JMIR Research Protocols最新文献

{"title":"Providing Education and Training to Health Care Professionals to Address COVID-19 Health Disparities: Protocol for Implementation Project Using Reach, Effectiveness, Adoption, Implementation, and Maintenance Framework.","authors":"Adati Tarfa, Nada Fadul, Erica Stohs, Jeffrey Wetherhold, Mahelet Kebede, Nuha Mirghani, Muhammad Salman Ashraf","doi":"10.2196/60901","DOIUrl":"https://doi.org/10.2196/60901","url":null,"abstract":"<p><strong>Background: </strong>The COVID-19 pandemic has underscored the need for targeted interventions to address health care disparities among specific health care professionals and mitigate the impact of the virus. In response, we developed a comprehensive statewide educational program protocol focused on subject areas of health equity, cultural sensitivity, infection prevention and control (IPC), and quality improvement (QI).</p><p><strong>Objective: </strong>The project aims to improve health care professionals' knowledge and practice skills in the 4 subject areas, increase their comfort level in implementing health disparities-related QI projects, and facilitate the successful completion of QI projects addressing COVID-19 health disparities within their practice settings.</p><p><strong>Methods: </strong>The Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework was used in the planning and evaluation of this innovative educational program, which combines the Extension for Community Healthcare Outcomes (ECHO) learning model with one-on-one QI coaching. Participants engage in virtual interactive sessions led by experts and consultants, covering didactic presentations, case discussions, COVID-19 updates, and assessments. QI and health equity coaches provide guidance on developing QI projects targeting COVID-19 and other health disparities. Evaluation surveys are used for baseline, midpoint, and end-of-program assessment for self-reported comfort levels with knowledge and practice-based learning competencies in all 4 subject areas and health disparities-related QI project implementation. The Wilcoxon rank-sum test and Cochran-Armitage trend test will be used to compare pre- and postsurvey responses. Data from semistructured qualitative interviews, which capture insights into participants' application of ECHO training, will be analyzed using an inductive content analysis approach.</p><p><strong>Results: </strong>A total of 50 ECHO sessions were held between November 2021 and May 2024. Overall, 510 participants attended at least one ECHO session, resulting in 3316 teaching encounters. The pre- and postsurvey data will be analyzed to study project impact and will be ready for publication in June 2026.</p><p><strong>Conclusions: </strong>By using implementation science methods, an innovative and comprehensive educational protocol was developed that integrates the training curriculum, evaluation metrics, and coaching support, allowing for the translation of the training into actionable community projects focused on addressing health disparities. This model has shown initial promise in terms of feasibility and uptake. Further studies are needed to evaluate the long-term effectiveness of these QI projects in reducing COVID-19 disparities.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/60901.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e60901"},"PeriodicalIF":1.4,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144078181","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 the Longitudinal Impact of Within- and Between-Day Fluctuations in Food Parenting Practices on Child Dietary Intake: Protocol for a Longitudinal Cohort Study Within a Sample of Preschooler-Parent Dyads.","authors":"Katie A Loth, Julian Wolfson, Martha Barnard, Natalie Hogan, T James Brandt, Jayne A Fulkerson, Jennifer O Fisher","doi":"10.2196/73276","DOIUrl":"https://doi.org/10.2196/73276","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;A healthful diet in early childhood is essential for healthy growth and disease prevention. Parents influence children's diets through supportive (eg, structure and autonomy support) and unsupportive (eg, coercive control and indulgence) food parenting practices. Historically, much of this work has focused on parents' \"usual\" feeding behaviors using survey methods. However, recent studies using ecological momentary assessment methods have allowed assessment of food parenting behaviors in \"real time.\" This work has revealed that the practices used by parents to feed children vary across contexts and are influenced by factors such as stress or time constraints. Research is needed to understand the dynamic nature of food parenting and its impact on children's diets.