suarez,Jessica %A Garcia Fernandez,Javier %A Sanz,Sergio %A Martinez Lopez,Daniel %A Reques,Leticia %A Forteza Gil,Alberto %+ Department of Anesthesiology and Critical Care, Puerta de Hierro Majadahonda University Hospital, C/Manuel de Falla 1, Majadahonda, Madrid, 28222, Spain, 34 911917428, jessicag.suarez@gmail.com %K del Nido cardioplegia %K cardiac surgery %K myocardial protection %D 2020 %7 14.7.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: The use of cardioplegia solutions as a myocardial protection technique is essential during cardiac surgery with cardiopulmonary bypass. The del Nido cardioplegia solution (DNS) has been widely used as a myocardial preservation technique for pediatric patients undergoing cardiac surgery with cardiopulmonary bypass. Its unique pharmacological features have created growing interest for adult cardiac surgery, especially for elderly patients or those with ventricular dysfunction who are more prone to ischemia-reperfusion injury. Ever since its implementation, several retrospective studies have been published to validate the efficacy, safety, and efficiency of DNS in adult patients undergoing coronary revascularization, valve replacement, or combined procedures. Recently, a meta-analysis based on nine retrospective studies was published claiming the noninferiority of DNS compared to other conventional cardioplegia solutions. Few prospective randomized studies have been conducted whose primary outcome was the assessment of DNS clinical efficacy compared to other solutions commonly used in adult patients. Objective: The aim of this randomized clinical trial is to assess the benefits of DNS compared to Cardi-Braun blood cardioplegia solution in clinical and biochemical terms regarding myocardial protection during adult cardiac surgery. Methods: This is the protocol of a controlled, randomized, single-center clinical trial carried out at the Puerta de Hierro Majadahonda University Hospital in Spain. A total of 474 participants over the age of 18 years undergoing elective cardiac surgery with cardiopulmonary bypass will be assigned to groups by simple randomization to receive either DNS or Cardi-Braun blood cardioplegia solution. The primary outcome will be the differences between groups in myocardial protection in biochemical terms (ie, perioperative troponin levels) and clinical terms (ie, presence of the composite variable acute cardiovascular event). The clinical trial will be carried out under conditions of respect for the fundamental rights of the person and the ethical principles that affect biomedical research with human beings, as well as in accordance with international recommendations contained in the Declaration of Helsinki and its subsequent revisions. Results: The inclusion process started in 2018. Data cleaning and analyses are expected to take place in the fall of 2020 and the results are expected in January 2021. Conclusions: This study is particularly relevant as it will be one of the first to analyze the clinical effects of del Nido cardioplegia on the basis of direct myocardial protection parameters. In light of published studies, carrying out prospective studies based on primary clinical objectives with a larger sample, high-risk patients, and longer cardiopulmonary bypass times continues to be necessary. We believe that our study addresses an important gap in the knowledge of del Nido cardioplegia in adult patient cardiac surgery and will be able to clarify the possible benefits of this method in a large population of patients undergoing these procedures. Trial Registration: European Union Drug Regulating Authorities Clinical Trials Database (EudraCT) 2017-005144-14; https://www.clinicaltrialsregister.eu/ctr-search/search?query=2017-005144-14+; ClinicalTrials.gov NCT04094168; https://clinicaltrials.gov/ct2/show/NCT04094168 International Registered Report Identifier (IRRID): DERR1-10.2196/17826 %M 32673265 %R 10.2196/17826 %U https://www.researchprotocols.org/2020/7/e17826 %U https://doi.org/10.2196/17826 %U http://www.ncbi.nlm.nih.gov/pubmed/32673265 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 7 %P e17788 %T HIV Self-Testing to Promote Serostatus Disclosure Among Men Who Have Sex With Men in China: Protocol for a Stepped Wedge Randomized Controlled Trial %A Lu,Tianyi %A Li,Hang %A Mao,Xiang %A Peng,Erlei %A Gao,Yangyang %A Chu,Zhenxing %A Zhang,Jing %A Dong,Willa %A Jiang,Yongjun %A Xu,Junjie %+ NHC Key Laboratory of AIDS Immunology, Department of Laboratory Medicine, First Affiliated Hospital of China Medical University, 155 Nanjing North Street, Heping District, Shenyang, 110001, China, 86 (24) 8328 2634, xjjcmu@163.com %K HIV %K HIV self-testing (HIVST), HIV serostatus disclosure %K men who have sex with men (MSM) %K stepped wedge randomized controlled trial %K China %D 2020 %7 9.7.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Disclosure of HIV serostatus is important for the prevention of HIV infection among men who have sex with men (MSM). However, knowledge of sexual partners’ HIV status among MSM in China is low. As a complement to HIV testing services, HIV self-testing (HIVST) has considerable potential to promote serostatus disclosure. Objective: The primary objective of our trial is to evaluate the effect of HIVST on improving serostatus disclosure to sexual partners. We hypothesize that MSM in an intervention condition will have a higher awareness of the HIV status of their sexual partners compared with MSM in the control condition. The secondary aims are to evaluate (i) changes in sexual behaviors after disclosure of HIV status by sexual partners, (ii) promotion of the frequency of HIV and syphilis testing on participants and their sexual partners, and (iii) factors that restrict the disclosure of HIV infection to sexual partners. We hypothesize that MSM in the intervention condition will exhibit safer sexual decision making and a higher rate of HIV testing uptake compared with MSM in the control condition. Methods: A stepped wedge randomized controlled trial will be conducted throughout China. Study recruitment of 800 MSM will be promoted through advertisements released on WeChat public accounts. Individuals who are born biologically male, aged ≥18 years, HIV negative, and who have not undergone HIV testing in the past 3 months will be recruited. Eligible men will be randomly divided (1:1:1:1) into four groups and randomized. The group cluster will initiate the intervention so that participants will be provided with 2-4 free finger prick–based HIVST kits until trial completion. The intervention period for participants in each of the four groups will be initiated at 3-month intervals. Men in both groups will be required to complete a baseline and four follow-up surveys every 3 months. The primary intervention outcome will evaluate the effect of the distribution of HIVST kits on improvement in the disclosure of sexual partners’ HIV status. The secondary outcomes will be changes in sexual behaviors after disclosure of HIV status from sexual partners, the promotion of the frequency of HIVST on participants and their sexual partners, and the factors that restrict disclosure of HIV status to sexual partners. Results: Subject recruitment began in August 2018. The first round of follow-up surveys post intervention is complete, with three rounds remaining to be done. Data analysis was scheduled for April 2020 and the results will be disseminated through conferences and peer-reviewed publications. Conclusions: Few studies have evaluated interventions to increase knowledge of sexual partners’ HIV status among MSM. Our trial will provide information on the link between HIVST and HIV serostatus disclosure. The findings of this trial will facilitate the implementation of HIVST services to help control the spread of HIV among MSM in China. Trial Registration: Chinese Clinical Trial Registry ChiCTR1800019453; http://www.chictr.org.cn/showproj.aspx?proj=30158 International Registered Report Identifier (IRRID): DERR1-10.2196/17788 %M 32673264 %R 10.2196/17788 %U https://www.researchprotocols.org/2020/7/e17788 %U https://doi.org/10.2196/17788 %U http://www.ncbi.nlm.nih.gov/pubmed/32673264 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 7 %P e17702 %T Effectiveness of the InCharge Prevention Program to Promote Healthier Lifestyles: Protocol for a Randomized Controlled Trial %A Mesman,Mathijs %A Onrust,Simone %A Verkerk,Renée %A Hendriks,Hanneke %A Van den Putte,Bas %+ Amsterdam School of Communication Research, University of Amsterdam, Nieuwe achtergracht 166, Amsterdam, , Netherlands, 31 0641711825, m.mesman@uva.nl %K school-based health intervention %K adolescents %K health behavior %K healthy lifestyle %K quality of life %K behavior change %D 2020 %7 8.7.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: InCharge is a newly developed school-based health intervention aimed at older adolescents. It aims to promote a healthier lifestyle by increasing self-regulation skills. After the InCharge program’s effectiveness was previously investigated in a pilot study, the content of the program was adapted. Objective: This study describes the protocol of a cluster randomized controlled trial that aims to investigate the effectiveness of the InCharge program. Methods: A cluster randomized controlled trial including 70 classes with older adolescents (aged 16 years or older) in the Netherlands will be conducted to test the effectiveness of the InCharge program. After schools are recruited, randomization occurs at the class level. The trial consists of the following two conditions: an experimental condition and a control condition. Participants in the experimental condition will be given the InCharge intervention, consisting of four lessons of 50 minutes, with each lesson containing three assignments of approximately 15 minutes. While participants in the experimental condition will receive InCharge, participants in the control condition will receive regular academic school courses. Surveys are administered 1 week before the intervention (baseline), 1 week after the intervention (posttest), and 12 weeks after the intervention (follow-up). Variables of interest include, but are not limited to, self-regulation; predictors of snack intake, physical activity, and alcohol use; and interpersonal communication regarding these health behaviors. In addition to surveys, observations will be conducted during the first and fourth lessons, teachers will be interviewed, and focus groups will be held with a selection of students from the intervention condition. Results: Enrollment started in September 2017. As of June 2019, a total of 1216 participants were enrolled for this trial. Findings will be published in peer-reviewed journals and presented at conferences. The trial has been approved by the Ethics Review Board of the Faculty of Social and Behavioral Sciences of the University of Amsterdam (reference no.: 2017-PC-8244). Conclusions: In this study protocol, the design of a cluster randomized controlled trial is described, which assesses how effectively the school-based intervention InCharge stimulates healthier lifestyles in late adolescents. We hypothesize that participants in the experimental condition will consume less alcohol, eat fewer unhealthy snacks, and be more physically active compared with participants in the control condition. Trial Registration: Netherlands Trial Register (NL6654); https://www.trialregister.nl/trial/6654 International Registered Report Identifier (IRRID): RR1-10.2196/17702 %M 32673278 %R 10.2196/17702 %U http://www.researchprotocols.org/2020/7/e17702/ %U https://doi.org/10.2196/17702 %U http://www.ncbi.nlm.nih.gov/pubmed/32673278 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 6 %P e17943 %T Interactive Guidance Intervention to Address Sustained Social Withdrawal in Preterm Infants in Chile: Protocol for a Randomized Controlled Trial %A Bustamante Loyola,Jorge %A Perez Retamal,Marcela %A Morgues Nudman,Monica Isabel %A Maturana,Andres %A Salinas Gonzalez,Ricardo %A Cox,Horacio %A González Mas,José Miguel %A Muñoz,Lucia %A Lopez,Lilian %A Mendiburo-Seguel,Andrés %A Simó,Sandra %A Palau Subiela,Pascual %A Guedeney,Antoine %+ Neonatology Unit, Clinica Alemana de Santiago, Av Manquehue Norte 1499, 5th Fl, Santiago, Chile, 56 999691389, jorbuslo@alumni.uv.es %K social withdrawal %K preterm %K early detection %K interactive guidance %K emotional stress %K social development %K postnatal depression %K posttraumatic stress %D 2020 %7 26.6.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Preterm newborns can be exposed early to significant perinatal stress, and this stress can increase the risk of altered socioemotional development. Sustained social withdrawal in infants is an early indicator of emotional distress which is expressed by low reactivity to the environment, and if persistent, is frequently associated with altered psychological development. Infants born prematurely have a higher probability of developing sustained social withdrawal (adjusted odds ratio 1.84, 95% CI 1.04-3.26) than infants born full term, and there is a correlation between weight at birth and sustained social withdrawal at 12 months of age. Objective: The aims of this study are to compare the effect of the interactive guidance intervention to that of routine pediatric care on sustained social withdrawal in infants born moderately or late preterm and to explore the relationship between sustained social withdrawal in these infants and factors such as neonatal intensive care unit hospitalization variables, parental depression, and posttraumatic stress symptoms. Methods: This study is designed as a multicenter randomized controlled trial. Moderate and late preterm newborns and their parents were recruited and randomized (1:1 allocation ratio) to control and experimental groups. During neonatal intensive care unit hospitalization, daily duration of skin-to-skin contact, breastfeeding, and parental visits were recorded. Also, a daily score for neonatal pain and painful invasive procedures were recorded. After discharge from neonatal intensive care, for the duration of the study, both groups will attend follow-up consultations with neonatologists at 2, 6, and 12 months of age (corrected for gestational age) and will receive routine pediatric care. Every consultation will be recorded and assessed with the Alarm Distress Baby Scale to detect sustained social withdrawal (indicated by a score of 5 or higher). The neonatologists will perform an interactive guidance intervention if an infant in the intervention group exhibits sustained social withdrawal. In each follow-up consultation, parents will fill out the Edinburgh Postnatal Depression Scale, the modified Perinatal Posttraumatic Stress Disorder Questionnaire, and the Impact of Event Scale–revised. Results: Recruitment for this trial started in September 2017. As of May 2020, we have completed enrollment (N=110 infants born moderately or late preterm). We aim to publish the results by mid-2021. Conclusions: This is the first randomized controlled trial with a sample of infants born moderately or late preterm infants who will attend pediatric follow-up consultations during their first year (corrected for gestational age at birth) with neonatologists trained in the Alarm Distress Baby Scale and who will receive this interactive guidance intervention. If successful, this early intervention will show significant potential to be implemented in both public and private health care, given its low cost of training staff and that the intervention takes place during routine pediatric follow-up. Trial Registration: ClinicalTrials.gov NCT03212547; https://clinicaltrials.gov/ct2/show/NCT03212547. International Registered Report Identifier (IRRID): DERR1-10.2196/17943 %M 32589156 %R 10.2196/17943 %U http://www.researchprotocols.org/2020/6/e17943/ %U https://doi.org/10.2196/17943 %U http://www.ncbi.nlm.nih.gov/pubmed/32589156 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 6 %P e17454 %T Sustainability of Community-Based Specialized Mental Health Services in Five European Countries: Protocol for Five Randomized Controlled Trial–Based Health-Economic Evaluations Embedded in the RECOVER-E Program %A Wijnen,Ben F M %A Smit,Filip %A Uhernik,Ana Ivičević %A Istvanovic,Ana %A Dedovic,Jovo %A Dinolova,Roumyana %A Nica,Raluca %A Velickovski,Robert %A Wensing,Michel %A Petrea,Ionela %A Shields-Zeeman,Laura %+ Center for Economic Evaluation and Machine Learning, Trimbos Institute, Da Costakade 45, Utrecht, 3521 VS, Netherlands, 31 0613650240, bwijnen@trimbos.nl %K community-based mental health care %K cost-effectiveness analysis %K cost-utility analysis %K economic evaluation %K mental health %D 2020 %7 1.6.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Community-based recovery-oriented mental health services for people with severe mental disorders have not been fully implemented in Bulgaria, Croatia, Macedonia, Montenegro, and Romania. The RECOVER-E project facilitates the implementation of specialized mental health care delivered by setting up services, implementing the services, and evaluating multidisciplinary community mental health teams. The outcomes of the RECOVER-E project are assessed in a trial-based outcome evaluation in each of the participating countries with a health-economic evaluation linked to these trials. Objective: The aim of this protocol paper is to describe the methodology that will be used for the health-economic evaluation alongside the trials. Methods: Implementation sites have been selected in each of the five countries where hospital-based mental health services are available (care as usual [CAU]) for patients with severe mental disorders (severe depression, bipolar disorder, schizophrenia, and other psychotic disorders). The newly implemented health care system will involve community-based recovery-oriented mental health care (CMHC). At each site, 180 consenting patients will be randomized to either CAU or CMHC. Patient-level outcomes are personal and social functioning and quality-adjusted life years (QALYs). Data on participants’ health care use will be collected and corresponding health care costs will be computed. This enables evaluation of health care costs of CMHC as compared with CAU, and these costs can be related to patient-level outcomes (functioning and QALY gains) in health-economic evaluation. Results: Data collection was started in December 2018 (Croatia), February 2019 (Montenegro), April 2019 (Romania), June 2019 (North Macedonia), and October 2019 (Bulgaria). The findings of the outcome evaluations will be reported for each of the five countries separately, and the five trials will be pooled for multilevel analysis on a combined dataset. Conclusions: The results of the health-economic evaluation of the RECOVER-E project will contribute to the growing evidence base on the health and economic benefits of recovery-oriented and community-based service models for health systems in transition. Trial Registration: (1) ClinicalTrials.gov NCT03922425 (Bulgaria); https://clinicaltrials.gov/ct2/show/NCT03922425 (2) ClinicalTrials.gov NCT03862209 (Croatia); https://clinicaltrials.gov/ct2/show/NCT03862209 (3) ClinicalTrials.gov NCT03892473 (Macedonia); https://clinicaltrials.gov/ct2/show/NCT03892473 (4) ClinicalTrials.gov NCT03837340 (Montenegro); https://clinicaltrials.gov/ct2/show/NCT03837340 (5) ClinicalTrials.gov NCT03884933 (Romania); https://clinicaltrials.gov/ct2/show/NCT03884933 International Registered Report Identifier (IRRID): DERR1-10.2196/17454 %M 32476658 %R 10.2196/17454 %U https://www.researchprotocols.org/2020/6/e17454 %U https://doi.org/10.2196/17454 %U http://www.ncbi.nlm.nih.gov/pubmed/32476658 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 5 %P e14309 %T Effectiveness of Group Cognitive Behavioral Therapy and Exercise in the Management of Major Depressive Disorder: Protocol for a Pilot Randomized Controlled Trial %A Yekrang Safakar,Mojtaba %A Hrabok,Marianne %A Urichuk,Liana %A Juhas,Michal %A Shalaby,Reham %A Parmar,Devashree %A Chue,Pierre %A Snaterse,Mark %A Mason,Judith %A Tchida,Donna %A Kelland,Jill %A Coulson,Pamela %A Sosdjan,Daniella %A Brown,Jason %A Hay,Katherine %A Lesage,Deanna %A Paulsen,Lacey %A Delday,Amy %A Duiker,Sherianna %A Surood,Shireen %A Abba-Aji,Adam %A Agyapong,Vincent Israel Opoku %+ Department of Psychiatry, Faculty of Medicine and Dentistry, University of Alberta, 1E1 Walter Mackenzie Health Sciences Centre, 8440 112 St NW, Edmonton, AB, T6G 2B7, Canada, 1 7802157771, agyapong@ualberta.ca %K depression %K major depressive disorder %K cognitive behavioral therapy %K group CBT %K exercise %D 2020 %7 25.5.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Despite evidence in scientific literature indicating the effectiveness of both cognitive behavioral therapy (CBT) and physical exercise in the management of major depressive disorder (MDD), few studies have directly compared them. Objective: This study aims to evaluate and compare the effectiveness of group CBT, physical exercise, and only wait-listing to receive treatment-as-usual (TAU) in the management of MDD. The investigators hypothesize that participants with MDD assigned to the group CBT or exercise arms of the study will achieve superior outcomes compared with participants wait-listed to receive TAU only. Methods: This prospective rater-blinded randomized controlled trial assesses the benefits of group CBT and exercise for participants with MDD. A total of 120 patients with MDD referred to addiction and mental health clinics in Edmonton, Canada, will be randomly assigned to one of the three equal-sized arms of the study to receive either weekly sessions of group CBT plus TAU, group exercise three times a week plus TAU, or only TAU for 14 weeks. Participants will be assessed at enrollment, 3 and 6 months post enrollment, midtreatment, and upon treatment completion for primary (functional and symptom variables) and secondary outcomes (service variables and health care utilization). In addition, participants in the intervention groups would be evaluated weekly with one functional measure. The data will be analyzed using repeated measures and effect size analyses, and correlational analyses will be completed between measures at each time point. Results: The study will be conducted in accordance with the Declaration of Helsinki (Hong Kong amendment) and Good Clinical Practice (Canadian guidelines). Written informed consent will be obtained from each subject. The study received ethical clearance from the Health Ethics Research Board of the University of Alberta on September 7, 2018 (Pro 00080975) and operational approval from the provincial health authority (Alberta Health Services 43638). As of October 13, 2019, we have enrolled 32 participants. The results will be disseminated at several levels, including patients, practitioners, academics, researchers, and health care organizations. Conclusions: The results of the pilot trial may inform the implementation of a multicenter clinical trial and provide useful information for administrators and clinicians who are interested in incorporating group CBT and group exercise interventions into existing care. Trial Registration: ClinicalTrials.gov NCT03731728; https://clinicaltrials.gov/ct2/show/NCT03731728 International Registered Report Identifier (IRRID): PRR1-10.2196/14309 %M 32449684 %R 10.2196/14309 %U https://www.researchprotocols.org/2020/5/e14309 %U https://doi.org/10.2196/14309 %U http://www.ncbi.nlm.nih.gov/pubmed/32449684 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 5 %P e15892 %T Mindfulness-Based Cognitive Therapy for Improving Subjective Well-Being Among Healthy Individuals: Protocol for a Randomized Controlled Trial %A Sado,Mitsuhiro %A Kosugi,Teppei %A Ninomiya,Akira %A Nagaoka,Maki %A Park,Sunre %A Fujisawa,Daisuke %A Shirahase,Joichiro %A Mimura,Masaru %+ Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan, 81 03 3353 1211 ext 62454, mitsusado@keio.jp %K mindfulness-based cognitive therapy %K subjective well-being %K healthy individuals %K randomized controlled trial %K cost-effectiveness %D 2020 %7 8.5.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Previous studies have indicated that higher subjective well-being works as a protective factor for health. Some studies have already shown the effects of mindfulness-based interventions on improving subjective well-being. However, these studies targeted specific populations rather than the general public. Furthermore, they assessed either life evaluation or affective aspects of subjective well-being rather than the concept as a whole, including the eudemonic aspect of well-being. Objective: This study aims to investigate the effectiveness and cost-effectiveness of mindfulness-based cognitive therapy (MBCT) for improving the wholistic aspects of subjective well-being in healthy individuals. Methods: This study was an 8-week, randomized, parallel-group, superiority trial with a 2-month follow-up. Healthy individuals aged 20-65 years with scores lower than 25 on the Satisfaction With Life Scale (SWLS) were eligible to participate and randomly allocated to the MBCT group or the wait-list control group. The intervention program was developed by modifying an MBCT program to improve the well-being of a nonclinical population. The primary outcome was the difference between the two groups in mean change scores from the baseline on the SWLS. The secondary outcomes included scores on the Flourishing Scale and the Scale of Positive and Negative Experience as well as the incremental cost-effectiveness ratio. Results: This study began recruiting participants in July 2018 and recruitment was completed at the end of September 2019. Data collection and dataset construction was completed by the end of March 2020. Conclusions: This study is unique in that it investigates MBCT’s effects on the three different aspects of subjective well-being: life evaluation, affect, and eudemonia. It is limited, as the specific effect attributable to MBCT cannot be detected because of the lack of an active control group. Trial Registration: University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) UMIN000031885; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036376 International Registered Report Identifier (IRRID): DERR1-10.2196/15892 %M 32005642 %R 10.2196/15892 %U https://www.researchprotocols.org/2020/5/e15892 %U https://doi.org/10.2196/15892 %U http://www.ncbi.nlm.nih.gov/pubmed/32005642 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 5 %P e17710 %T Reducing Antibiotic Prescriptions for Urinary Tract Infection in Nursing Homes Using a Complex Tailored Intervention Targeting Nursing Home Staff: Protocol for a Cluster Randomized Controlled Trial %A Arnold,Sif Helene %A Jensen,Jette Nygaard %A Kousgaard,Marius Brostrøm %A Siersma,Volkert %A Bjerrum,Lars %A Holm,Anne %+ The Section of General Practice and Research Unit for General Practice, Department of Public Health, University of Copenhagen, Øster Farimagsgade 5, Copenhagen, 1014, Denmark, 45 31603734, siar@sund.ku.dk %K urinary tract infection %K nursing home %K antibiotics %K antibiotic resistance %K drug prescription %K communication %K communication barriers %K interprofessional relationship %K elderly %D 2020 %7 8.5.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Urinary tract infection (UTI) is the most common reason for antibiotic prescription in nursing homes. Overprescription causes antibiotic-related harms in those who are treated and others residing within the nursing home. The diagnostic process in nursing homes is complicated with both challenging issues related to the elderly population and the nursing home setting. A physician rarely visits a nursing home for suspected UTI. Consequently, the knowledge of UTI and communication skills of staff influence the diagnosis. Objective: The objective of this study is to describe a cluster randomized controlled trial with a tailored complex intervention for improving the knowledge of UTI and communication skills of nursing home staff in order to decrease the number of antibiotic prescriptions for UTI in nursing home residents, without changing hospitalization and mortality. Methods: The study describes an open-label cluster randomized controlled trial with two parallel groups and a 1:1 allocation ratio. Twenty-two eligible nursing homes are sampled from the Capital Region of Denmark, corresponding to 1274 nursing home residents. The intervention group receives a dialogue tool, and all nursing home staff attend a workshop on UTI. The main outcomes of the study are the antibiotic prescription rate for UTI, all-cause hospitalization, all-cause mortality, and suspected UTI during the trial period. Results: The trial ended in April 2019. Data have been collected and are being analyzed. We expect the results of the trial to be published in a peer-reviewed journal in the fall of 2020. Conclusions: The greatest strengths of this study are the randomized design, tailored development of the intervention, and access to medical records. The potential limitations are the hierarchy in the prescription process, Hawthorne effect, and biased access to data on signs and symptoms through a UTI diary. The results of this trial could offer a strategy to overcome some of the challenges of increased antibiotic resistance and could have implications in terms of how to handle cases of suspected UTI. Trial Registration: ClinicalTrials.gov NCT03715062; https://clinicaltrials.gov/ct2/show/NCT03715062 International Registered Report Identifier (IRRID): DERR1-10.2196/17710 %M 32383679 %R 10.2196/17710 %U https://www.researchprotocols.org/2020/5/e17710 %U https://doi.org/10.2196/17710 %U http://www.ncbi.nlm.nih.gov/pubmed/32383679 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 4 %P e17206 %T Hemostatis Analyzer-Supported Hemotherapy Algorithm in Cardiac Surgery: Protocol for a Randomized Controlled Monocentric Trial %A Michel,Sophie %A Piekarski,Florian %A Fischer,Jan-Hendrik %A Hettler,Vanessa %A Adam,Elisabeth Hannah %A Holzer,Lars %A Lotz,Gösta %A Walther,Thomas %A Zacharowski,Kai %A Raimann,Florian Jürgen %+ Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University, Theodor-Stern-Kai 7, Haus 13, Frankfurt am Main, 60590, Germany, 49 15117190152, Florian.Raimann@kgu.de %K Quantra %K cardiothoracic surgery %K bypass %K coagulopathy %K point of care %K algorithm %K rotational thromboelastometry %K Multiplate %D 2020 %7 21.4.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Point of care devices for performing targeted coagulation substitution in patients who are bleeding have become increasingly important in recent years. New on the market is the Quantra. It is a device that uses sonorheometry, a sonic estimation of elasticity via resonance, which is a novel ultrasound-based technology that measures viscoelastic properties of whole blood. Several studies have already shown the comparability of the Quantra with devices already established on the market, such as the rotational thromboelastometry (ROTEM) device. Objective: In contrast to existing studies, this study is the first prospective interventional study using this new system in a cardiac surgical patient cohort. We will investigate the noninferiority between an already existing coagulation algorithm based on the ROTEM/Multiplate system and a new algorithm based on the Quantra system for the treatment of coagulopathic cardiac surgical patients. Methods: The study is divided into two phases. In an initial observation phase, whole blood samples of 20 patients obtained at three defined time points (prior to surgery, after completion of cardiopulmonary bypass, and on arrival in the intensive care unit) will be analyzed using both the ROTEM/Multiplate and Quantra systems. The obtained threshold values will be used to develop a novel algorithm for hemotherapy. In a second intervention phase, the new algorithm will be tested for noninferiority against an algorithm used routinely for years in our department. Results: The main objective of the examination is the cumulative loss of blood within 24 hours after surgery. Statistical calculations based on the literature and in-house data suggest that the new algorithm is not inferior if the difference in cumulative blood loss is <150 mL/24 hours. Conclusions: Because of the comparability of the Quantra sonorheometry system with the ROTEM measurement methods, the existing hemotherapy treatment algorithm can be adapted to the Quantra device with proof of noninferiority. Trial Registration: ClinicalTrials.gov NCT03902275; https://clinicaltrials.gov/ct2/show/NCT03902275 International Registered Report Identifier (IRRID): DERR1-10.2196/17206 %M 32314972 %R 10.2196/17206 %U http://www.researchprotocols.org/2020/4/e17206/ %U https://doi.org/10.2196/17206 %U http://www.ncbi.nlm.nih.gov/pubmed/32314972 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 4 %P e14807 %T Comparative Study of Postural Garment Versus Exercises for Patients With Nonspecific Cervical Pain: Protocol for a Randomized Crossover Trial %A Avellanet,Merce %A Boada-Pladellorens,Anna %A Perrot,Jean-Claude %A Loro,Laura %A Rodrigo Cansado,Lidia %A Monterde,David %A Romagosa,Josep %A Gea,Elvira %+ Rehabilitation Department, Hospital Nostra Senyora de Meritxell, Carrer dels Escalls, Escaldes- Engordany, Andorra, 376 871009, merceavellanet@gmail.com %K cervical pain %K postural garment %K cervical exercises %K posture %K musculoskeletal disorder %D 2020 %7 16.4.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: There is a high prevalence of work-related musculoskeletal disorders among health care professionals. Posture is an essential point to be addressed for health care professionals with musculoskeletal disorders. Cervical pain can result from several conditions. Treatment should include posture modification and home exercise. Objective: This study aims to compare a new postural garment (Posture Plus Force; Medi, Bayreuth, Germany) with exercises for women with nonspecific cervical pain. The investigators focus on nurses and allied health professionals due to the importance of posture in work-related musculoskeletal disorders. Methods: This randomized crossover clinical trial has a 3-month treatment sequence and a 3-month washout period. Participants will include nurses and allied health professionals 21 to 55 years of age with cervical pain. Participants are allocated at random to two intervention groups: a postural garment (Posture Plus Force) to be worn for 2 to 4 hours per day for 90 days (P+ group) and five physiotherapy sessions (20 minutes each) to learn stretching and strengthening exercises with instructions to continue at home on a daily basis for 90 days (Ex group). The participants in each group will crossover interventions after a 3-month washout period. The primary outcomes are postural control and pain intensity. A static posturography will be performed with a scan (SpinalMouse; Idiag AG, Fehraltorf, Switzerland). The visual analogue scale is a psychometric measuring instrument designed to document cervical pain severity in individual participants. The secondary outcomes are cervical pain-related disability, catastrophizing, the global perceived effect of treatment, and the evaluation of garment comfort. Physical activity is assessed with the International Physical Activity Questionnaire. Assessment of primary and secondary outcomes is performed at T0 (pre-intervention), T1 (immediately after garment fitting for P+ group), T30, T60, and T90. The same measurements are recorded after the washout period and during the second intervention following the same sequence. All patients are provided with a logbook for compliance recording, over the counter drug use, pain evaluation, and sick leave. Statistical analysis is conducted following intention-to-treat principles and the treatment effects calculated using linear mixed models. Results: The study design has been approved by the Ethics Commission of Hospital N Sra de Meritxell, Andorra in March 2017. A total of 32 participants are already enrolled in the study. An extension of the study is planned in a Spanish university hospital to achieve a larger sample. Study results are expected to be published during 2020. Conclusions: The Postural garment is expected to improve cervical pain by enhancing posture. Trial Registration: ClinicalTrials.gov NCT03560492; https://clinicaltrials.gov/ct2/show/NCT03560492 International Registered Report Identifier (IRRID): DERR1-10.2196/14807 %M 32297876 %R 10.2196/14807 %U https://www.researchprotocols.org/2020/4/e14807 %U https://doi.org/10.2196/14807 %U http://www.ncbi.nlm.nih.gov/pubmed/32297876 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 4 %P e17900 %T Effects of the ACT OUT! Social Issue Theater Program on Social-Emotional Competence and Bullying in Youth and Adolescents: Protocol for a Cluster Randomized Controlled Trial %A Agley,Jon %A Jayawardene,Wasantha %A Jun,Mikyoung %A Agley,Daniel L %A Gassman,Ruth %A Sussman,Steve %A Xiao,Yunyu %A Dickinson,Stephanie L %+ Prevention Insights, Department of Applied Health Science, School of Public Health, Indiana University Bloomington, 501 N Morton St, Suite 110, Bloomington, IN, 47404, United States, 1 8128551237, jagley@indiana.edu %K social and emotional learning %K bullying %K social-emotional competence %K psychodrama %K randomized controlled trial %D 2020 %7 13.4.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Students in the United States spend a meaningful portion of their developmental lives in school. In recent years, researchers and educators have begun to focus explicitly on social and emotional learning (SEL) in the school setting. Initial evidence from meta-analyses suggests that curricula designed to promote SEL likely produce benefits in terms of social-emotional competence (SEC) and numerous related behavioral and affective outcomes. At the same time, there are often barriers to implementing such curricula as intended, and some researchers have questioned the strength of the evaluation data from SEL programs. As part of the effort to improve programming in SEL, this paper describes the protocol for a cluster randomized trial of the ACT OUT! Social Issue Theater program, a brief psychodramatic intervention to build SEC and reduce bullying behavior in students. Objective: The objective of this trial is to examine if a short dose of interactive psychodrama can affect SEC metrics and bullying experiences in schoolchildren in either the short (2-week) or medium (6-month) term. Methods: The ACT OUT! trial is a cluster randomized superiority trial with 2 parallel groups. The unit of measurement is the student, and the unit of randomization is the classroom. For each grade (fourth, seventh, and 10th), an even number of classrooms will be selected from each school—half will be assigned to the intervention arm and half will be assigned to the control arm. The intervention will consist of 3 moderated psychodramatic performances by trained actors, and the control condition will be the usual school day. Outcome data will be collected at baseline (preintervention), 2-week postintervention (short term), and 6-month postintervention (medium term). Outcomes will include social-emotional competency; self-reported bullying and experiences of being bullied; receptivity to the program; and school-level data on truancy, absenteeism, and referrals to school displinary action for bullying. A power analysis adjusted for clustering effect, design effect, and potential attrition yielded a need for approximately 1594 students, consisting of an estimated 80 classrooms split evenly into intervention and control arms. Results: This study was funded in June 2019; approved by the Indiana University Institutional review board on September 17, 2019; began subject recruitment on November 5, 2019; and prospectively registered with ClinicalTrials.gov. Conclusions: Many states have issued recommendations for the integration of SEL into schools. The proposed study uses a rigorous methodology to determine if the ACT OUT! psychodramatic intervention is a cost-effective means of bolstering SEC and reducing bullying incidence in schools. Trial Registration: ClinicalTrials.gov NCT04097496; https://clinicaltrials.gov/ct2/show/NCT04097496 International Registered Report Identifier (IRRID): PRR1-10.2196/17900 %M 32281541 %R 10.2196/17900 %U http://www.researchprotocols.org/2020/4/e17900/ %U https://doi.org/10.2196/17900 %U http://www.ncbi.nlm.nih.gov/pubmed/32281541 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 4 %P e16664 %T Evaluation of the Safety and Efficacy of Avacopan, a C5a Receptor Inhibitor, in Patients With Antineutrophil Cytoplasmic Antibody–Associated Vasculitis Treated Concomitantly With Rituximab or Cyclophosphamide/Azathioprine: Protocol for a Randomized, Double-Blind, Active-Controlled, Phase 3 Trial %A Merkel,Peter A %A Jayne,David R %A Wang,Chao %A Hillson,Jan %A Bekker,Pirow %+ Division of Rheumatology, Department of Medicine, University of Pennsylvania, 5th Floor, White Building, 3400 Spruce Street, Philadelphia, PA, 19104, United States, 1 215 614 4401, pmerkel@upenn.edu %K ANCA-associated vasculitis %K avacopan %K C5a receptor %K ADVOCATE %D 2020 %7 7.4.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Antineutrophil cytoplasmic antibody (ANCA)–associated vasculitis is a serious, often life-threatening disease. In new-onset disease or a relapse, the standard treatment is immunosuppressive therapy with glucocorticoids; these therapies are associated with substantial short- and long-term toxicity. Complement component 5a (C5a) binding to C5a receptor (C5aR) may play a central role in the pathogenesis of ANCA-associated vasculitis. Avacopan is a novel, orally bioavailable, and highly selective antagonist of human C5aR. Avacopan does not interfere with the production of C5b or the membrane attack complex (ie, terminal complement complex) and does not block C5a binding to a second receptor, C5L2 (also called C5aR2), shown to be protective in antimyeloperoxidase glomerulonephritis. This trial will evaluate if avacopan replaces the need for chronic glucocorticoids in the treatment of ANCA-associated vasculitis. Objective: The aim of this study is to determine the proportions of patients in remission at week 26 and with sustained remission at week 52, defined as Birmingham Vasculitis Activity Score=0, and not taking glucocorticoids within the 4 weeks before week 26 and week 52, respectively. Methods: The Avacopan Development in Vasculitis to Obtain Corticosteroid elimination and Therapeutic Efficacy study is a randomized, double-blind, active-comparator (prednisone), 2-arm study evaluating the safety and efficacy of avacopan versus prednisone, administered in combination with other immunosuppressive therapy. Eligible subjects will have active disease requiring induction of remission. Subjects are stratified based on the type of immunosuppressive therapy, ANCA subtype, and new or relapsing disease. Target sample size is 300 patients, enrolled at over 200 sites globally. All authors and local ethics committees approved the study design. All patients will provide informed consent. Results: Enrollment of patients was completed in Q4 2018. Topline results are anticipated to be published by Q3 2020. Conclusions: Results will be released irrespective of whether the findings are positive or negative. Trial Registration: ClinicalTrials.gov NCT02994927; https://clinicaltrials.gov/ct2/show/NCT02994927 International Registered Report Identifier (IRRID): DERR1-10.2196/16664 %M 32088663 %R 10.2196/16664 %U https://www.researchprotocols.org/2020/4/e16664 %U https://doi.org/10.2196/16664 %U http://www.ncbi.nlm.nih.gov/pubmed/32088663 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 4 %P e16413 %T Effect of Various Invitation Schemes on the Use of Fecal Immunochemical Tests for Colorectal Cancer Screening: Protocol for a Randomized Controlled Trial %A Gruner,Laura Fiona %A Hoffmeister,Michael %A Ludwig,Leopold %A Brenner,Hermann %+ Division of Clinical Epidemiology and Aging Research, German Cancer Research Center, Im Neuenheimer Feld 581, Heidelberg, 69120, Germany, 49 6221 42 1300, h.brenner@dkfz.de %K colorectal cancer %K early detection %K screening %K fecal immunochemical test (FIT) %K invitation %K Germany %D 2020 %7 3.4.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Fecal occult blood testing has been offered for many years in the German health care system, but participation rates have been notoriously low. Objective: The aim of this study is to evaluate the effect of various personal invitation schemes on the use of fecal immunochemical tests (FITs) in persons aged 50-54 years. Methods: This study consists of a three-armed randomized controlled trial: (1) arm A: an invitation letter from a health insurance plan including a FIT test kit, (2) arm B: an invitation letter from a health insurance plan including an offer to receive a free FIT test kit by mail upon easy-to-handle request (ie, by internet, fax, or reply mail), and (3) arm C: an information letter on an existing colonoscopy offer (ie, control). Within arms A and B, a random selection of 50% of the study population will receive reminder letters, the effects of which are to be evaluated in a substudy. Results: A total of 17,532 persons aged 50-54 years in a statutory health insurance plan in the southwest of Germany—AOK Baden-Wuerttemberg—were sent an initial invitation, and 5825 reminder letters were sent out. The primary end point is FIT usage within 1 year from receipt of invitation or information letter. The main secondary end points include gender-specific FIT usage within 1 year, rates of positive test results, rates of colonoscopies following a positive test result, and detection rates of advanced neoplasms. The study was launched in September 2017. Data collection and workup were completed in fall 2019. Conclusions: This randomized controlled trial will provide important empirical evidence for enhancing colorectal cancer screening offers in the German health care system. Trial Registration: German Clinical Trials Register (DRKS) DRKS00011858; https://bit.ly/2UBTIdt International Registered Report Identifier (IRRID): DERR1-10.2196/16413 %M 32242518 %R 10.2196/16413 %U https://www.researchprotocols.org/2020/4/e16413 %U https://doi.org/10.2196/16413 %U http://www.ncbi.nlm.nih.gov/pubmed/32242518 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 3 %P e13922 %T Hypothermic Oxygenated Perfusion Versus Static Cold Storage for Expanded Criteria Donors in Liver and Kidney Transplantation: Protocol for a Single-Center Randomized Controlled Trial %A Ravaioli,Matteo %A Maroni,Lorenzo %A Angeletti,Andrea %A Fallani,Guido %A De Pace,Vanessa %A Germinario,Giuliana %A Odaldi,Federica %A Corradetti,Valeria %A Caraceni,Paolo %A Baldassarre,Maurizio %A Vasuri,Francesco %A D'Errico,Antonia %A Sangiorgi,Gabriela %A Siniscalchi,Antonio %A Morelli,Maria Cristina %A Rossetto,Anna %A Ranieri,Vito Marco %A Cescon,Matteo %A Del Gaudio,Massimo %A Zanfi,Chiara %A Bertuzzo,Valentina %A Comai,Giorgia %A La Manna,Gaetano %+ Department of Medical and Surgical Sciences, University of Bologna Sant'Orsola-Malpighi Hospital, Via Massarenti, 9, Bologna, 40138, Italy, 39 051 2144810, mrava1@hotmail.com %K organ grafts %K organ transplants %K perfusion %K kidney transplantation %K liver transplantation %K hypothermia %K clinical trials %K temperature %K randomized %D 2020 %7 19.3.