JMIR Research Protocols最新文献

{"title":"Escape Game to Promote Students' Mental Health Outcomes in the Aftermaths of COVID-19 Pandemic: Protocol for a Mixed Methods Study Evaluating a Cocreated Intervention.","authors":"David Labrosse, Clara Vié, Mireille Harb, Ilaria Montagni","doi":"10.2196/64068","DOIUrl":"https://doi.org/10.2196/64068","url":null,"abstract":"<p><strong>Background: </strong>The COVID-19 pandemic and the protracted lockdowns have heavily impacted university students' mental health. Digital Escape Games represent a good means to reach students and propose them solutions for their psychological well-being.</p><p><strong>Objective: </strong>This study aimed to evaluate a cocreated digital Escape Game on students' mental health in the aftermath of the COVID-19 pandemic, called EscapeCovid Game. The evaluation of the effectiveness of this stand-alone intervention concerns mental health outcomes (mental health literacy, appraisal and change of beliefs about mental health, management of emotions, and development of coping strategies) and the appreciation and relevance of the game.</p><p><strong>Methods: </strong>A randomized controlled trial with pre- and posttest data collection (online questionnaires with validated scales) is conducted among 500 students in Bordeaux, France, to evaluate the EscapeCovid Game cocreated with students, researchers, health professionals, and web developers. A subsample of students is randomly selected for responding to a semistructured interview following a mixed methods design. Recruitment is done through mail invitations from student associations and presentations in university classes. Half of the sample of the trial plays the Escape Game, while the other half receives an email with mental health-related information. Within the game, students discuss their personal experiences. The text is further used for the qualitative analyses. The whole study is carried out online.</p><p><strong>Results: </strong>The EscapeCovid Game has been developed, tested, and finalized by the end of March 2023. As of November 4, 2024, a total of 191 students have answered the baseline questionnaire (90 intervention vs 101 control). A total of 23 students have played the game and 53 are in the control arm. Among participants, by the end of September 20, 2023, twenty were interviewed (10 intervention and 10 control) reaching sample saturation. According to preliminary results, the EscapeCovid Game has had a positive impact on all defined outcomes, while the email has been effective in increasing knowledge on resources available and on coping strategies and meditation techniques. We expect the trial to be completed by the end of June 2025.</p><p><strong>Conclusions: </strong>The mixed methods findings of this study are due to demonstrate the effectiveness of the EscapeCovid Game in improving students' mental health outcomes. Preliminary results from the qualitative substudy are promising: in the aftermath of the COVID-19 crisis, this intervention is intended to promote players' mental health through gamification, knowledge transfer, and a learning-by-doing approach.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06720792; https://clinicaltrials.gov/study/NCT06720792.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/64068.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e64068"},"PeriodicalIF":1.4,"publicationDate":"2025-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143772489","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":"Conversion of Sensitive Data to the Observational Medical Outcomes Partnership Common Data Model: Protocol for the Development and Use of Carrot.","authors":"Samuel Cox, Erum Masood, Vasiliki Panagi, Calum Macdonald, Gordon Milligan, Scott Horban, Roberto Santos, Chris Hall, Daniel Lea, Simon Tarr, Shahzad Mumtaz, Emeka Akashili, Andy Rae, Esmond Urwin, Christian Cole, Aziz Sheikh, Emily Jefferson, Philip Roy Quinlan","doi":"10.2196/60917","DOIUrl":"https://doi.org/10.2196/60917","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;The use of data standards is low across the health care system, and converting data to a common data model (CDM) is usually required to undertake international research. One such model is the Observational Medical Outcomes Partnership (OMOP) CDM. It has gained substantial traction across researchers and those who have developed data platforms. The Observational Health Care Data Sciences and Informatics (OHDSI) partnership manages OMOP and provides many open-source tools to assist in converting data to the OMOP CDM. The challenge, however, is in the skills, knowledge, know-how, and capacity within teams to convert their data to OMOP. The European Health Care Data Evidence Network provided funds to allow data owners to bring in external resources to do the required conversions. The Carrot software (University of Nottingham) is a new set of open-source tools designed to help address these challenges while not requiring data access by external resources.