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aimed to describe the methods and procedures used in the Preschool Plates cohort study, which aimed to (1) describe within- and between-day fluctuations in food parenting practices across time and context, (2) examine the longitudinal impact of within- and between-day fluctuations in food parenting practices on child dietary intake, and (3) identify momentary predictors of within- and between-day fluctuations in food parenting practices across time and context.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Preschool Plates is a longitudinal cohort study examining the impact of food parenting practices on the dietary intake of 3- to 5-year-old children. A total of 273 parent-preschooler dyads consented and enrolled, and 254 (93%) dyads completed baseline data collection. Dyads will be followed for 2 years using state-of-the-art measures, including an 8-day ecological momentary assessment protocol to assess food parenting, contemporary measures of food parenting, and 3 interview-led 24-hour dietary recalls, collected at baseline, 6 months, 12 months, and 24 months. Child height and weight will be measured at 3 time points.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Recruitment for our baseline sample (N=254) occurred between October 2023 and September 2024. Participants will complete follow-up data collection after 6 months, 12 months, and 24 months. A racially and ethnically diverse cohort was enrolled, with 28.3% (72/254) of enrolled participants identifying as White and 71.7% (182/254) identifying as non-White.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Findings from the proposed study will inform the development of anticipatory guidance for feeding young children and randomized controlled trials designed to intervene on parents' responses to momentary factors to encourage interactions with children around feeding that promote optimal diet quality. For example, findings could inform the development of an ecological momentary (ie, real time) intervention that delivers content to participants' mobile devices in response to real-time assessments of context and circumstance.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;International registered report identifier (irrid): &lt;/stro","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e73276"},"PeriodicalIF":1.4,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144078175","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":"Power-Assist Add-Ons for Older Adult Manual Wheelchair Users: Protocol for a Scoping Review.","authors":"Oladele Atoyebi, Andrew Wister, Johanne Mattie, Gloria Gutman, Habib Chaudhury, Carolyn Sparrey, O Yvette Jones, W Ben Mortenson, Eireann O'Dea, Sogol Haji Hosseini, Jaimie Borisoff","doi":"10.2196/56375","DOIUrl":"https://doi.org/10.2196/56375","url":null,"abstract":"<p><strong>Background: </strong>Manual wheelchairs promote independence among older adult users. However, the user's level of disability, strength, and stamina, and the environmental conditions in which the wheelchair is used, may limit the functionality of manual wheelchairs and their impact on independence and active aging. The use of power-assist add-ons may mitigate these limitations and allow an individual to age in place.</p><p><strong>Objective: </strong>We propose to conduct a scoping review of scientific and gray literature to examine the use of power-assist add-ons by older adults who use manual wheelchairs, as well as their advantages, limitations, and potential benefits in promoting independence and active aging.</p><p><strong>Methods: </strong>The review will be guided by the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews checklist, and we will use the Arksey and O'Malley scoping review methodology. The literature search will use a comprehensive approach and will be carried out in two phases: (1) a keyword and Medical Subject Headings search of electronic databases, proceedings, and symposia for relevant titles and abstracts and (2) a search of Google and Google Scholar. Articles will be selected based on predefined inclusion and exclusion criteria. We will include studies of power-assist add-ons for older manual wheelchair users (aged ≥65 years) across any health condition or setting. We will exclude studies not focused on power-assist add-ons or older adults. Data will be synthesized through thematic analysis (attitudes and efficacy) and directed content analysis (limitations and gaps). Results will be summarized narratively and in tables. The findings will be disseminated in peer-reviewed publications and conferences focused on rehabilitation or gerontology.</p><p><strong>Results: </strong>We will synthesize data on power-assist add-ons by compiling a list of devices, analyzing attitudes toward their use, identifying limitations, and highlighting gaps in the literature. We expect to publish the results in 2025.</p><p><strong>Conclusions: </strong>The information obtained through this review could inform future research involving wheelchair producers, suppliers, and prescribers.</p><p><strong>International registered report identifier (irrid): </strong>PRR1-10.2196/56375.