JMIR Research Protocols最新文献

{"title":"Evaluation of the Comparative Efficacy of Honey Thermal Microcautery, Standard Physiotherapy, and <i>Sida cordifolia</i> Oil via Nasal Administration in the Management of Frozen Shoulder: Protocol for a Randomized Controlled Trial.","authors":"Shalini Pathania, Shweta Parwe, Punam Sawarkar, Milind Nisargandha","doi":"10.2196/64066","DOIUrl":"https://doi.org/10.2196/64066","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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).</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e64066"},"PeriodicalIF":1.5,"publicationDate":"2025-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145274436","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":"Promoting Healthier Meal Selection and Intake Among Children in Restaurants: Protocol for a Cluster-Randomized Trial.","authors":"Stephanie Anzman-Frasca, Sara Tauriello, Leonard Epstein, Mackenzie J Ferrante, April Gampp, Juliana Goldsmith, Jess Haines, Lucia A Leone, Rocco Paluch","doi":"10.2196/73618","DOIUrl":"https://doi.org/10.2196/73618","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;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).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;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 cur","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e73618"},"PeriodicalIF":1.5,"publicationDate":"2025-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145274414","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":"Just-in-Time Adaptive Intervention to Improve HIV Prevention and Substance Use in Youth Experiencing Homelessness (MY-RIDE): Protocol for a Randomized Controlled Trial.","authors":"Diane Santa Maria, Nikhil Padhye, Michael Businelle, Natasha Slesnick, Stefani Ricondo, Marguerita Lightfoot","doi":"10.2196/78006","DOIUrl":"https://doi.org/10.2196/78006","url":null,"abstract":"<p><strong>Background: </strong>Youth who are experiencing homelessness face a higher risk of HIV infection compared to their housed peers, and suicide and overdose remain the leading causes of death among homeless youth. Just-in-Time Adaptive Interventions (JITAIs) are gaining momentum for HIV prevention and substance use research. Yet, most interventions for homeless youth have not addressed modifiable real-time factors.</p><p><strong>Objective: </strong>This paper describes the development and implementation of a randomized attention-controlled trial to assess the efficacy of motivating youth to reduce infections, disconnections, and emotional dysregulation (MY-RIDE), a JITAI to improve HIV prevention and substance use in homeless youth.</p><p><strong>Methods: </strong>This study will enroll 320 homeless youth aged 18-25 years. The intervention was co-designed with homeless youth using the Information-Motivation-Behavioral Skills Model and consists of an individual nurse-led session about HIV prevention and 3 months of a JITAI with personalized messaging delivered by phone in real time in response to one's current level of risk. Participants also had access to an on-demand nurse helpline through the app.</p><p><strong>Results: </strong>Institutional review board approval was obtained in the summer of 2024. Recruitment began in the fall of 2024 at shelters, drop-in centers, and other organizations that serve homeless youth. Participants complete a baseline survey and HIV/sexually transmitted infection (STI) testing and are provided with a smartphone with the intervention app. Follow-up surveys and HIV/STI testing are conducted at immediate, 3-, 6-, and 12-month time points post intervention to assess uptake of HIV prevention strategies and substance use reduction. A total of 192 are enrolled to date.</p><p><strong>Conclusions: </strong>The results of this study will determine whether MY-RIDE increases HIV prevention strategies and decreases substance use when compared to homeless youth in the attention control group. We will also evaluate if MY-RIDE impacts protective factors such as willingness to take pre-exposure prophylaxis medication and use of mental health and substance use services, and antecedents of risk such as stress, substance use urge, and substance use.</p><p><strong>Trial registration: </strong>Clinicaltrials.gov NCT06074354; https://clinicaltrials.gov/study/NCT06074354.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/78006.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e78006"},"PeriodicalIF":1.5,"publicationDate":"2025-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145274428","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":"High-Throughput Computing to Detect Harmful Drug-Drug Interactions in Older Adults: Protocol for a Population-Based Cohort Study.","authors":"Neda Rostamzadeh, Rishabh Sharma, Sheikh S Abdullah, Eric McArthur, Niaz Chalabianloo, Jessica M Sontrop, Matthew A Weir, Kamran Sedig, Amit X Garg, Flory T Muanda","doi":"10.2196/77224","DOIUrl":"https://doi.org/10.2196/77224","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Drug-drug interactions (DDIs) are a major concern, especially for older adults taking multiple medications. Although Health Canada and the US Food and Drug Administration (FDA) use population-based studies to identify adverse drug events, detecting harmful DDIs is challenging due to the millions of potential drug combinations. Traditional pharmacoepidemiologic studies are slow and inefficient, often missing important harmful DDIs.