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The use of data protection rules is increasing, and privacy by design is a core principle under the European and UK legislations related to data protection. Our aims for the Carrot software were to have a standardized mechanism for managing the data curation process, capturing the rules used to convert the data, and creating a platform that can reuse rules across projects to drive standardization of process and improve the speed without compromising on quality. Most importantly, we aimed to deliver this design-by-privacy approach without requiring data access to those creating the rules.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The software was developed using Agile approaches by both software engineers and data engineers, who would ultimately use the system. Experts in OMOP were used to ensure the approaches were correct. An incremental release program was initiated to ensure we delivered continuous progress.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Carrot has been delivered and used on a project called COVID-Curated and Open Analysis and Research Platform (CO-CONNECT) to assist in the process of allowing datasets to be discovered via a federated platform. It has been used to create over 45,000 rules, and over 5 million patient records have been converted. This has been achieved while maintaining our principle of not allowing access to the underlying data by the team creating the rules. It has also facilitated the reuse of existing rules, with most rules being reused rather than manually curated.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Carrot has demonstrated how it can be used alongside existing OHDSI tools with a focus on the mapping stage. The COVID-Curated and Open Analysis and Research Platform project successfully managed to reuse rules across datasets. The approach is valid and brings the benefits expected, with future work continuing to optimize the generation of rules.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;International registered report identifier (irrid): &lt;/strong&gt;RR1-","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e60917"},"PeriodicalIF":1.4,"publicationDate":"2025-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143772486","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":"Assessment of Community Stakeholders' and Health Educators and Professionals' Needs for the Continuous Enhancement of Sexual and Reproductive Health and Rights in Mali (Project CLEFS): Protocol for a Convergent Mixed Methods Study.","authors":"Sabina Abou Malham, Doufain Traoré, Fatoumata Dicko, Gabriel Blouin Genest, Jennyfer Boudreau, Drissa Mansa Sidibé, Souleymane Sidibé, Issa Souleymane Goïta, Aminata Sangaré, Mohamed Togo, Delphine Diarra, Michèle Rietmann, Mahamane Mahamoudou Maïga, Suzie Boulanger, Ann Isabelle Grégoire, David-Martin Milot, Djamal Berbiche, Sarah Stecko","doi":"10.2196/64796","DOIUrl":"https://doi.org/10.2196/64796","url":null,"abstract":"<p><strong>Background: </strong>In Mali, a lack of qualified human resources in primary health care and sexual and reproductive health and rights (SRHR) is one of the greatest barriers to the population's access to standard health services. Frontline professional training must be strengthened to respond to the needs of the population, particularly those of women and girls. Training must be conducted using an interdisciplinary and adapted approach to promote gender equality.</p><p><strong>Objective: </strong>This study aims to identify the SRHR training needs among the community, educational actors, and primary health care providers.</p><p><strong>Methods: </strong>A concurrent mixed methods design was adopted, using 2 methods. A quantitative method, through a cross-sectional analytical survey, will be conducted at the community level with university community health centers (CSCom-U) users and adolescents in CSCom-U health areas, as well as at the health education institution and community health centers levels with teachers, students, and interdisciplinary professional groups within the CSCom-U and district hospital maternity. Descriptive and inferential analyses will be conducted to process quantitative data. This research is at the stage of data analysis and interpretation. A qualitative method, based on 3 sources of data (focus groups, individual semistructured interviews, and document analysis), which involved the same targets as the quantitative component, with additional community actors such as Community Health Associations (Associations de santé communautaire) and Women's Service User Communities. A thematic analysis of the qualitative data using a mixed deductive and inductive method will be performed.</p><p><strong>Results: </strong>: Field data collection took place from March to April 2022. Quantitative data from 3153 participants are being analyzed using SPSS. Qualitative data from 11 interviews and 27 focus groups were processed with Qualitative Data Analysis Miner. Data analysis is still ongoing.