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e56375"},"PeriodicalIF":1.4,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144078179","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":"Water, Sanitation, and Hygiene for Everyone Intervention Study: Protocol for a Controlled Before-and-After Trial.","authors":"Kondwani Chidziwisano, Mindy Panulo, Clara MacLeod, Marcella Vigneri, Blessings White, Joseph Wells, Ian Ross, Tracy Morse, Robert Dreibelbis","doi":"10.2196/68280","DOIUrl":"https://doi.org/10.2196/68280","url":null,"abstract":"<p><strong>Background: </strong>Community-based behavior change interventions are a common approach to Water, Sanitation, and Hygiene (WASH). Yet, published evaluations of how these interventions work in district-wide approaches are rare.</p><p><strong>Objective: </strong>This study reports the baseline characteristics and study design for a trial assessing the effectiveness of a district-level Community-led Total Sanitation (CLTS) intervention compared to the additional integration of local care groups (CG) on sanitation coverage and use and hygiene behaviors in Chiradzulu District, Malawi.</p><p><strong>Methods: </strong>This study is a controlled before-and-after trial with 2 treatment arms and a control group. Clusters are rural villages in 3 traditional authorities (TAs). One arm will receive CLTS and the CG model (CLTS+CG group), one arm CLTS only (CLTS group), and one group will serve as the control. The trial is part of the wider WASH for Everyone (W4E) project, led by World Vision Malawi that aims to expand access to WASH services across the entire district by 2025. Study participants were selected from the 3 TAs. Systematic sampling procedures were used to select 20 households per cluster with a total of 1400 households at both baseline and end line. The primary outcome is sanitation coverage. Secondary outcome measures include sanitation use, safe disposal of child feces, observed handwashing facility, and Sanitation-related Quality of Life Index (SanQoL-5).</p><p><strong>Results: </strong>The baseline observations indicate a balanced distribution of potential demographic confounders in the trial arms with a slight variation on some WASH proxy measures. We noted the low coverage of handwashing facilities with soap and water in all 3 arms: 8% in the CLTS group, 4% in the CLTS+CG group, and 4% in the control group. There was a marginal variation in handwashing practices among the study arms with 3% of individuals handwashing with soap and water in the CLTS group, 5% in the CLTS+CG group, and 2% in the control group. Sanitation coverage also varied among the study arms at baseline as 83% of households had access to unimproved sanitation in the CLTS group, 70% in the CLTS+CG group, and 81% in the control group.</p><p><strong>Conclusions: </strong>Results from this trial will provide evidence on whether the CLTS+CG approach is effective at improving sanitation and hygiene practices in the W4E program area compared to CLTS alone and no intervention, as well as inform implementing partners on future interventions in Chiradzulu District, Malawi. The results are expected to be published in 2025.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05808218; https://clinicaltrials.gov/study/NCT05808218.</p><p><strong>International registered report identifier (irrid): </strong>RR1-10.2196/68280.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e68280"},"PeriodicalIF":1.4,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144078132","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":"Jaw Bone Density in Chronic Areca Nut Chewers and Nonchewers Using Digital Panoramic Radiography Indices as a Screening Tool for Osteoporosis: Protocol for a Comparative Evaluation.","authors":"Aakanksha Tiwari, Suwarna Dangore-Khasbage","doi":"10.2196/72041","DOIUrl":"https://doi.org/10.2196/72041","url":null,"abstract":"<p><strong>Background: </strong>Jaw bone density can be altered due to various factors including aging, bone pathologies, hormonal levels, medications affecting bone density, and undue stress posed by parafunctional and adverse habits. Of these factors, chronic areca nut chewing, which creates a heavy load on jaw bones, is a commonly encountered adverse habit in patients. Digital panoramic radiography (OPG) indices are an easy and cost-effective method to evaluate jaw bone density. Index values can also be used as a screening tool for osteoporosis.</p><p><strong>Objective: </strong>This study aims to compare and evaluate jaw bone density in chronic areca nut chewers and nonchewers using OPG indices as a screening tool for osteoporosis.</p><p><strong>Methods: </strong>Patients aged 20 years to 40 years reporting to the Department of Oral Medicine and Radiology with and without a history of chronic areca nut chewing will be recruited. OPG will be collected for all recruited patients. The mandibular cortical index, panoramic mandibular index, gonial index, antegonial index, antegoinal notch depth, and mental index will be calculated.