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Extended criteria donors (ECD) are widely utilized due to organ shortage, but they may increase the risk of graft dysfunction and poorer outcomes. Hypothermic oxygenated perfusion (HOPE) is a recent organ preservation strategy for marginal kidney and liver grafts, allowing a redirect from anaerobic metabolism to aerobic metabolism under hypothermic conditions and protecting grafts from oxidative species–related damage. These mechanisms may improve graft function and survival. Objective: With this study, we will evaluate the benefit of end-ischemic HOPE on ECD grafts for livers and kidneys as compared to static cold storage (SCS). The aim of the study is to demonstrate the ability of HOPE to improve graft function and postoperative outcomes of ECD kidney and liver recipients. Methods: This is an open-label, single-center randomized clinical trial with the aim of comparing HOPE with SCS in ECD kidney and liver transplantation. In the study protocol, which has been approved by the ethics committee, 220 patients (110 liver recipients and 110 kidney recipients) will be enrolled. Livers and kidneys assigned to the HOPE group undergo machine perfusion with cold Belzer solution (4-10°C) and continuous oxygenation (partial pressure of oxygen of 500-600 mm Hg). In the control group, livers and kidneys undergoing SCS are steeped in Celsior solution and stored on ice. Using the same perfusion machine for both liver and kidney grafts, organs are perfused from the start of the back-table procedure until implantation, without increasing the cold ischemia time. For each group, we will evaluate clinical outcomes, graft function tests, histologic findings, perfusate, and the number of allocated organs. Publication of the results is expected to begin in 2021. Results: Dynamic preservation methods for organs from high-risk donors should improve graft dysfunction after transplantation. To date, we have recruited 108 participants. The study is ongoing, and recruitment of participants will continue until January 2020. Conclusions: The proposed preservation method should improve ECD graft function and consequently the postoperative patient outcomes. Trial Registration: ClinicalTrials.gov NCT03837197; https://clinicaltrials.gov/ct2/show/NCT03837197 ; Archived by WebCite® at http://www.webcitation.org/76fSutT3R International Registered Report Identifier (IRRID): DERR1-10.2196/13922 %M 32191209 %R 10.2196/13922 %U http://www.researchprotocols.org/2020/3/e13922/ %U https://doi.org/10.2196/13922 %U http://www.ncbi.nlm.nih.gov/pubmed/32191209 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 2 %P e14156 %T A 21-Day School-Based Toothbrushing Intervention in Children Aged 6 to 9 Years in Indonesia and Nigeria: Protocol for a Two-Arm Superiority Randomized Controlled Trial %A Melo,Paulo %A Malone,Sinead %A Rao,Arathi %A Fine,Charlotte %+ FDI World Dental Federation, Avenue Louis Casaï 51, Geneva-Cointrin, Switzerland, 41 022 560 81 33, cfine@fdiworlddental.org %K school children %K oral health %K OHIs %K DMFT %K school program %K knowledge transfer %K behavior change %D 2020 %7 21.2.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: The World Health Organization reports that dental cavities affect 60% to 90% of children globally. FDI World Dental Federation and Unilever Oral Care have developed public health programs to improve brushing habits over their 12-year partnership. The last of these (phase III) named Brush Day & Night aimed to educate children on brushing twice daily with a fluoride toothpaste and gave useful information for a new project, phase IV. The 21-day Brush Day & Night program is an intense education activity designed to establish the habit of brushing day and night with a fluoride toothpaste. The program involves daily brushing instruction and includes free toothpaste and toothbrushes. Objective: The main objective of the study is to evaluate the impact of a 21-day school program on children’s oral health. As a secondary objective, we aim to evaluate the impact on the knowledge, behavior, toothbrushing habits, and quality of life in school children aged 6 to 9 years after a 21-day school program and compare with baseline and a control group as measured by the self-reported questionnaires issued to children (in particular, the self-reported brushing frequency and positive responses on fluoridated toothpaste use). The enduring nature of the program will be determined by the inclusion of 8- and 24-week time points. Methods: The study is a 2-arm superiority randomized controlled trial. Clusters in this study are infant and junior schools in Indonesia and Nigeria. The study aims to recruit 20 schools with children aged 6 to 9 years in each country. At baseline, children in both intervention and control schools will answer a questionnaire and have their clinical oral health assessed using the Simplified Oral Hygiene Index (OHI) and Decayed Missing and Filled Teeth index. Children in the intervention schools will then take part in a structured 21-day Brush Day & Night intervention. Children in the control schools will be provided with free toothpaste and toothbrushes but will not receive the 21-day intervention. The questionnaires and OHI assessments are repeated after the 21-day program is completed and again 8 weeks later and 24 weeks later for all participating children. Parents/carers/guardians of all children will sign the informed consent and complete questionnaires on their own experience and attitudes toward oral health and toothbrushing routine at each of the four times points (baseline, 21 days, 8 weeks, and 24 weeks). The study will be conducted by the national dental associations of Indonesia and Nigeria and was approved by the ethics committees of both countries. Results: The study is ongoing. Recruitment of schools started in Indonesia in February 2018 and in Nigeria in April 2018 for the first part of the study, which concluded in Indonesia in September 2018 and in Nigeria in November 2018. The second part of the study (the second half of the schools) started in November 2018 in Indonesia and December 2018 in Nigeria. Conclusions: We expect to collect all the data during 2019 and publish findings from the study by March 2020. Trial Registration: ClinicalTrials.gov NCT04001296; https://tinyurl.com/selxraa International Registered Report Identifier (IRRID): DERR1-10.2196/14156 %M 32130186 %R 10.2196/14156 %U http://www.researchprotocols.org/2020/2/e14156/ %U https://doi.org/10.2196/14156 %U http://www.ncbi.nlm.nih.gov/pubmed/32130186 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 2 %P e14200 %T Nurse-Delivered Cognitive Behavioral Therapy for Adherence and Depression Among People Living With HIV (the Ziphamandla Study): Protocol for a Randomized Controlled Trial %A Joska,John A %A Andersen,Lena S %A Smith-Alvarez,Rosana %A Magidson,Jessica %A Lee,Jasper S %A O’Cleirigh,Conall %A Safren,Steven A %+ HIV Mental Health Research Unit, Neuroscience Institute, Department of Psychiatry and Mental Health, University of Cape Town, Groote Schuur Hospital, OPD Building, H-Floor, Rm 30, Groote Schuur Drive, Observatory, Cape Town, 7925, South Africa, 27 21 404 2164, John.Joska@uct.ac.za %K major depressive disorder %K cognitive behavioral therapy %K HIV %K medication adherence %K integrated treatment %K task shifting %D 2020 %7 3.2.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: There is an unmet need to develop effective, feasible, and scalable interventions for poor adherence and depression in persons living with HIV in low- and middle-income countries (LMIC). Objective: This study aims to investigate the effectiveness of a nurse-delivered cognitive behavioral therapy (CBT) intervention for adherence and depression (CBT-AD) among persons living with HIV who are failing first-line antiretroviral therapy (ART) in Cape Town, South Africa. Methods: This study is a 2-arm randomized controlled trial of CBT-AD integrated into the HIV primary care setting in South Africa. A total of 160 participants who did not achieve viral suppression from their first-line ART and have a unipolar depressive mood disorder will be randomized to receive either 8 sessions of CBT-AD or enhanced treatment as usual. Participants will be assessed for major depressive disorder using the Mini International Neuropsychiatric Interview at baseline and 4, 8, and 12 months. The primary outcomes are depression on the Hamilton Depression Scale (HAM-D; as assessed by a blinded assessor) at the 4-month assessment and changes in ART adherence (assessed via real-time, electronic monitoring with Wisepill) between baseline and the 4-month assessment. Secondary outcomes are HIV viral load and CD4 cell count at the 12-month assessment as well as ART adherence (Wisepill) and depression (HAM-D) over follow-up (4-, 8-, and 12-month assessments). Results: The trial commenced in August 2015 and recruitment began in July 2016. Enrollment was completed in June 2019. Conclusions: Results of this study will inform whether an existing intervention (CBT-AD) can be effectively administered in LMIC by nurses with training and ongoing supervision. This will present unique opportunities to further explore the scale-up of a behavioral intervention to enhance ART adherence among persons living with HIV with major depression in a high-prevalence setting, to move toward achieving The Joint United Nations Programme on HIV/AIDS 90-90-90 goals. Trial Registration: ClincialTrials.gov NCT02696824; https://clinicaltrials.gov/ct2/show/NCT02696824 International Registered Report Identifier (IRRID): DERR1-10.2196/14200 %M 32012114 %R 10.2196/14200 %U https://www.researchprotocols.org/2020/2/e14200 %U https://doi.org/10.2196/14200 %U http://www.ncbi.nlm.nih.gov/pubmed/32012114 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 1 %P e13578 %T Design and Development of a Viral Hepatitis and HIV Infection Screening Program (Hprolipsis) for the General, Greek Roma, and Migrant Populations of Greece: Protocol for Three Cross-Sectional Health Examination Surveys %A Touloumi,Giota %A Karakosta,Argiro %A Sypsa,Vana %A Petraki,Ioanna %A Anagnostou,Olga %A Terzidis,Agis %A Voudouri,Niki Maria %A , %A Gavana,Magda %A Vantarakis,Apostolos %A Rachiotis,George %A Kantzanou,Maria %A Rosenberg,Theofilos %A Papatheodoridis,George %A Hatzakis,Angelos %A , %+ Department of Hygiene, Epidemiology, and Medical Statistics, Medical School, National and Kapodistrian University of Athens, 75 Mikras Asias St, Athens, 11527, Greece, 30 2107462089, gtouloum@med.uoa.gr %K hepatitis %K HIV %K Greek general population %K Greek Roma %K migrants %K health examination surveys %D 2020 %7 31.1.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Although infectious diseases are globally on the decline, they remain a major global public health problem. Among them, the hepatitis B virus (HBV) or hepatitis C virus (HCV) and HIV infection are of primary interest. Valid prevalence data on these infections are sparse in Greece, especially for vulnerable populations. Objective: This study aimed to present the design and methods of Hprolipsis, an integrated viral hepatitis and HIV screening program administered to adults (≥18 years) from the general, Greek Roma, and migrant populations. Its aims were to estimate the prevalence of HBV, HCV, and HIV; assess infectious disease knowledge level; design, implement, and assess population-specific awareness actions; and offer individual counseling and referral when indicated and HBV vaccination to susceptible Roma and migrants. Methods: Multistage, stratified, random sampling based on the 2011 Census was applied to select the general population sample, and nonprobability multistage quota sampling was used for Roma and migrant sample selection. Trained personnel made home (general population) or community (Roma and migrants) visits. Collected blood samples were tested for Hepatitis B surface Antigen, Hepatitis B core Antibody, Hepatitis B surface Antibody, Hepatitis C Antibody, and HIV 1,2 Antibody. The surveys were conducted during May 2013 and June 2016. To estimate an HCV prevalence of 1.5% with 0.3 precision, the required general population sample size was estimated to be 6000. As migrants constitute 10% of the whole Greek population, the migrant sample size was set to 600. A feasible sample size of 500 Greek Roma was set. Results: In total, 6006 individuals from the general population (response rate 72%), 534 Greek Roma, and 612 migrants were recruited. Blood test results are available for 4245 individuals from the general population, 523 Roma, and 537 migrants. Conclusions: Hprolipsis is the first nationwide survey on HBV, HCV, and HIV. Its results will enhance our understanding of the health needs and disease burden of these diseases in the 3 studied populations. Its implementation provided useful recommendations for future studies, particularly in vulnerable populations. International Registered Report Identifier (IRRID): DERR1-10.2196/13578 %M 32004142 %R 10.2196/13578 %U http://www.researchprotocols.org/2020/1/e13578/ %U https://doi.org/10.2196/13578 %U http://www.ncbi.nlm.nih.gov/pubmed/32004142 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 1 %P e14542 %T Assessing Whether Meditation Improves Quality of Life for Adolescent Girls With Polycystic Ovary Syndrome: Protocol for a Randomized Controlled Trial %A Hewawasam,Erandi %A Brennan,Leah %A Giles,Lynne %A Hull,Mary Louise %A Short,Asha %A Norman,Robert %A Peña,Alexia S %+ Discipline of Paediatrics, Robinson Research Institute, University of Adelaide, 55 King William St, Adelaide, 5000, Australia, 61 8 8161 6402, erandi.hewawasam@adelaide.edu.au %K meditation %K quality of life %K polycystic ovary syndrome %K adolescent %D 2020 %7 28.1.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Polycystic Ovary Syndrome (PCOS) is a common endocrine condition characterized by irregular periods and hyperandrogenism. Adolescents with PCOS have impaired quality of life (QOL) and increased psychological distress. Transcendental Meditation (TM) is a well-established self-management strategy that has been used to improve stress and well-being. A meta-analysis of TM trials has shown beneficial effects on stress and blood pressure in adults. Recent data are suggesting that another self-management strategy called a mindfulness stress management program has a role in improving QOL in women with PCOS, but there are no studies in adolescents. Objective: This study aims to evaluate the effect of TM on QOL and psychological distress in adolescent girls with PCOS. Methods: This study is a randomized controlled trial that will be conducted over eight weeks at the Women’s and Children’s Hospital in Adelaide, South Australia, to determine the effect of TM on QOL and psychological distress in adolescent girls (aged 12-20 years) with PCOS. A total of 40 girls will be randomized into either the TM (n=20) or control group (n=20). The TM group will be asked to practice TM in a comfortable sitting position with the eyes closed, for 15 minutes twice daily over eight weeks. The control group will be asked to sit quietly for 15 minutes twice daily for eight weeks. The primary outcomes are any effects on improving QOL and psychological distress, and the secondary outcomes are any effects on lowering blood pressure and salivary cortisol levels. Results: The recruitment of study participants began in May 2019 and is expected to be completed by June 2020. It is expected that the adolescent girls with PCOS practicing TM over eight weeks will have a significant improvement in QOL and psychological distress compared to adolescents in the control group. Also, it is expected that adolescent girls in the TM group will have lower salivary cortisol levels and lower blood pressure. Conclusions: This study will be the first to evaluate the effect of TM on QOL in adolescent girls with PCOS. The study will provide valuable information on a potential self-management strategy to improve QOL and well-being in adolescent girls with PCOS. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN1261900019010; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376657&amp;isReview=true International Registered Report Identifier (IRRID): PRR1-10.2196/14542 %M 32012099 %R 10.2196/14542 %U https://www.researchprotocols.org/2020/1/e14542 %U https://doi.org/10.2196/14542 %U http://www.ncbi.nlm.nih.gov/pubmed/32012099 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 9 %N 1 %P e13998 %T Behavioral, Nutritional, and Genetic Risk Factors of Colorectal Cancers in Morocco: Protocol for a Multicenter Case-Control Study %A Mint Sidi Ould Deoula,Meimouna %A Huybrechts,Inge %A El Kinany,Khaoula %A Boudouaya,Hanae %A Hatime,Zineb %A El Asri,Achraf %A Benslimane,Abdelilah %A Nejjari,Chakib %A Sidi Adil,Ibrahimi %A El Rhazi,Karima %+ Sidi Mohamed Ben Abdellah University, Route d'Imouzzer, BP 2626, Fez, 30000, Morocco, 212 630364838, dolamouna@gmail.com %K diet %K colorectal cancer %K Morocco %K case-control study %K study protocol %D 2020 %7 13.1.2020 %9 Protocol %J JMIR Res Protoc %G English %X Background: Colorectal cancer (CRC) has been reported as the third most commonly diagnosed cancer worldwide and is currently considered as a major public health concern. A peak increase in incidence has been noted in economically transitioning countries like Morocco where industrialization started shifting from a traditional lifestyle and diet toward a more westernized diet and lifestyle. Objective: This paper aims to present the protocol of a large-scale Moroccan case-control study that aims at investigating associations of diet, other lifestyle factors, and genetic traits with CRC risk in Morocco. Methods: A case-control study was conducted between 2009 and 2017, including 3032 case-control pairs (1516 cases and 1516 controls) matched on sex, age, and center in 5 major public health hospitals in Morocco. Questionnaires on sociodemographic data, lifestyle, family history of CRC, and nonsteroidal anti-inflammatory drugs (NSAIDs) were completed by trained investigators during face-to-face interviews. In addition, participants completed a semiquantitative food-frequency questionnaire, developed to assess food intake in the Moroccan population. Information regarding genetic factors was recorded for cases, and paraffin blocks (with embedded tumor tissues) are available in 3 collaborating hospitals. Conditional logistic regression analysis is planned to assess associations between diet and CRC risk. Binary logistic regression is considered to predict associations between mutations and nutritional risk factors including only CRC case series. Results: Altogether, 2966 cases-control pairs (1483 cases and 1483 controls) were considered eligible and included in this study. Both cases and controls did not differ significantly with respect to age (P=.36), sex (P=.51), center (P>.99), marital status (P=.30), and NSAID use (P=.08). However, participants in the control group were significantly more likely to have a high income level and live in urban areas and to have a high level of education than cases. Conclusions: This is the first study investigating potential risk factors of CRC such as lifestyle, diet, and genetic factors, originating from a southern Mediterranean country with low but increasing CRC prevalence. Identified risk factors allow the establishment of evidence-based preventive actions regarding nutrition and other lifestyle habits adapted to the Moroccan context. In brief, this study will promote cancer research and prevention in Morocco. International Registered Report Identifier (IRRID): RR1-10.2196/13998 %M 31929106 %R 10.2196/13998 %U https://www.researchprotocols.org/2020/1/e13998 %U https://doi.org/10.2196/13998 %U http://www.ncbi.nlm.nih.gov/pubmed/31929106 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 12 %P e15557 %T Evaluating the Effects of a Rent Subsidy and Mentoring Intervention for Youth Transitioning Out of Homelessness: Protocol for a Mixed Methods, Community-Based Pilot Randomized Controlled Trial %A Thulien,Naomi S %A Kozloff,Nicole %A McCay,Elizabeth %A Nisenbaum,Rosane %A Wang,Andrea %A Hwang,Stephen W %+ School of Nursing, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4L8, Canada, 1 9055259140 ext 28690, thulienn@mcmaster.ca %K homeless youth %K community integration %K qualitative research %K randomized controlled trial %K housing %K mentorship %D 2019 %7 20.12.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Although the risk factors associated with young people entering and becoming entrenched in street life have been thoroughly investigated, peer-reviewed evidence is scarce to nonexistent for rigorous interventions targeting social integration outcomes for young people who have experienced homelessness. From the limited research that has been done, emerging evidence signals that, although structural supports such as subsidized housing and social service providers are important, these resources alone are insufficient to help young people integrate into the mainstream society. Objective: The overarching aim of this study is to assess whether and how rent subsidies and mentorship influence social integration outcomes for formerly homeless young people living in market rent housing in 3 Canadian cities. The primary outcome measures for this study are community integration (psychological and physical) and self-esteem at 18 months. Secondary outcomes include social connectedness, hope, and academic and vocational participation at 18 months. Exploratory outcomes include income, perceived housing quality, engulfment, psychiatric symptoms, and participant perspectives of intervention barriers and facilitators. Methods: This is a convergent mixed methods, open-label, 2-arm parallel randomized controlled trial (RCT) with 1:1 allocation embedded within a community-based participatory action research (CBPAR) framework. The intervention will provide 24 young people (aged 16-26 years), who have transitioned out of homelessness and into market rent housing within the past year, with rent subsidies for 24 months. Half of the young people will also be randomly assigned an adult mentor who has been recruited and screened by 1 of our 3 community partners. Data collection will occur every 6 months, and participants will be followed for 30 months. Results: Ethical approval for this study has been obtained from the Providence, St Joseph’s, and St Michael’s Healthcare Research Ethics Board (number 18-251). Enrollment took place from April 2019 to September 2019. Preliminary analysis of the baseline quantitative and qualitative data is underway. Conclusions: This pilot RCT will be the first to test the impact of economic and social support on meaningful social integration for formerly homeless young people living in market rent housing. We believe that the mixed methods design will illuminate important contextual factors that must be considered if the intervention is to be scaled up and replicated elsewhere. Importantly, the CBPAR framework will incorporate the perspectives of the community, including formerly homeless young people, who are in the best position to determine what might work best in the context of their lives. Trial Registration: Clinicaltrials.gov NCT03779204; https://clinicaltrials.gov/ct2/show/NCT03779204. International Registered Report Identifier (IRRID): DERR1-10.2196/15557 %M 31859688 %R 10.2196/15557 %U https://www.researchprotocols.org/2019/12/e15557 %U https://doi.org/10.2196/15557 %U http://www.ncbi.nlm.nih.gov/pubmed/31859688 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 12 %P e14696 %T Cash Transfer to Adolescent Girls and Young Women to Reduce Sexual Risk Behavior (CARE): Protocol for a Cluster Randomized Controlled Trial %A Wambura,Mwita %A Drake,Mary %A Kuringe,Evodius %A Majani,Esther %A Nyato,Daniel %A Casalini,Caterina %A Materu,Jacqueline %A Mjungu,Deusdedit %A Nnko,Soori %A Mbita,Gaspar %A Kalage,Esther %A Shao,Amani %A Changalucha,John %A Komba,Albert %+ National Institute for Medical Research, Mwanza Centre, Medical Street, Box 1462, Mwanza, , United Republic of Tanzania, 255 28 2500399, wmwita51@gmail.com %K adolescent %K female %K HIV infections/epidemiology %K HIV Infections/prevention and control %K Herpesvirus 2 %K humans %K incidence %K motivation %K Tanzania %D 2019 %7 20.12.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: The HIV epidemic in Eastern and Southern Africa is characterized by a high incidence and prevalence of HIV infection among adolescent girls and young women (AGYW) aged 15-24 years. For instance, in some countries, HIV prevalence in AGYW aged 20-24 years exceeds that in AGYW aged 15-19 years by 2:1. Sauti (meaning voices), a project supported by the United States Agency for International Development, is providing HIV combination prevention interventions to AGYW in the Shinyanga region, Tanzania. Objective: The aim of this study is to determine the impact of cash transfer on risky sexual behavior among AGYW receiving cash transfer and HIV combination prevention interventions. This paper describes the research methods and general protocol of the study. Risky sexual behavior will be assessed by herpes simplex virus type 2 (HSV-2) incidence, compensated sex (defined as sexual encounters motivated by exchange for money, material support, or other benefits), and intergenerational sex (defined as a sexual partnership between AGYW and a man 10 or more years older). Through a qualitative study, the study seeks to understand how the intervention affects the structural and behavioral drivers of the HIV epidemic. Methods: The trial employs audio computer-assisted self-interviewing, participatory group discussions (PGDs), and case studies to collect data. A total of 30 matched villages (15 intervention and 15 control clusters) were randomized to either receive cash transfer delivered over 18 months in addition to other HIV interventions (intervention arm) or to receive other HIV interventions without cash transfer (control arm). Study participants are interviewed at baseline and 6, 12, and 18 months to collect data on demographics, factors related to HIV vulnerabilities, family planning, sexual risk behavior, gender-based violence, and HSV-2 and HIV infections. A total of 6 PGDs (3 intervention, 3 control) were conducted at baseline to describe perceptions and preferences of different intervention packages, whereas 20 case studies are used to monitor and unearth the dynamics involved in delivery and uptake of cash transfer. Results: The study was funded in June 2017; enrollment took place in December 2017. A total of two rounds of the follow-up survey are complete, and one round has yet to be conducted. The results are expected in December 2019 and will be disseminated through conferences and peer-reviewed publications. Conclusions: This study will document the synergetic impact of cash transfer in the presence of HIV combination prevention interventions on risky sexual behavior among out-of-school AGYW. The results will strengthen the evidence of cash transfer in the reduction of risky sexual behavior and provide feasible HIV prevention strategies for AGYW. Trial Registration: Clinicaltrials.gov NCT03597243; https://clinicaltrials.gov/ct2/show/NCT03597243. International Registered Report Identifier (IRRID): DERR1-10.2196/14696 %M 31859686 %R 10.2196/14696 %U https://www.researchprotocols.org/2019/12/e14696 %U https://doi.org/10.2196/14696 %U http://www.ncbi.nlm.nih.gov/pubmed/31859686 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 12 %P e14647 %T Effect of Cognitive Behavioral Therapy for Insomnia on Insomnia Symptoms for Individuals With Type 2 Diabetes: Protocol for a Pilot Randomized Controlled Trial %A Alshehri,Mohammed M %A Alenazi,Aqeel M %A Hoover,Jeffrey C %A Alothman,Shaima A %A Phadnis,Milind A %A Rucker,Jason L %A Befort,Christie A %A Miles,John M %A Kluding,Patricia M %A Siengsukon,Catherine F %+ University of Kansas Medical Center, 8546 Caenen Lake Court, Lenexa, KS, 66215, United States, 1 4125512333, phdalshehri@gmail.com %K insomnia %K type 2 diabetes %K cognitive behavioral therapy %K sleep variability %K self-care %K fatigue %D 2019 %7 19.12.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Insomnia symptoms are a common form of sleep difficulty among people with type 2 diabetes (T2D) affecting sleep quality and health outcomes. Several interventional approaches have been used to improve sleep outcomes in people with T2D. Nonpharmacological approaches, such as cognitive behavioral therapy for insomnia (CBT-I), show promising results regarding safety and sustainability of improvements, although CBT-I has not been examined in people with T2D. Promoting sleep for people with insomnia and T2D could improve insomnia severity and diabetes outcomes. Objective: The objective of this study is to establish a protocol for a pilot randomized controlled trial (RCT) to examine the effect of 6 sessions of CBT-I on insomnia severity (primary outcome), sleep variability, and other health-related outcomes in individuals with T2D and insomnia symptoms. Methods: This RCT will use random mixed block size randomization with stratification to assign 28 participants with T2D and insomnia symptoms to either a CBT-I group or a health education group. Outcomes including insomnia severity; sleep variability; diabetes self-care behavior (DSCB); glycemic control (A1c); glucose level; sleep quality; daytime sleepiness; and symptoms of depression, anxiety, and pain will be gathered before and after the 6-week intervention. Chi-square and independent t tests will be used to test for between-group differences at baseline. Independent t tests will be used to examine the effect of the CBT-I intervention on change score means for insomnia severity, sleep variability, DSCB, A1c, fatigue, sleep quality, daytime sleepiness, and severity of depression, anxiety, and pain. For all analyses, alpha level will be set at .05. Results: This study recruitment began in February 2019 and was completed in September 2019. Conclusions: The intervention, including 6 sessions of CBT-I, will provide insight about its effect in improving insomnia symptoms, sleep variability, fatigue, and diabetes-related health outcomes in people with T2D and those with insomnia symptoms when compared with control. Trial Registration: ClinicalTrials.gov NCT03713996; https://clinicaltrials.gov/ct2/show/NCT03713996 International Registered Report Identifier (IRRID): DERR1-10.2196/14647 %M 31855189 %R 10.2196/14647 %U https://www.researchprotocols.org/2019/12/e14647 %U https://doi.org/10.2196/14647 %U http://www.ncbi.nlm.nih.gov/pubmed/31855189 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 10 %P e14771 %T Targeting the Infant Gut Microbiota Through a Perinatal Educational Dietary Intervention: Protocol for a Randomized Controlled Trial %A Dawson,Samantha L %A Craig,Jeffrey M %A Clarke,Gerard %A Mohebbi,Mohammadreza %A Dawson,Phillip %A Tang,Mimi LK %A Jacka,Felice N %+ Food & Mood Centre, IMPACT Strategic Research Centre, Deakin University, Health Education and Research Building, Level 2, 285 Ryrie Street, Geelong, 3220, Australia, 61 3 924 68383 ext 95449, sdawso@deakin.edu.au %K gastrointestinal microbiome %K diet %K pregnancy %K infant %K newborn %K randomized controlled trial %D 2019 %7 21.10.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: The early life gut microbiota are an important regulator of the biological pathways contributing toward the pathogenesis of noncommunicable disease. It is unclear whether improvements to perinatal diet quality could alter the infant gut microbiota. Objective: The aim of this study is to assess the efficacy of a perinatal educational dietary intervention in influencing gut microbiota in mothers and infants 4 weeks after birth. Methods: The Healthy Parents, Healthy Kids randomized controlled trial aimed to recruit 90 pregnant women from Melbourne, Victoria, Australia. At week 26 of gestation, women were randomized to receive dietary advice from their doctor (n=45), or additionally receive a dietary intervention (n=45). The intervention included an educational workshop and 2 support calls aiming to align participants’ diets with the Australian Dietary Guidelines and increase intakes of prebiotic and probiotic foods. The educational design focused on active learning and self-assessment. Behavior change techniques were used to support dietary adherence, and the target behavior was eating for the gut microbiota. Exclusion criteria were age under 18 years, diagnosed mental illnesses, obesity, diabetes mellitus, diagnosed bowel conditions, exclusion diets, illicit drug use, antibiotic use, prebiotic or probiotic supplementation, and those lacking dietary autonomy. The primary outcome measure is a between-group difference in alpha diversity in infant stool collected 4 weeks after birth. Secondary outcomes include evaluating the efficacy of the intervention in influencing infant and maternal stool microbial composition and short chain fatty acid concentrations, epigenetic profile, and markers of inflammation and stress, as well as changes in maternal dietary intake and well-being. The study and intervention feasibility and acceptance will also be evaluated as secondary outcomes. Results: The study results are yet to be written. The first participant was enrolled on July 28, 2016, and the final follow-up assessment was completed on October 11, 2017. Conclusions: Data from this study will provide new insights regarding the ability of interventions targeting the perinatal diet to alter the maternal and infant gut microbiota. If this intervention is proven, our findings will support larger studies aiming to guide the assembly of gut microbiota in early life. Trial Registration: Australian Clinical Trials Registration Number ACTRN12616000936426; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370939 International Registered Report Identifier (IRRID): DERR1-10.2196/14771 %M 31638593 %R 10.2196/14771 %U http://www.researchprotocols.org/2019/10/e14771/ %U https://doi.org/10.2196/14771 %U http://www.ncbi.nlm.nih.gov/pubmed/31638593 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 10 %P e14001 %T Effectiveness of a Walking Program Involving the Hybrid Assistive Limb Robotic Exoskeleton Suit for Improving Walking Ability in Stroke Patients: Protocol for a Randomized Controlled Trial %A Tsurushima,Hideo %A Mizukami,Masafumi %A Yoshikawa,Kenichi %A Ueno,Tomoyuki %A Hada,Yasushi %A Gosho,Masahiko %A Kohno,Yutaka %A Hashimoto,Koichi %A Iizumi,Yuichi %A Kikuchi,Toshihiro %A Matsumura,Akira %A , %+ Department of Neurosurgery, Faculty of Medicine, University of Tsukuba, 1-1-1 Tennoudai, Tsukuba, Japan, 81 298533220, hideo-tsurushima@md.tsukuba.ac.jp %K Hybrid Assistive Limb (HAL) %K gait training %K stroke %K hemiparesis %D 2019 %7 11.10.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Gait disturbance often occurs in stroke survivors. Recovery of walking function is challenging, as some gait disturbance due to hemiparesis often remains even after rehabilitation therapy, presenting a major obstacle towards regaining activities-of-daily-living performance and achieving social reintegration. Objective: This study aims to clarify the effectiveness of a walking program involving the wearable Hybrid Assistive Limb (HAL-TS01) robotic exoskeleton for improving walking ability in stroke patients with hemiparesis and stagnant recovery despite ongoing rehabilitation. Methods: This is a multicenter, randomized, parallel-group, controlled study (HAL group, n=27; control group, n=27). The study period includes preintervention observation (until stagnant recovery), intervention (HAL-based walking therapy or conventional rehabilitation; 5 weeks), and postintervention observation (2 weeks). Following provision of informed consent and primary registration, the patients undergo conventional rehabilitation for preintervention observation, during which the recovery of walking ability is monitored to identify patients with stagnant recovery (based on weekly assessments using the 10-meter maximum walking speed [MWS] test). Patients with an MWS of 30-60 m/minute and insufficient weekly improvement in MWS undergo secondary registration and are randomly assigned to undergo HAL-based walking therapy (HAL group) or conventional rehabilitation (control group). The primary outcome is the change in MWS from baseline to the end of the 5-week intervention. Results: This study began in November 2016 and is being conducted at 15 participating facilities in Japan. Conclusions: Assessments of walking ability vary greatly and it is difficult to define the threshold for significant differences. To reduce such variability, our study involves conducting conventional rehabilitation to the point of saturation before starting the intervention. Stagnation in the recovery of walking ability despite conventional rehabilitation highlights the limits of current medical care. The present study may bring evidence that HAL-based therapy can overcome such limitations and induce added recovery of walking ability, which would promote the use of HAL technology in the clinical setting. Trial Registration: UMIN Clinical Trials Registry UMIN000024805; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028545 %M 31605515 %R 10.2196/14001 %U https://www.researchprotocols.org/2019/10/e14001 %U https://doi.org/10.2196/14001 %U http://www.ncbi.nlm.nih.gov/pubmed/31605515 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 10 %P e14489 %T Evaluation of a Custom-Developed Computer Game to Improve Executive Functioning in 4- to 6-Year-Old Children Exposed to Alcohol in Utero: Protocol for a Feasibility Randomized Controlled Trial %A Louw,Jacobus Gidion %A Olivier,Leana %A Skeen,Sarah %A van Heerden,Alastair %A Tomlinson,Mark %+ Foundation for Alcohol Related Research, 42 Bloemhof Street, Bellville, Cape Town, 7560, South Africa, 27 216862646, jl@farrsa.org.za %K protocol %K fetal alcohol spectrum disorders %K FASD %K cognitive dysfunction/prevention and control %K executive function %K experimental games %K brain/drug effects %K child development %D 2019 %7 8.10.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Fetal alcohol spectrum disorder (FASD) is one of the most common causes of preventable intellectual disability, and the key associated deficits are in executive function (EF). Aspects of EF can be improved using cognitive training interventions. The highest prevalence of FASD globally (at a rate of 135.1 per 1000) has been found in a South African population in the Western Cape province. There is a shortage of specialized health service personnel, and there are limited remedial services. Computer-based cognitive training, if age and culturally appropriate, could be an effective way to provide the interventions with minimal need for skilled personnel and other resources. The Foundation for Alcohol Related Research has developed such a program for the South African context. Objective: This protocol aimed to evaluate whether it is feasible to use computerized cognitive training in a resource-poor context to improve cognitive function in children exposed to alcohol in utero. Methods: We are conducting a randomized controlled trial in the Saldanha Bay Municipal area, evaluating a custom-developed cognitive training program to improve the cognitive function of children aged between 4 and 6 years who were exposed to alcohol in the prenatal stage. Participants will be recruited from local Early Childhood Development centers. Community workers will interview biological mothers to identify alcohol-exposed pregnancies. Alcohol-exposed children will be randomized into an intervention or a control group of 40 participants each using block randomization. A group of 40 children not exposed to alcohol will be included in a normative group using individual randomization. The intervention group will play the game for 6 months (40 sessions). Normative and control groups will receive no intervention. Neurodevelopmental assessments will be done at baseline and upon completion of the study with all participants. Results: The intervention has started, and all baseline assessments have been done at the time of submission. Conclusions: This study will provide insight into whether computerized cognitive training is viable and effective in the South African context. It has the potential to provide a means of intervention globally and in other resource-poor context and expand the knowledge base regarding executive functioning and FASD. This paper presents the research protocol and intervention design of the study. Trial Registration: ISRCTN Registry ISRCTN17244156; http://www.isrctn.com/ISRCTN17244156. International Registered Report Identifier (IRRID): DERR1-10.2196/14489 %M 31596247 %R 10.2196/14489 %U https://www.researchprotocols.org/2019/10/e14489 %U https://doi.org/10.2196/14489 %U http://www.ncbi.nlm.nih.gov/pubmed/31596247 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 10 %P e12654 %T Promoting Smoke-Free Homes Through Biomarker Feedback Documenting Child Exposure to Tobacco Toxins: Protocol for a Randomized Clinical Trial %A Thomas,Janet Leigh %A Schreier,Meredith %A Luo,Xianghua %A Lowry,Sue %A Hennrikus,Deborah %A An,Lawrence %A Wetter,David W %A Ahluwalia,Jasjit S %+ Program in Health Disparities Research, Department of Medicine, Division of General Internal Medicine, University of Minnesota, 717 Delaware St, SE, Suite 166, Minneapolis, MN, 55414, United States, 1 6126250414, jthomas@umn.edu %K biomarker feedback %K second hand smoke %K randomized clinical trial %K cessation %D 2019 %7 4.10.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Exposure to secondhand smoke (SHS) early in life increases the risk of sudden infant death syndrome (SIDS), asthma, and respiratory illnesses. Since children’s primary exposure to SHS occurs in the home, these most vulnerable members of our society are not fully protected by recent increases in the adoption of smoking bans in public spaces. Although exposure to SHS is a quickly reversible cause of excess morbidity, few low-income homes strictly enforce smoking restrictions. Objective: This study aims to test a novel approach to motivate the adoption of home smoking restrictions and to eliminate child SHS exposure by providing parents with objective data documenting home SHS exposure and “biomarker feedback” of child ingestion of tobacco toxins, that is, objective, laboratory-based results of assays performed on child urine, documenting levels of nicotine; cotinine; and NNAL (4-[methylnitrosamino]-1-[3-pyridyl]-1-butanol), which is a metabolite of the known tobacco carcinogen NNK (4-[methylnitro-samino]-1-[3-pyridyl]-1-butanone). Methods: From 2011 to 2013, 195 low-income, female smokers with children aged ≤10 years residing in their homes were recruited into a two-arm randomized clinical trial. Participants were assigned to one of two groups: biomarker feedback (n=98) and health education (n=97). In-home assessments were administered at baseline, week 16, and week 26. Children’s home SHS exposure and nicotine, cotinine, and NNAL levels from urine samples, measured through a passive nicotine dosimeter and a surface sample of residual tobacco smoke (ie, thirdhand smoke), were collected at all three time points. Primary outcome was dosimeter-verified, self-reported complete home smoking restrictions at 6 months after randomization. Secondary outcomes included parental self-report of smoking behavior change and child urine tobacco toxin (biomarker) change. Results: Data collection and analyses are complete, and the results are being interpreted. Conclusions: The study protocol describes the development of a novel community-based controlled trial designed to examine the efficacy of biomarker feedback documenting home and child exposure to SHS on parental smoking behavior change. International Registered Report Identifier (IRRID): RR1-10.2196/12654 %M 31588910 %R 10.2196/12654 %U https://www.researchprotocols.org/2019/10/e12654 %U https://doi.org/10.2196/12654 %U http://www.ncbi.nlm.nih.gov/pubmed/31588910 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 9 %P e13176 %T Noninvasive Bimodal Neuromodulation for the Treatment of Tinnitus: Protocol for a Second Large-Scale Double-Blind Randomized Clinical Trial to Optimize Stimulation Parameters %A Conlon,Brendan %A Hamilton,Caroline %A Hughes,Stephen %A Meade,Emma %A Hall,Deborah A %A Vanneste,Sven %A Langguth,Berthold %A Lim,Hubert H %+ Neuromod Devices Limited, Unit J, Digital Court, Rainsford Street, Dublin, Ireland, 353 6125011143, hubert.lim@neuromoddevices.com %K tinnitus %K bimodal %K neuromodulation %K trigeminal nerve %K vagus nerve %K auditory nerve %K auditory cortex %K pain %K plasticity %K precision medicine %D 2019 %7 27.9.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: There is increasing evidence from animal and human studies that bimodal neuromodulation combining sound and electrical somatosensory stimulation of the tongue can induce extensive brain changes and treat tinnitus. Objective: The main objectives of the proposed clinical study are to confirm the efficacy, safety, and tolerability of treatment demonstrated in a previous large-scale study of bimodal auditory and trigeminal nerve (tongue) stimulation (Treatment Evaluation of Neuromodulation for Tinnitus - Stage A1); evaluate the therapeutic effects of adjusting stimulation parameters over time; and determine the contribution of different features of bimodal stimulation in improving tinnitus outcomes. Methods: This study will be a prospective, randomized, double-blind, parallel-arm, comparative clinical trial of a 12-week treatment for tinnitus using a Conformité Européenne (CE)–marked device with a pre-post and 12-month follow-up design. Four treatment arms will be investigated, in which each arm consists of two different stimulation settings, with the first setting presented during the first 6 weeks and the second setting presented during the next 6 weeks of treatment. The study will enroll 192 participants, split in a ratio of 80:80:16:16 across the four arms. Participants will be randomized to one of four arms and stratified to minimize baseline variability in four categories: two separate strata for sound level tolerance (using loudness discomfort level as indicators for hyperacusis severity), high tinnitus symptom severity based on the Tinnitus Handicap Inventory (THI), and tinnitus laterality. The primary efficacy endpoints are within-arm changes in THI and Tinnitus Functional Index as well as between-arm changes in THI after 6 weeks of treatment for the full cohort and two subgroups of tinnitus participants (ie, one hyperacusis subgroup and a high tinnitus symptom severity subgroup). Additional efficacy endpoints include within-arm or between-arm changes in THI after 6 or 12 weeks of treatment and in different subgroups of tinnitus participants as well as at posttreatment assessments at 6 weeks, 6 months, and 12 months. Treatment safety, attrition rates, and compliance rates will also be assessed and reported. Results: This study protocol was approved by the Tallaght University Hospital/St. James’s Hospital Joint Research Ethics Committee in Dublin, Ireland. The first participant was enrolled on March 20, 2018. The data collection and database lock are expected to be completed by February 2020, and the data analysis and manuscript submission are expected to be conducted in autumn of 2020. Conclusions: The findings of this study will be disseminated to relevant research, clinical, and health services and patient communities through publications in peer-reviewed journals and presentations at scientific and clinical conferences. Trial Registration: ClinicalTrials.gov NCT03530306; https://clinicaltrials.gov/ct2/show/NCT03530306 International Registered Report Identifier (IRRID): DERR1-10.2196/13176 %M 31573942 %R 10.2196/13176 %U https://www.researchprotocols.org/2019/9/e13176 %U https://doi.org/10.2196/13176 %U http://www.ncbi.nlm.nih.gov/pubmed/31573942 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 8 %P e13848 %T Using Pharmacogenomic Testing in Primary Care: Protocol for a Pilot Randomized Controlled Study %A Manzor Mitrzyk,Beatriz %A Kadri,Reema %A Farris,Karen B %A Ellingrod,Vicki L %A Klinkman,Michael S %A Ruffin IV,Mack T %A Plegue,Melissa A %A Buis,Lorraine R %+ Department of Family Medicine, University of Michigan, 1018 Fuller Street, Ann Arbor, MI, 48104, United States, 1 734 998 7120, buisl@umich.edu %K pharmacogenomics %K primary care %K antidepressive agents %D 2019 %7 19.08.