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This protocol outlines a novel approach to efficiently identify harmful DDIs using administrative health care data.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Using high-throughput computing, we will conduct multiple population-based, new-user cohort studies using Ontario's linked administrative health care data. The cohorts will be selected from the population of Ontario residents aged 66 years and older who filled at least one oral outpatient drug prescription from 2002 to 2023. In each cohort, the exposed group will comprise individuals who are regular users of one drug (drug A) who start a new prescription for a second drug (drug B); the referent group will comprise regular users of drug A not taking drug B. We will evaluate 74 acute outcomes within 30 days of cohort entry, including hospitalizations, emergency department visits, and mortality. Propensity score methods will balance exposed and referent groups on more than 400 baseline health characteristics. Modified Poisson and binomial regression models will estimate risk ratios (RRs) and risk differences (RDs). To ensure findings are both statistically and clinically meaningful, we will apply prespecified thresholds for effect sizes (eg, lower bounds of 95% CIs≥1.33 for RRs and ≥0.1% for RDs) and control the false discovery rate at 5% using the Benjamini-Hochberg procedure to address multiplicity. Subgroup and sensitivity analyses, including negative control outcomes and E-values, will assess robustness.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;In a preliminary analysis, we identified approximately 3.8 million older adults who filled prescriptions for over 500 unique medications during the study period (2002-2023), and therefore, approximately 200,000 potential drug combinations will be available for study. The initial drug pair cohorts had a median of 583 new users per cohort (IQR 237-2130); the median overlap in drug pair prescriptions was 57 days (IQR 30-90). The protocol was finalized on August 30, 2025, and outlines the analysis of data from 2002 to 2023. The analysis is scheduled to be completed by fall 2026, with results interpreted in 2027. The final manuscript submission is planned for December 2028.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This study aims to identify credible signals of harmful DDIs in older adults in routine care. This study will use an innovative approach that leverages data from provincial administrative health care databases and integrates high-throughput computing and rigorous pharmacoepidem","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e77224"},"PeriodicalIF":1.5,"publicationDate":"2025-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145274439","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":"Sustainability Evaluation of mHealth Apps and Wearables: Protocol for a Systematic Review.","authors":"Sehrish Khan, Pantea Keikhosrokiani, Kaisa Kauppinen, Sharon Guardado Medina, Minna Isomursu","doi":"10.2196/68649","DOIUrl":"https://doi.org/10.2196/68649","url":null,"abstract":"<p><strong>Background: </strong>Mobile health (mHealth) technology is widely used in health care systems globally to improve patients' quality of life and reduce the burden on caregivers. Mobile apps allow users to manage different health-related situations from their homes, such as self-monitoring their symptoms, keeping track of progress, and maintaining a profile for a particular condition. However, the benefits of mHealth apps are compromised due to a lack of sustainability evaluation. Currently, there is a lack of all-inclusive research that presents sustainability evaluation from economic, social, and environmental perspectives of mHealth and wearables. Thus, it is important to evaluate the sustainability of newly proposed or already in-use mHealth solutions.</p><p><strong>Objective: </strong>The objective of this systematic literature review is to deeply understand and analyze different dimensions of sustainability in the health care domain and identify existing evaluation criteria and frameworks for mHealth solutions.</p><p><strong>Methods: </strong>This protocol was developed following the PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols) guidelines. A planned and systematic approach will be used to identify, evaluate, and synthesize relevant studies reported in English. We have conducted a systematic search focusing on search terms related to sustainable health care, mHealth solutions, and evaluation or assessment criteria in digital databases of Scopus, Web of Science, ACM, PubMed, PubMed Central, and CINAHL.</p><p><strong>Results: </strong>As of September 19, 2024, preliminary searches have been conducted, identifying 1368 relevant papers that meet the inclusion and exclusion criteria and are eligible for further screening.</p><p><strong>Conclusions: </strong>This protocol will guide the review of existing literature on essential aspects of the sustainability of mHealth solutions and evaluation frameworks. To the best of our knowledge, the proposed systematic review will be the first review to extensively study essential concepts related to defining sustainable mHealth solutions, identifying key dimensions founding the basis for evaluation frameworks, and discussing the existing sustainability evaluation frameworks for mHealth solutions.</p><p><strong>Trial registration: </strong>PROSPERO CRD42024599333; https://www.crd.york.ac.uk/PROSPERO/view/CRD42024599333.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/68649.