</p><p><strong>Results: </strong>The values of these indices will be used to assess and compare osteoporosis in chronic areca nut chewers and nonchewers. Data will be entered and displayed in a tabular format, and correlations between osteoporosis and OPG index values will be determined. The study did not receive any external funding. Recruitment is expected to begin in summer 2025, and publication of the results is expected to occur in late 2026.</p><p><strong>Conclusions: </strong>Evaluation of jaw bone density in chronic areca nut chewers using OPG indices might prove to be a feasible and cost-effective technique for assessing osteoporotic bone changes. Although the gold standard modality is dual x-ray absorptiometry, its cost and availability create challenges for use in the general population. As osteoporosis of jaw bones does not usually present with symptoms, patients can be made aware of it using the findings from this evaluation. Hence, it will ultimately aid in early detection and prompt interventions, thereby halting disease progress.</p><p><strong>International registered report identifier (irrid): </strong>PRR1-10.2196/72041.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e72041"},"PeriodicalIF":1.4,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144078177","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":"Co-Designing an Antiracist Dental Health System: Protocol for an Aboriginal and Torres Strait Islander-Led Mixed Methods Study.","authors":"Brianna Poirier, Joanne Hedges, Dandara Haag, Yin Paradies, Tamara Mackean, João Bastos, Catherine Leane, Gustavo Soares, Sneha Sethi, Jessica Manuela, Pedro Santiago, Kelli Owen, Natalie Bauer, Jodie Milne, Ashleigh Smith, Kelly Smith, Priscilla Larkins, Madison Cachagee, Vaibhav Garg, Latisha Sykora, Nicolas Reid, Michael Larkin, Jayde Fuller, Lisa Jamieson","doi":"10.2196/69012","DOIUrl":"https://doi.org/10.2196/69012","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Racism arrived in Australia with colonization and its intentionally oppressive policies and actions toward Aboriginal and Torres Strait Islander Peoples. To a large extent, colonial and biomedical agendas are maintained by Australia's health system that underlies much of the racialized health inequities in the country. Dentistry significantly lags behind medicine and other health care areas in the uptake of antiracism, with the dental accreditation body only acknowledging racism as a determinant of oral health in 2022.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This project will comprehensively co-design strategies for an antiracist dental health system in Australia through the following objectives: (1) development of an antiracist curriculum for dental students; (2) workforce strategies that support the attraction, retention, and well-being of the Aboriginal and Torres Strait Islander dental workforce; and (3) oral health promotion training for Aboriginal Health Workers/Practitioners.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This project is grounded in decolonizing and Indigenous methodologies, which guide our ways of working at the knowledge interface. Co-design Yarning sessions will inform the development and implementation associated with each of the objectives through tabulation and narrative synthesis of sessions. Objectives will be evaluated with both quantitative and qualitative measures and analyzed accordingly with inverse probability of treatment weighting, content analysis, or reflexive thematic analysis.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The study received ethical review approval in February 2024 and received funding in June 2024. The co-design phase for each objective will run from July 2024 to February 2025. The dental curriculum will be developed in 2025 and delivered to the 2026 student cohort. Evaluation data will be collected from the comparator student cohort in 2025 and the implementation cohort in 2026. Data collection for the development of workforce strategies will be collected from October 2024 to July 2025; the framework will be developed from August to December 2025 and disseminated in 2026. Oral health promotion training will be developed from August to February 2024, implemented from March to June 2025, and qualitative evaluation data will be collected between July and September 2025.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;The proposed research will develop an antiracism curriculum for dental students, a tailored Aboriginal and Torres Strait Islander dental workforce framework, and an oral health promotion training program for Aboriginal Health Workers/Practitioners. The processes and final outcomes of this research will be scalable and able to be tailored to different contexts. Together, these strategies will build oral health knowledge at the Community level, in turn supporting Aboriginal and Torres Strait Islander self-determination of oral health.