JMIR Research Protocols最新文献

{"title":"Interactive Computer-Adaptive Chronic Kidney Disease (I-C-CKD) Education for Hospitalized African American Patients: Protocol for a Randomized Controlled Trial.","authors":"Akilah King, Tayo Omoniyi, Lindsay Zasadzinski, Cynthia Gaspard, Denesha Gorman, Milda Saunders","doi":"10.2196/66846","DOIUrl":"https://doi.org/10.2196/66846","url":null,"abstract":"<p><strong>Background: </strong>End-stage kidney disease (ESKD) or kidney failure is a condition where the kidneys lose the ability to function. African American individuals are 4 times as likely to develop ESKD compared to White American individuals. In addition, African American patients are less likely to have an optimal dialysis start and to choose renal replacement therapy modalities that align with their goals and values. Our prior work shows that culturally tailored, in-person education improves patient outcomes. This is the foundation for our innovative intervention using an African American virtual patient educator as an option for hospitalized patients with chronic kidney disease (CKD).</p><p><strong>Objective: </strong>The Interactive Computer-Adaptive Chronic Kidney Disease (I-C-CKD) study will determine whether the computerized adaptive education and usual hospital care impact the health literacy of African American patients with kidney disease. It will also assess how patients' lifestyle and commitment to health goals are impacted by the method of health literacy education.</p><p><strong>Methods: </strong>We will screen, recruit, and enroll hospitalized patients who self-identify as African American and have advanced CKD based on their estimated glomerular filtration rate. Eligible patients who verbally consented will be randomly assigned into either the computerized adaptive education intervention group or the control group (usual hospital care). Patients in the intervention group will receive a culturally tailored, adaptive education module. To analyze pretest, posttest, and follow-up survey results on patient CKD knowledge, ESKD treatment options, and health goals, we will use a paired, 2-tailed t test with a Bonferroni adjustment for multiple comparisons.</p><p><strong>Results: </strong>Recruitment for the I-C-CKD study began on May 2, 2023. We are currently recruiting and have enrolled 96 patients who completed both pretest and posttest surveys as of December 2024. This includes 50 patients in the control group and 46 patients in the intervention group. Data analysis has not occurred.</p><p><strong>Conclusions: </strong>African American individuals often receive less patient education about self-care and treatment options for CKD. We hope this study provides a solution to increase hospitalized African American patients' knowledge of CKD and motivation for CKD self-care through computerized adaptive education, reduce disparities, and improve patient outcomes.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06364358; https://clinicaltrials.gov/study/NCT06364358.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/66846.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e66846"},"PeriodicalIF":1.4,"publicationDate":"2025-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12046252/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143997124","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Impact of Long-Chain Omega-3 Polyunsaturated Fatty Acid Supplementation in Pregnant Women Toward the Intelligence Status of Early Childhood: Protocol for a Systematic Review and Meta-Analysis.","authors":"Han Yin Lim, Mohammad Adi Mohammad Fadzil, Suraiami Mustar, Imanul Hassan Abdul Shukor, Wan Ahmad Syazani Mohamed","doi":"10.2196/60417","DOIUrl":"https://doi.org/10.2196/60417","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Long-chain omega-3 polyunsaturated fatty acids (LCPUFAs) are essential fatty acids that protect cellular structures and provide energy, particularly for fetal growth and development. The maternal supplementations of omega-3 LCPUFA may affect the rate of intelligence in early childhood development.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This systematic review aims to synthesize available evidence on the impact of omega-3 LCPUFA supplementation during pregnancy toward intelligence in early childhood development by analyzing the outcomes specifying the aspects of intelligence such as neurodevelopment, social-emotional, language, attention, behavior, cognition, vision, hearing, and motor skills.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We will only include randomized controlled trials on pregnant women supplemented with omega-3 LCPUFA interventions and the outcome measured is the children's intelligence. Based on the World Health Organization's definition of early childhood, we will include children aged 8 years or younger. Children's intelligence can be indicated using several tools measuring their intelligence index, such as neurodevelopment, social-emotional, language, attention, behavior, cognition, vision, hearing, and motor skills. Irrelevant and unavailable studies will be excluded. A systematic search will be conducted in 3 electronic databases, namely PubMed, Scopus, and Cochrane using relevant and synonymous terms. Study screening and selection will be conducted by the authors based on eligibility criteria. Upon encountering conflicting decisions, a discussion will be held to reach a consensus. The screening and selection process will be recorded using a PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) flowchart. The included studies will be subjected to bias and quality assessment in accordance with the Critical Appraisal Skills Programme (CASP) and Grading of Recommendations Assessment, Development, and Evaluation (GRADE) assessment tool for randomized controlled trials.