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e68649"},"PeriodicalIF":1.5,"publicationDate":"2025-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145274467","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":"Comparative Evaluation of Autologous Sticky Bone, Platelet-Rich Fibrin, and Octacalcium Phosphate-Coated Deproteinized Bovine Bone Material for the Regeneration of Human Periodontal Infrabony Defects: Protocol for a Randomized Controlled Clinical Trial.","authors":"Sakshi Vishal Kotecha, Priyanka Jaiswal, Shweta Bhagat","doi":"10.2196/69666","DOIUrl":"https://doi.org/10.2196/69666","url":null,"abstract":"<p><strong>Background: </strong>The term periodontium encompasses the supporting structures around a tooth, including gingival tissue, alveolar bone, cementum, and periodontal ligament. Periodontal disorders are highly prevalent, affecting approximately 95% of the Indian population. Restoring the missing attachment apparatus is the main goal of regenerative therapy in cases of periodontal disease. The reproduction or rebuilding of damaged or lost periodontal tissue to restore the structure and functionality of the periodontium is known as regeneration. This study investigates the effectiveness of autologous sticky bone (ASB), autologous platelet-rich fibrin (PRF), and octacalcium phosphate-coated deproteinized bovine bone material (OCP-DBBM). These materials are being evaluated for their potential to enhance bone regeneration in infrabony defects, which are a significant concern in periodontal therapy. Effective bone regeneration is critical for the successful treatment of periodontal defects, as it can lead to improved clinical outcomes, including better attachment levels and reduced probing depths. This study aims to provide insights into the most effective methods for achieving these goals.</p><p><strong>Objective: </strong>We aim to assess the efficacy of ASB and autologous PRF in conjunction with OCP-DBBM in infrabony defects at 6 months after surgery with regard to radiographic bone fill, reduction in probing pocket depth, and increase in clinical attachment level.</p><p><strong>Methods: </strong>This randomized controlled clinical trial will be performed on 20 defects in patients diagnosed with stage 2 and 3 grade B periodontitis. It will be a parallel-designed study where group 1 (n=10) will be treated with ASB and group 2 (n=10) will be treated with autologous PRF and OCP-DBBM. One sitting will be required to perform the treatment, and a follow-up checkup will be done at 6 months.</p><p><strong>Results: </strong>Recruitment procedures started in June 2025. All data are anticipated to be collected by February 2026. Full trial results are anticipated to be analyzed and submitted for publication by March 2026. The study's anticipated end date is March 2026.</p><p><strong>Conclusions: </strong>Both treatment approaches are expected to lead to notable gains in periodontal health and bone regeneration. The primary outcome, radiographic bone fill, and the secondary outcomes, clinical attachment level gain and probing pocket depth reduction, are critical indicators of treatment success.</p><p><strong>Trial registration: </strong>Clinical Trials Registry-India CTRI/2024/06/069603; https://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTAzODk0&Enc=&userName=.</p><p><strong>International registered report identifier (irrid): </strong>PRR1-10.2196/69666.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e69666"},"PeriodicalIF":1.5,"publicationDate":"2025-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145274692","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":"Comparative Study of the Quality of Life of Patients With Ototoxicity Due to Platinum-Based Chemotherapy, With Hearing Aid Versus Those Without: Study Protocol for a Randomized Pilot Study-The PROTOTOX Study.","authors":"Romina Mastronicola, Elise Kayser, Yolanda Fernandez, Gilles Dolivet","doi":"10.2196/71562","DOIUrl":"https://doi.org/10.2196/71562","url":null,"abstract":"<p><strong>Background: </strong>Platinum salts are widely used for the treatment of cancers, including head and neck cancers. Despite their efficacy, platinum salts can induce neurosensory disorders such as ototoxicity, tinnitus, and decreased hearing acuity. These side effects can have a major impact on the quality of life of patients and are not often considered after treatment.</p><p><strong>Objective: </strong>The PROTOTOX study aims to compare the quality of life of patients with hearing aids in the case of ototoxicity due to platinum salt-based chemotherapy, according to 2 treatments: standard management without equipment versus standard management with equipment.</p><p><strong>Methods: </strong>The PROTOTOX study is an open pilot prospective monocentric and randomized study executed through collaboration of the Institut de Cancérologie de Lorraine (nonprofit comprehensive cancer institute). A total of 52 patients with head and neck cancer undergoing platinum-based chemotherapy and presenting with hypoacusis will be included and followed by an ear, nose, and throat specialist. Audiometric testing will be performed, and eligible participants who consent will be randomized to either receive or not receive hearing aids (groups 1 and 2). The primary endpoint of this study is to compare the quality of life of the patients undergoing platinum-based chemotherapy presenting with hypoacusis according to 2 ways of care: standard care without hearing aid versus standard care with hearing aid. Secondary outcomes are the evaluation of the hearing and the tinnitus, the evaluation of the patients' satisfaction at the end of the study, and the evaluation of the patients' adherence to hearing aid in case of ototoxicity due to platinum-based chemotherapy.