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;International registered report identifier (","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e69012"},"PeriodicalIF":1.4,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144078154","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":"Virtual Reality for the Prevention and Cessation of Nicotine Vaping in Youths: Protocol for a Randomized Controlled Trial.","authors":"Belinda Borrelli, Daniel Weinstein, Romano Endrighi, Nikki Ling, Kathleen Koval, Lisa M Quintiliani, Kaitlyn Konieczny","doi":"10.2196/71961","DOIUrl":"10.2196/71961","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Only a few trials target high school-aged teens with vaping interventions, typically focusing on prevention rather than cessation, with content limited to vaping harms and refusal skills. Given the co-occurrence and increasing incidence of vaping and mental health issues in teens, both must be simultaneously addressed by vaping interventions.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This randomized controlled trial aimed to evaluate the feasibility and preliminary efficacy of a virtual reality (VR) intervention for teens that targets both determinants of vaping (eg, mood and stress) and vaping prevention and cessation skills.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The participants are 150 students attending 1 of 2 racially and ethnically diverse Boston-area high schools. Health classes are randomly assigned to VR or control (assessment only). Students are eligible if not opted out by their parents, provided assent, and did not have health issues that preclude participation. While control classes (and ineligible students within them) have their regular classroom activity, VR classes are provided with Oculus Meta Quest 2 headsets and engage with the intervention during 3 class periods, once per week. Players solve a mystery with a vaping subplot and play a series of minigames to teach emotional regulation, coping strategies, and building resilience. A mobile app connects to the VR game, providing a home-based experience to reinforce skills learned. VR and control classes complete baseline and postintervention surveys on the same schedule. Primary outcome measures include feasibility, satisfaction and engagement with game play, and vaping awareness, knowledge, attitudes, and intentions to avoid or quit vaping. Secondary outcomes include vaping quit attempts, 7- and 30-day point prevalence abstinence, motivation and self-efficacy to quit or avoid vaping, positive and negative affect, emotional regulation and coping, and motion sickness.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The project was approved by the institutional review board on April 2, 2024, and data collection began in April 2024 and concluded in June 2024, and 150 participants were recruited (98 intervention and 52 control). Although freshmen and sophomore classes were targeted in this study, there were several juniors and seniors (n=5) in these classes due to school transfers and the need for them to take the mandatory curriculum. Data cleaning has been completed, and analyses are ongoing. The results are expected to be submitted for publication in August of 2025.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;As VR is visual, auditory, and tactile, it is ideal for practicing skills, facilitating memory, and increasing the likelihood of transfer to real-world settings. The immersion of VR promotes engagement with the intervention, rather than external digital temptations. Our study is innovative due to the cluster-randomized design, focus on both prevention and cessation, integration of m","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":" ","pages":"e71961"},"PeriodicalIF":1.4,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144014480","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":"Combination of Electroacupuncture and Medication for Patients With Tinnitus Associated With Idiopathic Sudden Sensorineural Hearing Loss: Protocol for a Prospective Randomized Controlled Trial.","authors":"Tuoran Wang, Lingyu Qi, Xinping Hao, Miao Zhang, Shihao Du, Biao Chen, Chang Liu, Jing Chen, Xinyue Zou, Ping Liu, Jin Huo","doi":"10.2196/69163","DOIUrl":"https://doi.org/10.2196/69163","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Tinnitus, a common and troublesome symptom of idiopathic sudden sensorineural hearing loss (ISSNHL), is the perception of sound without any external or internal sound source. The etiology of ISSNHL accompanied by tinnitus remains unclear. Tinnitus often occurs alongside or before hearing loss and can severely impact patients' quality of life, leading to psychological stress and emotional distress. Current treatments primarily focus on improving hearing loss while neglecting tinnitus treatment. Electroacupuncture (EA), a technique widely applied in China for tinnitus management, may become a promising intervention by addressing both auditory and psychological symptoms.