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Antidepressants are used by primary care providers to treat a variety of conditions, including (but not limited to) depression and anxiety. A trial-and-error approach is typically used to identify effective therapy, as treatment efficacy and safety can vary based on the response, which is affected by certain gene types. Pharmacokinetic pharmacogenomic (PGx) testing provides phenotypic classification of individuals as poor, intermediate, extensive, and ultrarapid CYP450 metabolizers, providing information for optimal drug selection. Objective: The objective of this pilot study is to examine the feasibility, acceptability, and preliminary effectiveness of PGx testing when used after starting a new antidepressant medication. Methods: We are conducting a pilot study with physicians from 6 Department of Family Medicine clinics at the University of Michigan who are willing to use PGx test results to manage antidepressant medication use. From enrolled physicians, patients were recruited to participate in a 6-month randomized, wait-list controlled trial in which patient participants newly prescribed an antidepressant had PGx testing and were randomized equally to have the results released to their primary care physician as soon as results were available or after 3 months. Patients were excluded if they had been taking the antidepressant for more than 4 weeks or if they had undergone PGx testing in the past. Physician participants completed a baseline survey to assess demographics, as well as knowledge, feasibility, and acceptability of PGx testing for this population. At the conclusion of the study, physician participants will complete a survey to assess knowledge, satisfaction, feasibility, acceptability, perceived effectiveness, and barriers to widespread adoption of PGx testing. Patient participants will complete a baseline, 3-month, and 6-month assessment, and control patient participants will have an additional 9-month assessment. Data collected will include the reason for antidepressant use, self-reported medication adherence, side effects, patient health questionnaire 8-item depression scale, generalized anxiety disorder 7-item scale, 12-Item Short-Form Health Survey, work status or changes, and physician and emergency department visits. PGx knowledge and perceptions (including acceptability and feasibility) as well as demographic information will also be obtained. Results: We recruited 23 physician participants between November 2017 and January 2019, and 52 patient participants between January 2018 and April 2019. Currently, all physician and patient participants have been recruited, and we expect data collection to conclude in January 2020. Conclusions: This study will examine the preliminary effectiveness of PGx testing after treatment initiation and determine the feasibility and acceptability of PGx testing for use in primary care. Through this study, we expect to demonstrate the benefit of PGx testing and lay the foundation for translating this approach into use within primary care. Trial Registration: ClinicalTrials.gov NCT03270891; https://clinicaltrials.gov/ct2/show/NCT03270891 International Registered Report Identifier (IRRID): RR1-10.2196/13848 %M 31429417 %R 10.2196/13848 %U http://www.researchprotocols.org/2019/8/e13848/ %U https://doi.org/10.2196/13848 %U http://www.ncbi.nlm.nih.gov/pubmed/31429417 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 8 %P e13973 %T Evaluation of a Collaborative Protocolized Approach by Community Pharmacists and General Medical Practitioners for an Australian Minor Ailments Scheme: Protocol for a Cluster Randomized Controlled Trial %A Dineen-Griffin,Sarah %A Garcia-Cardenas,Victoria %A Rogers,Kris %A Williams,Kylie %A Benrimoj,Shalom Isaac %+ Graduate School of Health, University of Technology Sydney, 15 Broadway, Ultimo, 2007, Australia, 61 (02) 9514 7677, sarah.dineen-griffin@uts.edu.au %K pharmacy %K pharmacists %K general practitioners %K primary health care %K community pharmacy services %K nonprescription drugs %K self care %K self medication %K randomized controlled trial %K Australia %D 2019 %7 09.08.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Internationally, governments have been investing in supporting pharmacists to take on an expanded role to support self-care for health system efficiency. There is consistent evidence that minor ailment schemes (MASs) promote efficiencies within the health care system. The cost savings and health outcomes demonstrated in the United Kingdom and Canada open up new opportunities for pharmacists to effect sustainable changes through MAS delivery in Australia. Objective: This trial aims to evaluate the clinical, economic, and humanistic impact of an Australian Minor Ailments Service (AMAS) compared with usual pharmacy care in a cluster randomized controlled trial (cRCT) in Western Sydney, Australia. Methods: The cRCT design has an intervention group and a control group, comparing individuals receiving a structured intervention (AMAS) with those receiving usual care for specific health ailments. Participants will be community pharmacies, general practices, and patients located in Western Sydney Primary Health Network (WSPHN) region. A total of 30 community pharmacies will be randomly assigned to either intervention or control group. Each will recruit 24 patients, aged 18 years or older, presenting to the pharmacy in person with a symptom-based or product-based request for one of the following ailments: reflux, cough, common cold, headache (tension or migraine), primary dysmenorrhea, or low back pain. Intervention pharmacists will deliver protocolized care to patients using clinical treatment pathways with agreed referral points and collaborative systems boosting clinician-pharmacist communication. Patients recruited in control pharmacies will receive usual care. The coprimary outcomes are rates of appropriate recommendation of nonprescription medicines and rates of appropriate medical referral. Secondary outcomes include self-reported symptom resolution, health services resource utilization, and EuroQoL Visual Analogue Scale. Differences in primary outcomes between groups will be analyzed at the individual patient level accounting for correlation within clusters with generalized estimating equations. The economic impact of the model will be evaluated by cost-utility and cost-effectiveness analysis compared with usual care. Results: The study began in July 2018. Thirty community pharmacies were recruited. Pharmacists from the 15 intervention pharmacies were trained. A total of 27 general practices consented. Pharmacy patient recruitment began in August 2018 and was completed on March 31, 2019. Conclusions: This study may demonstrate the efficacy of a protocolized intervention to manage minor ailments in the community and will assess the clinical, economic, and humanistic impact of this intervention in Australian pharmacy practice. Pharmacists supporting patient self-care and appropriate self-medication may contribute to greater efficiency of health care resources and integration of self-care in the health system. The proposed model and developed educational content may form the basis of a national MAS service in Australia, using a robust framework for management and referral for common ailments. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12618000286246; http://www.anzctr.org.au/ACTRN12618000286246.aspx International Registered Report Identifier (IRRID): DERR1-10.2196/13973 %M 31400107 %R 10.2196/13973 %U https://www.researchprotocols.org/2019/8/e13973/ %U https://doi.org/10.2196/13973 %U http://www.ncbi.nlm.nih.gov/pubmed/31400107 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 7 %P e14097 %T Effects of a School-Based Health Intervention Program in Marginalized Communities of Port Elizabeth, South Africa (the KaziBantu Study): Protocol for a Randomized Controlled Trial %A Müller,Ivan %A Smith,Danielle %A Adams,Larissa %A Aerts,Ann %A Damons,Bruce P %A Degen,Jan %A Gall,Stefanie %A Gani,Zaahira %A Gerber,Markus %A Gresse,Annelie %A van Greunen,Darelle %A Joubert,Nandi %A Marais,Tracey %A Nqweniso,Siphesihle %A Probst-Hensch,Nicole %A du Randt,Rosa %A Seelig,Harald %A Steinmann,Peter %A Utzinger,Jürg %A Wadhwani,Christina %A Walter,Cheryl %A Pühse,Uwe %+ Department of Sport, Exercise and Health, University of Basel, Gellertstrasse 156, Basel, CH-4052, Switzerland, 41 61 207 4784, ivan.mueller@unibas.ch %K anthropometry %K cardiovascular %K cognitive function %K diabetic complications %K children’s health %K marginalization %K physical activity %K physical fitness %K schools %K South Africa %D 2019 %7 11.07.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: The burden of poverty-related infectious diseases remains high in low- and middle-income countries, while noncommunicable diseases (NCDs) are rapidly gaining importance. To address this dual disease burden, the KaziBantu project aims at improving and promoting health literacy as a means for a healthy and active lifestyle. The project implements a school-based health intervention package consisting of physical education, moving-to-music, and specific health and nutrition education lessons from the KaziKidz toolkit. It is complemented by the KaziHealth workplace health intervention program for teachers. Objectives: The aim of the KaziBantu project is to assess the effect of a school-based health intervention package on risk factors for NCDs, health behaviors, and psychosocial health in primary school children in disadvantaged communities in Port Elizabeth, South Africa. In addition, we aim to test a workplace health intervention for teachers. Methods: A randomized controlled trial (RCT) will be conducted in 8 schools. Approximately 1000 grade 4 to grade 6 school children, aged 9 to 13 years, and approximately 60 teachers will be recruited during a baseline survey in early 2019. For school children, the study is designed as a 36-week, cluster RCT (KaziKidz intervention), whereas for teachers, a 24-week intervention phase (KaziHealth intervention) is planned. The intervention program consists of 3 main components; namely, (1) KaziKidz and KaziHealth teaching material, (2) workshops, and (3) teacher coaches. After randomization, 4 of the 8 schools will receive the education program, whereas the other schools will serve as the control group. Intervention schools will be further randomized to the different combinations of 2 additional intervention components: teacher workshops and teacher coaching. Results: This study builds on previous experience and will generate new evidence on health intervention responses to NCD risk factors in school settings as a decision tool for future controlled studies that will enable comparisons among marginalized communities between South African and other African settings. Conclusions: The KaziKidz teaching material is a holistic educational and instructional tool designed for primary school teachers in low-resource settings, which is in line with South Africa’s Curriculum and Assessment Policy Statement. The ready-to-use lessons and assessments within KaziKidz should facilitate the use and implementation of the teaching material. Furthermore, the KaziHealth interventions should empower teachers to take care of their health through knowledge gains regarding disease risk factors, physical activity, fitness, psychosocial health, and nutrition indicators. Teachers as role models will be able to promote better health behaviors and encourage a healthy and active lifestyle for children at school. We conjecture that improved health and well-being increase teachers’ productivity with trickle-down effects on the children they teach and train. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 18485542; http://www.isrctn.com/ISRCTN18485542 International Registered Report Identifier (IRRID): DERR1-10.2196/14097 %M 31298224 %R 10.2196/14097 %U http://www.researchprotocols.org/2019/7/e14097/ %U https://doi.org/10.2196/14097 %U http://www.ncbi.nlm.nih.gov/pubmed/31298224 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 7 %P e13566 %T Receipt of Curative Resection or Palliative Care for Hepatopancreaticobiliary Tumours (RICOCHET): Protocol for a Nationwide Collaborative Observational Study %A , %A , %+ Academic Department of Surgery, University of Birmingham, Birmingham, B15 2TT, United Kingdom, 44 01214158700, haldar@doctors.org.uk %K ERCP %K malignant jaundice %K palliative %K pancreatic cancer %K PTC %K patient pathway %D 2019 %7 08.07.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: There are variations in the management of patients with suspected pancreatic and periampullary cancers and/or malignant biliary obstruction. These differences may be due to a number of organizational, institutional, and patient factors that could affect outcomes for those with curable or incurable disease. The Receipt of Curative Resection or Palliative Care for Hepatopancreaticobiliary Tumours (RICOCHET) study will be the first to provide a snapshot of investigative pathways across the United Kingdom to reflect the real-world practice in these patients. The RICOCHET study is contemporary to new national and international clinical guidance and can potentially inform future local and national strategic planning to optimize care for patients with suspected hepatopancreaticobiliary (HPB) malignancies. Objective: The aim of this study is to define national variation in the investigative and management pathways of patients with suspected HPB malignancies and to determine the effect of these variations on patient outcomes. Methods: The RICOCHET study is a nationwide, multicenter, prospective study. It is led by trainees through collaboration between surgical and medical specialties. Patients with suspected pancreatic cancer, other periampullary cancer, or extrahepatic cholangiocarcinoma presenting to hospitals in the United Kingdom will be identified over 90 days. Each case will be followed up for 90 days to collect data on the mode of presentation, investigations, interventions, use of local and specialist multidisciplinary team meetings, and transfer of care between hub and spoke sites. Furthermore, the study will define dates and intervals between key points in the patient pathway. Results: The RICOCHET study results and analyses will be subject to peer review by presenting them at international cross-specialty conferences and by submitting them for publication in open-access journals. Moreover, our findings will be presented to patient groups and sponsoring charities (eg, Pancreatic Cancer UK), who in turn will disseminate key findings to the primary beneficiaries of the results: the patients. The RICOCHET study was funded in September 2017. Data collection started in April 2018 and the planned end date for data upload is spring 2019. Data analysis will take place in the summer of 2019 and the first results are expected to be published in late 2019 or early 2020. Conclusions: The RICOCHET study is a multidisciplinary, prospective, observational study that aims to highlight variability in practice and to determine whether these affect the outcomes of patients with HPB malignancies. This is a trainee-led initiative that utilizes a novel design to achieve full coverage of the differences in diagnostic and management pathways. The RICOCHET study may provide evidence to develop a more standardized approach to managing patients with suspected HPB malignancy. International Registered Report Identifier (IRRID): DERR1-10.2196/13566 %M 31287068 %R 10.2196/13566 %U http://www.researchprotocols.org/2019/7/e13566/ %U https://doi.org/10.2196/13566 %U http://www.ncbi.nlm.nih.gov/pubmed/31287068 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 7 %P e13015 %T Motivational Interviewing to Reduce Drug Use and HIV Incidence Among Young Men Who Have Sex With Men in Relationships and Are High Priority for Pre-Exposure Prophylaxis (Project PARTNER): Randomized Controlled Trial Protocol %A Starks,Tyrel J %A Robles,Gabriel %A Pawson,Mark %A Jimenez,Ruben H %A Gandhi,Monica %A Parsons,Jeffrey T %A Millar,Brett M %+ Hunter College, City University of New York, 695 Park Avenue, New York, NY, 10065, United States, 1 212 206 7919, tstarks@hunter.cuny.edu %K HIV %K pre-exposure prophylaxis %K substance-related disorders %K sexual behavior %K sexual partners %D 2019 %7 04.07.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Men who have sex with men (MSM) currently account for more than two-thirds of new HIV diagnoses in the United States and, among young MSM (YMSM) aged 20 to 29 years, as many as 79% to 84% of new infections occur between primary partners. Contributing to HIV risk, YMSM use drugs at comparatively high rates. To date, no interventions have been developed that specifically address the unique needs of partnered YMSM or incorporate a focus on relationship factors in addressing personal motivation for change. Objective: The study’s primary aim is to evaluate the efficacy of the PARTNER intervention and evaluate potential moderators or mediators of intervention effects. The study’s secondary aims were to gather ideographic data to inform a future effectiveness implementation study and develop a novel biomarker for pre-exposure prophylaxis (PrEP) adherence by analyzing PrEP drug levels in fingernails. Methods: PARTNER is a 4-session motivational interviewing–based intervention that integrates video-based communication training to address drug use and HIV prevention among partnered YMSM. This study utilizes a randomized controlled trial design to compare the PARTNER intervention with an attention-matched psychoeducation control arm that provides information about HIV-risk reduction, PrEP, and substance use. Participants are randomized in a 1-to-1 ratio stratified on age disparity between partners, racial composition of the couple, and relationship length. Follow-up assessments are conducted at 3-, 6-, 9-, and 12-months postbaseline. The study recruits and enrolls 240 partnered YMSM aged between 18 to 29 years at a research center in New York City. Participants will be HIV-negative and report recent (past 30-day) drug use and condomless anal sex with casual partners; a nonmonogamous primary partner (regardless of HIV status); or a serodiscordant primary partner (regardless of sexual agreement). Primary outcomes (drug use and HIV sexual transmission risk behavior) are assessed via a Timeline Follow-back interview. Biological markers of outcomes are collected for drug use (fingernail assay), sexual HIV transmission risk (rectal and urethral gonorrhea and chlamydia testing), and PrEP adherence (dried blood spots and fingernails for a novel PrEP drug level assay). Results: The study opened for enrollment in February 2018. Anticipated completion of enrollment is October 2021. Primary outcome analyses will begin after final follow-up completion. Conclusions: Existing research on partnered YMSM within the framework of Couples Interdependence Theory (CIT) has suggested that relationship factors (eg, dyadic functioning and sexual agreements) are meaningfully related to drug use and HIV transmission risk. Results pertaining to the efficacy of the proposed intervention and the identification of putative moderators and mediators will substantially inform the tailoring of interventions for YMSM in relationships and contribute to a growing body of relationship science focused on enhancing health outcomes. Trial Registration: ClinicalTrials.gov NCT03396367; https://clinicaltrials.gov/ct2/show/NCT03396367 (Archived by WebCite at http://www.webcitation.org/78ti7esTc. International Registered Report Identifier (IRRID): DERR1-10.2196/13015 %M 31274114 %R 10.2196/13015 %U https://www.researchprotocols.org/2019/7/e13015/ %U https://doi.org/10.2196/13015 %U http://www.ncbi.nlm.nih.gov/pubmed/31274114 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 6 %P e12138 %T Biological and Functional Changes in Healthy Adult Smokers Who Are Continuously Abstinent From Smoking for One Year: Protocol for a Prospective, Observational, Multicenter Cohort Study %A Tran,Cam Tuan %A Felber Medlin,Loyse %A Lama,Nicola %A Taranu,Brindusa %A Ng,Weeteck %A Haziza,Christelle %A Picavet,Patrick %A Baker,Gizelle %A Lüdicke,Frank %+ Philip Morris International Science and Innovation, Philip Morris Products SA, Quai Jeanrenaud 5, Neuchâtel, 2000, Switzerland, 41 58 242 1111, CamTuan.Tran@pmi.com %K smoking cessation %K smoking %K tobacco %K harm reduction %K tobacco products %K biomarkers %K metabolic networks %K pathways %D 2019 %7 7.6.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: The harm of smoking results mainly from long-term exposure to harmful and potentially harmful constituents (HPHCs) generated by tobacco combustion. Smoking cessation (SC) engenders favorable changes of clinical signs, pathomechanisms, and metabolic processes that together could reduce the harm of smoking-related diseases to a relative risk level approximating that of never-smokers over time. In most SC studies, the main focus is on the quitting rate of the SC program being tested. As there is limited information in the literature on short to multiple long-term functional or biological changes following SC, more data on short to mid-term favorable impacts of SC are needed. Objective: The overall aim of the study was to assess the reversibility of the harm related to smoking over 1 year of continuous smoking abstinence (SA). This has been verified by assessing a set of biomarkers of exposure to HPHCs and a set of biomarkers of effect indicative of multiple pathophysiological pathways underlying the development of smoking-related diseases. Methods: This multiregional (United States, Japan, and Europe), multicenter (42 sites) cohort study consisting of a 1-year SA period in an ambulatory setting was conducted from May 2015 to May 2017. A total of 1184 male and female adult healthy smokers, willing to quit smoking, were enrolled in the study. Nicotine replacement therapy (NRT) was provided for up to 3 months upon the subject’s request. SC counseling and behavioral support were continuously provided. Biomarkers of exposure to HPHCs and biomarkers of effect were assessed in urine and blood at baseline, Month 3, Month 6, and Month 12. Cardiovascular biomarkers of effect included parameters reflecting inflammation (white blood cell), lipid metabolism (high-density lipoprotein cholesterol), endothelial function (soluble intercellular adhesion molecule-1), platelet function (11-dehydrothromboxane B2), oxidative stress (8-epi-prostaglandin F2 alpha), and carbon monoxide exposure (carboxyhemoglobin). Respiratory biomarkers of effect included lung function parameters and cough symptoms. The biomarkers of effect to evaluate genotoxicity (total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol) and xenobiotic metabolism (cytochrome P450 2A6 activity) were also assessed. Continuous SA was verified at each visit following the actual quit date using self-reporting and chemical verification. Safety assessments included adverse events and serious adverse events, body weight, vital signs, spirometry, electrocardiogram, clinical chemistry, hematology and urine analysis safety panel, physical examination, and concomitant medications. Results: In total, 1184 subjects (50.1% male) were enrolled; 30% of them quit smoking successfully for 1 year. Data analyses of the study results are ongoing and will be published after study completion. Conclusions: This study provides insights into biological and functional changes and health effects, after continuous SA over 1 year. Study results will be instrumental in assessing novel alternative products to cigarettes considered for tobacco harm reduction strategies. Trial Registration: ClinicalTrials.gov NCT02432729; http://clinicaltrials.gov/ct2/show/NCT02432729 (Archived by WebCite at http://www.webcitation.org/78QxovZrr) International Registered Report Identifier (IRRID): DERR1-10.2196/12138 %M 31199335 %R 10.2196/12138 %U https://www.researchprotocols.org/2019/6/e12138/ %U https://doi.org/10.2196/12138 %U http://www.ncbi.nlm.nih.gov/pubmed/31199335 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 6 %P e13406 %T Transitional Experiences of Internationally Qualified Midwives Practicing in Australia: Protocol for a Mixed Methods Study %A Javanmard,Mitra %A Steen,Mary %A Vernon,Rachael %A Cooper,Megan %+ School of Nursing and Midwifery, Division of Health Sciences, University of South Australia, 108 North Terrace, Adelaide, 5000, Australia, 61 425477771, mitra.javanmard@mymail.unisa.edu.au %K internationally qualified midwives %K experiences %K views %K adjustment %K transition %K integration %D 2019 %7 1.6.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Approximately 13% of the total Australian midwifery workforce is internationally qualified. Although the internationally qualified midwives (IQMs) play a significant role in the Australian midwifery system, there is limited understanding of their transitional experiences. Objective: The objective of this study protocol is to explore the transitional experiences and views of IQMs practicing in Australia, through the investigation of demographic profiles and key challenges that influence a smooth transition. Methods: This paper presents an explanatory sequential mixed methods study protocol. This protocol incorporates an e-survey and individual interviews. The e-survey in the first phase will be distributed to IQMs in Australia via the website e-bulletins of the Australian Nursing and Midwifery Federation and the Australian College of Midwives. Additionally, potential respondents will be recruited via social media (ie, Twitter and Facebook) and associated snowball sampling. Data from the e-survey will be statistically analyzed. At the end of the e-survey, respondents will be asked whether they are willing to take part in an interview. The results of the e-survey and relevant literature review will help to develop a guideline for interview questions for the second phase. In phase two, a purposeful sample of participants will be recruited using the same selection criteria as for the e-survey. Semistructured interviews will provide a deeper insight into the transitional experiences of IQMs. Data from the interviews will then be thematically analyzed. Results: An integration of the e-survey results (phase one) and interview findings (phase two) will be synthesized to explore and better understand the transitional experiences of this group of midwives. It is anticipated that data collection and analysis will be completed by June 2019 and results will be disseminated through peer-reviewed publications in late 2019. Conclusions: This research protocol may generate new knowledge about the transition of IQMs in Australia. These findings could be used to formulate recommendations to inform the transition of future IQMs in Australia. International Registered Report Identifier (IRRID): DERR1-10.2196/13406 %M 31199309 %R 10.2196/13406 %U https://www.researchprotocols.org/2019/6/e13406/ %U https://doi.org/10.2196/13406 %U http://www.ncbi.nlm.nih.gov/pubmed/31199309 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 5 %P e13425 %T Communicating Uncertainty From Limitations in Quality of Evidence to the Public in Written Health Information: Protocol for a Web-Based Randomized Controlled Trial %A Büchter,Roland Brian %A Betsch,Cornelia %A Ehrlich,Martina %A Fechtelpeter,Dennis %A Grouven,Ulrich %A Keller,Sabine %A Meuer,Regina %A Rossmann,Constanze %A Waltering,Andreas %+ Institute for Quality and Efficiency in Health Care (IQWiG), Im Mediapark 8, Cologne, 50670, Germany, 49 35685 ext 413, roland.buechter@iqwig.de %K uncertainty %K consumer health information %K decision making %D 2019 %7 13.05.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Uncertainty is integral to evidence-informed decision making and is of particular importance for preference-sensitive decisions. Communicating uncertainty to patients and the public has long been identified as a goal in the informed and shared decision-making movement. Despite this, there is little quantitative research on how uncertainty in health information is perceived by readers. Objective: The objective of this study is to design an experiment to examine how different degrees of uncertainty (Q1) and different types of uncertainty (Q2) impact patients’ perception of treatment effectiveness, the body of evidence, text quality, and hypothetical treatment intention. The experiment also examines whether there is an additive effect when multiple sources of uncertainty are communicated (Q3). Methods: We developed 8 variations of a research summary set in a hypothetical scenario for a treatment decision in the context of tinnitus. These were modified only in the degree of uncertainty relating to the evidence of the presented treatment. We recruited members of the German public from a Web-based research panel and randomized them to one of 8 variations of the research summary to examine the 3 research questions. The trial was only open to the members of the research panel. The outcomes are perception of the effectiveness of the treatment (primary), certainty in the judgement of treatment effectiveness, perception of the body of evidence relating to the treatment, text quality, and decisional intention (secondary). Outcomes were self-assessed. We aimed to recruit 1500 participants to the trial. The recruitment and data collection was fully automated. Ethical approval was waivered by an ethics committee because of the negligible risk to participants. Results: This protocol is retrospectively published in its original format. In the meantime, the trial was set up and the data collection was completed. Data collection was conducted in May 2018. A total of 1727 eligible panel members were enrolled. Conclusions: We aim to publish the results in a peer-reviewed journal by the end of 2019. In addition, results will be presented at conferences and disseminated among developers of guidance for the development of evidence-based health information and decision aids. Trial Registration: German Clinical Trials Register DRKS00015911; https://www.drks.de/drks_web/navigate.do? navigationId=trial.HTML&TRIAL_ID=DRKS00015911 (Archived by WebCite at http://www.webcitation.org/77zyZTGzk) International Registered Report Identifier (IRRID): DERR1-10.2196/13425 %M 31094343 %R 10.2196/13425 %U http://www.researchprotocols.org/2019/5/e13425/ %U https://doi.org/10.2196/13425 %U http://www.ncbi.nlm.nih.gov/pubmed/31094343 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 5 %P e12453 %T Effective Information Provision About the Side Effects of Treatment for Malignant Lymphoma: Protocol of a Randomized Controlled Trial Using Video Vignettes %A Labrie,Nanon %A van Dulmen,Sandra %A Kersten,Marie José %A de Haes,Hanneke JCM %A Pieterse,Arwen H %A van Weert,Julia CM %A van Spronsen,Dick Johan %A Smets,Ellen MA %A , %+ Medical Psychology, Amsterdam Public Health Research Institute, Cancer Center Amsterdam, Amsterdam University Medical Centers, Amsterdam University Medical Centers, Amsterdam,, Netherlands, 31 205664768, e.m.smets@amc.uva.nl %K physician patient relationship %K health communication %K information dissemination %K immediate recall %K trust %K symptoms %K clinical trial protocol %K video vignettes %D 2019 %7 2.5.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Informing patients with cancer about the possible implications of prospective treatment is a crucial yet challenging task. Unfortunately, patients’ recall of medical information is generally poor and their information needs are not met. Effective information giving entails that oncologists help patients understand and recall the implications of their treatment, meanwhile fostering a trusting physician-patient relationship. Communication strategies that are often suggested to be effective are structuring and tailoring (cognition-oriented) but also are oncologists’ expressions of caring or empathy (affect-oriented). Objective: The aim of this study is to provide evidence concerning the pathways linking physician communication to (improved) consultation outcomes for patients. More specifically, the aim is to determine the effects of information structuring and information tailoring, combined with physician caring, on information recall, satisfaction with information, and trust in the physician (primary objective) and on symptom distress (secondary objective). Methods: A randomized controlled trial, systematically testing the effects of information structuring and information tailoring, each combined with caring, in 2 video-vignette experiments (2×2 and 2×2×2 design). Using an online survey platform, participants will be randomly allocated (blinded) to 1 of 12 conditions in which they are asked to view a video vignette (intervention) in which an oncologist discusses a treatment plan for malignant lymphoma with a patient. The independent variables of interest are systematically varied across conditions. The outcome measures are assessed in a survey, using validated instruments. Study participants are (former) patients with cancer and their relatives recruited via online panels and patient organizations. This protocol discusses the trial design, including the video-vignette design, intervention pretesting, and a pilot study. Results: Data collection has now been completed, and preliminary analyses will be available in Spring 2019. A total of 470 participants completed the first part of the survey and were randomized to receive the intervention. Conclusions: The results of the proposed trial will provide evidence concerning the pathways linking physician information, giving skills to (improved) consultation outcomes for patients. Trial Registration: Netherlands Trial Register NTR6153; https://www.trialregister.nl/trial/6022 (Archived by Webcite at http://www.webcitation.org/76xVV9xC8). International Registered Report Identifier (IRRID): DERR1-10.2196/12453 %R 10.2196/12453 %U http://www.researchprotocols.org/2019/5/e12453/ %U https://doi.org/10.2196/12453 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 4 %P e12990 %T A New Light-Emitting, Fabric-Based Device for Photodynamic Therapy of Actinic Keratosis: Protocol for a Randomized, Controlled, Multicenter, Intra-Individual, Phase II Noninferiority Study (the Phosistos Study) %A Vignion-Dewalle,Anne-Sophie %A Abi Rached,Henry %A Thecua,Elise %A Lecomte,Fabienne %A Deleporte,Pascal %A Béhal,Hélène %A Hommel,Theresa %A Duhamel,Alain %A Szeimies,Rolf-Markus %A Mortier,Laurent %A Mordon,Serge %+ U1189 – ONCO-THAI – Image Assisted Laser Therapy for Oncology, Université de Lille, INSERM, Centre Hospitalier Universitaire de Lille, 1, avenue Oscar Lambret, Lille, F-59037 Lille Cedex, France, 33 320 446 717, anne-sophie.vignion@inserm.fr %K photodynamic therapy %K actinic keratosis %K Aktilite CL 128 lamp %K light-emitting fabric %D 2019 %7 26.04.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Actinic keratosis (AK) is a common early in situ skin carcinoma caused by long-term sun exposure and usually develops on sun-exposed skin areas. Left untreated, AK may progress to squamous cell carcinoma. To prevent such risk, most clinicians routinely treat AK. Therapy options for AK include cryotherapy, topical treatments, curettage, excision surgery, and photodynamic therapy (PDT). Objective: The aim of this study is to assess the noninferiority, in terms of efficacy at 3 months, of a PDT protocol involving a new light-emitting device (PDT using the Phosistos protocol [P-PDT]) compared with the conventional protocol (PDT using the conventional protocol [C-PDT]) in the treatment of AK. Methods: In this randomized, controlled, multicenter, intra-individual, phase II noninferiority clinical study, subjects with AK of the forehead and scalp are treated with P-PDT on one area and with C-PDT on the contralateral area. In both areas, lesions are prepared and methyl aminolevulinate (MAL) is applied. Thirty minutes after MAL application, the P-PDT area is exposed to red light at low irradiance (1.3 mW/cm2) for 2.5 hours so that a light dose of 12 J/cm2 is achieved. In the control area (C-PDT area), a 37 J/cm2 red light irradiation is performed 3 hours after MAL application. Recurrent AK at 3 months is retreated. The primary end point is the lesion complete response rate at 3 months. Secondary end points include pain scores at 1 day, local tolerance at 7 days, lesion complete response rate at 6 months, cosmetic outcome at 3 and 6 months, and patient-reported quality of life and satisfaction throughout the study. A total of 45 patients needs to be recruited. Results: Clinical investigations are complete: 46 patients were treated with P-PDT on one area (n=285 AK) and with C-PDT on the contralateral area (n=285 AK). Data analysis is ongoing, and statistical results will be available in the first half of 2019. Conclusions: In case of noninferiority in efficacy and superiority in tolerability of P-PDT compared with C-PDT, P-PDT could become the treatment of choice for AK. Trial Registration: ClinicalTrials.gov NCT03076892; https://clinicaltrials.gov/ct2/show/NCT03076892 (Archived by WebCite at http://www.webcitation.org/779qqVKek) International Registered Report Identifier (IRRID): DERR1-10.2196/12990 %M 31025953 %R 10.2196/12990 %U http://www.researchprotocols.org/2019/4/e12990/ %U https://doi.org/10.2196/12990 %U http://www.ncbi.nlm.nih.gov/pubmed/31025953 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 4 %P e11530 %T Evaluating the Noninferiority of a New Photodynamic Therapy (Flexitheralight) Compared With Conventional Treatment for Actinic Keratosis: Protocol for a Phase 2 Study %A Lecomte,Fabienne %A Vignion-Dewalle,Anne Sophie %A Vicentini,Claire %A Thecua,Elise %A Deleporte,Pascal %A Duhamel,Alain %A Mordon,Serge %A Mortier,Laurent %+ U1189 - Image Assisted Laser Therapies for Oncology, Inserm, Centre Hospitalier et Universitaire de Lille, Université de Lille, 1 avenue Oscar Lambret, Lille, 59037, France, 33 3 20 44 67 22, fabienne.lecomte@inserm.fr %K photodynamic therapy %K actinic keratosis %K light-emitting fabrics %K Aktilite CL 128 (Galderma Laboratories) %D 2019 %7 26.04.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Actinic keratosis (AK) is characterized by preinvasive, cancerous lesions on sun-exposed skin that negatively affect patient quality of life and may progress to invasive squamous cell carcinoma (SCC). If untreated, AK may either regress or progress to SCC, with significant morbidity and possible lethal outcomes. The most commonly used treatments for AK are cryotherapy, topical chemotherapy and, more recently, photodynamic therapy (PDT). This clinical study is part of a project that aims to create specific light-emitting fabrics (LEFs) that strongly improve the efficiency and reliability of PDT as a treatment for AK. Objective: This study aims to compare the efficacy and tolerability of a new PDT protocol involving the Flexitheralight device (N-PDT) with the classical protocol involving the Aktilite CL 128 device (C-PDT; Galderma Laboratories) for the treatment of AK. All participants receive both protocols. The primary objective of this study is to compare the lesion response rate after 3 months of N-PDT with C-PDT. Secondary objectives are evaluations of pain and local tolerance during treatment, clinical evolution of the subject's skin, and evaluations of patient quality of life and satisfaction. Methods: The study is a split-face, intraindividual comparison of two PDT protocols. The total number of patients recruited was 42. Patients were exposed to a continuous red light with the Aktilite CL 128 device on one side of the face and to fractionated red illumination with the new device, Flexitheralight, on the other side of the face. Males or females over the age of 18 years with a clinical diagnosis of at least 10 previously untreated, nonpigmented, nonhyperkeratotic grade I and II AK lesions of the forehead and/or scalp were included and were recruited from the Department of Dermatology of the Centre Hospitalier Universitaire de Lille. The patients came to the investigational center for one treatment session (day 1), and they were followed up after 7 days, 3 months and 6 months. A second treatment session was performed on day 111 in cases in which an incomplete response was observed at the 3-month follow-up. Data will be analyzed using SAS software version 9.4 (SAS Institute Inc). Continuous variables will be reported as means and standard deviations, and categorical variables will be reported as frequencies and percentages. The Shapiro-Wilk test will be used to assess the normality of the distribution. Results: The clinical investigation was performed by July 2018. Data analysis was performed at the end of 2018, and results are expected to be published in early 2019. Conclusions: This phase II clinical trial aims to evaluate the noninferior efficacy and superior tolerability of N-PDT compared to that of C-PDT. If N-PDT is both efficacious and tolerable, N-PDT could become the treatment of choice for AK due to its ease of implementation in hospitals. Trial Registration: ClinicalTrials.gov NCT03076918; https://clinicaltrials.gov/ct2/show/NCT03076918 (archived by WebCite at http://www.webcitation.org/771KA0SSK) International Registered Report Identifier (IRRID): DERR1-10.2196/11530 %M 31025952 %R 10.2196/11530 %U http://www.researchprotocols.org/2019/4/e11530/ %U https://doi.org/10.2196/11530 %U http://www.ncbi.nlm.nih.gov/pubmed/31025952 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 4 %P e12205 %T Double-Blind, Single-Center, Randomized Three-Way Crossover Trial of Fitted, Thin, and Standard Condoms for Vaginal and Anal Sex: C-PLEASURE Study Protocol and Baseline Data %A Siegler,Aaron J %A Rosenthal,Elizabeth M %A Sullivan,Patrick S %A Ahlschlager,Lauren %A Kelley,Colleen F %A Mehta,C Christina %A Moore,Reneé H %A Rosenberg,Eli S %A Cecil,Michael P %+ Rollins School of Public Health, Department of Behavioral Sciences and Health Educaiton, Emory University, 1518 Clifton Road NE, Atlanta, GA,, United States, 1 404 712 9733, asiegle@emory.edu %K condoms %K HIV prevention %K sexual health %K clinical trial %D 2019 %7 23.04.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Male condoms are underused despite their ability to prevent transmission of HIV and other sexually transmitted infections. The perception of decreased sexual pleasure and poor condom fit are major contributors to condom nonuse. Objective: The purpose of this study was to compare event-level performance and pleasure using fitted, thin, and standard condoms among men who have sex with men (MSM) and men who have sex with women (MSW). We also sought to assess condom type preference. We present the study design and enrollment data from the trial. Methods: This study recruited sexually active men aged 18 to 54 years in Atlanta, Georgia, United States. We enrolled 252 MSM and 252 MSW in a double-blind, 3-way randomized crossover trial with conditions of fitted, thin, and standard condoms. A permuted block randomization scheme was used to assign each participant to the sequence in which they received each type of study condom. After a baseline screening and enrollment visit, randomized participants were followed for at least 6 and up to 12 weeks depending on their use of study condoms in each 2-week period between scheduled, in-person study visits. Participants were instructed to complete mobile-optimized coital logs as soon as possible after using condoms for anal or vaginal sex acts. The logs collected event-level pleasure and performance measures for the study condoms as well as other relevant data. A questionnaire was administered at the final study visit to assess overall study condom preference. Results: The study enrolled 252 MSM and 252 MSW, a total of 504 participants. MSM and MSW study arms were similar for a number of key traits including race and ethnicity, marital status, self-rated condom experience, and recent experience of condom failure. Men in the MSM arm were older, however, and fewer MSM were students. The majority of participants in both arms rated themselves as very experienced with using condoms, and the majority had used condoms recently. Over one-third of participants in each arm reported experiencing condom failure in the last 6 months. Conclusions: This is the first condom trial to compare the performance of standard, thin, and fitted condoms and to use pleasure and preference as primary outcomes. Given the disparate impact of HIV on MSM, equal enrollment of MSM and MSW was a key feature of this study. Trial results may inform an FDA label indication for anal sex and provide new information regarding the relative performance of different types of condoms. Trial Registration: ClinicalTrials.gov NCT02753842; https://clinicaltrials.gov/ct2/show/NCT02753842 (Archived by WebCite at http://www.webcitation.org/76RLTFyf0) International Registered Report Identifier (IRRID): DERR1-10.2196/12205 %M 31012862 %R 10.2196/12205 %U https://www.researchprotocols.org/2019/4/e12205/ %U https://doi.org/10.2196/12205 %U http://www.ncbi.nlm.nih.gov/pubmed/31012862 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 4 %P e12792 %T Promotion of Family Routines and Positive Parent-Child Interactions for Obesity Prevention: Protocol for the 3 Pillars Study Randomized Controlled Trial %A Marsh,Samantha %A Gerritsen,Sarah %A Taylor,Rachael %A Galland,Barbara %A Parag,Varsha %A Maddison,Ralph %+ National Institute for Health Innovation, School of Population Health, University of Auckland, 261 Morrin Rd, St Johns, Auckland, 1072, New Zealand, 64 21400904, sam.marsh@auckland.ac.nz %K screen time %K family routines %K parent-child relations %K child, preschool %K randomized controlled trial %K health behavior %K pediatric obesity %K sleep %K parenting %K New Zealand %D 2019 %7 02.04.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Childhood obesity is a challenging public health issue, with 30% of children aged 2 to 4 years classified as being overweight or obese in New Zealand. This is concerning, given that up to 90% of obese 3-year-old children are overweight or obese by the time they reach adolescence. Interventions that target this age range often fail to demonstrate long-term effectiveness and primarily focus on traditional weight-related behaviors, including diet and physical activity. However, research suggests that targeting nontraditional weight-related behaviors, such as sleep, screen time, and family meals, may be a more effective approach in this age group, given the immense challenges in changing traditional weight-related behaviors in the long term. Objective: The aim of the proposed study was to develop and pilot the 3 Pillars Study (3PS), a 6-week program for parents of New Zealand toddlers and preschoolers aged 2 to 4 years to promote positive parent-child interactions during 3 family routines, specifically adequate sleep, regular family meals, and restricted screen time. Methods: Screen time at the end of the 6-week program is the primary endpoint. The effects of the program on screen time, frequency of family meals, parent feeding practices, diet quality, and sleep duration will be piloted using a randomized controlled trial, with outcomes compared between the active intervention group and a wait-list control group at 6 weeks (at the end of the program) and 12 weeks (at final follow-up). We aim to recruit 50 participants (25 per arm). Eligibility criteria include parents of children aged 2 to 4 years who are currently exceeding screen use recommendations (ie, greater than 1 hour of screen time per day). The 3PS program involves a half-day workshop, run by a community worker trained to deliver the program content, and 6-week access to a study website that contains in-depth information about the program. All participants will also receive a study pack, which includes resources to encourage engagement in the 3 family routines promoted by the program. Study data will be collected in REDCap. All statistical analyses will be performed using SAS version 9.4 and have been specified a priori in a statistical analysis plan prepared by the study statistician. Results: Trial recruitment opened in July 2018. Final follow-up was completed in December 2018, with trial findings expected to be available in early 2019. Conclusions: Findings from this pilot study will provide relevant data to inform the design of a larger effectiveness study of the 3PS program. Trial Registration: Australian New Zealand Clinical Trials Register ACTRN12618000823279; https://www.anzctr.org. au/Trial/Registration/TrialReview.aspx?id=375004 (Archived by WebCite at http://www.webcitation.org/773CALeTK) International Registered Report Identifier (IRRID): DERR1-10.2196/12792 %M 30938692 %R 10.2196/12792 %U https://www.researchprotocols.org/2019/4/e12792/ %U https://doi.org/10.2196/12792 %U http://www.ncbi.nlm.nih.gov/pubmed/30938692 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 4 %P e12166 %T Coaching and Education for Diabetes Distress (CEDD): Protocol for a Randomized Controlled Trial %A Chima,Charles C %A Salemi,Jason L %A Sidani,Mohamad A %A Zoorob,Roger J %+ Department of Population Health Science, John D Bower School of Population Health, University of Mississippi Medical Center, 2500 North State Street, Jackson, MS, 39216, United States, 1 601 815 9544, cchima@umc.edu %K diabetes mellitus, type 2 %K diabetes distress %K coaching %K health coaching %K counselling %K self care %K behavioral medicine %K health psychology %K health education %K primary care %D 2019 %7 02.04.