</p><p><strong>Conclusions: </strong>This study will provide a better understanding of adolescents and SRHR user's service needs in terms of health services availability and quality and SRHR knowledge, issues related to student training quality, the level of adequacy between the training offered and the actual needs of the service recipients, and the level of preparation and ability of teachers to provide quality teaching taking gender equity into account. The recommendations drawn from this assessment will propose concrete actions to improve women and girls' health services provided by professionals, and to better adapt the future health professionals' profiles to the needs of communities, particularly those of women and girls.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/64796.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e64796"},"PeriodicalIF":1.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143763948","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":"Evaluation of the Tu'Washindi Na PrEP Intervention to Reduce Gender-Based Violence and Increase Preexposure Prophylaxis Uptake and Adherence Among Kenyan Adolescent Girls and Young Women: Protocol for a Cluster Randomized Controlled Trial.","authors":"Sarah T Roberts, Alexandra M Minnis, Sue Napierala, Elizabeth T Montgomery, Lina Digolo, Mackenzie L Cottrell, Erica N Browne, Jacqueline Ndirangu, Joyce Boke, Kawango Agot","doi":"10.2196/55931","DOIUrl":"https://doi.org/10.2196/55931","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Adolescent girls and young women constitute a priority population disproportionately affected by HIV, accounting for 25% of annual HIV incidence among people older than 15 years in Kenya. Although oral preexposure prophylaxis (PrEP) is effective in reducing HIV acquisition, its protective benefit has been limited among adolescent girls and young women in sub-Saharan Africa because of low uptake, adherence, and persistence. Intimate partner violence (IPV) and relationship power inequities are widespread among adolescent girls and young women and contribute to higher HIV incidence and lower PrEP use. Interventions are needed to support sustained PrEP use among adolescent girls and young women by addressing IPV and relationship dynamics.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aims to test the effectiveness of Tu'Washindi na PrEP (\"We are Winners with PrEP\"), a multilevel community-based intervention, to increase uptake and adherence to PrEP and reduce IPV among adolescent girls and young women in Siaya County, Kenya.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The Tu'Washindi na PrEP intervention was co-designed by our team and adolescent girls and young women using participatory methods and includes 3 components delivered over 6 months: an 8-session, empowerment-based support club for adolescent girls and young women, community sensitization targeted toward male partners, and PrEP education events for couples. The intervention will be evaluated using a cluster randomized controlled trial across 22 administrative wards in Siaya County, Kenya, enrolling 72 adolescent girls and young women per ward (total N=1584). The primary objectives are to test the effectiveness of the intervention on PrEP uptake and adherence immediately after delivery (month 6 after enrollment) and 6 months later (month 12). As secondary objectives, we will test the intervention effect on IPV. A rigorous process evaluation will explore mechanisms of change, contextual factors, and implementation considerations to inform future refinement and scale-up, using programmatic data, participant questionnaires, and qualitative interviews with participants and intervention providers.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Data collection started in September 2022. As of December 2024, enrollment has been completed in 16 of the 22 study wards, with 72.6% (1150/1584) of participants enrolled. We anticipate that data collection will be completed in May 2026 and results will be available by mid-2027.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;The study builds directly on our promising formative and pilot research to develop the evidence base for this youth-designed, multilevel HIV prevention intervention. If effective, Tu'Washindi will be ideally positioned for sustainable integration into existing youth-focused programming to expand and support PrEP use in this priority population.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial registration: &lt;/strong&gt;ClinicalTrials.gov NCT05599581; https://www.clinicaltri","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e55931"},"PeriodicalIF":1.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143763954","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":"Integrating Virtual Reality, Neurofeedback, and Cognitive Behavioral Therapy for Auditory Verbal Hallucinations (Hybrid): Protocol of a Pilot, Unblinded, Single-Arm Interventional Study.","authors":"Jessica Spark, Elise Rowe, Mario Alvarez-Jimenez, Imogen Bell, Linda Byrne, Ilvana Dzafic, Carli Ellinghaus, Suzie Lavoie, Jarrad Lum, Brooke McLean, Neil Thomas, Andrew Thompson, Greg Wadley, Thomas Whitford, Stephen Wood, Hok Pan Yuen, Barnaby Nelson","doi":"10.2196/63405","DOIUrl":"https://doi.org/10.2196/63405","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Current treatments for schizophrenia and other psychotic disorders have limited efficacy, with high rates of nonresponse to \"gold standard\" treatments. New approaches are therefore urgently required.