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aims to conduct a double-center, assessor-blinded, prospective randomized pilot clinical trial to explore the potential effects and feasibility of EA combined with medication for patients with ISSNHL accompanied by tinnitus, and to generate preliminary data to inform future large-scale trials of EA as an adjunctive therapy for this condition.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;In this double-center, assessor-blinded, randomized controlled trial, 60 patients with ISSNHL accompanied by tinnitus will be randomly allocated to either the EA group, receiving EA combined with medication, or the control group, receiving standard medication treatment, for a total treatment duration of 4 weeks. Follow-up assessments will be conducted at weeks 2 and 4, and at 1, 2, and 3 months after treatment. The feasibility primary outcomes are recruitment rate, adherence rate, data completeness, and safety outcomes. The primary outcome measures will include pure tone audiometry, tinnitus matching, and the Tinnitus Handicap Inventory, while the secondary outcome measures will comprise speech-recognition thresholds in noise, the Self-Rating Anxiety Scale, and the 36-item Short Form Health Survey Questionnaire.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;This study began recruitment on July 15, 2024, and is scheduled to conclude on August 31, 2025. To date, 42 participants have been enrolled, with 35 having completed the intervention and posttreatment assessments (control group: n=21; EA group: n=14). Following protocol publication, data compilation and analysis will be conducted, with results anticipated to be published in a relevant journal in 2026.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This pilot trial is expected to provide critical insights into the feasibility of integrating EA with standard medication for managing ISSNHL with tinnitus. By generating preliminary evidence on its practicality and potential benefits, this study aims to inform the design and sample size estimation of future multicenter trials, potentially advancing nonpharmacological treatment options for this challenging condition.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial registration: &lt;/strong&gt;Chinese Clinical Trial Registry ChiCTR2400086802; https://tinyurl.com/mtxthpzj.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;International ","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e69163"},"PeriodicalIF":1.4,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144078156","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":"Clinical Efficacy and Safety of the Herbal Prescription, HH333, in Preventing Recurrent Stroke in Patients With Ischemic Stroke Induced by Small-Vessel Disease: Protocol for Multicenter, Double-Blind, Randomized, Prospective, Pilot Clinical Trial.","authors":"Han-Gyul Lee, Seungwon Kwon, Woo-Sang Jung, Sang-Kwan Moon, Cheol-Hyun Kim, Dong-Jun Choi","doi":"10.2196/70953","DOIUrl":"https://doi.org/10.2196/70953","url":null,"abstract":"<p><strong>Background: </strong>Patients with ischemic stroke are at high risk of recurrence, making preventive care an important factor. Current antiplatelet therapy for recurrence prevention treatment has several limitations. Recent retrospective observational studies suggested that HH333, an herbal prescription, has an inhibitory effect on stroke recurrence in small-vessel diseases.</p><p><strong>Objective: </strong>This study aims to propose a protocol for evaluating the efficacy and safety of HH333 in patients with ischemic stroke induced by small-vessel disease.</p><p><strong>Methods: </strong>In this multicenter, double-blind, randomized, prospective, pilot clinical trial, 236 patients from 3 university Korean medicine hospitals in South Korea with ischemic stroke caused by small-vessel disease will be recruited and randomly assigned to either the HH333 or the placebo group. Both patients and investigators will be blinded to prevent access to the allocation results. The HH333 group will take 2 capsules of HH333 once daily for 720 days, whereas the placebo group will take HH333 placebo capsules in the same manner. Efficacy will be assessed using the recurrence rate of ischemic stroke, which will be assessed on days 30, 90, 180, 270, 360, 450, 540, 630, 720, and 750 after starting the medication. The effects on quality of life and fatigue with the Fatigue Severity Scale (FSS), Fatigue Assessment Scale (FAS), and Korean Patient Health Questionnaire (K-PHQ-9), functional improvement with Korean National Institutes of Health Stroke Scale (K-NIHSS), modified Rankin Scale (mRS), Korean modified Barthel Index (K-mBI), and Korean Montreal Cognitive Assessment (K-MoCA) and Pattern Identification also will be evaluated on days 0, 90, 180, 270, 360, 450, 540, 630, and 720 after starting the medication. Safety will be evaluated by performing blood and urine tests and electrocardiography on days 30, 90, 180, 270, 360, 450, 540, 630, and 720 after starting the medication.