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Diabetes distress (DD), a type of psychological distress specific to people with diabetes, is strongly associated with difficulties in performing self-care and inability to meet glycemic targets. Despite increased recognition of the need to manage DD, interventions that are both feasible and effective for reducing DD in routine care settings are not yet known. A pilot study showed that health coaching (HC) has some efficacy in addressing DD, but no adequately powered study has implemented a pragmatic research design capable of assessing the real-world effectiveness of HC in reducing DD. Objective: The aim of this study is to describe the rationale and design of an ongoing clinical trial, Coaching and Education for Diabetes Distress trial, that seeks to assess whether HC effectively reduces DD among primary care patients with diabetes and whether HC is more effective than an educational program targeting DD. Methods: The 2-arm randomized controlled trial is taking place at an academic family medicine practice in Houston, Texas. Both arms will receive usual care, which includes education about DD. In addition, the intervention arm will receive 8 HC sessions over a 5-month period. The primary outcome measure is reduction in DD over a 6-month period. Additional outcome measures include changes in hemoglobin A1c and self-care practices (medication-taking, dietary, and physical activity behaviors). Results: As of March 2019, screening and recruitment are ongoing, and the results are expected by July 2020. Conclusions: HC is feasible in primary care and has been successfully applied to improving chronic disease self-management and outcomes. This study will provide evidence as to whether it has significant value in addressing important unmet psychological and behavioral needs of patients with diabetes. Trial Registration: ClinicalTrials.gov NCT03617146; https://clinicaltrials.gov/ct2/show/NCT03617146 (Archived by WebCite at http://www.webcitation.org/76Va37dbO) International Registered Report Identifier (IRRID): DERR1-10.2196/12166 %M 30938687 %R 10.2196/12166 %U https://www.researchprotocols.org/2019/4/e12166/ %U https://doi.org/10.2196/12166 %U http://www.ncbi.nlm.nih.gov/pubmed/30938687 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 3 %P e12265 %T The Effects of Positive Affect and Episodic Future Thinking on Temporal Discounting and Healthy Food Demand and Choice Among Overweight and Obese Individuals: Protocol for a Pilot 2×2 Factorial Randomized Controlled Study %A Levens,Sara M %A Sagui-Henson,Sara J %A Padro,Meagan %A Martin,Laura E %A Trucco,Elisa M %A Cooperman,Nina A %A Baldwin,Austin S %A Kassianos,Angelos P %A Mdege,Noreen D %+ University of North Carolina at Charlotte, Department of Psychological Science, 9201 University City Boulevard, Charlotte, NC, 28223, United States, 1 704 687 1965, slevens@uncc.edu %K obesity %K cancer %K temporal discounting %K food choice %K eating behavior %K episodic future thinking %K positive affect %K guided imagery %K randomized controlled trial %D 2019 %7 20.03.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Unhealthy behaviors (eg, poor food choices) contribute to obesity and numerous negative health outcomes, including multiple types of cancer and cardiovascular and metabolic diseases. To promote healthy food choice, diet interventions should build on the dual-system model to target the regulation and reward mechanisms that guide eating behavior. Episodic future thinking (EFT) has been shown to strengthen regulation mechanisms by reducing unhealthy food choice and temporal discounting (TD), a process of placing greater value on smaller immediate rewards over larger future rewards. However, these interventions do not target the reward mechanisms that could support healthy eating and strengthen the impact of EFT-anchored programs. Increasing positive affect (PosA) related to healthy food choices may target reward mechanisms by enhancing the rewarding effects of healthy eating. An intervention that increases self-regulation regarding unhealthy foods and the reward value of healthy foods will likely have a greater impact on eating behavior compared with interventions focused on either process alone. Objective: This study aimed to introduce a protocol that tests the independent and interactive effects of EFT and PosA on TD, food choice, and food demand in overweight and obese adults. Methods: This protocol describes a factorial, randomized, controlled pilot study that employs a 2 (affective imagery: positive, neutral) by 2 (EFT: yes, no) design in which participants are randomized to 1 of 4 guided imagery intervention arms. In total, 156 eligible participants will complete 2 lab visits separated by 5 days. At visit 1, participants complete surveys; listen to the audio guided imagery intervention; and complete TD, food demand, and food choice tasks. At visit 2, participants complete TD, food demand, and food choice tasks and surveys. Participants complete a daily food frequency questionnaire between visits 1 and 2. Analyses will compare primary outcome measures at baseline, postintervention, and at follow-up across treatment arms. Results: Funding notification was received on April 27, 2017, and the protocol was approved by the institutional review board on October 6, 2017. Feasibility testing of the protocol was conducted from February 21, 2018, to April 18, 2018, among the first 32 participants. As no major protocol changes were required at the end of the feasibility phase, these 32 participants were included in the target sample of 156 participants. Recruitment, therefore, continued immediately after the feasibility phase. When this manuscript was submitted, 84 participants had completed the protocol. Conclusions: Our research goal is to develop novel, theory-based interventions to promote and improve healthy decision-making and behaviors. The findings will advance decision-making research and have the potential to generate new neuroscience and psychological research to further understand these mechanisms and their interactions. Trial Registration: ISRCTN Registry ISRCTN11704675; http://www.isrctn.com/ISRCTN11704675 (Archived by WebCite at http://www.webcitation.org/760ouOoKG) International Registered Report Identifier (IRRID): DERR1-10.2196/12265 %M 30892273 %R 10.2196/12265 %U https://www.researchprotocols.org/2019/3/e12265/ %U https://doi.org/10.2196/12265 %U http://www.ncbi.nlm.nih.gov/pubmed/30892273 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 2 %P e12121 %T Transforming Mental Health Delivery Through Behavioral Economics and Implementation Science: Protocol for Three Exploratory Projects %A Beidas,Rinad S %A Volpp,Kevin G %A Buttenheim,Alison N %A Marcus,Steven C %A Olfson,Mark %A Pellecchia,Melanie %A Stewart,Rebecca E %A Williams,Nathaniel J %A Becker-Haimes,Emily M %A Candon,Molly %A Cidav,Zuleyha %A Fishman,Jessica %A Lieberman,Adina %A Zentgraf,Kelly %A Mandell,David %+ Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3535 Market St, Philadelphia, PA, 19104, United States, 1 215 746 1759, rbeidas@upenn.edu %K implementation science %K behavioral economics %K mental health %D 2019 %7 12.02.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Efficacious psychiatric treatments are not consistently deployed in community practice, and clinical outcomes are attenuated compared with those achieved in clinical trials. A major focus for mental health services research is to develop effective and cost-effective strategies that increase the use of evidence-based assessment, prevention, and treatment approaches in community settings. Objective: The goal of this program of research is to apply insights from behavioral economics and participatory design to advance the science and practice of implementing evidence-based practice (EBP) for individuals with psychiatric disorders across the life span. Methods: Project 1 (Assisting Depressed Adults in Primary care Treatment [ADAPT]) is patient-focused and leverages decision-making heuristics to compare ways to incentivize adherence to antidepressant medications in the first 6 weeks of treatment among adults newly diagnosed with depression. Project 2 (App for Strengthening Services In Specialized Therapeutic Support [ASSISTS]) is provider-focused and utilizes normative pressure and social status to increase data collection among community mental health workers treating children with autism. Project 3 (Motivating Outpatient Therapists to Implement: Valuing a Team Effort [MOTIVATE]) explores how participatory design can be used to design organizational-level implementation strategies to increase clinician use of EBPs. The projects are supported by a Methods Core that provides expertise in implementation science, behavioral economics, participatory design, measurement, and associated statistical approaches. Results: Enrollment for project ADAPT started in 2018; results are expected in 2020. Enrollment for project ASSISTS will begin in 2019; results are expected in 2021. Enrollment for project MOTIVATE started in 2018; results are expected in 2019. Data collection had begun for ADAPT and MOTIVATE when this protocol was submitted. Conclusions: This research will advance the science of implementation through efforts to improve implementation strategy design, measurement, and statistical methods. First, we will test and refine approaches to collaboratively design implementation strategies with stakeholders (eg, discrete choice experiments and innovation tournaments). Second, we will refine the measurement of mechanisms related to heuristics used in decision making. Third, we will develop new ways to test mechanisms in multilevel implementation trials. This trifecta, coupled with findings from our 3 exploratory projects, will lead to improvements in our knowledge of what causes successful implementation, what variables moderate and mediate the effects of those causal factors, and how best to leverage this knowledge to increase the quality of care for people with psychiatric disorders. Trial Registration: ClinicalTrials.gov NCT03441399; https://www.clinicaltrials.gov/ct2/show/NCT03441399 (Archived by WebCite at http://www.webcitation.org/74dRbonBD) International Registered Report Identifier (IRRID): DERR1-10.2196/12121 %M 30747719 %R 10.2196/12121 %U http://www.researchprotocols.org/2019/2/e12121/ %U https://doi.org/10.2196/12121 %U http://www.ncbi.nlm.nih.gov/pubmed/30747719 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 2 %P e11441 %T The Safety, Tolerability, and Effects on the Systemic Inflammatory Response and Renal Function of the Human Chorionic Gonadotropin Hormone-Derivative EA-230 Following On-Pump Cardiac Surgery (The EASI Study): Protocol for a Randomized, Double-Blind, Placebo-Controlled Phase 2 Study %A van Groenendael,Roger %A Beunders,Remi %A Hofland,Jan %A Morshuis,Wim J %A Kox,Matthijs %A van Eijk,Lucas T %A Pickkers,Peter %+ Department of Intensive Care Medicine, Radboud University Medical Center, Geert Grooteplein Zuid 10, Nijmegen, 6525 GA, Netherlands, 31 243617273, peter.pickkers@radboudumc.nl %K EA-230 %K inflammation %K pregnancy %K cardiac surgery %K immunomodulation %K kidney/therapy %K clinical trials, phase II as topic %K safety %D 2019 %7 06.02.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: The cardiac surgery–induced systemic inflammatory response may induce postoperative hemodynamic instability and impairment of renal function. EA-230, a linear tetrapeptide (A-Q-G-V), is derived from the beta chain of the human chorionic gonadotropin pregnancy hormone. It has shown immunomodulatory and renoprotective effects in several animal models of systemic inflammation. In phase 1 and phase 2a studies, these immunomodulatory effects were confirmed during human experimental endotoxemia, and EA-230 was found to have an excellent safety profile. Objective: The objective of this first in-patient study is to test the safety and tolerability as well as the immunomodulatory and renoprotective effects of EA-230 in a proof-of-principle design in patients with systemic inflammation following on-pump cardiac surgery. Methods: We describe a prospective, randomized, double-blind, placebo-controlled study in which 180 elective patients undergoing on-pump coronary artery bypass grafting, with or without concomitant valve surgery, are enrolled. Patients will be randomized in a 1:1 ratio and will receive either EA-230 (90 mg/kg/hour) or a placebo. These will be infused at the start of the surgical procedure until the end of the use of the cardiopulmonary bypass. The primary focus of this first-in-patient study will be on safety and tolerability of EA-230. The primary efficacy end point is the modulation of the inflammatory response by EA-230 quantified as the change in interleukin-6 plasma concentrations after surgery. The key secondary end point is the effect of EA-230 on renal function. The study will be conducted in 2 parts to enable an interim safety analysis by an independent data monitoring committee at a sample size of 60. An adaptive design is used to reassess statistical power halfway through the study. Results: This study has been approved by the independent competent authority and ethics committee and will be conducted in accordance with the ethical principles of the Declaration of Helsinki, guidelines of Good Clinical Practice, and European Directive 2001/20/CE regarding the conduct of clinical trials. Results of this study will be submitted for publication in a peer-reviewed scientific journal. Enrollment of this study commenced in July 2016, and results are expected at the end of 2018. Conclusions: This adaptive phase 2 clinical study is designed to test the safety and tolerability of EA-230 in patients undergoing cardiac surgery. In addition, efficacy end points focused on the effect of the systemic inflammatory response and renal function are investigated. Trial Registration: ClinicalTrials.gov NCT03145220; https://clinicaltrials.gov/ct2/show/NCT03145220 (Archived by WebCite at http://www.webcitation.org/74JPh8GNN) International Registered Report Identifier (IRRID): DERR1-10.2196/11441 %M 30724734 %R 10.2196/11441 %U http://www.researchprotocols.org/2019/2/e11441/ %U https://doi.org/10.2196/11441 %U http://www.ncbi.nlm.nih.gov/pubmed/30724734 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 2 %P e10997 %T National Survey of Morbidity and Risk Factors (EMENO): Protocol for a Health Examination Survey Representative of the Adult Greek Population %A Touloumi,Giota %A Karakatsani,Anna %A Karakosta,Argiro %A Sofianopoulou,Eleni %A Koustenis,Panagiotis %A Gavana,Magda %A Alamanos,Yannis %A Kantzanou,Maria %A Konstantakopoulos,George %A Chryssochoou,Xenia %A Benos,Alexis %A Vantarakis,Apostolos %A Hadjichristodoulou,Christos %A Chlouverakis,Gregory %A Trypsianis,Gregory %A Voulgari,Paraskevi V %A Makrilakis,Konstantinos %A Liatis,Stavros %A Stergiou,George %A , %+ Department of Hygiene, Epidemiology and Medical Statistics, Medical School, National and Kapodistrian University of Athens, Mikras Asias 75, Athens,, Greece, 30 2107462089, gtouloum@med.uoa.gr %K health survey %K chronic diseases %K cardiovascular diseases %K respiratory %K risk factors %K epidemiology %K Greece %D 2019 %7 04.02.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Main causes of death in Greece are cardiovascular diseases (CVDs), malignant neoplasms, respiratory diseases, and road traffic crashes. To assess the population health status, monitor health systems, and adjust policies, national population-based health surveys are recommended. The previous health surveys that were conducted in Greece were restricted to specific regions or high-risk groups. Objective: This paper presents the design and methods of the Greek Health Examination Survey EMENO (National Survey of Morbidity and Risk Factors). The primary objectives are to describe morbidity (focusing on CVD, respiratory diseases, and diabetes), related risk factors, as well as health care and preventive measures utility patterns in a random sample of adults living in Greece. Methods: The sample was selected by applying multistage stratified random sampling on 2011 Census. Trained interviewers and physicians made home visits. Standardized questionnaires were administered; physical examination, anthropometric and blood pressure measurements, and spirometry were performed. Blood samples were collected for lipid profile, glucose, glycated hemoglobin, and transaminases measurements. The survey was conducted from May 2013 until June 2016. Results: In total, 6006 individuals were recruited (response rate 72%). Of these, 4827 participated in at least one physical examination, 4446 had blood tests, and 3622 spirometry, whereas 3580 provided consent for using stored samples for future research (3528 including DNA studies). Statistical analysis has started, and first results are expected to be submitted for publication by the end of 2018. Conclusions: EMENO comprises a unique health data resource and a bio-resource in a Mediterranean population. Its results will provide valid estimates of morbidity and risk factors’ prevalence (overall and in specific subdomains) and health care and preventive measures usage in Greece, necessary for an evidence-based strategy planning of health policies and preventive activities. International Registered Report Identifier (IRRID): DERR1-10.2196/10997 %M 30714576 %R 10.2196/10997 %U https://www.researchprotocols.org/2019/2/e10997/ %U https://doi.org/10.2196/10997 %U http://www.ncbi.nlm.nih.gov/pubmed/30714576 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e11545 %T TheraSphere Yttrium-90 Glass Microspheres Combined With Chemotherapy Versus Chemotherapy Alone in Second-Line Treatment of Patients With Metastatic Colorectal Carcinoma of the Liver: Protocol for the EPOCH Phase 3 Randomized Clinical Trial %A Chauhan,Nikhil %A Mulcahy,Mary F %A Salem,Riad %A Benson III,Al B %A Boucher,Eveline %A Bukovcan,Janet %A Cosgrove,David %A Laframboise,Chantal %A Lewandowski,Robert J %A Master,Fayaz %A El-Rayes,Bassel %A Strosberg,Jonathan R %A Sze,Daniel Y %A Sharma,Ricky A %+ Research and Development, BTG International group companies, 5 Fleet Place, London, EC4M 7RD, United Kingdom, 44 20 7575 0000, Nikhil.Chauhan@btgplc.com %K colorectal neoplasms %K neoplasm metastasis %K microspheres %K yttrium radioisotopes %K research design %K clinical trial, phase III %K randomized controlled trial %K metastatic colorectal cancer %K mCRC %D 2019 %7 17.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Colorectal cancer is one of the most common cancers and causes of cancer-related death. Up to approximately 70% of patients with metastatic colorectal cancer (mCRC) have metastases to the liver at initial diagnosis. Second-line systemic treatment in mCRC can prolong survival after development of disease progression during or after first-line treatment and in those who are intolerant to first-line treatment. Objective: The objective of this study is to evaluate the efficacy and safety of transarterial radioembolization (TARE) with TheraSphere yttrium-90 (90Y) glass microspheres combined with second-line therapy in patients with mCRC of the liver who had disease progression during or after first-line chemotherapy. Methods: EPOCH is an open-label, prospective, multicenter, randomized, phase 3 trial being conducted at up to 100 sites in the United States, Canada, Europe, and Asia. Eligible patients have mCRC of the liver and disease progression after first-line chemotherapy with either an oxaliplatin-based or irinotecan-based regimen and are eligible for second-line chemotherapy with the alternate regimen. Patients were randomized 1:1 to the TARE group (chemotherapy with TARE in place of the second chemotherapy infusion and subsequent resumption of chemotherapy) or the control group (chemotherapy alone). The addition of targeted agents is permitted. The primary end points are progression-free survival and hepatic progression-free survival. The study objective will be considered achieved if at least one primary end point is statistically significant. Secondary end points are overall survival, time to symptomatic progression defined as Eastern Cooperative Oncology Group Performance Status score of 2 or higher, objective response rate, disease control rate, quality-of-life assessment by the Functional Assessment of Cancer Therapy-Colorectal Cancer questionnaire, and adverse events. The study is an adaptive trial, comprising a group sequential design with 2 interim analyses with a planned maximum of 420 patients. The study is designed to detect a 2.5-month increase in median progression-free survival, from 6 months in the control group to 8.5 months in the TARE group (hazard ratio [HR] 0.71), and a 3.5-month increase in median hepatic progression-free survival time, from 6.5 months in the control group to 10 months in the TARE group (HR 0.65). On the basis of simulations, the power to detect the target difference in either progression-free survival or hepatic progression-free survival is >90%, and the power to detect the target difference in each end point alone is >80%. Results: Patient enrollment ended in October 2018. The first interim analysis in June 2018 resulted in continuation of the study without any changes. Conclusions: The EPOCH study may contribute toward the establishment of the role of combination therapy with TARE and oxaliplatin- or irinotecan-based chemotherapy in the second-line treatment of mCRC of the liver. Trial Registration: ClinicalTrials.gov NCT01483027; https://clinicaltrials.gov/ct2/show/NCT01483027 (Archived by WebCite at http://www.webcitation.org/734A6PAYW) International Registered Report Identifier (IRRID): RR1-10.2196/11545 %M 30664496 %R 10.2196/11545 %U https://www.researchprotocols.org/2019/1/e11545/ %U https://doi.org/10.2196/11545 %U http://www.ncbi.nlm.nih.gov/pubmed/30664496 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e11470 %T Rehabilitation for Children With Dystonic Cerebral Palsy Using Haptic Feedback in Virtual Reality: Protocol for a Randomized Controlled Trial %A McNish,Reika Nicole %A Chembrammel,Pramod %A Speidel,Nathaniel Christopher %A Lin,Julian Jwchun %A López-Ortiz,Citlali %+ Department of Kinesiology and Community Health, Department of Dance, Neuroscience Program, Illinois Informatics Institute, Beckman Institute for Advanced Science and Technology, University of Illinois at Urbana-Champaign, 906 South Goodwin Avenue, Urbana, IL, 61801, United States, 1 2173001022, lopezort@illinois.edu %K cerebral palsy %K child %K dystonia %K motor skills %K muscle spasticity %K randomized controlled trial %K rehabilitation %K robotics %K sensory feedback %K virtual reality %D 2019 %7 14.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Cerebral palsy (CP) is the most common developmental motor disorder in children. Individuals with CP demonstrate abnormal muscle tone and motor control. Within the population of children with CP, between 4% and 17% present dystonic symptoms that may manifest as large errors in movement tasks, high variability in movement trajectories, and undesired movements at rest. These symptoms of dystonia typically worsen with physical intervention exercises. Objective: The aim of this study is to establish the effect of haptic feedback in a virtual reality (VR) game intervention on movement outcomes of children with dystonic CP. Methods: The protocol describes a randomized controlled trial that uses a VR game-based intervention incorporating fully automated robotic haptic feedback. The study consists of face-to-face assessments of movement before, after, and 1 month following the completion of the 6-session game-based intervention. Children with dystonic CP, aged between 7 and 17 years, will be recruited for this study through posted fliers and laboratory websites along with a group of typically developing (TD) children in the same age range. We anticipate to recruit a total of 68 participants, 34 each with CP and TD. Both groups of children will be randomly allocated into an intervention or control group using a blocked randomization method. The primary outcome measure will be the smoothness index of the interaction force with the robot and of the accelerometry signals of sensors placed on the upper limb segments. Secondary outcomes include a battery of clinical tests and a quantitative measure of spasticity. Assessors administering clinical measures will be blinded. All sessions will be administered on-site by research personnel. Results: The trial has not started and is pending local institutional review board approval. Conclusions: Movement outcomes will be examined for changes in muscle activation and clinical measures in children with dystonic CP and TD children. Paired t tests will be conducted on movement outcomes for both groups of children independently. Positive and negative results will be reported and addressed. Trial Registration: ClinicalTrials.gov NCT03744884; https://clinicaltrials.gov/ct2/show/NCT03744884 (Archived by WebCite at http://www.webcitation.org/74RSvmbZP) International Registered Report Identifier (IRRID): PRR1-10.2196/11470 %M 31344678 %R 10.2196/11470 %U https://www.researchprotocols.org/2019/1/e11470/ %U https://doi.org/10.2196/11470 %U http://www.ncbi.nlm.nih.gov/pubmed/31344678 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e11911 %T Treatment of Atopic Dermatitis Using a Full-Body Blue Light Device (AD-Blue): Protocol of a Randomized Controlled Trial %A Kromer,Christian %A Nühnen,Viktoria P %A Pfützner,Wolfgang %A Pfeiffer,Sebastian %A Laubach,Hans-Joachim %A Boehncke,Wolf-Henning %A Liebmann,Joerg %A Born,Matthias %A Schön,Michael P %A Buhl,Timo %+ Department of Dermatology, Venereology, and Allergology, University Medical Centre Göttingen, Robert-Koch-Strasse 40, Göttingen,, Germany, 49 55139 ext 66402, timo.buhl@med.uni-goettingen.de %K atopic dermatitis %K atopic eczema %K blue light %K irradiation %K ultraviolet light %D 2019 %7 08.01.2019 %9 Protocol %J JMIR Res Protoc %G English %X Background: Irradiation with visible blue light (wavelength 400-495 nm) is a promising, effective, and safe new treatment option for chronic inflammatory skin diseases such as psoriasis and atopic dermatitis. Objective: We will perform a multicenter, placebo-controlled, double-blinded, 3-armed, prospective, randomized controlled trial to investigate the efficacy and safety of full-body blue light devices (wavelengths: 415 nm and 450 nm) compared with that of placebo irradiation for the treatment of atopic dermatitis. Methods: We are planning to enroll a total of 150 patients at the University hospitals in Göttingen (Germany), Marburg (Germany), and Geneva (Switzerland). Results: The trial was approved by the lead ethics committee of the medical faculty of the University of Göttingen (21/11/16). Further approvals were obtained from local and federal authorities (ethics committee Marburg, Cantonal Commission for Research Ethics Geneva, Suisse Medic, and Bundesinstitut für Arzneimittel und Medizinprodukte). Conclusions: We will disseminate the results in a peer-reviewed journal. Trial Registration: ClinicalTrials.gov NCT03085303; https://clinicaltrials.gov/ct2/show/NCT03085303 (Archived by WebCite at http://www.webcitation.org/73ucqkkA1) International Registered Report Identifier (IRRID): DERR1-10.2196/11911 %M 30622089 %R 10.2196/11911 %U http://www.researchprotocols.org/2019/1/e11911/ %U https://doi.org/10.2196/11911 %U http://www.ncbi.nlm.nih.gov/pubmed/30622089 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 8 %N 1 %P e11560 %T Recruitment and Baseline Characteristics of Participants in the Social, Emotional, and Economic Empowerment Through Knowledge of Group Support Psychotherapy Study (SEEK-GSP): Cluster Randomized Controlled Trial %A Nakimuli-Mpungu,Etheldreda %A Musisi,Seggane %A Wamala,Kizito %A Okello,James %A Ndyanabangi,Sheila %A Birungi,Josephine %A Nanfuka,Mastula %A Etukoit,Michael %A Mojtabai,Ramin %A Nachega,Jean %A Harari,Ofir %A Mills,Edward %+ Department of Psychiatry, College of Health Sciences, Makerere University, Old Mulago Hospital Complex, Mulago Hill Road, Kampala, 256, Uganda, 256 788994050, ethelmpungu@yahoo.com %K cluster randomized trial %K group support psychotherapy %K lay health workers %K depression %K recruitment %K psychosocial stressors %K persons living with HIV/AIDS %K Uganda %D 2019 %7 03.01.2019 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Psychosocial characteristics, including self-esteem, perceived social support, coping skills, stigma, discrimination, and poverty, are strongly correlated with depression symptoms. However, data on the extent of these correlations among persons living with HIV and the associations between psychosocial characteristics and HIV treatment outcomes are limited in sub-Saharan Africa. Objective: This paper aims to describe the recruitment process and baseline characteristics associated with depression in a sample of HIV-positive people in a cluster randomized trial of group support psychotherapy (GSP) for depression delivered by trained lay health workers (LHWs). Methods: Thirty eligible primary care health centers across three districts in Uganda were randomly allocated to have their LHWs trained to deliver GSP (intervention arm) or group HIV education and treatment as usual (control arm) to persons living with HIV comorbid with depression. Baseline demographic, socioeconomic, and psychosocial characteristics were collected via interviewer-administered questionnaires. Among eligible participants, differences between those enrolled versus those who refused enrollment were assessed using chi square for categorical variables and t tests for continuous variables. Spearman rank order correlation analyses were conducted to determine associations between baseline depression symptoms and adherence to antiretroviral therapy (ART), viral load suppression, and other psychosocial variables. Results: The study screened 1473 people and 1140 were found to be eligible and enrolled over 14 weeks. Participants recruited comprised 95% of the target sample size of 1200. The sample’s mean age was 38.5 (SD 10.9) years and both genders were well represented (males: 46.32%, 528/1140). Most participants met the diagnostic criteria for major depressive disorder (96.92%, 1105/1140), had significant posttraumatic stress symptoms (72.46%, 826/1140), reported moderate suicide risk (52.54%, 599/1140), had primary or no formal education (86.22%, 983/1140), and reported no income-generating activity (72.63%, 828/1140) and no food insecurity (81.67%, 931/1140). Among eligible participants, 48 of 1140 (4.21%) refused to participate in the interventions; these participants were more likely to be males (χ21=4.0, P=.045) and have significantly lower depression symptoms scores (t2=2.36, P=.01) than those who participated in the interventions. There was a significant positive correlation between viral load and number of traumatic experiences (ρ=.12, P=.05). Adherence to ART was positively correlated with perceived social support (ρ=.15, P<.001), but negatively correlated with depression symptoms (ρ=–.11, P=.05) and stigma (ρ=–.14, P<.001). Conclusions: Men and women with HIV and depression experience multiple social and economic vulnerabilities and disadvantages. Culturally tailored psychological interventions aimed at these individuals should address these socioeconomic disadvantages in addition to addressing their mental health care needs. Trial Registration: Pan African Clinical Trials Registry PACTR201608001738234; https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1738 (Archived by WebCite at http://www.webcitation.org/74NtMphom) %M 30609989 %R 10.2196/11560 %U http://www.researchprotocols.org/2019/1/e11560/ %U https://doi.org/10.2196/11560 %U http://www.ncbi.nlm.nih.gov/pubmed/30609989 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 12 %P e12046 %T The Japanese Early-Stage Trial of High-Dose Methylcobalamin for Amyotrophic Lateral Sclerosis (JETALS): Protocol for a Randomized Controlled Trial %A Oki,Ryosuke %A Izumi,Yuishin %A Nodera,Hiroyuki %A Sato,Yasutaka %A Nokihara,Hiroshi %A Kanai,Kazuaki %A Sonoo,Masahiro %A Urushitani,Makoto %A Nishinaka,Kazuto %A Atsuta,Naoki %A Kohara,Nobuo %A Shimizu,Toshio %A Kikuchi,Hitoshi %A Oda,Masaya %A Ikeda,Ken %A Nagai,Makiko %A Komai,Kiyonobu %A Kojima,Yasuhiro %A Kuzume,Daisuke %A Isose,Sagiri %A Shimohama,Shun %A Abe,Koji %A Ito,Hidefumi %A Noda,Kazuyuki %A Ishihara,Tomohiko %A Morita,Mitsuya %A Shimohata,Takayoshi %A Teramukai,Satoshi %A Kagimura,Tatsuo %A Noma,Kensuke %A Yanagawa,Hiroaki %A Kuwabara,Satoshi %A Kaji,Ryuji %A , %+ Department of Clinical Neuroscience, Institute of Biomedical Sciences, Tokushima University Graduate School, Kuramoto 2-50-1, Tokushima, 770-8503, Japan, 81 88 631 3111, yizumi@tokushima-u.ac.jp %K amyotrophic lateral sclerosis %K methylcobalamin %K vitamin B12 %K JETALS %K clinical trial %D 2018 %7 21.12.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease that affects the upper and lower motor neurons. Currently, only riluzole and edaravone are approved as drugs to treat ALS and new agents with larger effect sizes are warranted. Exploratory analyses in our previous study (study ID #E0302-J081-761) have suggested that high-dose methylcobalamin (E0302) prolonged the overall survival of ALS patients and suppressed ALS progression in patients with a disease duration of less than 12 months. Objective: This clinical trial aims to evaluate the efficacy and safety of E0302 for treatment of ALS patients within one year of onset. Methods: The Japanese early-stage trial of high-dose methylcobalamin for ALS (JETALS) is a prospective, multicenter, placebo-controlled, double-blind, randomized phase III study conducted at 24 tertiary neurology centers and is funded by the Japan Agency for Medical Research and Development. A total of 128 ALS patients within one year of onset were randomized at a 1:1 ratio to receive intramuscular injection with E0302 50 mg or placebo twice a week for 16 weeks. The primary endpoint is changes in the ALS Functional Rating Scale-Revised (ALSFRS-R) total score at 16 weeks. If patients wish to receive E0302 50 mg after the double-blind administration period, E0302 will be provided to them until March 2020 during the continuous administration period. Results: This study began in October 2017 and is being conducted at 24 participating institutions in Japan. The study is in progress and the patient enrollment period is scheduled to end in August 2019, with follow-up scheduled to end in March 2020. Conclusions: This study is being performed to revalidate the efficacy and safety of E0302 in patients with early-stage ALS in the first year of symptom onset. If positive results are obtained, the aim is to apply for E0302 approval as a new drug for the treatment of ALS. Trial Registration: ClinicalTrials.gov NCT03548311; https://clinicaltrials.gov/ct2/show/NCT03548311 (Archived by WebCite at http://www.webcitation.org/74Fw3rDzb) International Registered Report Identifier (IRRID): PRR1-10.2196/12046 %M 30578206 %R 10.2196/12046 %U http://www.researchprotocols.org/2018/12/e12046/ %U https://doi.org/10.2196/12046 %U http://www.ncbi.nlm.nih.gov/pubmed/30578206 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 11 %P e12334 %T Negative-Pressure Wound Therapy Versus Standard Treatment of Adult Patients With Conflict-Related Extremity Wounds: Protocol for a Randomized Controlled Trial %A Älgå,Andreas %A Wong,Sidney %A Haweizy,Rawand %A Conneryd Lundgren,Kalle %A von Schreeb,Johan %A Malmstedt,Jonas %+ Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Sjukhusbacken 10, Stockholm, 11883, Sweden, 46 702463287, andreas.alga@ki.se %K war-related injuries %K negative-pressure wound therapy %K extremity wounds %K resource-limited settings %D 2018 %7 26.11.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: In armed conflict, injuries commonly affect the extremities and contamination with foreign material often increases the risk of infection. The use of negative-pressure wound therapy has been described in the treatment of acute conflict-related wounds, but reports are retrospective and with limited follow-up. Objective: The objective of this study is to investigate the effectiveness and safety of negative-pressure wound therapy use in the treatment of patients with conflict-related extremity wounds. Methods: This is a multisite, superiority, pragmatic randomized controlled trial. We are considering for inclusion patients 18 years of age and older who are presenting with a conflict-related extremity wound within 72 hours after injury. Patients are block randomly assigned to either negative-pressure wound therapy or standard treatment in a 1:1 ratio. The primary end point is wound closure by day 5. Secondary end points include length of stay, wound infection, sepsis, wound complications, death, and health-related quality of life. We will explore economic outcomes, including direct health care costs and cost effectiveness, in a substudy. Data are collected at baseline and at each dressing change, and participants are followed for up to 3 months. We will base the primary statistical analysis on intention-to-treat. Results: The trial is ongoing. Patient enrollment started in June 2015. We expect to publish findings from the trial by the end of 2019. Conclusions: To the best of our knowledge, there has been no randomized trial of negative-pressure wound therapy in this context. We expect that our findings will increase the knowledge to establish best-treatment strategies. Trial Registration: ClinicalTrials.gov NCT02444598; http://clinicaltrials.gov/ct2/show/NCT02444598 (Archived by WebCite at http://www.webcitation.org/72hjI2XNX) International Registered Report Identifier (IRRID): DERR1-10.2196/12334 %M 30478024 %R 10.2196/12334 %U http://www.researchprotocols.org/2018/11/e12334/ %U https://doi.org/10.2196/12334 %U http://www.ncbi.nlm.nih.gov/pubmed/30478024 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 10 %P e178 %T Early Detection of Cardiovascular Changes After Radiotherapy for Breast Cancer: Protocol for a European Multicenter Prospective Cohort Study (MEDIRAD EARLY HEART Study) %A Walker,Valentin %A Crijns,Anne %A Langendijk,Johannes %A Spoor,Daan %A Vliegenthart,Rozemarijn %A Combs,Stephanie E %A Mayinger,Michael %A Eraso,Arantxa %A Guedea,Ferran %A Fiuza,Manuela %A Constantino,Susana %A Tamarat,Radia %A Laurier,Dominique %A Ferrières,Jean %A Mousseaux,Elie %A Cardis,Elisabeth %A Jacob,Sophie %+ Pôle Santé-Environnement (PSE-SANTE), Service de recherche sur les effets biologiques et sanitaires des rayonnements ionisants (SESANE), Laboratoire d'épidémiologie des rayonnements ionisants (LEPID), Institut de Radioprotection et de Sûreté Nucléaire (IRSN), BP17, Fontenay-aux-Roses,, France, 33 5 61 14 56 08, sophie.jacob@irsn.fr %K biomarkers %K breast cancer %K cardiotoxicity %K cardiac diagnostic imaging %K radiotherapy %K radiation dosimetry %D 2018 %7 01.10.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Breast cancer is the most common cancer among women, and radiotherapy plays a major role in its treatment. However, breast cancer radiotherapy can lead to incidental irradiation of the heart, resulting in an increased risk for a variety of heart diseases arising many years after radiotherapy. Therefore, identifying breast cancer patients at the highest risk for radiation-induced cardiac complications is crucial for developing strategies for primary and secondary prevention, which may contribute to healthy aging. There is still a need for precise knowledge on the relationship between radiation dose to specific cardiac structures and early subclinical cardiac changes and their occurrence over time that could finally lead to cardiac complications. Objective: The MEDIRAD EARLY HEART study aims to identify and validate new cardiac imaging and circulating biomarkers of radiation-induced cardiovascular changes arising within first 2 years of breast cancer radiotherapy and to develop risk models integrating these biomarkers combined with precise dose metrics of cardiac structures based on three-dimensional dosimetry. Methods: The EARLY HEART study is a multicenter, prospective cohort study in which 250 women treated for breast cancer and followed for 2 years after radiotherapy will be included. Women treated with radiotherapy without chemotherapy for a unilateral breast cancer and aged 40-75 years meet the inclusion criteria. Baseline and follow-up data include cardiac measurements based on two-dimensional speckle-tracking echocardiography, computed tomography coronary angiography, cardiac magnetic resonance imaging, and a wide panel of circulating biomarkers of cardiac injury. The absorbed dose will be evaluated globally for the heart and different substructures. Furthermore, the dose-response relationship will allow modeling the radiation-induced occurrence and evolution of subclinical cardiac lesions and biomarkers to develop prediction models. Results: This study details the protocol of the MEDIRAD EARLY HEART study and presents the main limits and advantages of this international project. The inclusion of patients began in 2017. Preliminary results are expected to be published in 2019, and complete analysis should be published in 2021. Conclusions: The MEDIRAD EARLY HEART study will allow identifying the main cardiac imaging and blood-based determinants of radiation-induced cardiac injuries to better propose primary and secondary preventive measures in order to contribute to enhanced patient care and quality of life. Trial Registration: ClinicalTrials.gov NCT03297346; https://clinicaltrials.gov/ct2/show/NCT03297346 (Archived by WebCite at http://www.webcitation.org/72KS7MIUU) Registered Report Identifier: RR1-10.2196/9906 %M 30274965 %R 10.2196/resprot.9906 %U https://www.researchprotocols.org/2018/10/e178/ %U https://doi.org/10.2196/resprot.9906 %U http://www.ncbi.nlm.nih.gov/pubmed/30274965 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 8 %P e11294 %T Evaluation of Biological and Functional Changes in Healthy Smokers Switching to the Tobacco Heating System 2.2 Versus Continued Tobacco Smoking: Protocol for a Randomized, Controlled, Multicenter Study %A Ansari,S Michael %A Lama,Nicola %A Blanc,Nicolas %A Bosilkovska,Marija %A Donelli,Andrea %A Picavet,Patrick %A Baker,Gizelle %A Haziza,Christelle %A Lüdicke,Frank %+ Philip Morris International Research & Development, Quai Jeanrenaud 5, 2000 Neuchâtel,, Switzerland, 41 58 242 2842, christelle.haziza@pmi.com %K smoking %K tobacco %K harm reduction %K tobacco products %K risk %K heated tobacco %K smoking cessation %K biomarkers %K metabolic networks %K pathways %D 2018 %7 24.08.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Tobacco harm reduction, substituting less harmful tobacco products for combustible cigarettes, is a complementary approach for smokers who would otherwise continue to smoke. The Philip Morris International (PMI) Tobacco Heating System (THS) 2.2 is a novel tobacco product with the potential to reduce the risk of harm in smokers compared to continued smoking of combustible cigarettes. It heats tobacco electrically in a controlled manner, never allowing the temperature to exceed 350°C, thereby preventing the combustion process from taking place and producing substantially lower levels of toxicants while providing nicotine, taste, ritual, and a sensory experience that closely parallels combustible cigarettes. Previous clinical studies have demonstrated reduced exposure to the toxicants (approaching the levels observed after quitting) for smokers who switched to THS 2.2, for three months. For adult smokers who would otherwise continue smoking combustible cigarettes, switching to THS 2.2 may represent an alternative way to reduce the risk of tobacco-related diseases. Objective: This study aimed to further substantiate the harm reduction potential of THS 2.2 by demonstrating favorable changes in a set of 8 coprimary endpoints, representative of pathomechanistic pathways (ie, inflammation, oxidative stress, lipid metabolism, respiratory function, and genotoxicity), linked to smoking-related diseases, in smokers switching from combustible cigarettes to THS 2.2. Methods: This study was a randomized, controlled, two-arm parallel group, multicenter ambulatory US study conducted in healthy adult smokers switching from combustible cigarettes to THS 2.2 compared with smokers continuing to smoke combustible cigarettes for six months. Subjects had a smoking history of at least ten years and did not intend to quit within the next six months. Results: Enrollment started in March 2015 and the trial was completed in September 2016. In total, 984 subjects were randomized (combustible cigarettes, n=483; THS 2.2, n=477), and 803 completed the study. The results are expected to be available in a subsequent publication in 2019. Conclusions: In this paper, we describe the rationale and design for this clinical study that focused on the evaluation of THS 2.2’s potential to reduce the risk of smoking-related diseases compared with that of combustible cigarettes. This study will provide insights regarding favorable changes in biological and functional endpoints informed by effects known to be seen upon smoking cessation. Trial Registration: ClinicalTrials.gov NCT02396381; http://clinicaltrials.gov/ct2/show/NCT02396381 (Archived by WebCite at http://www.webcitation.org/71PCRdagP) Registered Report Identifier: RR1-10.2196/11294 %M 30143474 %R 10.2196/11294 %U http://www.researchprotocols.org/2018/8/e11294/ %U https://doi.org/10.2196/11294 %U http://www.ncbi.nlm.nih.gov/pubmed/30143474 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 8 %P e10095 %T A Liftless Intervention to Prevent Preterm Birth and Low Birthweight Among Pregnant Ghanaian Women: Protocol of a Stepped-Wedge Cluster Randomized Controlled Trial %A Kwegyir-Afful,Emma %A Verbeek,Jos %A Aziato,Lydia %A Seffah,Joseph D %A Räsänen,Kimmo %+ Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, 3rd Floor, Canthia, Yliopistonranta 1C, Kuopio, FI-70211, Finland, 358 0404495521, emmakwe@uef.fi %K heavy lifting %K Ghana %K low birthweight %K liftless intervention %K low-and middle-income countries %K physical activity %K preterm birth %K randomized controlled trial %K stepped-wedge %D 2018 %7 23.08.