</p><p><strong>Results: </strong>The study protocol has been opened and is actively recruiting participants. The protocol was launched on November 23, 2023, and data collection is ongoing and will be completed once all patients have completed the protocol. At least 27 patients have been recruited to date. The date of publication of the results is not yet known.</p><p><strong>Conclusions: </strong>The PROTOTOX study aims at demonstrating that the huge impact of platinum-based chemotherapy on hearing abilities must be managed to maintain the patients' quality of life. Hearing aid is the solution experimented here.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e71562"},"PeriodicalIF":1.5,"publicationDate":"2025-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145274608","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":"Advancing Health Equity Through Primary Care: Protocol for the Spread, Scale, and Multimethod Developmental Evaluation of the Deep End Canada Network.","authors":"Joseph J O'Rourke, Mélanie Ann Smithman, Isabelle Fortuna, Ellah San Antonio, Archna Gupta, Leanne Kosowan, Andrew D Pinto","doi":"10.2196/75732","DOIUrl":"https://doi.org/10.2196/75732","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;The social determinants of health are \"the conditions in which people are born, grow, live, work and age,\" such as housing, employment, and race. Canadian primary health care organizations are increasingly looking for ways to systematically and routinely collect demographic and social needs data from patients to increase appropriate and responsive care by attending to the social determinants of health. The SPARK (screening for poverty and related determinants to improve knowledge of and links to local resources) tool is a standardized tool for use in primary health care settings that was developed, pilot-tested, refined, and validated in primary health care clinics across Canada. General Practitioners at the Deep End is a network of primary health care general practitioners working in the 100 most socioeconomically deprived areas in Scotland with the goal of connecting practitioners and advocating for better training, policies, and resources. Primary Health Care at the Deep End Canada or Soins primaires en milieux défavorisés Canada (Deep End Canada) was launched in June 2024 to offer guidance and resources to the growing number of primary health care teams interested in collecting and using demographic and social needs data.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;Our primary objective is to spread the sustainable implementation of the SPARK tool to systematically and routinely collect and use demographic and social needs data to respond to the social determinants of health in 20 to 25 primary health care organizations across Canada through the creation of Deep End Canada.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Deep End Canada is a network of primary health care teams, including health professionals, researchers, and patient partners, working in areas with high rates of poverty. This project will use a multimethod developmental evaluation approach guided by the reach, effectiveness, adoption, implementation, and maintenance framework. Web-based surveys will capture the reach and adoption of demographic and social needs data collection, and network activities will be evaluated using qualitative analysis of focus groups, interviews, and meetings.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The study was funded in February 2022. Recruitment to the network commenced in June 2024 and included 10 organizations as of submission of the manuscript. Web-based survey data collection commenced in September 2024. Implementation of the network will be assessed from June 2024 to December 2025, with expected findings available in June 2026 and published in the fall of 2026.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Efforts to systematically and routinely collect and use demographic and social needs data and address structural issues in Canadian primary health care have grown significantly in the last 10 years. This increased commitment involves using data to develop evidence-based interventions that can reduce health inequities and address local community need","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e75732"},"PeriodicalIF":1.5,"publicationDate":"2025-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145274682","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":"The Physical Activity, Imaging, and Ambulatory Testing (PHIAT) Project: Protocol for a High-Frequency Ambulatory Assessment Study.","authors":"Jonathan G Hakun, Daniel B Elbich, Jessie N Alwerdt, Ashley M Tate, Jennifer L Coyl, Bethany M Kanski, Tian Qiu","doi":"10.2196/66290","DOIUrl":"10.2196/66290","url":null,"abstract":"<p><strong>Background: </strong>Multiple independent lines of research on self-regulation point to executive cognitive ability (executive function/cognitive control) as a factor that underlies the capacity to successfully regulate one's thoughts, emotions, and behavior. Critically, while leading theories point to the role of executive control in modifying \"in-the-moment\" regulatory processes (eg, enacting physical activity, resisting a poor dietary choice, reflecting on a stressful experience), few studies have tested the executive hypothesis at this timescale. Moreover, given the normative changes in executive control across the adult lifespan, it is essential to understand how cognitive aging might impact these processes.