</p><p><strong>Results: </strong>Recruitment for the study started on May 22, 2024, and is scheduled to end on November 30, 2026. As of November 13, 2024, a total of 12 participants have been randomized.</p><p><strong>Conclusions: </strong>The protocol will provide a detailed process for a clinical trial evaluating the efficacy of preventing recurrent ischemic stroke caused by small-vessel disease and improving neurologic symptoms and the safety of HH333 in ischemic stroke. The results of this study provide a basis for alternative treatments to prevent and treat ischemic stroke.</p><p><strong>Trial registration: </strong>Clinical Research Information Service KCT0009431; https://tinyurl.com/y2ctvje8.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/70953.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e70953"},"PeriodicalIF":1.4,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144019492","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":"Evaluating the Efficacy and Safety of 48-Week Low-Dose Dienogest Administration in Patients With Dysmenorrhea Caused by Endometriosis: Protocol for a Randomized, Open-Label, Parallel-Group Trial.","authors":"Kyoko Kikuno, Ryuta Asada, Takuma Ishihara, Yoshimasa Bomoto, Saki Murase, Yoko Ueda, Tomomi Shiga, Yoh Hayasaki, Tatsuro Furui, Satoko Matsuzaki, Masahiko Takemura, Kazutoshi Matsunami, Makoto Kubo, Naoki Ito, Masanori Isobe, Ken-Ichirou Morishige","doi":"10.2196/66246","DOIUrl":"https://doi.org/10.2196/66246","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;The treatment of endometriosis includes analgesics, hormone therapy, and surgery. Even after surgical removal of endometriotic lesions, the risk of recurrence remains high once the normal menstrual cycle resumes. Therefore, long-term hormone therapy is essential to prevent recurrence. Among hormonal treatments, low-dose estrogen progestin preparations are not recommended for patients older than 40 years due to the increased risk of thrombotic side effects. In contrast, dienogest does not carry a thrombotic risk, making it a suitable option for older patients. Although dienogest requires long-term administration until menopause in patients with endometriosis, data on its long-term efficacy and potential adverse effects remain limited. In particular, comparative studies assessing the safety and effectiveness of long-term use of dienogest at different doses (1 mg/day vs 2 mg/day) have not been conducted, highlighting the need for further investigation.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The purpose of this study is to investigate the efficacy and the incidence of adverse events of dienogest 1 mg/day after 48 weeks in patients with dysmenorrhea due to endometriosis, compared with dienogest 2 mg/day.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This randomized, open-label, parallel-group, dose-comparison, multicenter trial follows the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 guidelines and is conducted at 6 centers in Japan. Participants are randomly assigned in a 1:1 ratio to receive either dienogest 1 mg/day or 2 mg/day. The drug is administered for 48 weeks, and its therapeutic effects and side effects are evaluated. Hospital visits include the use of questionnaires, vital sign measurements, imaging studies (magnetic resonance imaging and ultrasound), blood tests, and bone density assessments. The primary endpoint is the change in the pain visual analog scale (VAS) score from baseline to 48 weeks. The VAS is a 10 cm horizontal scale where 0 cm represents no pain and 10 cm represents the maximum imaginable pain; participants indicate their pain level on the scale, and the change is analyzed over time. The target sample size is 88, determined with a noninferiority margin based on existing literature. The protocol was approved by the Nagoya City University Hospital Clinical Research Review Board. Findings will be presented at academic conferences and published in peer-reviewed journals.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Currently, data collection is ongoing. The first participant was enrolled in August 2021. As of March 22, 2025, a total of 88 participants had been enrolled in this clinical trial.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This is the first trial to compare efficacy and safety between 1 mg/day and 2 mg/day of long-term dienogest use in patients with dysmenorrhea caused by endometriosis. Combining diagnostic imaging with patient questionnaires and blood tests allows the determination of ","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e66246"},"PeriodicalIF":1.4,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144036052","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}