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Preterm birth (PTB) is a leading cause of infant morbidity and mortality worldwide. Every year, 20 million babies are born with low birthweight (LBW), about 96% of which occur in low-income countries. Despite the associated dangers, in about 40%-50% of PTB and LBW cases, the causes remain unexplained. Existing evidence is inconclusive as to whether occupational physical activities such as heavy lifting are implicated. African women bear the transport burden of accessing basic needs for their families. Ghana’s PTB rate is 14.5%, whereas the global average is 9.6%. The proposed liftless intervention aims to decrease lifting exposure during pregnancy among Ghanaian women. We hypothesize that a reduction in heavy lifting among pregnant women in Ghana will increase gestational age and birthweight. Objective: To investigate the effects of the liftless intervention on the incidence of PTB and LBW among pregnant Ghanaian women. Methods: A cohort stepped-wedge cluster randomized controlled trial in 10 antenatal clinics will be carried out in Ghana. A total of 1000 pregnant participants will be recruited for a 60-week period. To be eligible, the participant should have a singleton pregnancy between 12 and 16 weeks gestation, be attending any of the 10 antenatal clinics, and be exposed to heavy lifting. All participants will receive standard antenatal care within the control phase; by random allocation, two clusters will transit into the intervention phase. The midwife-led 3-component liftless intervention consists of health education, a take-home reminder card mimicking the colors of a traffic light, and a shopping voucher. The primary outcome are gestational ages of <28, 28-32, and 33-37 weeks. The secondary outcomes are LBW (preterm LBW, term but LBW, and postterm), compliance, prevalence of low back and pelvic pain, and premature uterine contractions. Study midwives and participants will not be blinded to the treatment allocation. Results: Permission to conduct the study at all 10 antenatal clinics has been granted by the Ghana Health Service. Application for funding to begin the trial is ongoing. Findings from the main trial are expected to be published by the end of 2019. Conclusions: To the best of our knowledge, there has been no randomized trial of this nature in Ghana. Minimizing heavy lifting among pregnant African women can reduce the soaring rates of PTB and LBW. The findings will increase the knowledge of the prevention of PTB and LBW worldwide. Trial Registration: Pan African Clinical Trial Register (PACTR201602001301205); http://apps.who.int/trialsearch/ Trial2.aspx?TrialID=PACTR201602001301205 (Archived by WebCite at http://www.webcitation.org/71TCYkHzu) Registered Report Identifier: RR1-10.2196/10095 %M 30139723 %R 10.2196/10095 %U http://www.researchprotocols.org/2018/8/e10095/ %U https://doi.org/10.2196/10095 %U http://www.ncbi.nlm.nih.gov/pubmed/30139723 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 7 %P e10000 %T Community Volunteer Support for Families With Young Children: Protocol for the Volunteer Family Connect Randomized Controlled Trial %A Grace,Rebekah %A Kemp,Lynn %A Barnes,Jacqueline %A Elcombe,Emma %A Knight,Jennifer %A Baird,Kelly %A Webster,Vana %A Byrne,Fiona %+ Department of Educational Studies, Faculty of Human Sciences, Macquarie University, X5B Rm. 234, Macquarie University, North Ryde, 2109, Australia, 61 9850 9844, rebekah.grace@mq.edu.au %K randomized controlled trial %K volunteer home visiting %K families %K support services %D 2018 %7 16.07.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Use of community volunteers to support vulnerable families is a widely employed strategy with a long history. However, there has been minimal formal scientific investigation into the effectiveness of volunteer home visiting programs for families. There is also a need for research examining whether volunteer home visiting leads to improved outcomes for volunteers. Objective: The objective of this paper is to describe the research protocol for a pragmatic randomized controlled trial (RCT) of the Volunteer Family Connect intervention, a volunteer home visiting program designed to support families of young children who experience social isolation or a lack of parenting confidence and skills. The project is being conducted in partnership with 3 leading not-for-profit organizations, designed to contribute to the body of evidence that informs decisions about appropriate family support services according to the level of need. It is the first study to examine outcomes for both the families and the volunteers who deliver the service. Methods: The RCT is being conducted in 7 sites across Australia. We aim to recruit 300 families to the study: 150 control (services as usual) and 150 intervention (services as usual + volunteer home visiting) families. Intervention families will receive the service for 3-12 months according to their needs, and all participants will complete 6 data collection points over 15 months. A minimum of 80 volunteers will also be recruited, along with a matched community comparison group. The volunteers will complete 3 data collection points over 12 months. Primary outcomes include community connectedness and parenting competence. Secondary outcomes include parent physical and mental health; general parent well-being; parent empowerment; the child-parent relationship; sustainability of family routines; child immunization; child nutrition or breastfeeding; number of accidental injury reports; and volunteer health, well-being, and community connectedness. Results: This effectiveness trial was funded in 2016, and we aim to complete data collection by the end of 2018. The first results are expected to be submitted early in 2019. Conclusions: There is a need to rigorously assess volunteer home visiting and whether it has a unique and important role on the service landscape, complementary to professional services. This research is the first trial of a volunteer home visiting program to be conducted in Australia and one of the largest of its kind worldwide. Trial Registration: Australian New Zealand Clinical Trial Registry ACTRN12616000396426; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370304 (Archived by WebCite athttp://www.webcitation.org/70q42fU7V) Registered Report Identifier: RR1-10.2196/1000 %M 30012544 %R 10.2196/10000 %U http://www.researchprotocols.org/2018/7/e10000/ %U https://doi.org/10.2196/10000 %U http://www.ncbi.nlm.nih.gov/pubmed/30012544 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 6 %P e145 %T An Integrated Approach to Control Soil-Transmitted Helminthiasis, Schistosomiasis, Intestinal Protozoa Infection, and Diarrhea: Protocol for a Cluster Randomized Trial %A Raso,Giovanna %A Essé,Clémence %A Dongo,Kouassi %A Ouattara,Mamadou %A Zouzou,Fabien %A Hürlimann,Eveline %A Koffi,Veronique A %A Coulibaly,Gaoussou %A Mahan,Virginie %A Yapi,Richard B %A Koné,Siaka %A Coulibaly,Jean Tenena %A Meïté,Aboulaye %A Guéhi-Kabran,Marie-Claire %A Bonfoh,Bassirou %A N'Goran,Eliézer Kouakou %A Utzinger,Jürg %+ Swiss Tropical and Public Health Institute, Socinstrasse 57, Basel, CH-4002, Switzerland, 41 61 2848307, giovanna.raso@swisstph.ch %K community-led total sanitation %K Côte d’Ivoire %K diarrhea %K health education %K integrated control %K intestinal protozoa %K preventive chemotherapy %K schistosomiasis %K soil-transmitted helminthiasis %D 2018 %7 12.06.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: The global strategy to control helminthiases (schistosomiasis and soil-transmitted helminthiasis) emphasizes preventive chemotherapy. However, in the absence of access to clean water, improved sanitation, and adequate hygiene, reinfection after treatment can occur rapidly. Integrated approaches might be necessary to sustain the benefits of preventive chemotherapy and make progress toward interruption of helminthiases transmission. Objective: The aim of this study was to assess and quantify the effect of an integrated control package that consists of preventive chemotherapy, community-led total sanitation, and health education on soil-transmitted helminthiasis, schistosomiasis, intestinal protozoa infection, and diarrhea in rural Côte d’Ivoire. Methods: In a first step, a community health education program was developed that includes an animated cartoon to promote improved hygiene and health targeting school-aged children, coupled with a health education theater for the entire community. In a second step, a cluster randomized trial was implemented in 56 communities of south-central Côte d’Ivoire with 4 intervention arms: (1) preventive chemotherapy; (2) preventive chemotherapy plus community-led total sanitation; (3) preventive chemotherapy plus health education; and (4) all 3 interventions combined. Before implementation of the aforementioned interventions, a baseline parasitologic, anthropometric, and hygiene-related knowledge, attitudes, practices, and beliefs survey was conducted. These surveys were repeated 18 and 39 months after the baseline cross-sectional survey to determine the effect of different interventions on helminth and intestinal protozoa infection, nutritional indicators, and knowledge, attitudes, practices, and beliefs. Monitoring of diarrhea was done over a 24-month period at 2-week intervals, starting right after the baseline survey. Results: Key results from this cluster randomized trial will shed light on the effect of integrated approaches consisting of preventive chemotherapy, community-led total sanitation, and health education against infections with soil-transmitted helminths, schistosomes, an intestinal protozoa and prevention of diarrhea in a rural part of Côte d’Ivoire. Conclusions: The research provided new insights into the acceptability, strengths, and limitations of an integrated community-based control package targeting helminthiases, intestinal protozoa infections, and diarrhea in rural communities of Côte d’Ivoire. In the longer term, the study will allow determining the effect of the integrated control approach on infection patterns with parasitic worms and intestinal protozoa, diarrheal incidence, anthropometric measures, and hygiene-related knowledge, attitudes, practices, and beliefs. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 53102033; http://www.isrctn.com/ISRCTN53102033 (Archived by WebCite at http://www.webcitation.org/6wpnXEiHo) Registered Report Identifier: RR1-10.2196/9166 %M 29895511 %R 10.2196/resprot.9166 %U http://www.researchprotocols.org/2018/6/e145/ %U https://doi.org/10.2196/resprot.9166 %U http://www.ncbi.nlm.nih.gov/pubmed/29895511 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 6 %P e10053 %T Dental Home Visits for Caries Prevention Among Preschool Children: Protocol for a Cost-Effectiveness Analysis on a Randomized Control Trial %A Andiesta,Niekla Survia %A Hamid,Maimunah A %A Lee,KKC %A Pau,Allan %+ School of Dentistry, International Medical University, No 126, Jalan Jalil Perkasa 19, Bukit Jalil, Kuala Lumpur, 57000, Malaysia, 60 176132044, NieklaAndiesta@imu.edu.my %K cost-effectiveness analysis %K dental home visits %K caries prevention %K preschool children %D 2018 %7 06.06.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: In 2012, nearly 4000 children in Malaysia were referred to hospital pediatric dental services due to dental caries. Recent research has reported the effectiveness of dental home visits in preventing caries development in young children. Dental home visits (DHVs) are described as an ongoing relationship between the dentist and their patients, providing all aspects of a preventive oral health care program in the presence of the parents at home. Objective: The objective of this study is to evaluate the cost-effectiveness of dental home visits and oral health information, in the form of educational leaflets, in preventing new caries development in young children, compared to those receiving only educational leaflets over a period of two years. Cost-effectiveness analysis will be used to evaluate the cost-effectiveness of dental home visits. Methods: This is a collaborative project with the Oral Health Division of the Ministry of Health Malaysia. The Oral Health Division will provide access to a subsample from the National Oral Health of Preschoolers Survey which was carried out in 2015. The population of interest is children aged 5 and 6 years from kindergartens in the Selangor state of Malaysia. The study adopted a societal perspective for cost-effectiveness analysis and all types of resources that are of value to society will be included in analyzing the costs; such as cost to the patient, cost to the provider or institution, and indirect costs because of loss of productivity. Results: The trial has been approved by the International Medical University Malaysia’s Joint Research and Ethics Committee (Project ID: IMU R157-2014 [File III – 2016]). This trial is currently recruiting participants. Conclusions: The number of young children in Malaysia who have been referred to the hospital children’s dentistry service for severe caries is disturbing. The cost of dental treatment in young children is high due to the severity of the caries which require an aggressive treatment, and the need for general anesthesia or sedation. This study will provide information on the cost and effectiveness of DHVs in caries prevention of young children in Malaysia. Registered Report Identifier: RR1-10.2196/10053 %R 10.2196/10053 %U http://www.researchprotocols.org/2018/6/e10053/ %U https://doi.org/10.2196/10053 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 5 %P e124 %T Effect of Rebound Exercises and Circuit Training on Complications Associated with Type 2 Diabetes: Protocol for a Randomized Controlled Trial %A Kaka,Bashir %A Maharaj,Sonill Sooknunan %+ Discipline of Physiotherapy, School of Health Sciences, College of Health Sciences, University of KwaZulu-Natal, Block E-5, University road, Durban, 4000, South Africa, 27 312607938 ext 7938, bkaka.pth@buk.edu.ng %K diabetes %K musculoskeletal pain %K exercise %D 2018 %7 07.05.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: The incidence of type 2 diabetes mellitus, a chronic lifestyle disease, and its complications are on the rise. Exercise has been documented as being effective in the management of musculoskeletal pain, depression, and reduction of hyperglycemia in diabetic patients. However, there is no consensus regarding the types of exercise that reduce musculoskeletal pain and depression and improve quality of life as well as respiratory function among individuals with type 2 diabetes. Objective: The objective of this study is to determine the effects of rebound and circuit training on musculoskeletal pain, blood glucose level, cholesterol level, quality of life, depression, and respiratory parameters in patients with type 2 diabetes mellitus. Methods: A total of 70 participants are expected to be recruited in this single blind randomized controlled trial. Computer-generated random numbers will be used to randomize the participants into 3 groups, namely, the rebound exercise group, the circuit exercise group, and the control group. Measurements will be taken at baseline and at the end of the 8 weeks of the study. Participants’ musculoskeletal pain will be assessed using the visual analog scale, quality of life will be assessed using the SF 12 Health Survey Questionnaire, depression using the Beck Depression Inventory, respiratory parameters using the spirometer, and biochemical parameters such as glucose level and cholesterol level using the glucometer. Data will be analyzed using descriptive statistics and inferential statistics of multivariate analysis of variance between the groups and paired t test within the group. Alpha will be set at .05. Results: The results of this study will identify the effectiveness of rebound exercise and circuit training, compared with the control, in the management of type 2 diabetes mellitus and on quality of life, musculoskeletal pain, depression, glycemic control, cholesterol level, as well as improvement in respiratory function. Conclusions: Though different additional strategies such as exercise and dietary and lifestyle modifications exist for the control of type 2 diabetes, they are mostly applied for the control of glucose level. No strategies have been identified for the control of complications associated with diabetes such as musculoskeletal pain, depression, and reduction in quality of life. Trial Registration: Clinicaltrials.gov NCT03200795; https://clinicaltrials.gov/ct2/show/NCT03200795 (Archived by WebCite at http://www.webcitation.org/6mBgcj6z7) %M 29735476 %R 10.2196/resprot.8827 %U http://www.researchprotocols.org/2018/5/e124/ %U https://doi.org/10.2196/resprot.8827 %U http://www.ncbi.nlm.nih.gov/pubmed/29735476 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 5 %P e118 %T A Challenge-Based Approach to Body Weight–Supported Treadmill Training Poststroke: Protocol for a Randomized Controlled Trial %A Naidu,Avantika %A Brown,David %A Roth,Elliot %+ Department of Physical Therapy and Occupational Therapy, University of Alabama at Birmingham, South School of Health Professions Building, 3rd Floor, 1716 9th Avenue, Birmingham, AL, 35294 1212, United States, 1 205 934 3566, avnaidu@uab.edu %K stroke %K rehabilitation %K falls %K walking %K hemiparesis %K body weight support treadmill training %K balance %K robotics %K mobility %K walking challenges %D 2018 %7 03.05.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Body weight support treadmill training protocols in conjunction with other modalities are commonly used to improve poststroke balance and walking function. However, typical body weight support paradigms tend to use consistently stable balance conditions, often with handrail support and or manual assistance. Objective: In this paper, we describe our study protocol, which involved 2 unique body weight support treadmill training paradigms of similar training intensity that integrated dynamic balance challenges to help improve ambulatory function post stroke. The first paradigm emphasized walking without any handrails or manual assistance, that is, hands-free walking, and served as the control group, whereas the second paradigm incorporated practicing 9 essential challenging mobility skills, akin to environmental barriers encountered during community ambulation along with hands-free walking (ie hands-free + challenge walking). Methods: We recruited individuals with chronic poststroke hemiparesis and randomized them to either group. Participants trained for 6 weeks on a self-driven, robotic treadmill interface that provided body weight support and a safe gait-training environment. We assessed participants at pre-, mid- and post 6 weeks of intervention-training, with a 6-month follow-up. We hypothesized greater walking improvements in the hands-free + challenge walking group following training because of increased practice opportunity of essential mobility skills along with hands-free walking. Results: We assessed 77 individuals with chronic hemiparesis, and enrolled and randomized 30 individuals poststroke for our study (hands-free group=19 and hands-free + challenge walking group=20) from June 2012 to January 2015. Data collection along with 6-month follow-up continued until January 2016. Our primary outcome measure is change in comfortable walking speed from pre to post intervention for each group. We will also assess feasibility, adherence, postintervention efficacy, and changes in various exploratory secondary outcome measures. Additionally, we will also assess participant responses to a study survey, conducted at the end of training week, to gauge each group's training experiences. Conclusions: Our treadmill training paradigms, and study protocol represent advances in standardized approaches to selecting body weight support levels without the necessity for using handrails or manual assistance, while progressively providing dynamic challenges for improving poststroke ambulatory function during rehabilitation. Trial Registration: ClinicalTrials.gov NCT02787759; https://clinicaltrials.gov/ct2/show/NCT02787759 (Archived by Webcite at http://www.webcitation.org/6yJZCrIea) %M 29724706 %R 10.2196/resprot.9308 %U http://www.researchprotocols.org/2018/5/e118/ %U https://doi.org/10.2196/resprot.9308 %U http://www.ncbi.nlm.nih.gov/pubmed/29724706 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 4 %P e114 %T Intervention to Increase HIV Testing Among Substance-Using Young Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial %A Stephenson,Rob %A Bonar,Erin E %A Carrico,Adam %A Hunter,Alexis %A Connochie,Daniel %A Himmelstein,Rebecca %A Bauermeister,Jose %+ Center for Sexuality & Health Disparities, University of Michigan, 400 North Ingalls Building, Room 3303, Ann Arbor, MI, 48109, United States, 1 734 615 0149, rbsteph@umich.edu %K HIV %K men who have sex with men %K drug abuse %K substance use disorders %K motivational interviewing %D 2018 %7 30.04.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Young men who have sex with men (YMSM) and transgender people in the Detroit Metro Area are the only risk group for whom the incidence of HIV and sexually transmitted infections (STI) has increased since 2000, with HIV incidence nearly doubling among youth. Substance use (including alcohol), which is relatively frequent among YMSM and transgender people, creates barriers to the optimal delivery of HIV prevention and care services. Standard HIV counseling, testing, and referral (CTR) is limited in providing strategies to identify and address substance use. Hence, in its current form, CTR may not be serving the prevention needs of substance-using YMSM and transgender people. Brief counseling interventions, grounded in principles of motivational interviewing, may offer a mechanism to meet the HIV prevention and care needs of substance-using YMSM and transgender people. Objective: This prospective, 4-arm, factorial randomized controlled trial aims to examine the efficacy of an motivational interviewing–based substance use brief intervention (SUBI) on participants’ substance use and engagement in HIV prevention. Methods: The research implements a prospective randomized controlled trial (Project Swerve) of 600 YMSM and transgender people recruited both online and in person. Eligibility criteria include participants who (1) are between the ages of 15 to 29 years, (2) live in the Detroit Metro Area, (3) self-identify as a man or transgender man or woman, (4) have had sexual contact with a man in the 6 months before enrollment, (5) self-report binge drinking or any substance use in the 3 months before enrollment, and (6) self-report an unknown or negative HIV status upon enrollment. Participants are randomized to receive, 3-months apart starting at baseline, 2 individual sessions. Sessions are CTR-only, SUBI-only, CTR followed by SUBI, or SUBI followed by CTR. Results: Project Swerve was launched in April 2017 and enrollment is ongoing. Conclusions: Incorporating a SUBI that utilizes the principles of motivational interviewing into HIV CTR provides an opportunity to tailor counseling services for YMSM and transgender people to address additional client barriers to HIV and STI testing. Trial Registration: ClinicalTrials.gov NCT02945436; http://clinicaltrials.gov/ct2/show/NCT02945436 (Archived by WebCite at http://www.webcitation.org/6yFyOK57w) %M 29712625 %R 10.2196/resprot.9414 %U http://www.researchprotocols.org/2018/4/e114/ %U https://doi.org/10.2196/resprot.9414 %U http://www.ncbi.nlm.nih.gov/pubmed/29712625 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 4 %P e111 %T Tailored Versus Generic Knowledge Brokering to Integrate Mood Management Into Smoking Cessation Interventions in Primary Care Settings: Protocol for a Cluster Randomized Controlled Trial %A Minian,Nadia %A Noormohamed,Aliya %A Baliunas,Dolly %A Zawertailo,Laurie %A Mulder,Carol %A Ravindran,Arun %A de Oliveira,Claire %A Selby,Peter %+ Centre for Addiction and Mental Health, 100 Stokes Street, Toronto, ON, M6J 1H4, Canada, 1 416 535 8501 ext 36859, peter_selby@camh.net %K tobacco %K depression %K health care practitioner %K primary health care %K knowledge broker %K clinical decision support system %K screening %K brief intervention %K integrated care pathways %D 2018 %7 27.04.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Both tobacco smoking and depression are major public health problems associated with high morbidity and mortality. In addition, individuals with depression are almost twice as likely to smoke and less likely to achieve smoking cessation. In the Smoking Treatment for Ontario Patients program, an established smoking cessation program in Ontario, Canada, 38% of smokers in primary care settings have current or past depression with 6-month quit rates that are significantly lower than those without depression (33% versus 40%, P<.001). Integrating self-help mood management (eg, relaxation exercises and mood monitoring) with smoking cessation treatment increases long-term quit rates by 12%-20%. However, integration in real-world settings has not been reported. It is unclear which knowledge translation strategy would be more effective for motivating clinicians to provide resources on mood management to eligible patients. Objective: The objectives of this study are to investigate the following comparisons among depressed smokers enrolled in a smoking cessation program: 1) the effectiveness of generalized, exclusively email-based prompts versus a personalized knowledge broker in implementing mood management interventions; 2) the effectiveness of the two knowledge translation strategies on smoking quit rates; and 3) the incremental costs of the two knowledge translation strategies on the implementation of mood management interventions. Methods: The study design is a cluster randomized controlled trial of Family Health Teams participating in the Smoking Treatment for Ontario Patients program. Family Health Teams will be randomly allocated 1:1 to receive either generalized messages (related to depression and smoking) exclusively via email (group A) or be assigned a knowledge broker who provides personalized support through phone- and email-based check-ins (group B). The primary outcome, measured at the site level, is the proportion of eligible baseline visits that result in the provision of the mood management intervention to eligible patients. Results: Recruitment for the primary outcome of this study will be completed in 2018/2019. Results will be reported in 2019/2020. Conclusions: This study will address the knowledge gap in the implementation strategies (ie, email-based prompts versus a knowledge broker) of mood management interventions for smokers with depression in primary care settings. Trial Registration: ClinicalTrials.gov NCT03130998; https://clinicaltrials.gov/ct2/show/NCT03130998 (Archived on WebCite at www.webcitation.org/6ylyS6RTe) %M 29703714 %R 10.2196/resprot.9715 %U http://www.researchprotocols.org/2018/4/e111/ %U https://doi.org/10.2196/resprot.9715 %U http://www.ncbi.nlm.nih.gov/pubmed/29703714 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 4 %P e75 %T An Exercise Intervention to Unravel the Mechanisms Underlying Insulin Resistance in a Cohort of Black South African Women: Protocol for a Randomized Controlled Trial and Baseline Characteristics of Participants %A Goedecke,Julia H %A Mendham,Amy E %A Clamp,Louise %A Nono Nankam,Pamela A %A Fortuin-de Smidt,Melony C %A Phiri,Lindokuhle %A Micklesfield,Lisa K %A Keswell,Dheshnie %A Woudberg,Nicholas J %A Lecour,Sandrine %A Alhamud,Ali %A Kaba,Mamadou %A Lutomia,Faith M %A van Jaarsveld,Paul J %A de Villiers,Anniza %A Kahn,Steven E %A Chorell,Elin %A Hauksson,Jon %A Olsson,Tommy %+ Non-Communicable Diseases Research Unit, South African Medical Research Council, Francie van Zijl Drive, Parow Valley, Cape Town, 7505, South Africa, 27 0828255616, julia.goedecke@mrc.ac.za %K diabetes mellitus, type 2 %K insulin resistance %K body fat distribution %K adipose tissue %K skeletal muscle %K gastrointestinal microbiome %K exercise %K fatty liver %K inflammation %K energy metabolism %K cardiorespiratory fitness %K lipids %K metabolomics %K fatty acids %K diet records %K mitochondria %K ectopic fat %D 2018 %7 18.04.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: The pathogenesis of type 2 diabetes (T2D) in black African women is complex and differs from that in their white counterparts. However, earlier studies have been cross-sectional and provide little insight into the causal pathways. Exercise training is consistently used as a model to examine the mechanisms underlying insulin resistance and risk for T2D. Objective: The objective of the study was to examine the mechanisms underlying the changes in insulin sensitivity and secretion in response to a 12-week exercise intervention in obese black South African (SA) women. Methods: A total of 45 obese (body mass index, BMI: 30-40 kg/m2) black SA women were randomized into a control (n=22) or experimental (exercise; n=23) group. The exercise group completed 12 weeks of supervised combined aerobic and resistance training (40-60 min, 4 days/week), while the control group maintained their typical physical activity patterns, and both groups were requested not to change their dietary patterns. Before and following the 12-week intervention period, insulin sensitivity and secretion (frequently sampled intravenous glucose tolerance test) and its primary and secondary determinants were measured. Dietary intake, sleep quality and quantity, physical activity, and sedentary behaviors were measured every 4 weeks. Results: The final sample included 20 exercise and 15 control participants. Baseline sociodemographics, cardiorespiratory fitness, anthropometry, cardiometabolic risk factors, physical activity, and diet did not differ between the groups (P>.05). Conclusions: The study describes a research protocol for an exercise intervention to understand the mechanisms underlying insulin sensitivity and secretion in obese black SA women and aims to identify causal pathways underlying the high prevalence of insulin resistance and risk for T2D in black SA women, targeting specific areas for therapeutic intervention. Trial Registration: Pan African Clinical Trial Registry PACTR201711002789113; http://www.pactr.org/ATMWeb/ appmanager/atm/atmregistry?_nfpb=true&_pageLabel=portals_app_atmregistry_portal_page_13 (Archived by WebCite at http://www.webcitation.org/6xLEFqKr0) %M 29669711 %R 10.2196/resprot.9098 %U http://www.researchprotocols.org/2018/4/e75/ %U https://doi.org/10.2196/resprot.9098 %U http://www.ncbi.nlm.nih.gov/pubmed/29669711 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 4 %P e99 %T Universal Versus Conditional Third Day Follow-Up Visit for Children With Nonsevere Unclassified Fever at the Community Level in Ethiopia: Protocol for a Cluster Randomized Noninferiority Trial %A Källander,Karin %A Alfven,Tobias %A Workineh,Ayalkibet Abebe %A Hailemariam,,Abreham %A Petzold,Max %A Getachew,Dawit %A Barat,Lawrence %A Steinhardt,Laura C %A Gutman,Julie R %+ Malaria Consortium, 56-64 Leonard Street, Development House, London, EC2A 4LT, United Kingdom, 44 207549 ext 0270, k.kallander@malariaconsortium.org %K community health workers %K Ethiopia %K malaria %K fever %K child %D 2018 %7 12.04.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Under the World Health Organization’s integrated community case management strategy, febrile children seen by community health workers (on day 1) without a diagnosable illness and without danger signs are advised to return on day 3, regardless of symptom resolution. This advice might be unnecessary and place additional time and cost burdens on caregivers and community health workers. However, the safety of not following up with respect to children with unclassified fever is unknown. Objective: The objective of this study is to establish the safety of conditional follow-up of nonsevere unclassified fever, that is, nonsevere illness with fever, no malaria, pneumonia, diarrhea, or danger signs, compared with universal follow-up on day 3, through a 2-arm cluster randomized controlled noninferiority trial. Methods: The study is being conducted in 3 districts in southwest Ethiopia. A total of 25 health facilities are randomized to one of the 2 intervention arms; all 144 health posts and 284 community health workers are included. All enrolled children are followed-up after 1 week (on day 8) for re-assessment. If still sick on day 8, additional follow-up takes place after 2 weeks (day 15) and 1 month (day 29). To demonstrate that there is no significant increase in the percentage of children deteriorating clinically, the sample size needed for a noninferiority margin of 4%, a power of 80%, an alpha of 5%, and a design effect of 3 is 4284 children with unclassified fever. Main outcome is treatment failure on day 8, defined as death, hospitalization, one or more danger signs, or persistent fever. Results: The project was funded in 2015 and enrollment was completed 2016. Data analysis is currently under way, and the first results are expected to be submitted for publication in 2018. Conclusions: This study addresses the question as to whether there is any benefit in recommending universal follow-up among children seen for nonsevere unclassified fever, or whether parents can be counseled to return in the event of persistent fever, using a cluster randomized controlled trial design embedded in a national program. Outcomes will be relevant for policy makers and are important for the evaluation of current and future World Health Organization guidelines for the management of children with fever. Trial Registration: ClinicalTrials.gov NCT02926625; https://clinicaltrials.gov/ct2/show/NCT02926625 (Archived by WebCite at http://www.webcitation.org/6xrQWn50t) %M 29650505 %R 10.2196/resprot.9780 %U http://www.researchprotocols.org/2018/4/e99/ %U https://doi.org/10.2196/resprot.9780 %U http://www.ncbi.nlm.nih.gov/pubmed/29650505 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 3 %P e85 %T Investigating the Impact of Hearing Aid Use and Auditory Training on Cognition, Depressive Symptoms, and Social Interaction in Adults With Hearing Loss: Protocol for a Crossover Trial %A Nkyekyer,Joanna %A Meyer,Denny %A Blamey,Peter J %A Pipingas,Andrew %A Bhar,Sunil %+ Australian Research Council Training Centre in Biodevices, Faculty of Science, Engineering and Technology, Swinburne University of Technology, John Street Hawthorn, Mail H11, P O Box 218, Hawthorn Victoria, 3122, Australia, 61 422733157, jnkyekyer@swin.edu.au %K sensorineural hearing loss %K hearing aids %K crossover design %D 2018 %7 23.03.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Sensorineural hearing loss is the most common sensory deficit among older adults. Some of the psychosocial consequences of this condition include difficulty in understanding speech, depression, and social isolation. Studies have shown that older adults with hearing loss show some age-related cognitive decline. Hearing aids have been proven as successful interventions to alleviate sensorineural hearing loss. In addition to hearing aid use, the positive effects of auditory training—formal listening activities designed to optimize speech perception—are now being documented among adults with hearing loss who use hearing aids, especially new hearing aid users. Auditory training has also been shown to produce prolonged cognitive performance improvements. However, there is still little evidence to support the benefits of simultaneous hearing aid use and individualized face-to-face auditory training on cognitive performance in adults with hearing loss. Objective: This study will investigate whether using hearing aids for the first time will improve the impact of individualized face-to-face auditory training on cognition, depression, and social interaction for adults with sensorineural hearing loss. The rationale for this study is based on the hypothesis that, in adults with sensorineural hearing loss, using hearing aids for the first time in combination with individualized face-to-face auditory training will be more effective for improving cognition, depressive symptoms, and social interaction rather than auditory training on its own. Methods: This is a crossover trial targeting 40 men and women between 50 and 90 years of age with either mild or moderate symmetric sensorineural hearing loss. Consented, willing participants will be recruited from either an independent living accommodation or via a community database to undergo a 6-month intensive face-to-face auditory training program (active control). Participants will be assigned in random order to receive hearing aid (intervention) for either the first 3 or last 3 months of the 6-month auditory training program. Each participant will be tested at baseline, 3, and 6 months using a neuropsychological battery of computer-based cognitive assessments, together with a depression symptom instrument and a social interaction measure. The primary outcome will be cognitive performance with regard to spatial working memory. Secondary outcome measures include other cognition performance measures, depressive symptoms, social interaction, and hearing satisfaction. Results: Data analysis is currently under way and the first results are expected to be submitted for publication in June 2018. Conclusions: Results from the study will inform strategies for aural rehabilitation, hearing aid delivery, and future hearing loss intervention trials. Trial Registration: ClinicalTrials.gov NCT03112850; https://clinicaltrials.gov/ct2/show/NCT03112850 (Archived by WebCite at http://www.webcitation.org/6xz12fD0B). %M 29572201 %R 10.2196/resprot.8936 %U http://www.researchprotocols.org/2018/3/e85/ %U https://doi.org/10.2196/resprot.8936 %U http://www.ncbi.nlm.nih.gov/pubmed/29572201 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 3 %P e80 %T Symptomatic Treatment of Vascular Cognitive Impairment (STREAM-VCI): Protocol for a Cross-Over Trial %A Leijenaar,Jolien Fleur %A Groeneveld,Geert Jan %A van der Flier,Wiesje Maria %A Scheltens,Philip %A Klaassen,Erica Surya %A Weinstein,Henry Chanoch %A Biessels,Geert Jan %A Barkhof,Frederik %A Prins,Niels Daniël %+ Alzheimer Center & Department of Neurology, Amsterdam Neuroscience, VU University Medical Center, De Boelelaan 1118, Amsterdam, 1081 HZ, Netherlands, 31 0204440183, j.leijenaar@vumc.nl %K Vascular cognitive impairment %K dementia %K methylphenidate %K galantamine %K cognition %K Magnetic Resonance Imaging %K small vessel disease %K vascular disease %K clinical trial %D 2018 %7 20.03.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: People with vascular cognitive impairment (VCI) constitute a clinically heterogeneous group, but previous symptomatic drug trials in VCI did not take this clinical heterogeneity into account. Executive dysfunction and memory impairment are the cognitive domains that are most frequently impaired in VCI, and these impairments are likely to reflect vascular damage to specific neurotransmitter systems, which opens the possibility for targeted symptomatic treatment directed at specific neurotransmitters. Objective: Here we describe the design of the “Symptomatic Treatment of Vascular Cognitive Impairment” (STREAM-VCI) trial. In this proof-of-concept study, we investigate whether people with VCI with executive dysfunction due to vascular damage to the monoaminergic neurotransmitter system differentially respond to a monoaminergic challenge, whereas people with VCI with memory dysfunction associated with vascular damage to the cholinergic system will in turn respond to a cholinergic challenge. Methods: The STREAM-VCI is a single center, double blind, three-way cross-over trial among 30 people with VCI, in which subjects received a single dose of galantamine, methylphenidate, or placebo on separate occasions. The most important inclusion criteria were a diagnosis of VCI with a Mini-Mental State Examination score of ≥16 and a Clinical Dementia Rating of 0.5-1.0. For each person, the challenges consisted of a single 16 mg dose of galantamine, 10 mg of methylphenidate, and placebo, in random order on three separate visits. Change in performance in executive functioning and memory was assessed directly after the challenge using standardized neuropsychological tests. We will correlate a positive response to the cholinergic and monoaminergic treatment with differences in structural and functional connectivity at baseline using structural magnetic resonance imaging (MRI), diffusion tension MRI, and resting-state functional MRI. Results: The protocol of this study is approved by the Medical Ethics Committee of VU University Medical Center and the competent authority. The first participant was enrolled in April 2014. In September 2017, enrolment for the study was completed. We expect to publish the results in 2018. Conclusions: STREAM-VCI is the first study to investigate the association of a response to a cholinergic and monoaminergic treatment with structural and functional connectivity of the monoaminergic and/or cholinergic systems on MRI. We aim to predict on an individual basis which individuals show a positive response to a cholinergic and/or monoaminergic challenge in people with VCI. This may be instrumental in moving in the direction of individually-tailored pharmacological interventions based on MRI measures in people with VCI. Trial Registration: ClinicalTrials.gov NCT02098824; https://clinicaltrials.gov/ct2/show/NCT02098824 (Archived by WebCite at http://www.webcitation.org/6xhO7Ya1q) %M 29559423 %R 10.2196/resprot.9192 %U http://www.researchprotocols.org/2018/3/e80/ %U https://doi.org/10.2196/resprot.9192 %U http://www.ncbi.nlm.nih.gov/pubmed/29559423 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 3 %P e44 %T Outcome of Critically ill Patients Undergoing Mandatory Insulin Therapy Compared to Usual Care Insulin Therapy: Protocol for a Pilot Randomized Controlled Trial  %A Watkinson,Peter J %A Barber,Vicki S %A Young,J Duncan %+ Critical Care Trials Group, University of Oxford, Kadoorie Centre for Critical Care Research and Education, John Radcliffe Hospital, Oxford, OX3 9DU, United Kingdom, 44 01865 741166 ext 4265, peter.watkinson@ndcn.ox.ac.uk %K intensive care %K insulin %K glycaemic control %D 2018 %7 08.03.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Observational and interventional studies in patients with both acute medical conditions and long-standing diabetes have shown that improved blood glucose control confers a survival advantage or reduces complication rates. Policies of “tight” glycaemic control were rapidly adopted by many general intensive care units (ICUs) worldwide in the mid 00’s, even though the results of the studies were not generalizable to mixed medical/surgical ICUs with different intravenous feeding policies. Objective: The primary objective of the study is to assess the safety of mandatory insulin infusion in critically ill patients in a general ICU setting. Methods: This protocol summarizes the rationale and design of a randomized, controlled, single-center trial investigating the effect of mandatory insulin therapy versus usual care insulin therapy for those patients admitted for a stay of longer than 48 hours. In total, 109 critically ill adults predicted to stay in intensive care for longer than 48 hours consented. The primary outcome is to determine the safety of mandatory insulin therapy in critically ill patients using the number of episodes of hypoglycaemia and hypokalaemia per unit length of stay in intensive care. Secondary outcomes include the duration of mechanical ventilation, duration of ICU and hospital stay, hospital mortality, and measures of renal, hepatic, and haematological dysfunction. Results: The project was funded in 2005 and enrolment was completed 2007. Data analysis is currently underway and the first results are expected to be submitted for publication in 2018. Conclusions: This protocol for a randomized controlled trial investigating the effect of mandatory insulin therapy should provide an answer to a key question for the management of patients in the ICU and ultimately improving outcome. Trial Registration: International Standard Randomized Controlled Trial Number ISRCTN00550641; http://www.isrctn.com/ISRCTN00550641 (Archived at WebCite: http://www.webcitation.org/6xk8NXxNv). %M 29519778 %R 10.2196/resprot.5912 %U http://www.researchprotocols.org/2018/3/e44/ %U https://doi.org/10.2196/resprot.5912 %U http://www.ncbi.nlm.nih.gov/pubmed/29519778 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 3 %P e69 %T Treatment with Creatine Monohydrate in Spinal and Bulbar Muscular Atrophy: Protocol for a Randomized, Double-Blind, Placebo-Controlled Trial %A Hijikata,Yasuhiro %A Katsuno,Masahisa %A Suzuki,Keisuke %A Hashizume,Atsushi %A Araki,Amane %A Yamada,Shinichiro %A Inagaki,Tomonori %A Ito,Daisuke %A Hirakawa,Akihiro %A Kinoshita,Fumie %A Gosho,Masahiko %A Sobue,Gen %K spinal and bulbar muscular atrophy %K creatine %K randomized controlled trials %D 2018 %7 05.03.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Although spinal and bulbar muscular atrophy (SBMA) has been classified as a motor neuron disease, several reports have indicated the primary involvement of skeletal muscle in the pathogenesis of this devastating disease. Recent studies reported decreased intramuscular creatine levels in skeletal muscles in both patients with SBMA and transgenic mouse models of SBMA, which appears to contribute to muscle weakness. Objective: The present study aimed to examine the efficacy and safety of oral creatine supplementation to improve motor function in patients with SBMA. Methods: A randomized, double-blind, placebo-controlled, three-armed clinical trial was conducted to assess the safety and efficacy of creatine therapy in patients with SBMA. Patients with SBMA eligible for this study were assigned randomly in a 1:1:1 ratio to each group of placebo, 10 g, or 15 g daily dose of creatine monohydrate in a double-blind fashion. Participants took creatine or placebo orally 3 times a day for 8 weeks. Outcome measurements were results of neurological assessments, examinations, and questionnaires collected at baseline and at weeks 4, 8, and 16 after a washout period. The primary endpoint was the change in handgrip strength values from baseline to week 8. The secondary endpoints included the following: results of maximum voluntary isometric contraction tests of extremities; tongue pressure; results of the 15-foot timed walk test and the rise from bed test; modified quantitative myasthenia gravis score; respiratory function test results; activities of daily living assessed with the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale and the Spinal and Bulbar Muscular Atrophy Functional Rating Scale; skeletal muscle mass measured with dual-energy X-ray absorptiometry; urinary 8-hydroxydeoxyguanosine levels; and questionnaires examining the quality of life, swallowing function, and fatigue. Results: Participant enrollment in the trial started from June 2014 and follow-up was completed in July 2015. The study is currently being analyzed. Conclusions: This is the first clinical trial evaluating creatine therapy in SBMA. Given that creatine serves as an energy source in skeletal muscles, recovery of intramuscular creatine concentration is expected to improve muscle strength. Trial Registration: University Hospital Medical Information Network Clinical Trials Registry UMIN000012503; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014611 (Archived by WebCite at http://www.webcitation.org/6xOlbPkg3). %M 29506970 %R 10.2196/resprot.8655 %U https://www.researchprotocols.org/2018/3/e69/ %U https://doi.org/10.2196/resprot.8655 %U http://www.ncbi.nlm.nih.gov/pubmed/29506970 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 3 %P e47 %T Uterine Artery Embolization Versus Hysterectomy in the Treatment of Symptomatic Adenomyosis: Protocol for the Randomized QUESTA Trial %A de Bruijn,Annefleur Machteld %A Lohle,Paul NM %A Huirne,Judith AF %A de Vries,Jolanda %A Twisk,Moniek %A , %A Hehenkamp,Wouter JK %+ Department of Gynaecology and Obstetrics, Vrije Universiteit Medical Center, Vrije Universiteit, De boelelaan, 1117, Amsterdam, 1081HV, Netherlands, 31 624938924, a.debruijn@vumc.nl %K adenomyosis %K uterine artery embolization %K hysterectomy %K randomized trial %K quality of life %D 2018 %7 01.03.