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The aims of this pilot study are to investigate the feasibility, acceptability, safety, and usability of Hybrid treatment (primary aim); and to explore Hybrid's treatment efficacy and engagement of treatment targets (secondary aim). The primary aim will be assessed via face-to-face user experience surveys on a (self-assessed) 5-point Likert scale (and qualitative open-ended questions) examining: (1) acceptability, (2) helpfulness, (3) engagement, and (4) perceived safety. We will also examine consent and completion rates, and the number of sessions attended. Our threshold for moving on to efficacy trials will be at least 70% of our participants to rate 3 and above (which corresponds to agree or strongly agree) that the intervention package was acceptable, feasible, and safe. The secondary aims will be assessed by observing whether individuals achieve self-directed modulation of high-β neurophysiological activity (neural target) and progression upwards through the VR-based exposure hierarchy (psychological target), and by assessing symptom change scores. This study developed a new treatment approach for auditory verbal hallucinations, a major symptom of psychotic disorders, that integrates advances in psychological therapy (cognitive behavioral therapy for psychosis), technology (virtual reality, VR), and neuroscience (electroencephalography-based neurofeedback).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Hybrid takes a \"symptom capture\" approach using individually tailored VR-based exposure exercises. Participants (N=10) will receive the intervention package weekly over 12 face-to-face sessions. Here, participants will be progressively exposed to symptom triggers and develop methods of downregulating neural activity associated with these symptoms (neurofeedback component) while concurrently receiving clinician-delivered cognitive behavioral therapy for psychosis.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;As of February 2025, Hybrid has commenced (unblinded) recruitment activities from Orygen clinical services in Northwestern Melbourne, Australia. A total of 75 individuals have been approached and 64 individuals have been prescreened (41 individuals were deemed eligible, 15 individuals were ineligible, and 8 individuals declined or did not respond to contact attempts) and 5 individuals have been included in the study. Of the 5 individuals who have commenced the Hybrid treatment, 4 are actively engaged in the program and 1 individual has withdrawn. We expect recruitment to conclude in July 2025 and for the results to be published in 2026.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;The Hybrid study is piloting a novel approach that has the potential to address the shortcomings of current treatments for psychotic sym","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e63405"},"PeriodicalIF":1.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143763955","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":"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.","authors":"Hongji Liu, Yan Dai, Ming Yu, Jian Zeng, Chao Wang, Sa Tan, Ming Xiong, Ran Zhang, Xuemeng Yu, Mingsong Shi, Xing Yan, Fengming Lai","doi":"10.2196/67737","DOIUrl":"https://doi.org/10.2196/67737","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;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.&lt;/p&gt;&lt;p","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e67737"},"PeriodicalIF":1.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143763951","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":"Examining Quality of Work Life in Atlantic Canadian Long-Term Care Homes: Protocol for a Cross-Sectional Survey Study.","authors":"Janice M Keefe, Rose McCloskey, Marilyn J Hodgins, Caitlin McArthur, Adrian MacKenzie, Lori E Weeks, Carole A Estabrooks","doi":"10.2196/66338","DOIUrl":"https://doi.org/10.2196/66338","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;The Canadian long-term care (LTC) workforce cares for increasingly complex residents. With greater care needs come greater demands. Despite this, LTC staffing and resources are largely unchanged and underresearched over the last decade. The Atlantic provinces are home to the oldest population in Canada, indicating a high need for LTC. The health and well-being of the LTC workforce are critical components of care quality, yet only in Western Canada are such data routinely and systematically collected. Translating Research in Elder Care is a 2-decade research program studying the LTC work environment and has found strong links between the working conditions of LTC staff and resident outcomes. We draw upon their success to generate the evidence needed to understand, support, and manage the LTC workforce in Canada's four Atlantic provinces.