</p><p><strong>Objective: </strong>The Physical Activity, Imaging, and Ambulatory Testing (PHIAT) project was designed to test how variation in executive control at multiple timescales (from moment-to-moment within days to age differences across decades) influences self-regulation across the adult lifespan.</p><p><strong>Methods: </strong>A 14-day, high-frequency, ambulatory assessment protocol was designed for this study. The study was conducted in a measurement burst design and included a 14-day ecological momentary assessment (EMA) protocol involving 6 assessments per day. Ultra-brief ambulatory cognitive assessments of multiple domains of cognition were included in the EMA protocol. Throughout the measurement burst, participants also wore 3 activity monitors on the hip, thigh, and wrist to measure physical activity/exercise, measure sedentary behavior, and self-monitor physical activity behavior, respectively.</p><p><strong>Results: </strong>A total of 221 participants ranging from 18 to 89 years of age completed the PHIAT protocol over the course of 2021-2024, and data collection is complete. EMA data were collected from participants reflecting a wide range of psychosocial factors surrounding participation in health-promoting behaviors (motivation, intention, stress, built environment, and social cognitive factors). This EMA data stream is complemented by data from high-frequency, ambulatory cognitive assessments measuring processing speed, working memory capacity, inhibitory control, and divided/sustained attention administered 5 times per day throughout the 14-day burst. In addition, health-promoting behaviors, including sleep, diet, hydration, physical activity, and exercise, were assessed throughout the 14-day burst through a combination of EMA self-report and continuous activity monitoring.</p><p><strong>Conclusions: </strong>A rich, high-frequency dataset was generated by the PHIAT project that will provide a range of novel insights into the motivational factors, information processing, and environmental factors that surround self-regulation of health-promoting behavior.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e66290"},"PeriodicalIF":1.5,"publicationDate":"2025-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12510614/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145258199","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":"Effects of a Violence Prevention Intervention Therapeutic Meeting With Aggression in Forensic Psychiatric Inpatient Care: Protocol for an Observational Study.","authors":"Panagiotis Doinakis, Lilas Ali, Anna-Kari Sjödin, Peter Andiné, Eirini Alexiou, Sara Wallström","doi":"10.2196/74295","DOIUrl":"10.2196/74295","url":null,"abstract":"<p><strong>Background: </strong>Aggression and violence are prevalent in forensic psychiatric inpatient care. These behaviors significantly impact treatment outcomes, create challenging work environments for staff, and strain relationships between patients and caregivers. Managing such behaviors poses a formidable challenge that necessitates innovative approaches and evidence-based interventions. The Therapeutic Meeting with Aggression (TERMA) model is a staff training program designed to equip staff with strategies to de-escalate patient aggression, thus reducing violence and increasing patients' and staffs' perceived safety.</p><p><strong>Objective: </strong>The aim of this project is to evaluate the violence prevention model TERMA regarding perceived safety by patients and staff and adverse events within forensic psychiatric inpatient care. In addition, the project will investigate whether the organizational culture affects the implementation of the TERMA model.</p><p><strong>Methods: </strong>The project includes an observational study with a before and after design. Implementation of the TERMA model consists of an 8-seminar staff training program. Data sources include questionnaires, medical records, and registries. Quantitative data will be analyzed using descriptive and comparative statistics. To analyze changes between measurements, dependent sample 2-tailed t tests will be used for normally distributed data, and the Wilcoxon signed-rank test will be applied when normality is not met. The project will also include qualitative interview studies, which are planned to be analyzed using qualitative inductive content analysis.</p><p><strong>Results: </strong>Participant enrollment began in July 2023 and was concluded by the end of 2024. Data collection and analysis of quantitative data are expected to be completed by early 2026, after which the study findings will be submitted for publication in peer-reviewed scientific journals. Collection of qualitative data is scheduled for the second half of 2025 and 2026.</p><p><strong>Conclusions: </strong>This study can add valuable knowledge about the effects of the violence prevention model TERMA.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e74295"},"PeriodicalIF":1.5,"publicationDate":"2025-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12510672/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145258261","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}