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;An initial search was conducted on November 1, 2023, which returned 1998 studies for screening. The extracted data will be classified into groups and subgroups according to the indicator of intelligence measured in the study. Next, the extracted data will be summarized using tables of evidence. Whenever possible, a meta-analysis of homogeneous groups of studies will be conducted using statistical software such as RevMan (version 5.4; Cochrane Collaboration). Studies with significant heterogeneity will be discussed narratively. The systematic review is estimated to be published in November 2025.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This systematic review will systematically pool the evidence on the potential use of omega-3 LCPUFA supplementation to improve children's intelligence status. This review is also important in addressing any existing knowledge gaps on this topic. Finally, a deeper underst","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e60417"},"PeriodicalIF":1.4,"publicationDate":"2025-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12046255/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143984093","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Testing a Machine Learning-Based Adaptive Motivational System for Socioeconomically Disadvantaged Smokers (Adapt2Quit): Protocol for a Randomized Controlled Trial.","authors":"Ariana Kamberi, Benjamin Weitz, Julie Flahive, Julianna Eve, Reem Najjar, Tara Liaghat, Daniel Ford, Peter Lindenauer, Sharina Person, Thomas K Houston, Megan E Gauvey-Kern, Jackie Lobien, Rajani S Sadasivam","doi":"10.2196/63693","DOIUrl":"https://doi.org/10.2196/63693","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Individuals who are socioeconomically disadvantaged have high smoking rates and face barriers to participating in smoking cessation interventions. Computer-tailored health communication, which is focused on finding the most relevant messages for an individual, has been shown to promote behavior change. We developed a machine learning approach (the Adapt2Quit recommender system), and our pilot work demonstrated the potential to increase message relevance and smoking cessation effectiveness among individuals who are socioeconomically disadvantaged.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study protocol describes our randomized controlled trial to test whether the Adapt2Quit recommender system will increase smoking cessation among individuals from socioeconomically disadvantaged backgrounds who smoke.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Individuals from socioeconomically disadvantaged backgrounds who smoke were identified based on insurance tied to low income or from clinical settings (eg, community health centers) that provide care for low-income patients. They received text messages from the Adapt2Quit recommender system for 6 months. Participants received daily text messages for the first 30 days and every 14 days until the end of the study. Intervention participants also received biweekly texting facilitation messages, that is, text messages asking participants to respond (yes or no) if they were interested in being referred to the quitline. Interested participants were then actively referred to the quitline by study staff. Intervention participants also received biweekly text messages assessing their current smoking status. Control participants did not receive the recommender messages but received the biweekly texting facilitation and smoking status assessment messages. Our primary outcome is the 7-day point-prevalence smoking cessation at 6 months, verified by carbon monoxide testing. We will use an inverse probability weighting approach to test our primary outcome. This involves using a logistic regression model to predict nonmissingness, calculating the inverse probability of nonmissingness, and using it as a weight in a logistic regression model to compare cessation rates between the two groups.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The Adapt2Quit study was funded in April 2020 and is still ongoing. We have completed the recruitment of individuals (N=757 participants). The 6-month follow-up of all participants was completed in November 2024. The sample consists of 64% (486/757) female participants, 35% (265/757) Black or African American individuals, 51.1% (387/757) White individuals, and 16% (121/757) Hispanic or Latino individuals. In total, 52.6% (398/757) of participants reported having a high school education or being a high school graduate; 70% (529/757) smoked their first cigarette within 30 minutes of waking, and half (379/757, 50%) had stopped smoking for at least one day in the past year. Moreover, 16.6% (126/","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e63693"},"PeriodicalIF":1.4,"publicationDate":"2025-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12044314/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144003986","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Calibration and Validation of Machine Learning Models for Physical Behavior Characterization: Protocol and Methods for the Free-Living Physical Activity in Youth (FLPAY) Study.","authors":"Samuel Robert LaMunion, Paul Robert Hibbing, Scott Edward Crouter","doi":"10.2196/65968","DOIUrl":"https://doi.org/10.2196/65968","url":null,"abstract":"<p><strong>Background: </strong>Wearable activity monitors are increasingly used to characterize physical behavior. The development and validation of these characterization methods require criterion-labeled data typically collected in a laboratory or simulated free-living environment, which does not generally translate well to free-living due to limited behavior engagement in development that is not representative of free living.</p><p><strong>Objective: </strong>The Free-Living Physical Activity in Youth (FLPAY) study was designed in 2 parts to establish a criterion dataset for novel method development for identifying periods of transition between activities in youth.