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Adenomyosis is a benign uterine disease characterized by invasion of endometrium into the myometrium resulting in heavy menstrual bleeding and pain (dysmenorrhea). Hysterectomy is established as the final treatment option when conservative treatment fails. Uterine artery embolization (UAE) in patients with symptomatic adenomyosis has demonstrated to reduce symptoms and improve quality of life. However, randomized controlled trials are lacking. Objective: With this study, we aim to evaluate the impact of UAE on Health-Related Quality of Life (HRQOL) in a randomized comparison to hysterectomy in patients with symptomatic adenomyosis. Methods: This is a multicenter non-blinded randomized controlled trial comparing UAE and hysterectomy. Eligible patients are symptomatic premenopausal women without the desire to conceive and who have symptomatic magnetic resonance imaging (MRI)–confirmed pure adenomyosis or dominant adenomyosis accompanied by fibroids. After obtaining informed consent, patients will be randomly allocated to treatment in a 2:1 UAE versus hysterectomy ratio. The primary objective is HRQOL at 6 months following the assigned intervention. Secondary outcomes are technical results, pain management, clinical outcomes, HRQOL, and cost effectiveness during 2 years of follow-up. In addition, transvaginal ultrasound (TVUS) and MRI will be performed at regular intervals after UAE. Results: Patient enrollment started November 2015. The follow-up period will be completed two years after inclusion of the last patient. At the time of submission of this article, data cleaning and analyses have not yet started. Conclusions: This trial will provide insight for caretakers and future patients about the effect of UAE compared to the gold standard hysterectomy in the treatment of symptomatic adenomyosis and is therefore expected to improve patients’ wellbeing and quality of life. Trial Registration: Netherlands Trial Register NTR5615; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5615 (Archived by WebCite at http://www.webcitation.org/6xZRyXeIF) %M 29496654 %R 10.2196/resprot.8512 %U https://www.researchprotocols.org/2018/3/e47/ %U https://doi.org/10.2196/resprot.8512 %U http://www.ncbi.nlm.nih.gov/pubmed/29496654 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 2 %P e53 %T Prehospital Advanced Diagnostics and Treatment of Acute Stroke: Protocol for a Controlled Intervention Study %A Bache,Kristi G %A Hov,Maren Ranhoff %A Larsen,Karianne %A Solyga,Volker Moræus %A Lund,Christian G %+ Research and Development, The Norwegian Air Ambulance Foundation, Holterveien 24, Drøbak, 1448, Norway, 47 46542271, kristi.bache@norskluftambulanse.no %K biomarkers %K blood analysis %K stroke scales %K cerebral CT examinations %K rtPa %K air ambulance model %K MSU %D 2018 %7 28.02.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Acute ischemic stroke (AIS) is a medical emergency. The outcome is closely linked to the time elapsing from symptom onset to treatment, and seemingly small delays can mean the difference between full recovery and physical and cognitive dysfunction. Recanalization to allow blood to reenter the affected area is most efficient immediately after symptoms occur, and intravenous thrombolysis must be initiated no later than 4.5 hours after the symptom onset. A liable diagnosis is mandatory to administer the appropriate treatment. Prehospital diagnosis and, in cases where contraindications are ruled out, prehospital initiation of intravenous thrombolysis have been shown to significantly decrease the time from alarm to the treatment. Objective: The objective of this paper is to investigate the effectiveness of prehospital thrombolysis as measured by (1) time spent from symptom onset to treatment and (2) the number of patients treated within 4.5 hours. In addition, we want to conduct explorative studies. These will include (1) the use of biomarkers for diagnostic and prognostic use where we will collect blood samples from various time points, including the hyperacute phase and (2) the study of magnetic resonance imaging (MRI) images at day 1 to determine the infarct volume and if the time to thrombolysis has an influence on this. Methods: This is a prospective controlled intervention study. The intervention will involve a computed tomography (CT) and thrombolysis in a physician-manned ambulance called a mobile stroke unit (MSU). The control will be the conventional pathway where the patient is transported to the hospital for CT, and thrombolysis as per current procedure. Results: Patient inclusion has started and a total of 37 patients are enrolled (control and intervention combined). The estimated time to completed inclusion is 36 months, starting from May 2017. The results of this study will be analyzed and published at the end of the trial. Conclusions: This trial aims to document the feasibility of saving time for all stroke patients by providing prehospital diagnostics and treatment, as well as transport to appropriate level of care, in a safe environment provided by anesthesiologists trained in prehospital critical care. Trial Registration: ClinicalTrials.gov NCT03158259; https://clinicaltrials.gov/show/NCT03158259 (Archived by WebCite at http://www.webcitation.org/6wxNEUMUD) %M 29490898 %R 10.2196/resprot.8110 %U http://www.researchprotocols.org/2018/2/e53/ %U https://doi.org/10.2196/resprot.8110 %U http://www.ncbi.nlm.nih.gov/pubmed/29490898 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 2 %P e58 %T Effect of Impulsive Compression Treatment on Postoperative Complications After Open Peripheral Vascular Revascularization (In Situ): Protocol for a Randomized Control Trial %A Klit,Tenna %A Dahl,Marie %A Houlind,Kim Christian %A Ravn,Hans %+ Department of Vascular Surgery, Hospital Lillebaelt, University of Southern Denmark, Hospital Lillebaelt, Kolding, 6000, Denmark, 45 28718505, doc.hans.ravn@gmail.com %K Critical leg ischemia %K postoperative edema %K Foot pump %D 2018 %7 20.02.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: In patients with critical leg ischemia (CLI), the standard operative choice is an in situ bypass to the lower extremity to improve the patients´ prognosis and quality of life. Postoperative complications after surgery occur in 18 % of the patients, prolonging hospitalization and convalescence. The main operative complication is edema. This can be prevented by early mobilization or stimulation of the natural venous pump in the leg. Objective: To investigate whether compression therapy with foot pump reduces postoperative edema, facilitates wound healing of the operation wounds, promotes healing of ischemic ulcers, and shortens hospitalization, increasing and improving the patient’s subjective quality of life faster. Methods: The protocol is designed as a randomized, unblinded prospective study with 50 patients in each group. Standard postoperative routines after bypass surgery, including short-stretch bandaging of the operated legs, are compared to supportive stimulation of the venous pump by an impulsive compression foot pump. The postoperative edema of the leg is measured 10 cm below the patella and 8 cm proximal to the medial malleolus. Measurements are performed preoperatively, 1 and 4 days postoperatively and at discharge. Results: The primary endpoint is reduction of leg edema by at least 50%. The secondary endpoint includes earlier mobilization in the pump group and decreased length of stay in hospital. Quality of life is evaluated through the European Health Related Quality of Life Questionnaire 5 Dimensions (EQ-5D) and Vascular Quality of Life Questionnaire-6 (VascuQol-6) questionnaires. The start of the study is February 1, 2018, and the end of the study is February 1, 2020. First results will be available April 2020. Conclusions: In orthopedic surgery of the lower extremities, the use of foot pumps has shown a reduction of edema and thrombosis in risk patients. Although important positive effects may be expected after vein bypass surgery, no reports have yet investigated the use of the device in vascular-operated patients and no analysis or meta Cochrane reviews are available in this field. Trial Registration: ClinicalTrials.gov NCT03192982; https://clinicaltrials.gov/ct2/show/NCT03192982 (Archived by WebCite at http://www.webcitation.org/6xMZJ06dw) %M 29463493 %R 10.2196/resprot.8799 %U http://www.researchprotocols.org/2018/2/e58/ %U https://doi.org/10.2196/resprot.8799 %U http://www.ncbi.nlm.nih.gov/pubmed/29463493 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 2 %P e57 %T Motivational Interviewing and Medication Review in Coronary Heart Disease (MIMeRiC): Protocol for a Randomized Controlled Trial Investigating Effects on Clinical Outcomes, Adherence, and Quality of Life %A Östbring,Malin Johansson %A Eriksson,Tommy %A Petersson,Göran %A Hellström,Lina %+ Pharmaceutical Department, Kalmar County Council, Building 2, Floor 2, County Council Hospital, Kalmar, SE-391 85, Sweden, 46 70 289 32 55, malin.johansson.ostbring@ltkalmar.se %K medication adherence %K medication therapy management %K pharmacist %K coronary artery disease %K randomized controlled trial %D 2018 %7 20.02.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Preventive treatment goals for blood pressure and cholesterol levels continue to be unmet for many coronary patients. The effect of drug treatment depends on both its appropriateness and the patients’ adherence to the treatment regimen. There is a need for adherence interventions that have a measurable effect on clinical outcomes. Objective: This study aims to evaluate the effects on treatment goals of an intervention designed to improve patient adherence and treatment quality in secondary prevention of coronary heart disease. A protocol for the prespecified process evaluation of the trial is published separately. Methods: The Motivational Interviewing and Medication Review in Coronary heart disease (MIMeRiC) trial is a prospective, randomized, outcomes-blinded trial designed to compare individualized follow-up by a clinical pharmacist using motivational interviewing (MI) and medication review with standard follow-up. Patients were randomized to 2 groups after stratification according to their beliefs about medicines. After standard follow-up at the cardiology clinic, patients in the intervention group are seen individually by a clinical pharmacist 2 to 5 times as required over 7 months, at the clinic. The pharmacist reviews each patient’s medication and uses MI to manage any problems with prescribing and adherence. The primary study outcome is the proportion of patients who have reached the treatment goal for low-density lipoprotein cholesterol by 12 months after discharge. Secondary outcomes are the effects on patient adherence, systolic blood pressure, disease-specific quality of life, and health care use. Results: The protocol for this study was approved by the Regional Ethics Committee, Linköping, in 2013. Enrollment started in October 2013 and ended in December 2016 when 417 patients had been included. Follow-up data collection will conclude in March 2018. Publication of the primary and secondary outcome results from the MIMeRiC trial is anticipated in 2019. Conclusions: The MIMeRiC trial will assess the effectiveness of an intervention involving medication reviews and individualized support. The results will inform the continued development of support for this large group of patients who use preventive medicines for lifelong treatment. The design of this adherence intervention is based on a theoretical framework and is the first trial of an intervention that uses beliefs about medicines to individualize the intervention protocol. Trial Registration: ClinicalTrials.gov NCT02102503; https://clinicaltrials.gov/ct2/show/NCT02102503 (Archived by WebCite at http://www.webcitation.org/6x7iUDohy) %M 29463490 %R 10.2196/resprot.8659 %U http://www.researchprotocols.org/2018/2/e57/ %U https://doi.org/10.2196/resprot.8659 %U http://www.ncbi.nlm.nih.gov/pubmed/29463490 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 2 %P e11 %T Testing Behavior Change Techniques to Encourage Primary Care Physicians to Access Cancer Screening Audit and Feedback Reports: Protocol for a Factorial Randomized Experiment of Email Content %A Vaisson,Gratianne %A Witteman,Holly O %A Bouck,Zachary %A Bravo,Caroline A %A Desveaux,Laura %A Llovet,Diego %A Presseau,Justin %A Saragosa,Marianne %A Taljaard,Monica %A Umar,Shama %A Grimshaw,Jeremy M %A Tinmouth,Jill %A Ivers,Noah M %+ Department of Epidemiology, Faculty of Medicine, Laval University, Pavillon Ferdinand-Vandry 2881, 1050 Avenue de la Médecine, Quebec City, QC,, Canada, 1 418 656 2131 ext 3981, gratianne.vaisson.1@ulaval.ca %K early detection of cancer %K primary health care %K feedback %K electronic mail %K persuasive communication %K clinical trials as topic %K behavior change techniques %K process evaluation %K implementation science %D 2018 %7 16.02.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Cancer Care Ontario’s Screening Activity Report (SAR) is an online audit and feedback tool designed to help primary care physicians in Ontario, Canada, identify patients who are overdue for cancer screening or have abnormal results requiring follow-up. Use of the SAR is associated with increased screening rates. To encourage SAR use, Cancer Care Ontario sends monthly emails to registered primary care physicians announcing that updated data are available. However, analytics reveal that 50% of email recipients do not open the email and less than 7% click the embedded link to log in to their report. Objective: The goal of the study is to determine whether rewritten emails result in increased log-ins. This manuscript describes how different user- and theory-informed messages intended to improve the impact of the monthly emails will be experimentally tested and how a process evaluation will explore why and how any effects observed were (or were not) achieved. Methods: A user-centered approach was used to rewrite the content of the monthly email, including messages operationalizing 3 behavior change techniques: anticipated regret, material incentive (behavior), and problem solving. A pragmatic, 2x2x2 factorial experiment within a multiphase optimization strategy will test the redesigned emails with an embedded qualitative process evaluation to understand how and why the emails may or may not have worked. Trial outcomes will be ascertained using routinely collected administrative data. Physicians will be recruited for semistructured interviews using convenience and snowball sampling. Results: As of April 2017, 5576 primary care physicians across the province of Ontario, Canada, had voluntarily registered for the SAR, and in so doing, signed up to receive the monthly email updates. From May to August 2017 participants received the redesigned monthly emails with content specific to their allocated experimental condition prompting use of the SAR. We have not yet begun analyses. Conclusions: This study will inform how to communicate effectively with primary care providers by email and identify which behavior change techniques tested are most effective at encouraging engagement with an audit and feedback report. Trial Registration: ClinicalTrials.gov NCT03124316; https://clinicaltrials.gov/ct2/show/NCT03124316 (Archived by WebCite at http://www.webcitation.org/6w2MqDWGu) %M 29453190 %R 10.2196/resprot.9090 %U https://www.researchprotocols.org/2018/2/e11/ %U https://doi.org/10.2196/resprot.9090 %U http://www.ncbi.nlm.nih.gov/pubmed/29453190 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 1 %P e26 %T Effect of a Titanium Tetrafluoride Varnish in the Prevention and Treatment of Carious Lesions in the Permanent Teeth of Children Living in a Fluoridated Region: Protocol for a Randomized Controlled Trial %A Souza,Beatriz Martines %A Santos,Daiana Moreli Soares %A Braga,Aline Silva %A Santos,Natália Mello Dos %A Rios,Daniela %A Buzalaf,Marilia Afonso Rabelo %A Magalhães,Ana Carolina %+ Department of Biological Sciences, Bauru School of Dentistry, University of São Paulo, Al Octávio Pinheiro Brisola, 9-75, Bauru, 17012-901, Brazil, 55 14 32358497, acm@usp.br %K clinical trial %K dental caries %K topical fluorides %D 2018 %7 26.01.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: Titanium tetrafluoride (TiF4) has regained interest due to new formulations that have been shown to be more effective against tooth demineralization than sodium fluoride (NaF) formulations in vitro and in situ. Objective: The aim of this study is to evaluate the effect of two types of varnishes (4% TiF4 and a commercial 5% NaF) on the prevention of carious lesions and the treatment of noncavitated enamel carious lesions in the permanent teeth of children living in a fluoridated area. Methods: This randomized, controlled, parallel and single-blind clinical trial involves 63 children, 6-7 years old, living in Bauru, São Paulo, Brazil. Children were selected according to their caries activity (ie, presence of at least 1 tooth with a Nyvad score of 1) and randomly divided into the following treatment categories: 4% TiF4 varnish (2.45 % F-, pH 1, FGM); 5% NaF varnish (2.26% F-, pH 5, Duraphat, Colgate) and control (placebo varnish, pH 5, FGM). The varnishes will be applied on all permanent teeth, once a week for 4 weeks and they will be reapplied only once 6 and 12 months after the study begins. Two calibrated examiners will carry out the clinical examination (International Caries Detection and Assessment System [ICDAS] and Nyvad indexes, kappa>.8) at baseline, before the first application, after the 1st, 6th, 12th, and 18th month of the study begins. Furthermore, quantitative fluorescence changes will be measured using Quantitative Light-Induced Fluorescence (QLF). The degree of patient satisfaction with the treatment will also be computed. The data will undergo statistical analysis (P<.05). Results: This ongoing study is funded by funding agencies from Brazil (São Paulo Research Foundation, FAPESP-015/14149-1, and National Council for Scientific and Technological Development, CNPq-401313/2016-6). We expect to confirm the efficacy of TiF4 on the prevention and treatment of carious lesions by comparing it to NaF varnish. The subjects are under 1 month evaluation and the dropout was about 8%. No differences between the treatments have been detected at the first month so far (P>.05). Conclusions: If our hypothesis is confirmed, TiF4 varnish can be marketed and applied at the individual level and used in community programs to control dental caries. Trial Registration: Brazilian Clinical Trials Registry: RBR-5VWJ4Y; http://www.ensaiosclinicos.gov.br/rg/?q=RBR-5VWJ4Y (Archived by WebCite at http://www.webcitation.org/6wUurEnm7) %M 29374001 %R 10.2196/resprot.9376 %U http://www.researchprotocols.org/2018/1/e26/ %U https://doi.org/10.2196/resprot.9376 %U http://www.ncbi.nlm.nih.gov/pubmed/29374001 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 7 %N 1 %P e17 %T Transitions Between Circulatory States After Out-of-Hospital Cardiac Arrest: Protocol for an Observational, Prospective Cohort Study %A Langeland,Halvor %A Bergum,Daniel %A Løberg,Magnus %A Bjørnstad,Knut %A Damås,Jan Kristian %A Mollnes,Tom Eirik %A Skjærvold,Nils-Kristian %A Klepstad,Pål %+ Department of Anesthesiology and Intensive Care Medicine, St. Olav’s University Hospital, Akutten og Hjerte-lunge-senteret, Prinsesse Kristinas Gate 3, Trondheim, 7030, Norway, 47 72 57 35 55, halvor.langeland@ntnu.no %K out-of-hospital cardiac arrest %K critical care %K hemodynamics %K inflammation %K biomarkers %D 2018 %7 19.01.2018 %9 Protocol %J JMIR Res Protoc %G English %X Background: The post cardiac arrest syndrome (PCAS) is responsible for the majority of in-hospital deaths following cardiac arrest (CA). The major elements of PCAS are anoxic brain injury and circulatory failure. Objective: This study aimed to investigate the clinical characteristics of circulatory failure and inflammatory responses after out-of-hospital cardiac arrest (OHCA) and to identify patterns of circulatory and inflammatory responses, which may predict circulatory deterioration in PCAS. Methods: This study is a single-center cohort study of 50 patients who receive intensive care after OHCA. The patients are followed for 5 days where detailed information from circulatory variables, including measurements by pulmonary artery catheters (PACs), is obtained in high resolution. Blood samples for inflammatory and endothelial biomarkers are taken at inclusion and thereafter daily. Every 10 min, the patients will be assessed and categorized in one of three circulatory categories. These categories are based on mean arterial pressure; heart rate; serum lactate concentrations; superior vena cava oxygen saturation; and need for fluid, vasoactive medications, and other interventions. We will analyze predictors of circulatory failure and their relation to inflammatory biomarkers. Results: Patient inclusion started in January 2016. Conclusions: This study will obtain advanced hemodynamic data with high resolution during the acute phase of PCAS and will analyze the details in circulatory state transitions related to circulatory failure. We aim to identify early predictors of circulatory deterioration and favorable outcome after CA. Trial Registration: ClinicalTrials.gov: NCT02648061; https://clinicaltrials.gov/ct2/show/NCT02648061 (Archived by WebCite at http://www.webcitation.org/6wVASuOla) %M 29351897 %R 10.2196/resprot.8558 %U http://www.researchprotocols.org/2018/1/e17/ %U https://doi.org/10.2196/resprot.8558 %U http://www.ncbi.nlm.nih.gov/pubmed/29351897 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 11 %P e223 %T Behavioral Interventions to Prevent or Delay Dementia: Protocol for a Randomized Comparative Effectiveness Study %A Smith,Glenn %A Chandler,Melanie %A Locke,Dona EC %A Fields,Julie %A Phatak,Vaishali %A Crook,Julia %A Hanna,Sherrie %A Lunde,Angela %A Morris,Miranda %A Graff-Radford,Michelle %A Hughes,Christine A %A Lepore,Susan %A Cuc,Andrea %A Caselli,Maria %A Hurst,Duane %A Wethe,Jennifer %A Francone,Andrea %A Eilertsen,Jeanne %A Lucas,Pauline %A Hoffman Snyder,Charlene %A Kuang,LeeAnn %A Becker,Marigrace %A Dean,Pamela %A Diehl,Nancy %A Lofquist,Marvin %A Vanderhook,Shirley %A Myles,Diana %A Cochran,Denise %+ Department of Clinical and Health Psychology, University of Florida, 1225 Center Dr, Rm 3154, PO Box 10065, Gainesville, FL, 32610, United States, 1 3252736556, glennsmith@phhp.ufl.edu %K cognition disorders %K dementia %K secondary prevention %K behavioral research %D 2017 %7 27.11.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: Currently, people at risk for dementia and their caregivers are confronted with confusing choices about what behavioral interventions are most effective. Objective: The objective of this study is to determine which empirically supported behavioral interventions most impact the outcomes highly valued by patients with mild cognitive impairment and their partners. Methods: This protocol describes a comparative effectiveness trial targeting 300 participants with mild cognitive impairment and their study partners. The trial is being conducted at the Mayo Clinic campuses in Arizona, Florida, Minnesota, and the University of Washington in Seattle. The study examines the contribution of five behavioral interventions (yoga, memory compensation training, computerized cognitive training, support groups, and wellness education) on primary outcomes of participant and partner quality of life and self-efficacy. In this unique 10-day multicomponent intervention, groups of couples were randomized to have one of the five interventions withheld while receiving the other four. Although the longitudinal follow-up is still under way, enrollment results are available and reported. Results: In total, 272 couples have been enrolled in the trial and follow-up visits continue. Outcomes will be assessed at the end-of-intervention and 6-, 12-, and 18-month follow-ups. We anticipate reporting on our primary and secondary outcomes across time points in the next 2 years. Conclusions: This paper describes the protocol for a randomized comparative effectiveness study of behavioral interventions to prevent or delay dementia. We describe of the rationale, design, power analysis, and analysis plan. Also because enrollment is complete and we are in follow-up phases of the study, we have included enrollment data from the trial. Trial Registration:  ClinicalTrials.gov NCT02265757; http://clinicaltrials.gov/ctsshow/ NCT02265757 (Archived by WebCite at http://www.webcitation.org/6ueRfwSYv) %M 29180344 %R 10.2196/resprot.8103 %U http://www.researchprotocols.org/2017/11/e223/ %U https://doi.org/10.2196/resprot.8103 %U http://www.ncbi.nlm.nih.gov/pubmed/29180344 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 10 %P e199 %T Assessing the Value of Prehabilitation in Patients Undergoing Colorectal Surgery According to the Enhanced Recovery After Surgery (ERAS) Pathway for the Improvement of Postoperative Outcomes: Protocol for a Randomized Controlled Trial %A Merki-Künzli,Cornelia %A Kerstan-Huber,Marta %A Switalla,Denise %A Gisi,David %A Raptis,Dimitri Aristotle %A Greco,Nicola %A Mungo,Giuseppe %A Wirz,Markus %A Gloor,Severin %A Misirlic,Merima %A Breitenstein,Stefan %A Tschuor,Christoph %+ Department of Surgery, Cantonal Hospital Winterthur, Brauerstrasse 15, Winterthur,, Switzerland, 41 522662488, stefan.breitenstein@ksw.ch %K prehabilitation %K enhanced recovery after surgery %K ERAS %D 2017 %7 27.10.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: A key element in the postoperative phase of the standardized Enhanced Recovery After Surgery (ERAS) treatment pathways is mobilization. Currently, there are no recommendations in the ERAS guidelines for preoperative physical activity. Patients undergoing major surgery are prone to functional decline due to the impairment of muscle, cardiorespiratory, and neurological function as a response to surgical stress. It has been shown that preoperative physical training reduces postoperative complications. To date, there are limited studies that investigate preoperative physical training combined with ERAS. Objective: The aim of this study is to assess the impact of tailored physical training prior to colorectal surgery conducted according to an ERAS protocol on overall morbidity. This study proposes the initial hypothesis that 3-6 weeks of prehabilitation before elective colorectal surgery may improve postoperative outcome and reduce complication rates, assessed using the Comprehensive Complication Index. The primary objective is to evaluate overall morbidity due to postoperative complications. Additionally, complications are assessed according to the Clavien-Dindo classification, length of stay, readmission rate, mortality rate, and treatment-related costs. Methods: The prehabilitation Enhanced Recovery After colorectal Surgery (pERACS) study is a single-center, single-blinded prospective randomized controlled trial. Patients scheduled for colorectal resections are randomly assigned either to the prehabilitation group or the control group. All patients are treated with the ERAS pathway for colorectal resections according to a standardized study schedule. Sample size calculation performed by estimating a clinically relevant 25% reduction of postoperative complications (alpha=.05, power 80%, dropout rate of 10%) resulted in 56 randomized patients per group. Results: Following ethical approval of the study protocol, the first patient was included in June 2016. At this time, a total of 40 patients have been included; 27 patients terminated the study by the end of March 2017. Results are expected to be published in 2018. Conclusions: The pERACS trial is a single-center, single-blinded prospective randomized controlled trial to assess the impact of tailored physical training prior to colorectal surgery, conducted according to an ERAS protocol, in order to evaluate overall morbidity. Trial Registration: Clinicaltrials.gov NCT02746731; https://clinicaltrials.gov/ct2/show/NCT02746731 (Archived by WebCite at http://www.webcitation.org/6tzblGwge) %M 29079551 %R 10.2196/resprot.7972 %U http://www.researchprotocols.org/2017/10/e199/ %U https://doi.org/10.2196/resprot.7972 %U http://www.ncbi.nlm.nih.gov/pubmed/29079551 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 8 %P e170 %T Project Stronger Together: Protocol to Test a Dyadic Intervention to Improve Engagement in HIV Care Among Sero-Discordant Male Couples in Three US Cities %A Stephenson,Rob %A Suarez,Nicolas A %A Garofalo,Robert %A Hidalgo,Marco A %A Hoehnle,Samuel %A Thai,Jennie %A Mimiaga,Matthew J %A Brown,Emily %A Bratcher,Anna %A Wimbly,Taylor %A Sullivan,Patrick %+ Department of Health Behaviors and Biological Sciences, School of Nursing, University of Michigan, 400 N Ingalls St, Ann Arbor, MI, 48109, United States, 1 734 615 0149, rbsteph@med.umich.edu %D 2017 %7 31.08.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: An estimated one- to-two-thirds of new human immunodeficiency virus (HIV) infections among US men who have sex with men (MSM) occur within the context of primary partnerships. Despite this fact, there remains a lack of prevention interventions that focus on male sero-discordant dyads. Interventions that provide male couples with skills to manage HIV risk, and to support each other towards active engagement in HIV prevention and care, are urgently needed. Objective: The objective of this paper is to describe the protocol for an innovative dyadic intervention (Stronger Together) that combines couples’ HIV testing and dyadic adherence counseling to improve treatment adherence and engagement in care among HIV sero-discordant male couples in the United States. Methods: The research activities involve a prospective randomized controlled trial (RCT) of approximately 165 venue- and clinic-recruited sero-discordant male couples (330 individuals: 165 HIV sero-negative and 165 HIV sero-positive). Couples randomized into the intervention arm receive couples’ HIV counseling and testing plus dyadic adherence counseling, while those randomized to the control arm receive individual HIV counseling and testing. The study takes place in three cities: Atlanta, GA (study site Emory University); Boston, MA (study site The Fenway Institute); and Chicago, IL (study site Ann & Robert H. Lurie Children’s Hospital of Chicago). Cohort recruitment began in 2015. Couples are followed prospectively for 24 months, with study assessments at baseline, 6, 12, 18, and 24 months. Results: Stronger Together was launched in August 2014. To date, 160 couples (97% of the target enrollment) have been enrolled and randomized. The average retention rate across the three sites is 95%. Relationship dissolution has been relatively low, with only 13 couples breaking up during the RCT. Of the 13 couples who have broken up, 10 of the 13 HIV-positive partners have been retained in the cohort; none of these HIV-positive partners have enrolled new partners into the RCT. Conclusions: The intervention offers a unique opportunity for sero-discordant couples to support each other towards common HIV management goals by facilitating their development of tailored prevention plans via couples-based HIV testing and counseling, as well as problem-solving skills in Partner Strategies to Enhance Problem-solving Skills (STEPS). Trial Registration: ClinicalTrials.gov NCT01772992; https://clinicaltrials.gov/ct2/show/NCT01772992 (Archived by WebCite at http://www.webcitation.org/6szFBVk1R) %M 28860107 %R 10.2196/resprot.7884 %U http://www.researchprotocols.org/2017/8/e170/ %U https://doi.org/10.2196/resprot.7884 %U http://www.ncbi.nlm.nih.gov/pubmed/28860107 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 8 %P e137 %T Ivermectin Treatment in Patients With Onchocerciasis-Associated Epilepsy: Protocol of a Randomized Clinical Trial %A Colebunders,Robert %A Mandro,Michel %A Mukendi,Deby %A Dolo,Housseini %A Suykerbuyk,Patrick %A Van Oijen,Marieke %+ University of Antwerp, Global Health Institute, Doornstraat 331, Antwerp,, Belgium, 32 486 92 01 49, robert.colebunders@uantwerpen.be %K onchocerciasis %K epilepsy %K nodding syndrome %K ivermectin %K randomized clinical trial %K Democratic Republic of the Congo %D 2017 %7 30.08.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: Many studies have reported an association between epilepsy, nodding syndrome (NS), and onchocerciasis (river blindness). A high prevalence of epilepsy has been noted particularly in onchocerciasis hyperendemic areas where onchocerciasis is not or insufficiently controlled with mass ivermectin distribution. There is evidence that increasing the coverage of ivermectin reduces the incidence of epilepsy, and anecdotal evidence suggests a reduction in seizure frequency in onchocerciasis-associated epilepsy (OAE) patients who receive ivermectin. Finding an alternative treatment for epilepsy in these patients will have major consequences. Objective: The goal of the study is to assess whether ivermectin treatment decreases the frequency of seizures and leads to seizure freedom in OAE patients, including patients with NS. If we are able to demonstrate such an effect, this would strengthen the argument that onchocerciasis is causing epilepsy and therefore we should increase our efforts to eliminate onchocerciasis. Methods: We will conduct a randomized clinical trial in the Democratic Republic of Congo to compare seizure freedom in onchocerciasis-infested epilepsy patients who receive immediate ivermectin treatment with delayed (after 4 months) ivermectin treatment. All participants will simultaneously receive antiepilepsy drugs (AEDs) according to local guidelines for epilepsy treatment. The primary endpoint is seizure freedom defined as no seizures during the 4 month of follow-up. Secondary endpoint is significant (>50%) seizure reduction compared to baseline seizure frequency. Reduction of seizures will be compared between ivermectin and nonivermectin arms. Results: Start of enrollment is planned for August 2017, and we expect to have enrolled all 110 participants by December 2017. Results are expected in June 2018. Conclusions: If ivermectin treatment in addition to AEDs is able to lead to seizure freedom or significantly reduces seizure frequency in OAE patients, this will have major consequences for epilepsy treatment in onchocerciasis-endemic regions. Ivermectin is donated for free and in non Loa-Loa–endemic regions has negligible side effects. Reducing the burden of epilepsy will have a major impact on quality of life and socioeconomic status of families with affected members in Africa. Trial Registration: ClinicalTrials.gov NCT03052998; https://clinicaltrials.gov/ct2/show/NCT03052998 (Archived by WebCite at http://www.webcitation.org/6roFVQSG0) %M 28855148 %R 10.2196/resprot.7186 %U http://www.researchprotocols.org/2017/8/e137/ %U https://doi.org/10.2196/resprot.7186 %U http://www.ncbi.nlm.nih.gov/pubmed/28855148 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 8 %P e149 %T The Spanish Version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) Adapted as a School-Based Anxiety and Depression Prevention Program: Study Protocol for a Cluster Randomized Controlled Trial %A García-Escalera,Julia %A Valiente,Rosa M %A Chorot,Paloma %A Ehrenreich-May,Jill %A Kennedy,Sarah M %A Sandín,Bonifacio %+ Faculty of Psychology, Universidad Nacional de Educación a Distancia, Juan del Rosal, 10, Madrid, 28040, Spain, 34 913987940, pchorot@psi.uned.es %K universal prevention %K transdiagnostic %K cluster %K randomized controlled trial %K unified protocol %K adolescents %K anxiety %K depression %K emotional disorders %K school intervention %D 2017 %7 21.08.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: Anxiety and depression are common, impairing conditions that evidence high comorbidity rates in adolescence. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) is one of the few existing resources aimed at applying transdiagnostic treatment principles to target core dysfunctions associated with both anxiety and depression within a single protocol. To our knowledge, this is the first study examining the efficacy of the UP-A adapted as a universal preventive intervention program. Objective: The primary aim of this study is to examine whether the Spanish version of the UP-A is more effective than a waitlist (WL) control group in reducing and preventing symptoms of anxiety and depression when employed as a universal, classroom-based preventive intervention. The secondary aim is to investigate changes in a broad range of secondary outcome measures, including negative and positive affect, anxiety sensitivity, emotional avoidance, top problems ratings, school grades, depression and anxiety-related interference, self-esteem, life satisfaction, quality of life, conduct problems, hyperactivity/inattention symptoms, peer problems, prosocial behavior, school adjustment, and discipline problems. Other aims are to assess a range of possible predictors of intervention effects and to examine the feasibility and the acceptability of implementing UP-A in a prevention group format and in a school setting. Methods: A cluster, randomized, WL, controlled trial design with classroom as the unit of randomization was used in this study. Five classes including a total of 152 adolescents were randomized to the experimental or WL control groups. Participants in the experimental group received 9 55-minute sessions delivered by advanced doctoral and masters students in clinical psychology. The WL control group will receive the intervention once the 3-month follow-up assessment is completed. Results: We have recruited participants to the cluster randomized controlled trial (RCT) and have conducted the intervention with the experimental group. We expect the WL control group to complete the intervention in July 2017. Data analysis will take place during the second semester of 2017. Conclusions: We expect the experimental group to outperform the WL control group at post-intervention and 3-month follow-up. We also expect the WL control group to show improvements in primary and secondary outcome measures after receiving the intervention. Results will have implications for researchers, families, and education providers. Trial Registration: Clinicaltrials.gov NCT03123991; https://clinicaltrials.gov/ct2/show/NCT03123991 (Archived by WebCite at http://www.webcitation.org/6qp7GIzcR) %M 28827212 %R 10.2196/resprot.7934 %U http://www.researchprotocols.org/2017/8/e149/ %U https://doi.org/10.2196/resprot.7934 %U http://www.ncbi.nlm.nih.gov/pubmed/28827212 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 8 %P e159 %T Are Routine Radiographs Needed the Day After Open Reduction and Internal Fixation Surgery for Distal Radius and Ankle Fractures: Study Protocol for a Prospective, Open Label, Randomized Controlled Trial %A Oehme,Florian %A Rühle,Annika %A Mühlhäusser,Julia %A Fourie,Lana %A Link,Björn-Christian %A Babst,Reto %A Beeres,Frank JP %+ Lucerne Cantonal Hospital, Surgery Department, Spitalstrasse, Lucerne, 6003, Switzerland, 41 41 205 1577, florianoehme85@gmail.com %K wrist fracture %K distal radius fracture %K ankle fracture %K postoperative radiograph %K functional outcome %K cost reduction %K radiation exposure %D 2017 %7 16.08.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: Distal radius and ankle fractures are one of the most common operatively treated fractures. To date, there is no consensus concerning the need for a standard postoperative radiograph. This leads to undesirable practice variations. A standardized radiograph in the department of radiology would theoretically be more reproducible and operator independent than an intraoperatively obtained fluoroscopic image. However, if adequate intraoperative radiographs have been obtained, it is questionable if these postoperative radiographs are necessary and will lead to changes in the treatment strategy. If standard postoperative radiographs are no longer required, this would lead to a reduction in radiation exposure and health care costs. The hypothesis is that routine standardized postoperative radiographs do not influence the quality of care for patients operated on for either a distal radius or an ankle fracture if adequate intraoperative standardized radiographs have been obtained. Objective: The primary aim of this study is to evaluate if there is a need for routine postoperative radiographs after an osteosynthesis of a distal radius or ankle fracture. Methods: In a prospective, randomized controlled, open label trial based on a noninferiority design, we will enroll 332 patients. Patients will be randomized either in the control or the intervention group. The control group will be treated according to our current, standard protocol in which all patients receive a standard anterior-posterior and lateral radiograph on the first postoperative day. Patients randomized to the intervention group will be treated without a standard postoperative radiograph. All patients (N=332) will have a routine clinical and radiographic control after 6 weeks in the outpatient clinic. Primary outcome is a change in treatment plan, defined as either additional imaging or a reoperation based on the postoperative imaging. Secondary outcome measures include a 36-Item Short Form Survey, Patient-Rated Wrist Hand Evaluation, Foot and Ankle Outcome Score, Visual Analogue Scale, and the range of motion. Those questionnaires will be filled out at the 6-week outpatient control. Results: The trial was started in August 2016, and 104 patients have been enrolled up to this point. Conclusions: Our findings will be reported in peer-reviewed publications and may lead to a strong reduction in radiation exposure and health care costs. A preliminary, conservative estimation suggests a yearly cost saving of CHF 1.3 million in Switzerland. %M 28814379 %R 10.2196/resprot.7698 %U http://www.researchprotocols.org/2017/8/e159/ %U https://doi.org/10.2196/resprot.7698 %U http://www.ncbi.nlm.nih.gov/pubmed/28814379 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 8 %P e153 %T Simulation-Based Training of Non-Technical Skills in Colonoscopy: Protocol for a Randomized Controlled Trial %A Khan,Rishad %A Scaffidi,Michael A %A Walsh,Catharine M %A Lin,Peter %A Al-Mazroui,Ahmed %A Chana,Barinder %A Kalaichandran,Ruben %A Lee,Woojin %A Grantcharov,Teodor P %A Grover,Samir C %+ St. Michael's Hospital, Division of Gastroenterology, University of Toronto, 30 Bond Street, Toronto, ON, M5B 1W8, Canada, 1 4168646060, samir.grover@utoronto.ca %K simulation %K colonoscopy %K non-technical skills %K skill acquisition %D 2017 %7 04.08.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: Non-technical skills (NTS), such as communication and professionalism, contribute to the safe and effective completion of procedures. NTS training has previously been shown to improve surgical performance. Moreover, increases in NTS have been associated with improved clinical endoscopic performance. Despite this evidence, NTS training has not been tested as an intervention in endoscopy. Objective: The aim of this study is to evaluate the effectiveness of a simulation-based training (SBT) curriculum of NTS on novice endoscopists’ performance of clinical colonoscopy. Methods: Novice endoscopists were randomized to 2 groups. The control group received 4 hours of interactive didactic sessions on colonoscopy theory and 6 hours of SBT. Hours 5 and 6 of the SBT were integrated scenarios, wherein participants interacted with a standardized patient and nurse, while performing a colonoscopy on the virtual reality (VR) simulator. The NTS (intervention) group received the same teaching sessions but the last hour was focused on NTS teaching. The NTS group also reviewed a checklist of tasks relevant to NTS concepts prior to each integrated scenario case and was provided with dedicated feedback on their NTS performance during the integrated scenario practice. All participants were assessed at baseline, immediately after training, and 4 to 6 weeks post-training. The primary outcome measure is colonoscopy-specific performance in the clinical setting. Results: In total, 42 novice endoscopists completed the study. Data collection and analysis is ongoing. We anticipate completion of all assessments by August 2017. Data analysis, manuscript writing, and subsequent submission for publication is expected to be completed by December 2017. Conclusions: Results from this study may inform the implementation of NTS training into postgraduate gastrointestinal curricula. NTS curricula may improve attitudes towards patient safety and self-reflection among trainees. Moreover, enhanced NTS may lead to superior clinical performance and outcomes in colonoscopy. Trial Registration: Clinicaltrial.gov NCT02877420; https://www.clinicaltrials.gov/ct2/show/NCT02877420 (Archived by WebCite at http://www.webcitation.org/6rw94ubXX NCT02877420) %M 28778849 %R 10.2196/resprot.7690 %U http://www.researchprotocols.org/2017/8/e153/ %U https://doi.org/10.2196/resprot.7690 %U http://www.ncbi.nlm.nih.gov/pubmed/28778849 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 6 %P e111 %T Pain Improvement With Novel Combination Analgesic Regimens (PAIN-CARE): Randomized Controlled Trial Protocol %A Gilron,Ian %A Tu,Dongsheng %A Holden,Ronald %A Jackson,Alan C %A Ghasemlou,Nader %A Duggan,Scott %A Vandenkerkhof,Elizabeth %A Milev,Roumen %+ Queen's University, Department of Anesthesiology and Perioperative Medicine, Victory 2, Anesthesiology, Kingston General Hospital, 76 Stuart Street, Kingston, ON,, Canada, 1 613 548 7827, gilroni@queensu.ca %K neuropathic pain %K alpha-lipoic acid %K antioxidant %K pregabalin %K anticonvulsant %D 2017 %7 08.06.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: Neuropathic pain (NP) (including painful diabetic neuropathy, postherpetic neuralgia, etc) affects approximately 7% to 8% of the population and is associated with a devastating symptom burden as well as a profound economic impact for patients, their families, and the health care system. Current therapies have limited efficacy and dose-limiting adverse effects (AEs). Rational combination therapy with carefully selected NP drugs has shown potential for measurable improvements in pain relief, quality of life, and health care use. Today, over half of NP patients concurrently receive 2 or more analgesics but combination use is based on little evidence. Research is urgently needed to identify safer, more effective combinations. Objective: We hypothesize that analgesic combinations containing at least 1 nonsedating agent would be as safe but more effective than either monotherapy without increasing overall AEs because of additive pain relief. Pregabalin (PGB), a sedating anticonvulsant, is proven effective for NP; the antioxidant alpha-lipoic acid (ALA) is one of the only nonsedating systemic agents proven effective for NP. Thus, we will conduct a clinical trial to compare a PGB+ALA combination to each monotherapy for NP. Methods: Using a double-blind, double-dummy, crossover design, 54 adults with NP will be randomly allocated to 1 of 6 sequences of treatment with PGB, ALA and PGB+ALA combination. During each of 3 different treatment periods, participants will take 2 sets of capsules containing (1) ALA or placebo and (2) PGB or placebo for 31 days, followed by an 11-day taper/washout period. The primary outcome will be mean daily pain intensity (0-10) at maximally tolerated dose (MTD) during each period. Secondary outcomes, assessed at MTD, will include global improvement, adverse events, mood, and quality of life. Results: Participant recruitment is expected to begin September 1, 2017. The proposed trial was awarded external peer-reviewed funding by the Canadian Institutes of Health Research (Canada) on July 15, 2016. Conclusions: This trial will provide rigorous evidence comparing the efficacy of a PGB+ALA combination to PGB alone and ALA alone in the treatment of NP. Trial Registration: International Standard Randomized Controlled Trial Number ISRCTN14577546; http://www.isrctn.com/ISRCTN14577546?q=&filters=conditionCategory:Signs%20and%20Symptoms,trialStatus: Ongoing,recruitmentCountry:Canada&sort=&offset=1&totalResults=2&page=1&pageSize=10&searchType=basic-search (Archived by WebCite at http://www.webcitation.org/6qvHFDc6m) %M 28596150 %R 10.2196/resprot.7493 %U http://www.researchprotocols.org/2017/6/e111/ %U https://doi.org/10.2196/resprot.7493 %U http://www.ncbi.nlm.nih.gov/pubmed/28596150 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 6 %P e109 %T The Effect of Core Stabilization Exercise on the Kinematics and Joint Coordination of the Lumbar Spine and Hip During Sit-to-Stand and Stand-to-Sit in Patients With Chronic Nonspecific Low Back Pain (COSCIOUS): Study Protocol for a Randomized Double-Blind Controlled Trial %A Pourahmadi,Mohammad Reza %A Ebrahimi Takamjani,Ismail %A Jaberzadeh,Shapour %A Sarrafzadeh,Javad %A Sanjari,Mohammad Ali %A Mohsenifar,Holakoo %A Bagheri,Rasool %A Taghipour,Morteza %+ School of Rehabilitation Sciences, Department of Physical Therapy, Iran University of Medical Sciences, Madadkaran All., Shahnazari St., Madar Sq., Mirdamad Blvd., Tehran,, Islamic Republic Of Iran, 98 21 2222 8051, dr_i_ebrahimi@yahoo.com %K kinematics %K lumbar spine %K hip %K chronic nonspecific low back pain %K joint coordination %K core stabilization exercise %D 2017 %7 01.06.