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aims (1) to assess the quality of work life among staff in LTC homes in Atlantic Canada; (2) to examine the effects of the work environment on the quality of work life; and (3) to build capacity for research in the LTC sector in Atlantic Canada among knowledge users, researchers, and trainees. The objective of this paper is to describe the approach needed to examine the quality of work life and health of care staff in LTC homes.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Stratified random sampling will be used to recruit homes in Atlantic Canada. The sampling frame was designed to recruit 25% of the LTC homes in each of the 4 provinces with proportional representation by size; ownership model; and, if applicable, region or language. Key outcome variables include measures of mental health and well-being, quality of work life, intention to leave, workplace context, and missed or rushed care. Primary data will be obtained through structured interviews with care aides and web-based surveys from registered nurses, licensed practical nurses, managers, and allied health providers. Eligible participants were from an LTC home with at least 25 residents, 90% of whom were aged 65 years or older, and had worked in the home for at least 3 months. Multivariate analyses include regression analysis for explaining predictors of quality of work-life outcomes and multilevel modeling for more complex relationships of staff outcomes by provinces and LTC home characteristics.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Data collection and cleaning are complete as of October 2024 (N=2305). Care aides (n=1338), nurses (n=724), allied health providers (n=154), and managers (n=89) from 53 homes make up the sample. Data analysis is ongoing. Initially, individual reports will present descriptive data for each participating LTC home. Concurrent analysis is planned for publication in peer-reviewed journals.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This peer-reviewed research protocol lays the foundation for a comprehensive analysis of the effects of the work environment on the quality of work li","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e66338"},"PeriodicalIF":1.4,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143752928","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":"Ayurveda Management of Menorrhagia (Raktapradara): Protocol for a Randomized Controlled Trial.","authors":"Shivshankar Rajput, Shweta Mata, Upma Saxena, Sarada Ota, Bharti Gupta","doi":"10.2196/60801","DOIUrl":"https://doi.org/10.2196/60801","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;In India, heavy menstrual bleeding or menorrhagia (Raktapradara) constitutes about 15% to 20% of all gynecological admissions in an institution. Of these, 43% of patients are aged 20-40 years. This condition is worsening because of the high prevalence of anemia among Indian women. Menorrhagia can have a significant impact on women's lives. Medical treatment is usually the first choice in excessive bleeding, but it reduces menstrual blood loss by only 50%, and up to 50% of women undergo surgical treatment within 5 years. However, none of these treatments proved their definite efficacy in spite of the high price and side effects. This condition presents a major financial burden on health care services. In Ayurveda, encouraging work has been done on the compound drug Ashokarishta, and the drug Trinakantamani pishti is indicated in Ayurvedic classics and the Ayurvedic Formulary of India. Also, these medicines have been used in Ayurvedic practice for a long time. However, no clinical trial has been carried out on these formulations.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The primary objective is to evaluate the efficacy of Ayurvedic intervention in the management of menorrhagia, and the secondary objective is to assess the efficacy of Ayurvedic intervention on the quality of life of the women with menorrhagia.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This ongoing study is an open-label, interventional, randomized controlled trial, with a sample size of 140 in the treatment and control groups combined (including 20% dropouts), and will be carried out within the duration of 36 months. Participants in the treatment group will receive Ayurvedic treatment, that is, 20 mL of Ashokarishta, 250 mg of Trinakantamani pishti, and 1 iron and folic acid tablet (100 mg of elemental iron and 1.5 mg of folic acid) twice a day orally for 3 months. Participants in the control group will receive a 500-mg tranexamic acid tablet thrice a day for 7 days from the first day of menses for 3 cycles and 1 iron and folic acid tablet twice a day orally for 3 months. The primary outcomes are changes in the amount of uterine bleeding evaluated by the Pictorial Blood Loss Assessment Chart, changes in the duration of bleeding, and attainment of a normal quantity of blood loss during the interval of cycles. The secondary outcome is changes in the Menorrhagia Impact Questionnaire.