</p><p><strong>Methods: </strong>The FLPAY study used criterion measures of behavior (direct observation) and energy expenditure (indirect calorimetry) to label data from research-grade accelerometer-based devices for the purpose of developing and cross-validating models to identify transitions, classify activity type, and estimate energy expenditure in youth aged 6-18 years. The first part of this study was a simulated free-living protocol in the laboratory, comprising short (roughly 60-90 s) and long (roughly 4-5 min) bouts of 16 activities that were completed in various orders over the span of 2 visits. The second part of this study involved an independent sample of participants who agreed to be measured twice (2 hours each time) in free-living environments such as the home and community.</p><p><strong>Results: </strong>The FLPAY study was funded from 2016 to 2020. A no-cost extension was granted for 2021. A few secondary outcomes have been published, but extensive analysis of primary data is ongoing.</p><p><strong>Conclusions: </strong>The 2-part design of the FLPAY study emphasized the collection of naturalistic behaviors and periods of transition between activities in both structured and unstructured environments. This filled an important gap, considering the traditional focus on scripted activity routines in structured laboratory environments. This protocol paper details the FLPAY procedures and participants, along with details about criterion datasets, which will be useful in future studies analyzing the wealth of device-based data in diverse ways.</p><p><strong>International registered report identifier (irrid): </strong>RR1-10.2196/65968.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e65968"},"PeriodicalIF":1.4,"publicationDate":"2025-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12044308/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143991070","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"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.","authors":"Reagan Conner, Cynthia Porter, Karen Lutrick, Shawn C Beitel, James Hollister, Olivia Healy, Krystal J Kern, Floris Wardenaar, John J Gulotta, Kepra Jack, Matthew Huentelman, Jefferey L Burgess, Melissa Furlong","doi":"10.2196/67120","DOIUrl":"https://doi.org/10.2196/67120","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Participant activities and data collection will conclude by December 2025.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial registration: &lt;/strong&gt;ClinicalTrials.gov NCT05869747; https://clinicaltrials.gov/study/NCT05869747.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;International registered report ide","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e67120"},"PeriodicalIF":1.4,"publicationDate":"2025-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12044307/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143967734","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Using Music to Promote Hong Kong Young People's Emotion Regulation and Reduce Their Mood Symptoms and Loneliness: Protocol for a Pilot Randomized Controlled Trial.","authors":"Yuan Cao, Yuanxin Shi, Debbie Chi Wing Low, Daniel T L Shek, David H K Shum, Radhika Tanksale, Genevieve Dingle","doi":"10.2196/67764","DOIUrl":"https://doi.org/10.2196/67764","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Mental health needs in the community surged during the pandemic, with concerning reports of increased negative mood symptoms among youth. At the same time, preventive psychoeducational interventions were insufficient within frontline youth mental health services in Hong Kong, and research specifically addressing youth loneliness remained limited on an international scale. Given the association between loneliness and other mental health symptoms, psychoeducational programs that empower adolescents to cope with emotions may help address both the research gap and local demand. As such, Tuned In, a previously validated intervention program originally developed in Australia, was introduced to the local context. Cultural adaptations and an added focus on loneliness were incorporated into the project to enhance its acceptability and test its effectiveness.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aims to evaluate an adapted version of the Tuned In music-based psychoeducation program, designed to reduce loneliness, depression, and anxiety symptoms among young people in Hong Kong by enhancing their emotion regulation skills.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Participants aged 16-19 years will be randomly assigned to either the experimental or control group. The experimental group will receive an online, group-based psychoeducation program focused on emotion recognition and management, delivered weekly over 4 consecutive weeks. The intervention is grounded in Russell's emotion circumplex model and music psychology, and program content included: The 2D model and characteristics of emotions from different quadrants (session 1); happiness and loneliness (session 2); high-arousal and negative-valence emotions, for example, stress and anxiety (sessions 3); and anxiety, perfectionism, and a celebration of achievement (session 4). Both therapist- and participant-selected music will be used in the intervention to provide a rich repertoire for group discussion, psychoeducation, reflection, and the practice of social skills. The main outcome measures will be assessed using the Emotion Regulation Questionnaire, the Difficulties in Emotion Regulation Scale, the Depression Anxiety Stress Scale, and the De Jong Gierveld Loneliness Scale. Feedback on the project arrangement will be gathered through qualitative input. A mixed methods analysis will be conducted following data collection.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The project was successfully funded in February 2023 by the Health and Medical Research Fund in Hong Kong and commenced in August 2023. As of September 16, 2024, a total of 316 completed questionnaires had been received through Qualtrics for screening purposes, with 89 participants deemed eligible for the program. The project is scheduled to conclude in August 2025, with results to be published thereafter.