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: Chronic nonspecific low back pain (CNLBP) is among the most prevalent health problems. Lumbar spine and hips kinematics and coordination can be affected in CNLBP. The effects of exercises on the kinematics and coordination of lumbar spine and hips during sit-to-stand (STS) and its reverse have not been evaluated. Objective: The aim of this study is to investigate the effect of core stabilization exercise on the kinematics and joint coordination of the lumbar spine and hip during STS and its reverse in CNLBP patients. Methods: COSCIOUS is a parallel randomized double-blind controlled trial. A total of 30 CNLBP patients and 15 asymptomatic participants will be included. The kinematics and joint coordination of the lumbar spine and hips will be evaluated during STS and its reverse using a motion capture system. The participants will be asked to sit in their usual posture on a stool. Reflective markers will be placed over the T12, S2, anterior and posterior superior iliac spines, greater trochanters, and lateral femoral epicondyles of both legs. The participants will be instructed to stand up at natural speed, remain in the erect posture for 3 seconds, and then sit down. Kinematic variables of the lumbar spine and hip will be computed. Afterward, the CNLBP participants will be allocated at random to receive one of 2 interventions: core stabilization or general exercise. Treatment sessions will be held 3 times per week for 16 sessions. After intervention, CNLBP participants will be assessed again. Results: Funding for the study was provided in 2016 by Iran University of Medical Sciences. The study is expected to last approximately 12 months, depending on recruitment. Findings on the study’s primary outcomes are expected to be finalized by December 2017. The results of the study will be published in a peer-reviewed journal. Conclusions: This investigation will evaluate the effects of core stabilization exercise on the kinematics and joint coordination of the lumbar spine and hip during STS and its reverse in patients with CNLBP. In addition, the effects of CNLBP on STS and its reverse will be investigated in COSCIOUS. Trial Registration: Iranian Registry of Clinical Trials IRCT2016080812953N2; http://en.search.irct.ir/view/32003?format=xml (Archived by WebCite at http://www.webcitation.org/6qjTWd4Az) %M 28572078 %R 10.2196/resprot.7378 %U http://www.researchprotocols.org/2017/6/e109/ %U https://doi.org/10.2196/resprot.7378 %U http://www.ncbi.nlm.nih.gov/pubmed/28572078 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 5 %P e93 %T The Effectiveness of a Computer Game-Based Rehabilitation Platform for Children With Cerebral Palsy: Protocol for a Randomized Clinical Trial %A Kanitkar,Anuprita %A Szturm,Tony %A Parmar,Sanjay %A Gandhi,Dorcas BC %A Rempel,Gina Ruth %A Restall,Gayle %A Sharma,Monika %A Narayan,Amitesh %A Pandian,Jeyaraj %A Naik,Nilashri %A Savadatti,Ravi R %A Kamate,Mahesh Appasaheb %+ College of Rehabilitation Sciences, University of Manitoba, R 106, 771 McDermot Ave, Winnipeg, MB, R3E0T6, Canada, 1 204 787 7747, tony.szturm@umanitoba.ca %K repetitive task practice %K cerebral palsy %K fine motor skills %K game-based exercise %K randomized controlled trial %K upper extremity function %D 2017 %7 18.05.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: It is difficult to engage young children with cerebral palsy (CP) in repetitive, tedious therapy. As such, there is a need for innovative approaches and tools to motivate these children. We developed the low-cost, computer game-based rehabilitation platform CGR that combines fine manipulation and gross movement exercises with attention and planning game activities appropriate for young children with CP. Objective: The objective of this study is to provide evidence of the therapeutic value of CGR to improve upper extremity (UE) motor function for children with CP. Methods: This randomized controlled, single-blind, clinical trial with an active control arm will be conducted at 4 sites. Children diagnosed with CP between the ages of 4 and 10 years old with moderate UE impairments and fine motor control abnormalities will be recruited. Results: We will test the difference between experimental and control groups using the Quality of Upper Extremity Skills Test (QUEST) and Peabody Developmental Motor Scales, Second Edition (PDMS-2) outcome measures. The parents of the children and the therapist experiences with the interventions and tools will be explored using semi-structured interviews using the qualitative description approach. Conclusions: This research protocol, if effective, will provide evidence for the therapeutic value and feasibility of CGR in the pediatric rehabilitation of UE function. Trial Registration: Clinicaltrials.gov NCT02728375; http:https://clinicaltrials.gov/ct2/show/NCT02728375 (Archived by WebCite at http://www.webcitation.org/6qDjvszvh) %M 28526673 %R 10.2196/resprot.6846 %U http://www.researchprotocols.org/2017/5/e93/ %U https://doi.org/10.2196/resprot.6846 %U http://www.ncbi.nlm.nih.gov/pubmed/28526673 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 5 %P e86 %T Testing the Effectiveness of a Primary Care Intervention to Improve Uptake of Colorectal Cancer Screening: A Randomized Controlled Trial Protocol %A Dodd,Natalie %A Carey,Mariko Leanne %A Mansfield,Elise %A Oldmeadow,Christopher %+ University of Newcastle, School of Medicine and Public Health, Faculty of Health and Medicine, University Drive, Callaghan,, Australia, 61 02 4042 0425, natalie.dodd@newcastle.edu.au %K clinical trial %K colorectal cancer %K early detection of cancer %K general practice %K primary care %K primary care provider %D 2017 %7 10.05.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: Screening for colorectal cancer (CRC) significantly reduces mortality associated with this disease. In Australia, the National Bowel Cancer Screening Program provides regular fecal occult blood tests (FOBT) for those aged 50 to 74 years, however, participation rates in the program have plateaued at 36%. Given low uptake in the National Bowel Cancer Screening Program, it is necessary to explore alternate methods to increase CRC screening rates. Primary care is a promising adjunct setting to test methods to increase CRC screening participation. Primary care guidelines support the recommendation and provision of CRC screening to primary care patients. Those in the National Bowel Cancer Screening Program target age range frequently present to their primary care provider. Objective: This study tests the effect that a multicomponent primary care–based intervention has on CRC screening uptake when compared to usual care. Methods: Primary care patients presenting for an appointment with their primary care provider complete a touchscreen survey to determine eligibility for the trial. Those aged 50 to 74 years, at average risk of CRC, with no history of CRC or inflammatory bowel disease, who have not had an FOBT in the past 2 years or a colonoscopy in the past 5 years are eligible to participate in the trial. Trial participants are randomized to the intervention or usual care group by day of attendance at the practice. The intervention consists of provision of an FOBT, printed information sheet, and primary care provider endorsement to complete the FOBT. The usual care group receives no additional care. Results: The primary outcome is completion of CRC screening 6 weeks after recruitment. The proportion of patients completing CRC screening will be compared between trial groups using a logistic regression model. Conclusions: CRC screening rates in Australia are suboptimal and interventions to increase screening participation are urgently required. This protocol describes the process of implementing a multicomponent intervention designed to increase CRC screening uptake in a primary care setting. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12616001299493; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371136&isReview=true (Archived by WebCite at http://www.webcitation.org/6pL0VYIj6). Universal Trial Number U1111-1185-6120. %M 28490420 %R 10.2196/resprot.7432 %U http://www.researchprotocols.org/2017/5/e86/ %U https://doi.org/10.2196/resprot.7432 %U http://www.ncbi.nlm.nih.gov/pubmed/28490420 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 5 %P e77 %T Simple Wound Irrigation in the Postoperative Treatment for Surgically Drained Spontaneous Soft Tissue Abscesses: Study Protocol for a Prospective, Single-Blinded, Randomized Controlled Trial %A Rühle,Annika %A Oehme,Florian %A Börnert,Katja %A Fourie,Lana %A Babst,Reto %A Link,Björn-Christian %A Metzger,Jürg %A Beeres,Frank JP %+ Lucerne Cantonal Hospital, Surgery Department, Spitalstrasse, Lucerne,, Switzerland, 41 412056804, annika.ruehle@gmx.de %K skin and soft-tissue infections %K recurrent infection %K wound irrigation %K surgical draining of abscesses %K aftercare %D 2017 %7 01.05.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: Skin abscesses are a frequent encountered health care problem and lead to a significant source of morbidity. They consequently have an essential impact on the quality of life and work. To date, the type of aftercare for surgically drained abscesses remains under debate. This leads to undesirable practice variations. Many clinical standard protocols include sterile wound dressings twice a day by a home-care service to reduce the chance of a recurrent wound infection. It is unknown, however, whether reinfection rates are comparable to adequate wound irrigation with a nonsterile solution performed by the patient. Our hypothesis is that simple wound irrigation with nonsterile water for postoperative wound care after an abscess is surgically drained is feasible. We assume that in terms of reinfection and reintervention rates unsterile wound irrigation is equal to sterile wound irrigation. Objective: The primary aim of this study is therefore to investigate if there is a need for sterile wound irrigation after surgically drained spontaneous skin abscesses. Methods: In a prospective, randomized controlled, single-blinded, single-center trial based on a noninferiority design, we will enroll 128 patients randomized to either the control or the intervention group. The control group will be treated according to our current, standard protocol in which all patients receive a sterile wound irrigation performed by a home-care service twice a day. Patients randomized to the intervention group will be treated with a nonsterile wound irrigation (shower) twice a day. All patients will have a routine clinical control visit after 1, 3, 6, and 12 weeks in the outpatient clinic. Primary outcome is the reinfection and reoperation rate due to insufficient wound healing diagnosed either at the outpatient control visit or during general practitioner visits. Secondary outcome measures include a Short Form Health Survey, Visual Analog Scale, Patient and Observer Scar Assessment Scale, Vancouver Scar Scale, and the EurolQol 5-Dimension Questionnaire. Those questionnaires will be completed at the outpatient control visits. Results: The trial was started in June 2016 and enrolled 50 patients by article publication. Regarding the adherence to our protocol, we found 10% of loss to follow-up until now. Only 2 patients needed reoperation and only 1 patient needed a change of treatment (antiseptic therapy). Most patients are happy with their randomized treatment but as expected some patients in the sterile group complained about timing problems with their working hours and home-care service appointments. Most patients in the nonsterile group are satisfied being able to take care of their wounds independently although some patients still depend on the home-care service for the wound dressing. We are hoping to have enrolled enough patients by summer 2017. The follow-up will take until autumn 2017, and study results are expected to be published by the end of 2017. This trial is solely supported by the cantonal hospital of Lucerne. Conclusions: Nonsterile wound irrigation is more likely to be carried out independently by the patient than sterile wound irrigation. Therefore, if nonsterile wound care shows comparable results in terms of reinfection and reintervention rates, patient independence in the aftercare of surgically drained abscesses will increase, patients can return to work earlier, and health care costs can be reduced. In a preliminary, conservative estimation of health care costs, an annual savings of 300,000 CHF will be achieved in our hospital. Trial Registration: German Clinical Trials Register DRKS00010418; https://drks-neu.uniklinik-freiburg.de/ drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00010418 (Archived by WebCite at http://www.webcitation.org/6q0AXp5EX) %M 28461284 %R 10.2196/resprot.7419 %U http://www.researchprotocols.org/2017/5/e77/ %U https://doi.org/10.2196/resprot.7419 %U http://www.ncbi.nlm.nih.gov/pubmed/28461284 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 3 %P e43 %T Protocol for Combined Analysis of FOXFIRE, SIRFLOX, and FOXFIRE-Global Randomized Phase III Trials of Chemotherapy +/- Selective Internal Radiation Therapy as First-Line Treatment for Patients With Metastatic Colorectal Cancer %A Virdee,Pradeep S %A Moschandreas,Joanna %A Gebski,Val %A Love,Sharon B %A Francis,E Anne %A Wasan,Harpreet S %A van Hazel,Guy %A Gibbs,Peter %A Sharma,Ricky A %+ National Institute for Health Research University College London Hospitals Biomedical Research Centre, UCL Cancer Institute, University College London, London,, United Kingdom, 44 020 3108 2212, ricky.sharma@oncology.ox.ac.uk %K colorectal neoplasms %K liver %K neoplasm metastasis %K radiation oncology %K survival analysis %K meta-analysis %D 2017 %7 28.03.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: In colorectal cancer (CRC), unresectable liver metastases are associated with a poor prognosis. The FOXFIRE (an open-label randomized phase III trial of 5-fluorouracil, oxaliplatin, and folinic acid +/- interventional radioembolization as first-line treatment for patients with unresectable liver-only or liver-predominant metastatic colorectal cancer), SIRFLOX (randomized comparative study of FOLFOX6m plus SIR-Spheres microspheres versus FOLFOX6m alone as first-line treatment in patients with nonresectable liver metastases from primary colorectal carcinoma), and FOXFIRE-Global (assessment of overall survival of FOLFOX6m plus SIR-Spheres microspheres versus FOLFOX6m alone as first-line treatment in patients with nonresectable liver metastases from primary colorectal carcinoma in a randomized clinical study) clinical trials were designed to evaluate the efficacy and safety of combining first-line chemotherapy with selective internal radiation therapy (SIRT) using yttrium-90 resin microspheres, also called transarterial radioembolization. Objective: The aim of this analysis is to prospectively combine clinical data from 3 trials to allow adequate power to evaluate the impact of chemotherapy with SIRT on overall survival. Methods: Eligible patients are adults with histologically confirmed CRC and unequivocal evidence of liver metastases which are not treatable by surgical resection or local ablation with curative intent at the time of study entry. Patients may also have limited extrahepatic metastases. Final analysis will take place when all participants have been followed up for a minimum of 2 years. Results: Efficacy and safety estimates derived using individual participant data (IPD) from SIRFLOX, FOXFIRE, and FOXFIRE-Global will be pooled using 2-stage prospective meta-analysis. Secondary outcome measures include progression-free survival (PFS), liver-specific PFS, health-related quality of life, response rate, resection rate, and adverse event profile. The large study population will facilitate comparisons of low frequency adverse events and allow for more robust safety analyses. The potential treatment benefit in those patients who present with disease confined to the liver will be investigated using 1-stage IPD meta-analysis. Efficacy will be analyzed on an intention-to-treat basis. Conclusions: This analysis will assess the impact of SIRT combined with chemotherapy on overall survival in the first-line treatment of metastatic CRC. If positive, the results will change the standard of care for this disease. Trial Registration: FOXFIRE ISRCTN Registry ISRCTN83867919; http://www.isrctn.com/ISRCTN83867919 (Archived by WebCite at http://www.webcitation.org/6oN7axrvA). SIRFLOX ClinicalTrials.gov NCT00724503; https://clinicaltrials.gov/ ct2/show/NCT00724503 (Archived by WebCite at http://www.webcitation.org/6oN7lEGbD). FOXFIRE-Global ClinicalTrials.gov NCT01721954; https://clinicaltrials.gov/ct2/show/NCT01721954 (Archived by WebCite at http://www.webcitation.org/ 6oN7vvQvG). %M 28351831 %R 10.2196/resprot.7201 %U http://www.researchprotocols.org/2017/3/e43/ %U https://doi.org/10.2196/resprot.7201 %U http://www.ncbi.nlm.nih.gov/pubmed/28351831 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 3 %P e35 %T Effectiveness of a 16-Week Multimodal Exercise Program on Individuals With Dementia: Study Protocol for a Multicenter Randomized Controlled Trial %A Trautwein,Sandra %A Scharpf,Andrea %A Barisch-Fritz,Bettina %A Niermann,Christina %A Woll,Alexander %+ Institute of Sports and Sports Science, Karlsruhe Institute of Technology, Engler-Bunte-Ring 15, Karlsruhe,, Germany, 49 721 608 48513, sandra.trautwein@kit.edu %K physical activity %K dementia %K postural balance %K gait %K activities of daily living %K cognition %K exercise %D 2017 %7 03.03.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: The increasing prevalence of dementia in the next decades is accompanied by various societal and economic problems. Previous studies have suggested that physical activity positively affects motor and cognitive skills in individuals with dementia (IWD). However, there is insufficient evidence probably related to several methodological limitations. Moreover, to date adequate physical activity interventions specifically developed for IWD are lacking. Objective: This study aims to investigate the effectiveness of a multimodal exercise program (MEP) on motor and cognitive skills in IWD in a high-quality multicenter trial. Methods: A multicenter randomized controlled trial with baseline and postassessments will be performed. It is planned to enroll 405 participants with dementia of mild to moderate stage, aged 65 years and older. The intervention group will participate in a 16-week ritualized MEP especially developed for IWD. The effectiveness of the MEP on the primary outcomes balance, mobility, and gait will be examined using a comprehensive test battery. Secondary outcomes are strength and function of lower limbs, activities of daily living, and cognition (overall cognition, language, processing speed, learning and memory, and visual spatial cognition). Results: Enrollment for the study started in May 2015. It is planned to complete postassessments by the beginning of 2017. Results are expected to be available in the first half of 2017. Conclusions: This study will contribute to enhancing evidence for the effects of physical activity on motor and cognitive skills in IWD. Compared to previous studies, this study is characterized by a dementia-specific intervention based on scientific knowledge, a combination of motor and cognitive tasks in the intervention, and high standards regarding methodology. Findings are highly relevant to influence the multiple motor and cognitive impairments of IWD who are often participating in limited physical activity. Trial Registration: German Clinical Trials Register DRKS00010538; https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00010538 (Archived by WebCite at http://www.webcitation.org/6oVGMbbMD) %M 28258048 %R 10.2196/resprot.6792 %U http://www.researchprotocols.org/2017/3/e35/ %U https://doi.org/10.2196/resprot.6792 %U http://www.ncbi.nlm.nih.gov/pubmed/28258048 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 2 %P e20 %T Local Anesthesia Versus Local Anesthesia and Conscious Sedation for Inguinal Hernioplasty: Protocol of a Randomized Controlled Trial %A Leake,Pierre-Anthony %A Toppin,Patrick J %A Reid,Marvin %A Plummer,Joseph M %A Roberts,Patrick O %A Harding-Goldson,Hyacinth %A McFarlane,Michael E %+ Department of Surgery, Radiology, Anaesthesia and Intensive Care, Faculty of Medical Sciences, University of the West Indies, Mona Campus, Kingston,, Jamaica, 1 876 927 1270, paeleake@yahoo.com %K inguinal hernioplasty %K local anesthesia %K conscious sedation %K patient satisfaction %K randomized controlled trial %D 2017 %7 07.02.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: Conscious sedation is regularly used in ambulatory surgery to improve patient outcomes, in particular patient satisfaction. Reports suggest that the addition of conscious sedation to local anesthesia for inguinal hernioplasty is safe and effective in improving patient satisfaction. No previous randomized controlled trial has assessed the benefit of conscious sedation in this regard. Objective: To determine whether the addition of conscious sedation to local anesthesia improves patient satisfaction with inguinal hernioplasty. Methods: This trial is designed as a single-center, randomized, placebo-controlled, blinded trial of 148 patients. Adult patients diagnosed with a reducible, unilateral inguinal hernia eligible for hernioplasty using local anesthesia will be recruited. The intervention will be the use of intravenous midazolam for conscious sedation. Normal saline will be used as placebo in the control group. The primary outcome will be patient satisfaction, measured using the validated Iowa Satisfaction with Anesthesia Scale. Secondary outcomes will include intra- and postoperative pain, operative time, volumes of sedative agent and local anesthetic used, time to discharge, early and late complications, and postoperative functional status. Results: To date, 171 patients have been recruited. Surgery has been performed on 149 patients, meeting the sample size requirements. Follow-up assessments are still ongoing. Trial completion is expected in August 2017. Conclusions: This randomized controlled trial is the first to assess the effectiveness of conscious sedation in improving patient satisfaction with inguinal hernioplasty using local anesthesia. If the results demonstrate improved patient satisfaction with conscious sedation, this would support routine incorporation of conscious sedation in local inguinal hernioplasty and potentially influence national and international hernia surgery guidelines. Trial registration: Clinicaltrials.gov NCT02444260; https://clinicaltrials.gov/ct2/show/NCT02444260 (Archived by WebCite at http://www.webcitation.org/6no8Dprp4) %M 28174148 %R 10.2196/resprot.6754 %U http://www.researchprotocols.org/2017/2/e20/ %U https://doi.org/10.2196/resprot.6754 %U http://www.ncbi.nlm.nih.gov/pubmed/28174148 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 2 %P e14 %T Protocol for a 24-Week Randomized Controlled Study of Once-Daily Oral Dose of Flax Lignan to Healthy Older Adults %A Alcorn,Jane %A Whiting,Susan %A Viveky,Navita %A Di,Yunyun %A Mansell,Kerry %A Fowler,Sharyle %A Thorpe,Lilian %A Almousa,Ahmed %A Cheng,Pui Chi %A Jones,Jennifer %A Billinsky,Jennifer %A Hadjistavropoulos,Thomas %+ College of Pharmacy and Nutrition, University of Saskatchewan, 104 Clinic Place, Saskatoon, SK, S7N 2Z4, Canada, 1 306 966 6365, susan.whiting@usask.ca %K flax %K lignan %K inflammation %K oxidative stress %K clinical trial %K older adults %D 2017 %7 03.02.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: Increased oxidative stress and inflammation are associated with aging, and contribute to an increased risk of chronic disease in older adults. Flaxseed lignans demonstrate antioxidant and anti-inflammatory activity, but their ability to reduce oxidative stress and inflammation markers in older adult populations has received limited investigation. Objective: This is a chronic intervention trial of community-dwelling healthy older adults to examine the effects of a flaxseed lignan (secoisolariciresinol diglucoside; SDG) enriched supplement (BeneFlax) compared to a placebo. The primary aim was to demonstrate the safety of BeneFlax and confirm its anti-inflammatory efficacy on markers of oxidative stress and inflammation, and subsequent functional outcomes, including those associated with its anti-inflammatory efficacy. A secondary aim was to determine flaxseed lignan metabolite concentrations in blood. Methods: A double-blind randomized clinical trial was conducted. Subjects were healthy community-dwelling adults aged 60-80 years. Testing was performed at baseline, 8, 16, and 24 weeks. The 24-week intervention consisted of 600 milligrams (mg) of SDG daily or an equivalent amount (volume) of placebo. All participants received 1000 international units of vitamin D to ensure adequate vitamin D status. Measurements consisted of blood pressure, hematology, and tolerability for safety assessments; blood oxidative stress and inflammatory biomarkers for efficacy; and cognition, muscle strength, and pain as functional outcomes. Secondary endpoints of plasma levels of lignan metabolites were analyzed by mass spectrometry. Other tests, such as bone turnover markers and fecal levels of flax cyclolinopeptides, will be performed at a later date. Results: Thirty-two participants were recruited (19 intervention and 13 control) and all completed the trial. Numerous Health Canada-imposed exclusion criteria limited recruitment success. Analyses are ongoing, but the baseline data available for a number of parameters indicate no differences between treatment groups. Safety measures (vital signs) did not change from baseline and were not significantly different between treatment and placebo groups at 24 weeks. Conclusions: Preliminary results indicate that no safety concerns are associated with administering 600 mg SDG for 24 weeks to adults between the ages of 60 and 80 years. Trial Registration: Clinicaltrials.gov NCT01846117; https://clinicaltrials.gov/ct2/show/NCT01846117 (Archived by WebCite at http://www.webcitation.org/6nlDZNjmA) %M 28159728 %R 10.2196/resprot.6817 %U https://www.researchprotocols.org/2017/2/e14/ %U https://doi.org/10.2196/resprot.6817 %U http://www.ncbi.nlm.nih.gov/pubmed/28159728 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 6 %N 1 %P e13 %T Neurofeedback as a Treatment for Impulsivity in a Forensic Psychiatric Population With Substance Use Disorder: Study Protocol of a Randomized Controlled Trial Combined With an N-of-1 Clinical Trial %A Fielenbach,Sandra %A Donkers,Franc CL %A Spreen,Marinus %A Bogaerts,Stefan %+ Research Department, Forensic Psychiatric Centre Dr S van Mesdag, Helperlinie 2, Groningen,, Netherlands, 31 505221221, s.fielenbach@fpcvanmesdag.nl %K impulsive behavior %K substance use disorders %K neurofeedback %K craving %K offenders %D 2017 %7 25.01.2017 %9 Protocol %J JMIR Res Protoc %G English %X Background: Impulsivity and substance use disorder (SUD) are strongly interconnected, with persons scoring high on impulsivity being more vulnerable to develop substance abuse, facing more challenges for successful treatment, and being more prone to engage in criminal behavior. Studies have shown that impulsivity and craving for substances are strongly correlated. Neurofeedback is an effective treatment to reduce impulsive behavior. This study intends to determine to what extent a neurofeedback-intervention that is aimed at reducing impulsivity can also reduce levels of craving in forensic patients with SUD and comorbid Axis I and/or II diagnoses. Objective: The main objective of this study is to investigate to what extent a reduction in impulsivity by a sensorimotor rhythm (SMR)-neurofeedback intervention will lead to a reduction in craving in a population of forensic psychiatric patients with a diagnosis of SUD. Methods: Participants will be male SUD patients with various comorbidities residing in an inpatient forensic treatment facility approached through treatment supervisors for participation. Participants have tested positive for drug use in the past 24 months. The study consists of 2 parts: a randomized controlled trial (RCT) and a n-of-1 clinical series. In the RCT, 50 patients will be randomly assigned to an intervention (n=25) or a control (n=25) condition. Patients in the intervention group will receive 20 SMR neurofeedback sessions aimed at reducing impulsivity; participants in the control group receive treatment-as-usual (TAU). Additionally, 4 in depth n-of-1 clinical trials will be conducted where effects of an SMR neurofeedback intervention will be compared to effects of sham neurofeedback. Results: Results of this study are expected by the end of 2017. Conclusions: This protocol describes the design of a study testing the effects of an impulsivity-based neurofeedback protocol among forensic patients with SUD and various comorbidities. We expect a significant reduction in impulsive behavior, level of craving, and actual drug-use for participants receiving the SMR neurofeedback protocol. The n-of-1 approach might help to explain effects possibly found in the RCT study since it allows for a more direct focus on treatment effects by following participants more closely and thereby being able to directly attribute behavioral and neurophysiological change to the SMR neurofeedback protocol employed. ClinicalTrial: Dutch National Trial Register NTR5386; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5386 (Archived by WebCite at http://www.webcitation.org/6nXLQuoLl) %M 28122696 %R 10.2196/resprot.6907 %U http://www.researchprotocols.org/2017/1/e13/ %U https://doi.org/10.2196/resprot.6907 %U http://www.ncbi.nlm.nih.gov/pubmed/28122696 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 4 %P e244 %T Deep Brain Stimulation for Tremor Tractographic Versus Traditional (DISTINCT): Study Protocol of a Randomized Controlled Feasibility Trial %A Sajonz,Bastian Elmar Alexander %A Amtage,Florian %A Reinacher,Peter Christoph %A Jenkner,Carolin %A Piroth,Tobias %A Kätzler,Jürgen %A Urbach,Horst %A Coenen,Volker Arnd %+ Department of Stereotactic and Functional Neurosurgery, Medical Center, Faculty of Medicine, University of Freiburg, Neurozentrum Universitätsklinikum Freiburg, Breisacher Str. 64, Freiburg,, Germany, 49 761 270 50010, bastian.sajonz@uniklinik-freiburg.de %K deep brain stimulation %K essential tremor %K magnetic resonance tractographic-assisted implantation %D 2016 %7 22.12.2016 %9 Protocol %J JMIR Res Protoc %G English %X Background: Essential tremor is a movement disorder that can result in profound disability affecting the quality of life. Medically refractory essential tremor can be successfully reduced by deep brain stimulation (DBS) traditionally targeting the thalamic ventral intermediate nucleus (Vim). Although this structure can be identified with magnetic resonance (MR) imaging nowadays, Vim-DBS electrodes are still implanted in the awake patient with intraoperative tremor testing to achieve satisfactory tremor control. This can be attributed to the fact that the more effective target of DBS seems to be the stimulation of fiber tracts rather than subcortical nuclei like the Vim. There is evidence that current coverage of the dentatorubrothalamic tract (DRT) results in good tremor control in Vim-DBS. Diffusion tensor MR imaging (DTI) tractography-assisted stereotactic surgery targeting the DRT would therefore not rely on multiple trajectories and intraoperative tremor testing in the awake patient, bearing the potential of more patient comfort and reduced operation-related risks. This is the first randomized controlled trial comparing DTI tractography-assisted stereotactic surgery targeting the DRT in general anesthesia with stereotactic surgery of thalamic/subthalamic region as conventionally used. Objective: This clinical pilot trial aims at demonstrating safety of DTI tractography-assisted stereotactic surgery in general anesthesia and proving its equality compared to conventional stereotactic surgery with intraoperative testing in the awake patient. Methods: The Deep Brain Stimulation for Tremor Tractographic Versus Traditional (DISTINCT) trial is a single-center investigator-initiated, randomized, controlled, observer-blinded trial. A total of 24 patients with medically refractory essential tremor will be randomized to either DTI tractography-assisted stereotactic surgery targeting the DRT in general anesthesia or stereotactic surgery of the thalamic/subthalamic region as conventionally used. The primary objective is to assess the tremor reduction, obtained by the Fahn-Tolosa-Marin Tremor Rating Scale in the 2 treatment groups. Secondary objectives include (among others) assessing the quality of life, optimal electrode contact positions, and safety of the intervention. The study protocol has been approved by the independent ethics committee of the University of Freiburg. Results: Recruitment to the DISTINCT trial opened in September 2015 and is expected to close in June 2017. At the time of manuscript submission the trial is open to recruitment. Conclusions: The DISTINCT trial is the first to compare DTI tractography-assisted stereotactic surgery with target point of the DRT in general anesthesia to stereotactic surgery of the thalamic/subthalamic region as conventionally used. It can serve as a cornerstone for the evolving technique of DTI tractography-assisted stereotactic surgery. ClinicalTrial: ClinicalTrials.gov NCT02491554; https://clinicaltrials.gov/ct2/show/NCT02491554 (Archived by WebCite at http://www.webcitation.org/6mezLnB9D). German Clinical Trials Register DRKS00008913; http://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00008913 (Archived by WebCite at http://www.webcitation.org/6mezCtxhS). %M 28007690 %R 10.2196/resprot.6885 %U http://www.researchprotocols.org/2016/4/e244/ %U https://doi.org/10.2196/resprot.6885 %U http://www.ncbi.nlm.nih.gov/pubmed/28007690 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 4 %P e220 %T Effect on Nitrogen Balance, Thermogenesis, Body Composition, Satiety, and Circulating Branched Chain Amino Acid Levels up to One Year after Surgery: Protocol of a Randomized Controlled Trial on Dietary Protein During Surgical Weight Loss %A Moizé,Violeta %A Pi-Sunyer,Xavier %A Vidal,Josep %A Miner,Patricia %A Boirie,Yves %A Laferrère,Blandine %+ Institut Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Rosellon 149, Barcelona, 08036, Spain, 34 932275707, vmoize@clinic.ub.es %K bariatric surgery %K protein intake %K nitrogen balance %K body composition %K satiety %K BCAA %D 2016 %7 28.11.2016 %9 Protocol %J JMIR Res Protoc %G English %X Background: Bariatric surgery (BS), the most effective treatment for severe obesity, typically results in 40-50 kg weight loss in the year following the surgery. Beyond its action on protein metabolism, dietary protein intake (PI) affects satiety, thermogenesis, energy efficiency, and body composition (BC). However, the required amount of PI after surgical weight loss is not known. The current daily PI recommendation for diet-induced weight loss is 0.8 g/kg ideal body weight (IBW) per day, but whether this amount is sufficient to preserve fat-free mass during active surgical weight loss is unknown. Objective: To evaluate the effect of a 3-month dietary protein supplementation (PS) on nitrogen balance (NB), BC, energy expenditure, and satiety in women undergoing either gastric bypass or vertical sleeve gastrectomy. Methods: In this randomized prospective study, participants will be randomized to a high protein supplementation group (1.2 g/kg IBW per day) or standard protein supplementation group (0.8 g/kg IBW per day) based on current guidelines. Outcome measures including NB, BC, circulating branched chain amino acids, and satiety, which will be assessed presurgery, and at 3-months and 12-months postsurgery. Results: To date, no studies have examined the effect of dietary PS after BS. Current guidelines for PI after surgery are based on weak evidence. Conclusions: The results of this study will contribute to the development of evidence-based data regarding the safe and optimal dietary PI and supplementation after BS. Trial Registration: Clinicaltrials.gov NCT02269410; http://clinicaltrials.gov/ct2/show/NCT02269410 (Archived by WebCite at http://www.webcitation.org/6m2f2QLeg). %M 27895003 %R 10.2196/resprot.6438 %U http://www.researchprotocols.org/2016/4/e220/ %U https://doi.org/10.2196/resprot.6438 %U http://www.ncbi.nlm.nih.gov/pubmed/27895003 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 4 %P e210 %T A Prospective, Multicenter, Randomized Phase II Study to Evaluate the Efficacy and Safety of Eculizumab in Patients with Guillain-Barré Syndrome (GBS): Protocol of Japanese Eculizumab Trial for GBS (JET-GBS) %A Yamaguchi,Nobuko %A Misawa,Sonoko %A Sato,Yasunori %A Nagashima,Kengo %A Katayama,Kanako %A Sekiguchi,Yukari %A Iwai,Yuta %A Amino,Hiroshi %A Suichi,Tomoki %A Yokota,Takanori %A Nishida,Yoichiro %A Kohara,Nobuo %A Hirata,Koichi %A Nishiyama,Kazutoshi %A Yabe,Ichiro %A Kaida,Ken-Ichi %A Suzuki,Norihiro %A Nodera,Hiroyuki %A Tsuji,Shoji %A Koike,Haruki %A Kira,Jun-Ichi %A Hanaoka,Hideki %A Kusunoki,Susumu %A Kuwabara,Satoshi %A , %+ Department of Neurology, Chiba University Graduate School of Medicine, Inohana 1-8-1, Chuo-ku, Chiba, Japan, 81 43 222 7171 ext 5414, sonoko.m@mb.infoweb.ne.jp %K Guillain-Barré syndrome %K eculizumab %K complement activation %K clinical trial %K antiganglioside antibody %D 2016 %7 07.11.2016 %9 Protocol %J JMIR Res Protoc %G English %X Background: Guillain-Barré syndrome (GBS) is an immune-mediated neuropathy that causes acute flaccid paralysis. Immunoglobulin and plasma exchange are established treatments for GBS; however, a substantial number of patients, particularly those with severe disease, have poor recovery and residual deficits. Recent studies suggest that complement activation plays a pivotal role in GBS-associated axonal degeneration, and eculizumab is a humanized monoclonal antibody that specifically binds to complement component 5 and potently inhibits complement activation. Objective: This clinical trial aims to evaluate the efficacy and safety of eculizumab, a humanized monoclonal antibody directed against complement component 5, for treatment of GBS. Methods: The Japanese Eculizumab Trial for GBS (JET-GBS) is a prospective, multicenter, placebo-controlled, double-blind, randomized phase II study conducted at 13 tertiary neurology centers and is funded by the Japan Agency for Medical Research and Development. A total of 33 GBS patients unable to walk independently within 2 weeks from symptom onset (Hughes functional grade 3-5) were randomized at a 2:1 ratio to receive either intravenous eculizumab (900 mg/day) or placebo once weekly for 4 weeks, followed by 20 weeks of follow-up. The primary endpoint for efficacy is the proportion of patients who regain their ability to walk without aid at 4 weeks after the first dose of the study treatment, while primary safety outcomes are the incidence of adverse events and serious adverse events during the trial. Results: Enrollment for the trial began in August 2015. This trial is still ongoing. All participants have been enrolled, and follow-up will be completed in October 2016. Conclusions: This study is the first to investigate the efficacy and safety of eculizumab for GBS. In case of a positive result, we will plan a phase III trial to investigate this issue in a larger number of patients. ClinicalTrial: UMIN Clinical Trials Registry UMIN 000018171; https:/upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function= brows&action=brows&type=summary&language=J&recptno=R000020978 (Archived by WebCite at http://www.webcitation.org/ 6lTiG8ltG). Clinical Trials.gov NCT02493725; https://clinicaltrials.gov/ct2/show/NCT02493725 (Archived by WebCite at http://www.webcitation.org/6lVJZXKSL) %M 27821382 %R 10.2196/resprot.6610 %U http://www.researchprotocols.org/2016/4/e210/ %U https://doi.org/10.2196/resprot.6610 %U http://www.ncbi.nlm.nih.gov/pubmed/27821382 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 4 %P e203 %T The Effectiveness of Hand Massage on Pain in Critically Ill Patients After Cardiac Surgery: A Randomized Controlled Trial Protocol %A Boitor,Madalina %A Martorella,Géraldine %A Laizner,Andréa Maria %A Maheu,Christine %A Gélinas,Céline %+ Ingram School of Nursing, Faculty of Medicine, McGill University, 3506 University, Montreal, QC, Canada, 1 514 398 4144, madalina.boitor@mail.mcgill.ca %K massage %K pain %K critical care %K randomized controlled trial %K anxiety %K muscle tension %K vital signs %K clinical protocol %K complementary therapies %K thoracic surgery %D 2016 %7 07.11.2016 %9 Protocol %J JMIR Res Protoc %G English %X Background: Postoperative pain is common in the intensive care unit despite the administration of analgesia. Some trials suggest that massage can be effective at reducing postoperative pain in acute care units; however, its effects on pain relief in the intensive care unit and when pain severity is highest remain unknown. Objective: The objective is to evaluate the effectiveness of hand massage on the pain intensity (primary outcome), unpleasantness and interference, muscle tension, anxiety, and vital signs of critically ill patients after cardiac surgery. Methods: A 3-arm randomized controlled trial will be conducted. A total of 79 patients who are 18 years or older, able to speak French or English and self-report symptoms, have undergone elective cardiac surgery, and do not have a high risk of postoperative complications and contraindications to hand massage will be recruited. They will be randomly allocated (1:1:1) to standard care plus either 3 20-minute hand massages (experimental), 3 20-minute hand holdings (active control), or 3 20-minute rest periods (passive control). Pain intensity, unpleasantness, anxiety, muscle tension, and vital signs will be evaluated before, immediately after, and 30 minutes later for each intervention administered within 24 hours postoperatively. Peer-reviewed competitive funding was received from the Quebec Nursing Intervention Research Network and McGill University in December 2015, and research ethics approval was obtained February 2016. Results: Recruitment started in April 2016, and data collection is expected to be complete by January 2017. To date, 24 patients were randomized and had data collection done. Conclusions: This study will be one of the first randomized controlled trials to examine the effect of hand massage on the pain levels of critically ill patients after cardiac surgery and to provide empirical evidence for the use of massage among this population. ClinicalTrial: ClinicalTrials.gov NCT02679534; https://clinicaltrials.gov/ct2/show/NCT02679534 (Archived by WebCite at http://www.webcitation.org/6l8Ly5eHS) %M 27821384 %R 10.2196/resprot.6277 %U http://www.researchprotocols.org/2016/4/e203/ %U https://doi.org/10.2196/resprot.6277 %U http://www.ncbi.nlm.nih.gov/pubmed/27821384 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 3 %P e188 %T A Cluster-Randomized Controlled Trial Evaluating the Effectiveness and Cost-Effectiveness of Tobacco Cessation on Prescription in Swedish Primary Health Care: A Protocol of the Motivation 2 Quit (M2Q) Study %A Leppänen,Anne %A Lindgren,Peter %A Sundberg,Carl Johan %A Petzold,Max %A Tomson,Tanja %+ Karolinska Institutet, Department of Learning, Informatics, Management and Ethics, Tomtebodavägen 18A, Stockholm, 17177, Sweden, 46 8 524 836 12, anne.leppanen@ki.se %K tobacco use cessation %K primary health care %K vulnerable populations %K randomized controlled trial %K pragmatic clinical trial %K cost-effectiveness analysis %K Sweden %D 2016 %7 16.09.2016 %9 Protocol %J JMIR Res Protoc %G English %X Background: In Sweden, the prevalence of tobacco use is disproportionately high among socioeconomically disadvantaged groups. Previous research and clinical experience suggest that prescribed lifestyle interventions in the primary health care (PHC) setting such as Physical Activity on Prescription are effective in changing behavior. However, there is a lack of evidence for if and how such a prescription approach could be effectively transferred into the tobacco cessation context. Objective: The aim of this trial is to evaluate the effectiveness and cost-effectiveness of Tobacco Cessation on Prescription (TCP) compared to current practice for tobacco cessation targeting socioeconomically disadvantaged groups in the PHC setting in Sweden. Methods: The design is a pragmatic cluster-randomized controlled trial. The sample will consist of 928 daily tobacco users with Swedish social security numbers and permanent resident permits, recruited from 14-20 PHC centers located in socioeconomically disadvantaged areas in Stockholm County. The primary outcome will be measured in self-reported 7-day abstinence at 6 and 12 months after the intervention. The secondary outcomes will be measured in daily tobacco consumption, number of quit attempts, and health-related quality of life at 6 and 12 months after the intervention. Data will be collected through questionnaires and review of electronic medical records. Cost-effectiveness will be estimated through decision analytic modeling and measured by the incremental cost per quality-adjusted life year. Results: In the first set of PHC centers participating in the study, eight centers have been included. Recruitment of individual study participants is currently ongoing. Inclusion of a second set of PHC centers is ongoing with expected study start in September 2016. Conclusions: If TCP is found effective and cost-effective compared to standard treatment, the method could be implemented to facilitate tobacco cessation for socioeconomically disadvantaged groups in the PHC setting in Sweden. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 11498135; http://www.isrctn.com/ISRCTN11498135 (Archived by WebCite at http://www.webcitation.org/6kTu6giYQ) %M 27637517 %R 10.2196/resprot.6180 %U http://www.researchprotocols.org/2016/3/e188/ %U https://doi.org/10.2196/resprot.6180 %U http://www.ncbi.nlm.nih.gov/pubmed/27637517 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 3 %P e161 %T The Effectiveness Of Social Media (Facebook) Compared With More Traditional Advertising Methods for Recruiting Eligible Participants To Health Research Studies: A Randomized, Controlled Clinical Trial %A Frandsen,Mai %A Thow,Megan %A Ferguson,Stuart G %+ School of Health Sciences, Faculty of Health, University of Tasmania, Locked Bag 1377, Launceston,, Australia, +61 3 6777 8167, Mai.Frandsen@utas.edu.au %K Facebook %K recruitment methods %K smoking %K clinical trial %D 2016 %7 10.08.2016 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Recruiting participants for research studies can be difficult and costly. The popularity of social media platforms (eg, Facebook) has seen corresponding growth in the number of researchers turning to social networking sites and their embedded advertising frameworks to locate eligible participants for studies. Compared with traditional recruitment strategies such as print media, social media advertising has been shown to be favorable in terms of its reach (especially with hard-to-reach populations), cost effectiveness, and usability. However, to date, no studies have examined how participants recruited via social media progress through a study compared with those recruited using more traditional recruitment strategies. Objectives: (1) Examine whether visiting the study website prior to being contacted by researchers creates self-screened participants who are more likely to progress through all study phases (eligible, enrolled, completed); (2) compare conversion percentages and cost effectiveness of each recruitment method at each study phase; and, (3) compare demographic and smoking characteristics of participants recruited through each strategy to determine if they attract similar samples. Methods: Participants recruited to a smoking cessation clinical trial were grouped by how they had become aware of the study: via social media (Facebook) or traditional media (eg, newspaper, flyers, radio, word of mouth). Groups were compared based on throughput data (conversion percentages and cost) as well as demographic and smoking characteristics. Results: Visiting the study website did not result in individuals who were more likely to be eligible for (P=.24), enroll in (P=.20), or complete (P=.25) the study. While using social media was more cost effective than traditional methods when we examined earlier endpoints of the recruitment process (cost to obtain a screened respondent: AUD $22.73 vs $29.35; cost to obtain an eligible respondent: $37.56 vs $44.77), it was less cost effective in later endpoints (cost per enrolled participant: $56.34 vs $52.33; cost per completed participant: $103.66 vs $80.43). Participants recruited via social media were more likely to be younger (P=.001) and less confident in their quit attempts (P=.004) compared to those recruited via traditional methods. Conclusions: Our study suggests that while social media advertising may be effective in generating interest from potential participants, this strategy’s ability to attract conscientious recruits is more questionable. Researchers considering using online resources (eg, social media advertising, matrix codes) should consider including prescreening questions to promote conversion percentages. Ultimately, researchers seeking to maximize their recruitment budget should consider using a combination of advertising strategies. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN 12614000329662; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=365947l (Archived by WebCite at http://www.webcitation.org/6jc6zXWZI) %M 27511829 %R 10.2196/resprot.5747 %U http://www.researchprotocols.org/2016/3/e161/ %U https://doi.org/10.2196/resprot.5747 %U http://www.ncbi.nlm.nih.gov/pubmed/27511829 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 3 %P e145 %T Effect of Sitagliptin and Metformin on Prediabetes Progression to Type 2 Diabetes - A Randomized, Double-Blind, Double-Arm, Multicenter Clinical Trial: Protocol for the Sitagliptin and Metformin in PreDiabetes (SiMePreD) Study %A Naidoo,Poobalan %A Wing,Jeffrey %A Rambiritch,Virendra %+ University of Witwatersrand, Faculty of Health Sciences, Department of Endocrinology, 7 York Road, Parktown, Johannesburg, Gauteng, 2193, South Africa, 27 718937672, poobalan1naidoo@yahoo.com %K primary prevention %K type 2 diabetes mellitus %K prediabetes %K dipeptidyl peptidase-IV %D 2016 %7 04.08.2016 %9 Protocol %J JMIR Res Protoc %G English %X Background: The high prevalence and incidence of type 2 diabetes mellitus (DM), and its associated morbidity and mortality, has prompted growing international interest and effort in the primary prevention of this disease. Primary prevention is possible since type 2 DM is preceded by prediabetes, offering a window opportunity to treat patients, and prevent the emergence of advanced disease. Sitagliptin is an oral dipeptidyl peptidase-IV inhibitor that preserves existing beta cell function and increases beta cell mass. These two effects have been demonstrated both in vitro and in animal studies, and current clinical data show that sitagliptin is safe. Metformin, a biguanide, reduces insulin resistance and inhibits hepatic gluconeogenesis, and has an excellent safety profile. The combination of metformin and sitagliptin, targeting both characteristics of prediabetes (insulin resistance and progressive beta cell degeneration), may potentially slow or halt the progression from prediabetes to type 2 DM. This paper describes the rationale and design of the Sitagliptin and Metformin in PreDiabetes (SiMePreD) study. Objective: The aim of this study is to determine the effect of sitagliptin and metformin on progression from prediabetes to type 2 DM. The objectives of the study are to determine the effects of metformin and placebo on glycemic endpoints, the effects of sitagliptin and metformin on glycemic endpoints, the effects of metformin and placebo on incidence of cardiovascular disease and death, and the effects of sitagliptin and metformin on incidence of cardiovascular disease and death. Methods: This is a randomized, double-blind, multicenter clinical study that will determine if the combination of metformin and sitagliptin is effective in preventing the progression from prediabetes to type 2 DM. The study will contain two arms (metformin/sitagliptin and metformin/placebo). Primary endpoints include the number of subjects progressing from prediabetes to type 2 DM, the number of cardiovascular events, and the number of deaths. The planned duration of the study is five years, and 410 subjects will be included in each group. Data analyses will include clinically relevant measures (eg, numbers needed to treat and numbers needed to harm) and will be performed according to the intention-to-treat principle. Results: This study is currently in the process of acquiring research funding. Conclusions: The SiMePreD study is the first study to investigate the utility of sitagliptin in combination with metformin for the primary prevention of type 2 DM.  %M 27491324 %R 10.2196/resprot.5073 %U http://www.researchprotocols.org/2016/3/e145/ %U https://doi.org/10.2196/resprot.5073 %U http://www.ncbi.nlm.nih.gov/pubmed/27491324 %0 Journal Article %@ 1929-0748 %I JMIR Publications %V 5 %N 3 %P e97 %T The Deckled Incision: Study Protocol for a Randomized Controlled Trial %A Singla,Apresh %A Lord,Sarah J %A Ngo,Quan %+ St Vincents Hospital, 390 Victoria St, Darlinghurst, Sydney, 2010, Australia, 61 412258889, apresh.singla@gmail.com %K scar improvement %K post-operative %D 2016 %7 12.07.2016 %9 Protocol %J JMIR Res Protoc %G English %X Background: Scar visibility is multifactorial and skin closure technique is thought to play an important role. It is an established principle in plastic surgery that Z plasties generally reduce scar contracture by breaking up the lines of tension in a wound. As an extension of this principle, it is postulated that irregular “deckled” skin incisions made during tumor excision would produce aesthetically superior scars. Objective: The primary objective of this study is to assess both the clinician and patient opinion of scar quality using the Patient and Observer Scar Assessment Scale (POSAS). Secondary objectives include the proportion of scars judged as good by the both the patient and clinician (less than or equal to 5 on the overall PSOAS scale), the number of adverse events, and the proportion of the scar visible at 1 meter. Methods: The deckling study will be a patient-blinded, simple randomized controlled trial (RCT) at a single center institution. The two groups will be equally allocated on a 1:1 ratio into the control and treatment arms. All patients greater than 18 years of age undergoing a plastic surgery procedure involving excision of skin lesions will be enrolled. Any patients requiring re-excision through the wound or undergoing injectable corticosteroid therapy will be excluded. A total of 500 patients will be enrolled. The patients will be followed-up at 1 week, 3 months, and 6 months post-operatively. Results: The study is expected to begin enrolment in August 2016. We anticipate that the deckling study group will have superior scar outcomes when compared to the straight line incision. From clinical experience this is especially true for lesions involving the face and in those areas of the skin that have undergone radiation therapy. The study will be funded by the Plastics and Reconstructive Surgery Department at St Vincent’s Hospital, Sydney, Australia. Ethics approval has been obtained for the study. Conclusion: We believe this will be an important study to assess a novel method to improve the appearance of post-operative scars. The deckling study is simple to master, can be applicable to almost any surgical procedure, and can have good generalizability to a large population cohort. Conclusions: We believe this will be an important study to assess a novel method to improve the appearance of post-operative scars. The deckling study is simple to master, can be applicable to almost any surgical procedure, and can have good generalizability to a large population cohort. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12616000193471; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12616000193471 (Archived by Webcite at http://www.webcitation.org/6gmG8yf1A) %M 27405523 %R 10.2196/resprot.5491 %U http://www.researchprotocols.org/2016/3/e97/ %U https://doi.org/10.2196/resprot.5491 %U http://www.ncbi.nlm.nih.gov/pubmed/27405523 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 5 %N 2 %P e51 %T The Effectiveness of Parent Training as a Treatment for Preschool Attention-Deficit/Hyperactivity Disorder: Study Protocol for a Randomized Controlled, Multicenter Trial of the New Forest Parenting Program in Everyday Clinical Practice %A Lange,Anne-Mette %A Daley,David %A Frydenberg,Morten %A Rask,Charlotte U %A Sonuga-Barke,Edmund %A Thomsen,Per H %+ Centre for Child & Adolescent Psychiatry, Research Department, Aarhus University Hospital, Skovagervej 2, Risskov, 8240, Denmark, 45 28771566, annelang@rm.dk %K ADHD %K preschool %K child %K treatment %K parents %K parent training %K psycho-social %K RCT, clinical %K psychological %K multi-centre %K TAU %K non-pharmacological %D 2016 %7 13.04.2016 %9 Protocol %J JMIR Res Protoc %G English %X Background: Parent training is recommended as the first-line treatment for attention-deficit/hyperactivity disorder (ADHD) in preschool children. The New Forest Parenting Programme (NFPP) is an evidence-based parenting program developed specifically to target preschool ADHD. Objective: The objective of this trial is to investigate whether the NFPP can be effectively delivered for children referred through official community pathways in everyday clinical practice. Methods: A multicenter randomized controlled parallel arm trial design is employed. There are two treatment arms, NFPP and treatment as usual. NFPP consists of eight individually delivered parenting sessions, where the child attends during three of the sessions. Outcomes are examined at three time points (T1, T2, T3): T1 (baseline), T2 (week 12, post intervention), and T3 (6 month follow/up). 140 children between the ages of 3-7, with a clinical diagnosis of ADHD, informed by the Development and Well Being Assessment, and recruited from three child and adolescent psychiatry departments in Denmark will take part. Randomization is on a 1:1 basis, stratified for age and gender. Results: The primary endpoint is change in ADHD symptoms as measured by the Preschool ADHD-Rating Scale (ADHD-RS) by T2. Secondary outcome measures include: effects on this measure at T3 and T2 and T3 measures of teacher reported Preschool ADHD-RS scores, parent and teacher rated scores on the Strength & Difficulties Questionnaire, direct observation of ADHD behaviors during Child’s Solo Play, observation of parent-child interaction, parent sense of competence, and family stress. Results will be reported using the standards set out in the Consolidated Standards of Reporting Trials Statement for Randomized Controlled Trials of nonpharmacological treatments. Conclusions: The trial will provide evidence as to whether NFPP is a more effective treatment for preschool ADHD than the treatment usually offered in everyday clinical practice. Trial Registration: ClinicalTrials.gov NCT01684644; https://clinicaltrials.gov/ct2/show/NCT01684644?term= NCT01684644&rank=1 (Archived by WebCite at http://www.webcitation/6eOOAe8Qe) %M 27076496 %R 10.2196/resprot.5319 %U http://www.researchprotocols.org/2016/2/e51/ %U https://doi.org/10.2196/resprot.5319 %U http://www.ncbi.nlm.nih.gov/pubmed/27076496 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 5 %N 2 %P e38 %T Use of Subperiosteal Drain Versus Subdural Drain in Chronic Subdural Hematomas Treated With Burr-Hole Trepanation: Study Protocol for a Randomized Controlled Trial %A Soleman,Jehuda %A Lutz,Katharina %A Schaedelin,Sabine %A Mariani,Luigi %A Fandino,Javier %+ Department of Neurosurgery, University Hospital Basel, Basel, Switzerland, Spitalstrasse 21, Basel, , Switzerland, 41 62 2654141, jehuda.soleman@gmail.com %K chronic subdural hematoma %K drain %K hematoma %K recurrent hematoma %K burr-hole trepanation %D 2016 %7 08.04.2016 %9 Protocol %J JMIR Res Protoc %G English %X Background: Chronic subdural hematoma (cSDH) is one of the most frequent neurosurgical conditions affecting elderly people and is associated with substantial morbidity and mortality. The use of a subdural drain (SDD) after burr-hole trepanation for cSDH was proven to reduce recurrence and mortality at 6 months. To date in neurosurgery practice, evidence-based guidelines on whether an SDD or subperiosteal drain (SPD) should be used do not exist. Currently both methods are being practiced depending on the institute and/or the practicing neurosurgeon. Objective: The aim of this study is to compare the reoperation rates after burr-hole trepanation and insertion of an SPD or SDD in patients with cSDH. Methods: This is a prospective, noninferiority, multicenter, randomized controlled trial designed to include 220 patients over the age of 18 years presenting with a symptomatic cSDH verified on cranial computed tomography or magnetic resonance imaging who are to undergo surgical evacuation with burr-hole trepanation. After informed consent is obtained, patients are randomly allocated to an SPD or SDD group. The primary endpoint is recurrence indicating a reoperation within 12 months. Results: This research is investigator-initiated and has received ethics approval. Patient recruitment started in April 2013, and we expect all study-related activities to be completed by the end of 2016 or beginning of 2017. Conclusions: To date, evidence-based recommendations concerning the operative treatment of cSDH are sparse. Results of this research are expected to have applications in evidence-based practice for the increasing number of patients suffering from cSDH and possibly lead to more efficient treatment of this disease with fewer postoperative complications. Trial Registration: ClinicalTrials.gov NCT01869855; https://clinicaltrials.gov/ct2/show/NCT01869855 (Archived by WebCite at http://www.webcitation.org/6fNK4Jlxk) %M 27059872 %R 10.2196/resprot.5339 %U http://www.researchprotocols.org/2016/2/e38/ %U https://doi.org/10.2196/resprot.5339 %U http://www.ncbi.nlm.nih.gov/pubmed/27059872 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 5 %N 1 %P e21 %T Benefits of E-Cigarettes Among Heavy Smokers Undergoing a Lung Cancer Screening Program: Randomized Controlled Trial Protocol %A Lucchiari,Claudio %A Masiero,Marianna %A Veronesi,Giulia %A Maisonneuve,Patrick %A Spina,Stefania %A Jemos,Costantino %A Omodeo Salè,Emanuela %A Pravettoni,Gabriella %+ Università Degli Studi di Milano, Department of Philosophy, Via Festa del Perdono 7, Milano, 20122, Italy, 39 0250312240, claudio.lucchiari@unimi.it %K tobacco cessation %K electronic cigarettes %K lung cancer screening %K smoking related diseases. %D 2016 %7 03.02.2016 %9 Protocol %J JMIR Res Protoc %G English %X Background: Smoking is a global public health problem. For this reason, experts have called smoking dependence a global epidemic. Over the past 5 years, sales of electronic cigarettes, or e-cigarettes, have been growing strongly in many countries. Yet there is only partial evidence that e-cigarettes are beneficial for smoking cessation. In particular, although it has been proven that nicotine replacement devices may help individuals stop smoking and tolerate withdrawal symptoms, e-cigarettes’ power to increase the quitting success rate is still limited, ranging from 5% to 20% dependent on smokers’ baseline conditions as shown by a recent Cochrane review. Consequently, it is urgent to know if e-cigarettes may have a higher success rate than other nicotine replacement methods and under what conditions. Furthermore, the effects of the therapeutic setting and the relationship between individual characteristics and the success rate have not been tested. This protocol is particularly innovative, because it aims to test the effectiveness of electronic devices in a screening program (the COSMOS II lung cancer prevention program at the European Institute of Oncology), where tobacco reduction is needed to lower individuals’ lung cancer risks. Objective: This protocol was designed with the primary aim of investigating the role of tobacco-free cigarettes in helping smokers improve lung health and either quit smoking or reduce their tobacco consumption. In particular, we aim to investigate the impact of a 3-month e-cigarettes program to reduce smoking-related respiratory symptoms (eg, dry cough, shortness of breath, mouth irritation, and phlegm) through reduced consumption of tobacco cigarettes. Furthermore, we evaluate the behavioral and psychological (eg, well-being, mood, and quality of life) effects of the treatment. Methods: This is a prospective, randomized, placebo-controlled, double-blind, three-parallel group study. The study is organized as a nested randomized controlled study with 3 branches: a nicotine e-cigarettes group, a nicotine-free e-cigarettes group, and a control group. The study is nested in a screening program for early lung cancer detection in heavy smokers. Results: The study is open and is still recruiting. Conclusions: Stopping or reducing tobacco consumption should be a main goal of any health organization. However, traditional antismoking programs are expensive and not always effective. Therefore, favoring a partial or complete shift to e-cigarettes in heavy smokers (eg, persons at high risk for a number of diseases) could be considered a moral imperative. However, before following this path, sound and reliable data on large samples and in a variety of contexts are required. Trial Registration: Clinicaltrials.gov NCT02422914; https://clinicaltrials.gov/ct2/show/NCT02422914 (Archived by WebCite at http://www.webcitation.org/6etwz1bPL) %M 26842790 %R 10.2196/resprot.4805 %U http://www.researchprotocols.org/2016/1/e21/ %U https://doi.org/10.2196/resprot.4805 %U http://www.ncbi.nlm.nih.gov/pubmed/26842790 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 3 %P e109 %T Treatment of Basal Cell Carcinoma Using a One-Stop-Shop With Reflectance Confocal Microscopy: Study Design and Protocol of a Randomized Controlled Multicenter Trial %A Kadouch,Daniel J %A Wolkerstorfer,Albert %A Elshot,Yannick %A Zupan-Kajcovski,Biljana %A Crijns,Marianne B %A Starink,Markus V %A Bekkenk,Marcel W %A van der Wal,Allard C %A Spuls,Phyllis I %A de Rie,Menno A %+ Academic Medical Center, Department of Dermatology, University of Amsterdam, Meibergdreef 9, Amsterdam, 1105 AZ, Netherlands, 31 20 5662587, d.j.kadouch@amc.nl %K carcinoma, basal cell %K microscopy, confocal %K diagnostic services %K sensitivity and specificity %K surgical procedures, operative %D 2015 %7 10.09.2015 %9 Protocol %J JMIR Res Protoc %G English %X Background: Basal cell carcinoma (BCC) is the most common cancer diagnosed in white populations worldwide. The rising incidence of BCC is becoming a major worldwide public health problem. Therefore, there is a need for more efficient management. Objective: The aim of this research is to assess the efficacy and safety of a one-stop-shop (OSS) concept, using real-time in vivo reflectance confocal microscopy (RCM) (Vivascope 1500; Lucid Technologies, Henrietta, NY, USA) as a diagnostic tool, prior to surgical management of new primary BCCs. Methods: This is a prospective non-inferiority multi-center RCT designed to compare the “OSS concept using RCM” to current standards of care in diagnosing and treating clinically suspected BCC. Patients ≥ 18 years attending our outpatient clinic at the Department of Dermatology, Academic Medical Center, University of Amsterdam, and the Department of Dermatology, the Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital (Amsterdam, The Netherlands) with a clinically suspected new primary BCC lesion will be considered for enrollment using predefined inclusion and exclusion criteria, and will be randomly allocated to the experimental or control group. The main outcome parameter is the assessment of incomplete surgical excision margins on the final pathology report of confirmed BCC lesions (either by punch biopsy or RCM imaging). Other outcome measures include diagnostic accuracy (sensitivity and specificity) of RCM for diagnosing BCC and dividing between subtypes, and throughput time. Patient satisfaction data will be collected postoperatively after 3 months during routine follow-up. Results: This research is investigator-initiated and received ethics approval. Patient recruitment started in February 2015, and we expect all study-related activities to be completed by fall 2015. Conclusions: This RCT is the first to examine an OSS concept using RCM for diagnosing and treating clinically suspected BCC lesions. Results of this research are expected to have applications in evidence-based practice for the increasing number of patients suffering from BCC and possibly lead to a more efficient disease management strategy. Trial Registration: ClinicalTrials.gov: NCT02285790; https://clinicaltrial.gov/ct2/show/NCT02285790 (Archived by WebCite at http://www.webcitation.org/6b2LfDKWu). %M 26362616 %R 10.2196/resprot.4303 %U http://www.researchprotocols.org/2015/3/e109/ %U https://doi.org/10.2196/resprot.4303 %U http://www.ncbi.nlm.nih.gov/pubmed/26362616 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 2 %P e59 %T Normothermic Versus Hypothermic Cardiopulmonary Bypass in Children Undergoing Open Heart Surgery (Thermic-2): Study Protocol for a Randomized Controlled Trial %A Baos,Sarah %A Sheehan,Karen %A Culliford,Lucy %A Pike,Katie %A Ellis,Lucy %A Parry,Andrew J %A Stoica,Serban %A Ghorbel,Mohamed T %A Caputo,Massimo %A Rogers,Chris A %+ Clinical Trials and Evaluation Unit, School of Clinical Sciences, University of Bristol, Level 7 Queen's Building, Bristol Royal Infirmary, Bristol, BS2 8HW, United Kingdom, 44 0 117 342 2507, chris.rogers@bristol.ac.uk %K pediatrics %K cardiac surgery %K cardiopulmonary bypass %K temperature %K hypothermia %K normothermia %K clinical trials %K randomized %D 2015 %7 25.05.2015 %9 Protocol %J JMIR Res Protoc %G English %X Background: During open heart surgery, patients are connected to a heart-lung bypass machine that pumps blood around the body (“perfusion”) while the heart is stopped. Typically the blood is cooled during this procedure (“hypothermia”) and warmed to normal body temperature once the operation has been completed. The main rationale for “whole body cooling” is to protect organs such as the brain, kidneys, lungs, and heart from injury during bypass by reducing the body’s metabolic rate and decreasing oxygen consumption. However, hypothermic perfusion also has disadvantages that can contribute toward an extended postoperative hospital stay. Research in adults and small randomized controlled trials in children suggest some benefits to keeping the blood at normal body temperature throughout surgery (“normothermia”). However, the two techniques have not been extensively compared in children. Objective: The Thermic-2 study will test the hypothesis that the whole body inflammatory response to the nonphysiological bypass and its detrimental effects on different organ functions may be attenuated by maintaining the body at 35°C-37°C (normothermic) rather than 28°C (hypothermic) during pediatric complex open heart surgery. Methods: This is a single-center, randomized controlled trial comparing the effectiveness and acceptability of normothermic versus hypothermic bypass in 141 children with congenital heart disease undergoing open heart surgery. Children having scheduled surgery to repair a heart defect not requiring deep hypothermic circulatory arrest represent the target study population. The co-primary clinical outcomes are duration of inotropic support, intubation time, and postoperative hospital stay. Secondary outcomes are in-hospital mortality and morbidity, blood loss and transfusion requirements, pre- and post-operative echocardiographic findings, routine blood gas and blood test results, renal function, cerebral function, regional oxygen saturation of blood in the cerebral cortex, assessment of genomic expression changes in cardiac tissue biopsies, and neuropsychological development. Results: A total of 141 patients have been successfully randomized over 2 years and 10 months and are now being followed-up for 1 year. Results will be published in 2015. Conclusions: We believe this to be the first large pragmatic study comparing clinical outcomes during normothermic versus hypothermic bypass in complex open heart surgery in children. It is expected that this work will provide important information to improve strategies of cardiopulmonary bypass perfusion and therefore decrease the inevitable organ damage that occurs during nonphysiological body perfusion. Trial Registration: ISRCTN Registry: ISRCTN93129502, http://www.isrctn.com/ISRCTN93129502 (Archived by WebCitation at http://www.webcitation.org/6Yf5VSyyG). %M 26007621 %R 10.2196/resprot.4338 %U http://www.researchprotocols.org/2015/2/e59/ %U https://doi.org/10.2196/resprot.4338 %U http://www.ncbi.nlm.nih.gov/pubmed/26007621 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 2 %P e56 %T Contribution of Transcranial Direct Current Stimulation on Inhibitory Control to Assess the Neurobiological Aspects of Attention Deficit Hyperactivity Disorder: Randomized Controlled Trial %A Cosmo,Camila %A Baptista,Abrahão Fontes %A de Sena,Eduardo Pondé %+ Spaulding Neuromodulation Center, Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital/ Harvard Medical School, 79/96 13th St, Charlestown, MA, 02129, United States, 1 617 952 6164, ccosmo@ufba.br %K Attention deficit hyperactivity disorder %K inhibitory control %K transcranial direct current stimulation %D 2015 %7 18.05.2015 %9 Original Paper %J JMIR Res Protoc %G English %X Background: The applicability of transcranial direct current stimulation (tDCS) in individuals with attention deficit hyperactivity disorder (ADHD) has not yet been investigated. This low-cost, non-invasive, and safe technique optimized to modulate the inhibitory response might be a useful treatment option for those affected by this condition. Objective: The aim of this single center, parallel, randomized, double-blinded, sham-controlled trial is to investigate the efficacy of transcranial direct current stimulation over the prefrontal cortex on the modulation of inhibitory control in adults with attention deficit hyperactivity disorder. Methods: A total of 60 individuals will be divided into 2 groups by block randomization to receive active or sham stimulation. Anodal stimulation over the left dorsolateral prefrontal cortex will be applied at 1 mA during a single 20-minute session. Before and after interventions, subjects will perform 2 go/no go tasks and the brain electrical activity will be recorded by electroencephalogram (EEG) with 32 channels, according to the 10-20 international EEG system. Results: The trial began in May 2013 and we are currently performing the statistical analysis for the secondary outcomes. Conclusions: The findings from this study will provide preliminary results about the role of prefrontal cortex activation through tDCS on ADHD patients. Trial Registration: Clinicaltrials.gov NCT01968512; http://clinicaltrials.gov/ct2/show/NCT01968512 (Archived by WebCite at www.webcitation.org/6YMSW2tkD). %M 25986784 %R 10.2196/resprot.4138 %U http://www.researchprotocols.org/2015/2/e56/ %U https://doi.org/10.2196/resprot.4138 %U http://www.ncbi.nlm.nih.gov/pubmed/25986784 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 2 %P e49 %T Timing of High-Dose Rate Brachytherapy With External Beam Radiotherapy in Intermediate and High-Risk Localized Prostate CAncer (THEPCA) Patients and Its Effects on Toxicity and Quality of Life: Protocol of a Randomized Feasibility Trial %A Palvai,Sreekanth %A Harrison,Michael %A Shibu Thomas,Sharon %A Hayden,Karen %A Green,James %A Anderson,Oliver %A Romero,Lavinia %A Lodge,Richard %A Burns,Patricia %A Ahmed,Imtiaz %+ Southend University Hospital National Health Service Foundation Trust, National Health Service, Prittlewell Chase, Westcliff-on-Sea, Essex, SS0 0RY, United Kingdom, 44 01702 435555, Imtiaz.Ahmed@southend.nhs.uk %K prostate cancer %K radiotherapy %K brachytherapy %K external beam radiotherapy %K EBRT %K randomized controlled trial %K RCT %K Southend Hospital %D 2015 %7 29.04.2015 %9 Protocol %J JMIR Res Protoc %G English %X Background: Prostate cancer is the most common cancer in males in the UK and affects around 105 men for every 100,000. The role of radiotherapy in the management of prostate cancer significantly changed over the last few decades with developments in brachytherapy, external beam radiotherapy (EBRT), intensity-modulated radiotherapy (IMRT), and image-guided radiotherapy (IGRT). One of the challenging factors of radiotherapy treatment of localized prostate cancer is the development of acute and late genitourinary and gastrointestinal toxicities. The recent European guidelines suggest that there is no consensus regarding the timing of high-dose rate (HDR) brachytherapy and EBRT. The schedules vary in different institutions where an HDR boost can be given either before or after EBRT. Few centers deliver HDR in between the fractions of EBRT. Objective: Assessment of acute genitourinary and gastrointestinal toxicities at various time points to better understand if the order in which treatment modality is delivered (ie, HDR brachytherapy or EBRT first) has an effect on the toxicity profile. Methods: Timing of HDR brachytherapy with EBRT in Prostate CAncer (THEPCA) is a single-center, open, randomized controlled feasibility trial in patients with intermediate and high-risk localized prostate cancer. A group of 50 patients aged 18 years old and over with histological diagnosis of prostate cancer (stages T1b-T3BNOMO), will be randomized to one of two treatment arms (ratio 1:1), following explanation of the study and informed consent. Patients in both arms of the study will be treated with HDR brachytherapy and EBRT, however, the order in which they receive the treatments will vary. In Arm A, patients will receive HDR brachytherapy before EBRT. In Arm B (control arm), patients will receive EBRT before HDR brachytherapy. Study outcomes will look at prospective assessment of genitourinary and gastrointestinal toxicities. The primary endpoint will be grade 3 genitourinary toxicity and the secondary endpoints will be all other grades of genitourinary toxicities (grades 1 and 2), gastrointestinal toxicities (grades 1 to 4), prostate-specific antigen (PSA) recurrence-free survival, overall survival, and quality of life. Results: Results from this feasibility trial will be available in mid-2016. Conclusions: If the results from this feasibility trial show evidence that the sequence of treatment modality does affect the patients’ toxicity profiles, then funding would be sought to conduct a large, multicenter, randomized controlled trial. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 15835424; http://www.isrctn.com/ISRCTN15835424 (Archived by WebCite at http://www.webcitation.org/6Xz7jfg1u). %M 25926023 %R 10.2196/resprot.4462 %U http://www.researchprotocols.org/2015/2/e49/ %U https://doi.org/10.2196/resprot.4462 %U http://www.ncbi.nlm.nih.gov/pubmed/25926023 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 2 %P e43 %T A Shared Mealtime Approach to Improving Social and Nutritional Functioning Among Older Adults Living Alone: Study Protocol for a Randomized Controlled Trial %A McHugh,Joanna %A Lee,Olga %A Aspell,Niamh %A Lawlor,Brian A %A Brennan,Sabina %+ NEIL Program, Institute of Neuroscience, Trinity College Dublin, Room 3.10, Institute of Neuroscience, Lloyd Building, Trinity College, Dublin, Dublin 2, Ireland, 353 1896 ext 8414, mchughje@tcd.ie %K nutrition %K randomized controlled trial %K older %K aging %K intervention %K social support %K anthropometry %K social cognitive theory %D 2015 %7 21.04.2015 %9 Protocol %J JMIR Res Protoc %G English %X Background: Older adults living alone are at increased risk of malnutrition as well as social isolation. Previous research has evaluated psychosocial interventions aimed at improving social support for older adults living alone. One meta-analysis in particular has suggested that multimodal psychosocial interventions are more effective than unimodal interventions. As such, it may be more effective to deliver an intervention which combines nutritional and social support together. Consequently, we designed the RelAte intervention, which focuses on shared mealtimes as a source of combined social and nutritional support for older adults living alone who are at risk of social isolation. Objective: The objective of the RelAte trial was to evaluate the impact of such an intervention on energy intake, anthropometric measurements, and nutritional social cognitive variables among older adults living alone in the community. Methods: There are 100 participants that will be recruited and randomized to either the treatment (n=50) or the control group. The treatment group will receive a visit from a trained peer volunteer once weekly for a period of 8 weeks. Outcomes of interest include: energy intake, social cognitive factors related to diet, abdominal circumference, body mass index, psychosocial well-being, frailty, nutritional status, and health utilities. Outcomes will be obtained at baseline, immediately postintervention (8 weeks after baseline), 12-week follow-up, and 26-week follow-up by assessors blinded to participants’ randomized assignment. Results: The Relate trial is currently active. We are currently at data analysis stage. The study started in June 2013 and will run until June 2015. Conclusions: Results from this study will primarily describe the effectiveness of a shared mealtime intervention for older adults living alone in terms of their dietary well-being, physical health, and psychosocial well-being. Trial Registration: Trial Registration: Clinicaltrials.gov NCT02007551; http://clinicaltrials.gov/ct2/show/NCT00102401 (Archived by WebCite at http://www.webcitation/6WptuVTtz). %M 25900904 %R 10.2196/resprot.4050 %U http://www.researchprotocols.org/2015/2/e43/ %U https://doi.org/10.2196/resprot.4050 %U http://www.ncbi.nlm.nih.gov/pubmed/25900904 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 4 %N 1 %P e36 %T Determinants of Weight Gain Prevention in Young Adult and Midlife Women: Study Design and Protocol of a Randomized Controlled Trial %A Metzgar,Catherine J %A Nickols-Richardson,Sharon M %+ University of Illinois at Urbana-Champaign, Department of Food Science and Human Nutrition, 260A Bevier Hall, 905 S Goodwin Ave, Urbana, IL, 61801, United States, 1 217 244 4498, nickrich@illinois.edu %K body weight %K weight gain prevention %K weight maintenance %K women %D 2015 %7 26.03.2015 %9 Protocol %J JMIR Res Protoc %G English %X Background: Treatment of overweight and obesity through body weight reduction has been monumentally ineffective as few individuals are able to sustain weight loss. Rather than treating weight gain once it has become problematic, prevention of weight gain over time may be more effective. Objective: The aim of this research is to preclude the burden of adult obesity in women by identifying the determinants of weight gain prevention. The objective of this randomized controlled trial (RCT) is to compare a weight gain prevention intervention delivered by the registered dietitian versus counselor. Methods: This is a 12-month parallel-arm weight gain prevention RCT designed to increase self-efficacy, self-regulation, outcome expectations and family and social support through the use of a nutrition education intervention in women, aged 18-45 years, from the Urbana-Champaign (Illinois, USA) area. Women have been randomized to registered dietitian, counselor or wait-list control groups (August 2014) and are undergoing weekly nutrition education sessions for four months, followed by monthly sessions for eight months (through August 2015). Outcome measures, including: (1) dietary intake, (2) physical activity, (3) anthropometric and blood pressure measurements, (4) biochemical markers of health, (5) eating behaviors and health perceptions, and (6) mediators of behavior change, were collected before the intervention began (baseline) and will be collected at 3, 6, 9, and 12 months of the study. Results: In total, 87 women have been randomized to intervention groups, and 81 women have completed first week of the study. Results are expected in early 2016. Conclusions: This RCT is one of the first to examine weight gain prevention in women across normal, overweight, and obese body mass index categories. Results of this research are expected to have application to evidence-based practice in weight gain prevention for women and possibly have implication for policy regarding decreasing the encumbrance of overweight and obesity in the United States. %M 25831450 %R 10.2196/resprot.4008 %U http://www.researchprotocols.org/2015/1/e36/ %U https://doi.org/10.2196/resprot.4008 %U http://www.ncbi.nlm.nih.gov/pubmed/25831450 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 3 %N 3 %P e42 %T The Nurse-Based Age Independent Intervention to Limit Evolution of Disease After Acute Coronary Syndrome (NAILED ACS) Risk Factor Trial: Protocol for a Randomized Controlled Trial %A Mooe,Thomas %A Björklund,Fredrik %A Graipe,Anna %A Huber,Daniel %A Jakobsson,Stina %A Kajermo,Ulf %A Strömvall,Anna %A Ulvenstam,Anders %+ Department of Public Health and Clinical Medicine, Umeå University, 83183, Östersund, , Sweden, 46 153000, thomas.mooe@medicin.umu.se %K acute coronary syndrome %K myocardial infarction %K secondary prevention %K cardiovascular disease %K randomized controlled trial %D 2014 %7 15.08.2014 %9 Original Paper %J JMIR Res Protoc %G English %X Background: Secondary prevention after acute coronary syndrome (ACS) is essential to reduce morbidity and mortality, but related studies have been fairly small or performed as clinical trials with non-representative patient selection. Long-term follow-up data are also minimal. A nurse-led follow-up for risk factor improvement may be effective, but the evidence is limited. Objective: The aims of this study are to perform an adequately sized, nurse-led, long-term secondary preventive follow-up with inclusion of an unselected population of ACS patients. The focus will be on lipid and blood pressure control as well as tobacco use and physical activity. Methods: The study will consist of a randomized, controlled, long-term, population-based trial with two parallel groups. Patients will be included during the initial hospital stay. Important outcome variables are total cholesterol, low-density lipoprotein (LDL) cholesterol, and sitting systolic and diastolic blood pressure. Outcomes will be measured after 12, 24, and 36 months of follow-up. Trained nurses will manage the intervention group with the aim of achieving set treatment goals as soon as possible. The control group will receive usual care. At least 250 patients will be included in each group to reliably detect a difference in mean LDL of 0.5 mmol/L and in mean systolic blood pressure of 5 mmHg. Results: The study is ongoing and recruitment of participants will continue until December 31, 2014. Conclusions: This study will test the hypothesis that a nurse-led, long-term follow-up after an ACS with a focus on achieving treatment goals as soon as possible is an effective secondary preventive method. If proven effective, this method could be implemented in general practice at a low cost. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 96595458; http://www.controlled-trials.com/ISRCTN96595458 (Archived by WebCite at http://www.webcitation.org/6RlyhYTYK). %M 25131960 %R 10.2196/resprot.3466 %U http://www.researchprotocols.org/2014/3/e42/ %U https://doi.org/10.2196/resprot.3466 %U http://www.ncbi.nlm.nih.gov/pubmed/25131960 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 3 %N 3 %P e35 %T The Effects of Propofol Cardioplegia on Blood and Myocardial Biomarkers of Stress and Injury in Patients With Isolated Coronary Artery Bypass Grafting or Aortic Valve Replacement Using Cardiopulmonary Bypass: Protocol for a Single-Center Randomized Controlled Trial %A Plummer,Zoe E %A Baos,Sarah %A Rogers,Chris A %A Suleiman,M-Saadeh %A Bryan,Alan J %A Angelini,Gianni D %A Hillier,James %A Downes,Richard %A Nicholson,Eamonn %A Reeves,Barnaby C %+ Clinical Trials and Evaluation Unit, University of Bristol, Level 7 Queens Building, Bristol Royal Infirmary, Bristol, , United Kingdom, 44 117 342 ext 3143, Barney.Reeves@bristol.ac.uk %K cardiac surgery %K anesthetics %K cardiopulmonary bypass %K ischemia %K reperfusion %K cardioplegia %K aortic valve %K coronary artery %K troponin %K clinical trials, randomized %D 2014 %7 08.07.2014 %9 Protocol %J JMIR Res Protoc %G English %X Background: Despite improved myocardial protection strategies, cardioplegic arrest and ischemia still result in reperfusion injury. We have previously published a study describing the effects of propofol (an anesthetic agent commonly used in cardiac surgery) on metabolic stress, cardiac function, and injury in a clinically relevant animal model. We concluded that cardioplegia supplementation with propofol at a concentration relevant to the human clinical setting resulted in improved hemodynamic function, reduced oxidative stress, and reduced reperfusion injury when compared to standard cardioplegia. Objective: The Propofol cardioplegia for Myocardial Protection Trial (ProMPT) aims to translate the successful animal intervention to the human clinical setting. We aim to test the hypothesis that supplementation of the cardioplegic solution with propofol will be cardioprotective for patients undergoing isolated coronary artery bypass graft or aortic valve replacement surgery with cardiopulmonary bypass. Methods: The trial is a single-center, placebo-controlled, randomized trial with blinding of participants, health care staff, and the research team. Patients aged between 18 and 80 years undergoing nonemergency isolated coronary artery bypass graft or aortic valve replacement surgery with cardiopulmonary bypass at the Bristol Heart Institute are being invited to participate. Participants are randomly assigned in a 1:1 ratio to either cardioplegia supplementation with propofol (intervention) or cardioplegia supplementation with intralipid (placebo) using a secure, concealed, Internet-based randomization system. Randomization is stratified by operation type and minimized by diabetes mellitus status. Biomarkers of cardiac injury and metabolism are being assessed to investigate any cardioprotection conferred. The primary outcome is myocardial injury, studied by measuring myocardial troponin T. The trial is designed to test hypotheses about the superiority of the intervention within each surgical stratum. The sample size of 96 participants has been chosen to achieve 80% power to detect standardized differences of 0.5 at a significance level of 5% (2-tailed) assuming equal numbers in each surgical stratum. Results: A total of 96 patients have been successfully recruited over a 2-year period. Results are to be published in late 2014. Conclusions: Designing a practicable method for delivering a potentially protective dose of propofol to the heart during cardiac surgery was challenging. If our approach confirms the potential of propofol to reduce damage during cardiac surgery, we plan to design a larger multicenter trial to detect differences in clinical outcomes. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 84968882; http://www.controlled-trials.com/ISRCTN84968882/ProMPT (Archived by WebCite at http://www.webcitation.org/6Qi8A51BS). %M 25004932 %R 10.2196/resprot.3353 %U http://www.researchprotocols.org/2014/3/e35/ %U https://doi.org/10.2196/resprot.3353 %U http://www.ncbi.nlm.nih.gov/pubmed/25004932 %0 Journal Article %@ 1929-0748 %I JMIR Publications Inc. %V 2 %N 2 %P e46 %T Internet-Based Cognitive Behavior Therapy for Procrastination: Study Protocol for a Randomized Controlled Trial %A Rozental,Alexander %A Carlbring,Per %+ Division of Clinical Psychology, Department of Psychology, University of Stockholm, Frescati Hagväg 8, Stockholm, 10691, Sweden, 46 8 16 39 20, per@carlbring.se %K procrastination %K cognitive behavior therapy %K Internet-administered %K randomized controlled trial %D 2013 %7 12.11.2013 %9 Protocol %J JMIR Res Protoc %G English %X Background: Procrastination, to voluntarily delay an intended course of action despite expecting to be worse-off for the delay, is a persistent behavior pattern that can cause major psychological suffering. Approximately half of the student population and 15%-20% of the adult population are presumed having substantial difficulties due to chronic and recurrent procrastination in their everyday life. However, preconceptions and a lack of knowledge restrict the availability of adequate care. Cognitive behavior therapy (CBT) is often considered treatment of choice, although no clinical trials have previously been carried out. Objective: The aim of this study will be to test the effects of CBT for procrastination, and to investigate whether it can be delivered via the Internet. Methods: Participants will be recruited through advertisements in newspapers, other media, and the Internet. Only people residing in Sweden with access to the Internet and suffering from procrastination will be included in the study. A randomized controlled trial with a sample size of 150 participants divided into three groups will be utilized. The treatment group will consist of 50 participants receiving a 10-week CBT intervention with weekly therapist contact. A second treatment group with 50 participants receiving the same treatment, but without therapist contact, will also be employed. The intervention being used for the current study is derived from a self-help book for procrastination written by one of the authors (AR). It includes several CBT techniques commonly used for the treatment of procrastination (eg, behavioral activation, behavioral experiments, stimulus control, and psychoeducation on motivation and different work methods). A control group consisting of 50 participants on a wait-list control will be used to evaluate the effects of the CBT intervention. For ethical reasons, the participants in the control group will gain access to the same intervention following the 10-week treatment period, albeit without therapist contact. Results: The current study is believed to result in three important findings. First, a CBT intervention is assumed to be beneficial for people suffering from problems caused by procrastination. Second, the degree of therapist contact will have a positive effect on treatment outcome as procrastination can be partially explained as a self-regulatory failure. Third, an Internet based CBT intervention is presumed to be an effective way to administer treatment for procrastination, which is considered highly important, as the availability of adequate care is limited. The current study is therefore believed to render significant knowledge on the treatment of procrastination, as well as providing support for the use of Internet based CBT for difficulties due to delayed tasks and commitments. Conclusions: To our knowledge, the current study is the first clinical trial to examine the effects of CBT for procrastination, and is assumed to render significant knowledge on the treatment of procrastination, as well as investigating whether it can be delivered via the Internet. Trial Registration: ClinicalTrials.gov: NCT01842945; http://clinicaltrials.gov/show/NCT01842945 (Archived by WebCite at http://www.webcitation.org/6KSmaXewC). %M 24220277 %R 10.2196/resprot.2801 %U http://www.researchprotocols.org/2013/2/e46/ %U https://doi.org/10.2196/resprot.2801 %U http://www.ncbi.nlm.nih.gov/pubmed/24220277