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;As of December 2024, a total of 79 patients have been enrolled. Data analysis should be completed by February 2026. The study will be reported following standard guidelines for reporting randomized controlled trials. Clinical results will be disseminated through conferences and peer-reviewed publications in a relevant journal.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;The Ayurvedic approach may provide an evidence-based therapeutic tactic for the management of menorrhagia.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial registration: &lt;/strong&gt;Clinical Trial Registry India CTRI/2023/05/052929; ","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e60801"},"PeriodicalIF":1.4,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143752824","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":"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.","authors":"Yanchun Zhao, Ting Huang, Yanli Chen, Songmei Li, Juan Zhao, Xu Han, Qing Ni, Ning Su","doi":"10.2196/58951","DOIUrl":"https://doi.org/10.2196/58951","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Objective: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Trial registration: </strong>International Traditional Medicine Clinical Trial Registry ITMCTR2022000048; https://tinyurl.com/y4jd68h4.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/58951.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e58951"},"PeriodicalIF":1.4,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143752926","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":"Assessment and Intervention for Diabetes Distress in Primary Care Using Clinical and Technological Interventions: Protocol for a Single-Arm Pilot Trial.","authors":"Marisa Kostiuk, Susan L Moore, E Seth Kramer, Joshua Felton Gilens, Ashwin Sarwal, David Saxon, John F Thomas, Tamara K Oser","doi":"10.2196/62916","DOIUrl":"https://doi.org/10.2196/62916","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Diabetes distress (DD) is a common emotional response to living with diabetes. If not addressed, DD can have negative impacts on diabetes management, including the progression to mental health conditions such as depression and anxiety. Routine screening and treatment for DD is recommended, with primary care being an ideal setting given that the majority of people with diabetes receive their diabetes care from primary care providers. However, consistent screening of DD does not routinely occur in primary care settings. Research is needed to understand how to effectively and feasibly integrate DD screening and treatment into routine diabetes care.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aims to (1) design and implement individualized technology-supported DD workflows, (2) evaluate the primary outcome of determining the acceptability and feasibility of integrating technology-based workflows to provide treatment for DD, and (3) evaluate the secondary outcomes of changes in DD, depression, and anxiety (baseline, 3 months, and 6 months) in patients receiving screening and personalized treatment.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;In total, 30 English and Spanish-speaking primary care patients with either type 1 or type 2 diabetes will receive screening for DD during clinical visits and subsequent support from an artificial intelligence (AI)-based health care chatbot with interactive tailored messaging. In addition, the use of electronic consultation with a specialist or referral to a behavioral health provider could occur depending on the severity and source of DD. The use of electronic consultations allows providers convenient and timely asynchronous access to a range of specialty care providers. Health outcomes will be measured through changes in validated screening measures for DD, depression, and anxiety. Digital outcomes will be measured through surveys assessing user experience with technology and system usability, and by system performance data. Qualitative data on acceptability and satisfaction with the clinical workflows and technological interventions will be collected through interviews with patients and clinical providers. Descriptive statistics will summarize quantitative outcome measures and responses to closed-ended survey items, and rapid thematic and content analysis will be conducted on open-ended survey and interview data.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Workflows for screening and treating DD have been approved and clinical staff have received training on the process. Electronic surveys for screening measure collection have been created. Data from visit screeners will be entered into the electronic medical record during the medical appointment. Recruitment will begin late June-July 2024.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This study is expected to demonstrate the feasibility and acceptability of integrating individualized workflows for DD into primary care. Improving clinical and digital interventi","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e62916"},"PeriodicalIF":1.4,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143752819","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}