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Participants are expected to show improvements in emotion regulation, along with red","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e67764"},"PeriodicalIF":1.4,"publicationDate":"2025-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12044316/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143967816","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mental Health Apps Available in App Stores for Indian Users: Protocol for a Systematic Review.","authors":"Seema Mehrotra, Ravikesh Tripathi, Pramita Sengupta, Abhishek Karishiddimath, Angelina Francis, Pratiksha Sharma, Paulomi Sudhir, Srikanth Tk, Girish N Rao, Rajesh Sagar","doi":"10.2196/71071","DOIUrl":"https://doi.org/10.2196/71071","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;There has been a surge in mental health apps over the past few years. While these have great potential to address the unmet mental health needs of the population, the recent proliferation of mental health apps in the commercial marketplace has raised several concerns, such as privacy, evidence-based, and quality. Although there is mounting research on the effectiveness of mental health apps, the majority of these are not accessible to the public and most of those available have not been researched. Despite the rapid growth of the digital health market in India, there are no comprehensive reviews of publicly available mental health apps for Indian users. Hence it becomes important to review mental health apps freely available to potential end users in terms of their scope, functions, and quality.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aims to systematically evaluate mental health apps available to Indian users in app stores.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This systematic review of mental health apps will be performed following the Target user, Evaluation focus, Connectedness and Health domain approach and the PASSR (Protocol for App Store Systematic Reviews) checklist. Fifteen key search terms covering various mental health conditions and therapies will be used on the Android and iOS stores. The identified apps will be further screened and reviewed based on the inclusion and exclusion criteria. The pool of eligible apps will be downloaded for detailed review. The following steps will be adopted to streamline the review process and interrater consistency. Six apps will be randomly selected from the downloaded apps, for joint discussion and review by a team of 4 primary reviewers and 2 mentors. Following this, a new set of 6 randomly selected apps will be rated independently by the primary reviewers and the differences in ratings will be jointly discussed for generating consensus. Subsequently, the primary reviewers will individually review the remaining apps in the list. Data will be extracted based on predecided parameters such as privacy policy, basic purpose, type of developer, nature of intervention strategies, and guided versus unguided nature. Additionally, the apps will be reviewed for quality using the Mobile Application Rating Scale. The data analysis and synthesis strategy will incorporate descriptive statistics based on quality evaluation using the Mobile Application Rating Scale and examining the content of the apps for generating descriptive information.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The initial screening of mental health apps available for Indian users on the Google Play Store and Apple App Store was initiated in October 2024. We expect to complete the detailed systematic review by April 2025.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This study will offer a comprehensive review of mental health apps available in digital marketplaces for Indian users and has implications for end users, policy makers,","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e71071"},"PeriodicalIF":1.4,"publicationDate":"2025-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12044312/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143993399","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Resource-Oriented Case Management to Implement Recommendations for Patients With Chronic Pain and Frequent Use of Analgesics in General Practices (Project RELIEF): Protocol for a Single-Arm Exploratory Feasibility Study.","authors":"Regina Poß-Doering, Sabrina Brinkmöller, Alexandra Balzer, Viktoria Sophie Wurmbach, Cinara Paul, Regina Stolz, Marco Richard Zugaj, Jonas Tesarz, Michel Wensing, Cornelia Straßner","doi":"10.2196/66335","DOIUrl":"https://doi.org/10.2196/66335","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Chronic noncancer pain (CNCP) is a frequent reason for counseling in general practice. Current German guidelines emphasize its biopsychosocial etiology and the importance of self-care and nonpharmacological treatment strategies such as education, physical and social activity, and psychological approaches. Comprehensive assessments are necessary to individualize treatment maximally and monitor appropriate use of pain medication. General practitioners face many challenges in implementing holistic pain management, which considers biological, psychological, and social aspects. In project RELIEF (resource-oriented case management to implement recommendations for patients with chronic pain and frequent use of analgesics in general practices), a case management program was developed to facilitate implementation of guideline recommendations on pain management regarding medical assessment and monitoring, patient and practice team education, promotion of self-care strategies, and rational pharmacotherapy.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;We evaluated the feasibility of the intervention and study procedures before applying them in a larger cluster randomized controlled trial. Our secondary objective is to estimate potential effects of the complex intervention.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;A single-arm trial with general practices and patients with CNCP and analgesics use will be conducted, accompanied by a mixed methods process evaluation. The intervention comprises 5 components, including software-supported medical pain history, 3 scheduled structured appointments, e-learning on CNCP for general practitioners and medical assistants, educational material for patients, toolbox with information on (regional) resources for patients and practice teams. Participating practices will be located in the federal state of Baden-Württemberg, Germany, and will recruit eligible patients (adults with CNCP for more than 3 months, with at least moderate pain-related disability, permanent or on-demand use of analgesics or co-analgesics in the previous 4 weeks, and practice team assessed ability to participate actively in the trial). A questionnaire given to the first 150 adult patients entering the practice in February 2025 will help screen eligible patients. The primary objective will be measured by a set of predefined indicators. The key secondary outcome is pain-related disability measured by the Pain Disability Index German version. All participants will be asked to participate in the process evaluation. Outcome evaluation data will be gathered by paper-based and digitally provided questionnaires to be completed by participants. Process evaluation data will be gathered in surveys and a qualitative study. Descriptive analyses will be performed.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Recruitment occurred between October and December 2024. Targeted sample size was 6 practices and 50 patients. The intervention period will be February-June 2025. I","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e66335"},"PeriodicalIF":1.4,"publicationDate":"2025-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12041818/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144024941","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Insight inTo Stress and POOping on work TIME (ITS POO TIME): an online and cross-sectional study protocol.","authors":"Phillip Tully, Suzanne Cosh, Gary Wittert, Sean Martin, Andrew Vincent, Antonina Mikocka-Walus, Deborah Turnbull","doi":"10.2196/58655","DOIUrl":"https://doi.org/10.2196/58655","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Long occupational working hours and shift work are common in high, middle, and lower-income economies. Bowel movement frequency and stool form in occupational settings may be important markers of stressful working conditions as well as diurnal gut microbiota action, gastrointestinal discomfort, and disorders of gut-brain interaction (DGBI). Characterizing DGBI in shift and non-shift workers could help identify the impact of diurnal work patterns on worker's physical and mental health, including anxiety related to bowel movements.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The paper outlines the Insight inTo Stress and POOping on work TIME (ITS POO TIME) protocol describing a web-based multi-methods research project on DGBI, stool form and frequency, psychological factors, sleep, diet and anxiety related to bowel movements in occupational settings by comparison to residential settings.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Study 1 comprises a web-based convenience sampling survey to acquire quantitative data from adults who are engaged in paid employment. We seek to assess occupational characteristics, organizational factors, as well as standardized questionnaires for stool form, DGBI assessed by Rome-IV criteria, sleep, diet, bowel movement anxiety (i.e. parcopresis), and distress. Study 2 is a qualitative study which asks open-ended questions about respondents' attitudes to defecation at work. Analyses for Study 1 will explore rates of DGBI in shift vs. non-shift workers and explore how occupational characteristics are associated with occupational bowel movement stool form and frequency. With regards to distress, and parcopresis, Study 1 will analyse how parcopresis, distress, and contamination fears are associated with stool form and frequency in occupational settings compared with residential settings. Study 1 is designed to have 90% power to detect a 5% difference in DGBI prevalence between groups at α = 0.05 based on the conservative estimate of 15% DGBI prevalence in shift workers and 10% DGBI prevalence in non-shift workers, with a final sample of N=1967 required. Study 2 qualitative data will be analysed using inductive thematic analysis to identify themes concerning feelings and attitudes about bowel movements in occupational settings.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The findings of ITS POO TIME will elicit important information on what factors are associated with bowel movements and stool form and frequency in occupational settings and identify associations pertinent to occupational health. Data collection commenced in January 2019 and finished enrolment in December 2023. Study 1 obtained 1872 responses and fell short of the desired sample size. Study 2 received 337 responses, and the primary results are expected to be published in 2025 and qualitative results published in 2026.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;The results of the research described in this research protocol will have direct implications for industry,","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":" ","pages":""},"PeriodicalIF":1.4,"publicationDate":"2025-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143972208","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"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.","authors":"Beth E Meyerson, Alissa Davis, Richard A Crosby, Linnea B Linde-Krieger, Benjamin R Brady, Gregory A Carter, Arlene N Mahoney, David Frank, Janet Rothers, Zhanette Coffee, Elana Deuble, Jonathon Ebert, Mary F Jablonsky, Marlena Juarez, Barbara Lee, Heather M Lorenz, Michael D Pava, Kristen Tinsely, Sana Yousaf","doi":"10.2196/69829","DOIUrl":"10.2196/69829","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial registration: &lt;/strong&gt;ClinicalTrials.gov NCT06513728; https://clinicaltrials.gov/study/NCT06513728 and ClinicalTrials.gov NCT06556602; https://clinicaltrials.gov/study/NCT06556602.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Inter","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":" ","pages":"e69829"},"PeriodicalIF":1.4,"publicationDate":"2025-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12041824/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143657107","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}