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Evaluation of the Comparative Efficacy of Navak Guggulu Versus Vachaharidradi Gana Vati in the Management of Sthaulya (Overweight) in Children: Protocol for a Randomized Controlled Trial. Navak Guggulu与Vachaharidradi Gana Vati治疗儿童超重的比较疗效评价:一项随机对照试验方案。
IF 1.5
JMIR Research Protocols Pub Date : 2025-10-07 DOI: 10.2196/58838
Kavita Kishor Fadnavis, Renu Bharat Rathi, Karuna Sunil Ratnaparkhi, Bharat Jagdishji Rathi, Paresh Rameshrao Deshmukh
{"title":"Evaluation of the Comparative Efficacy of Navak Guggulu Versus Vachaharidradi Gana Vati in the Management of Sthaulya (Overweight) in Children: Protocol for a Randomized Controlled Trial.","authors":"Kavita Kishor Fadnavis, Renu Bharat Rathi, Karuna Sunil Ratnaparkhi, Bharat Jagdishji Rathi, Paresh Rameshrao Deshmukh","doi":"10.2196/58838","DOIUrl":"10.2196/58838","url":null,"abstract":"<p><strong>Background: </strong>Childhood obesity is a lifestyle-oriented disorder, which may lead to many comorbidities such as hypertension, coronary diseases, increased incidence of diabetes, and metabolic syndromes. Lack of diet control and increased screen time specifically after the COVID-19 pandemic among children and adolescents are the major reasons for this rising global concern. Despite various campaigns being carried out to lessen the rising rates of childhood obesity, the objectives have not yet been achieved. Ayurveda offers a multidimensional modality in managing children with overweight. The purpose of this study is to evaluate the combined efficacy of Ayurvedic medicine administration, diet restriction, and Sun Salutation. Navak Guggulu is a herbo-mineral compound already proven for its antiobesity action. Vachaharidradi Gana mentioned in Ayurvedic classics is a group of herbs, which are Kaphamedohara and Karshana. Ayurveda also emphasizes the importance of diet and physical activities for the treatment of obesity. The interventions together may help in promoting a healthy weight, improving metabolism, and reducing fat accumulation. So, in this study, the efficacy of Vachaharidradi Gana Vati will be compared with Navak Guggulu to treat children with overweight in addition to diet restrictions and Sun Salutation.</p><p><strong>Objective: </strong>The aim of the study is to evaluate the efficacy of Navak Guggulu versus Vachaharidradi Gana Vati along with diet restriction and Sun Salutation in overweight (Sthaulya) children.</p><p><strong>Methods: </strong>A double-blind randomized interventional study will be conducted on selected children with overweight in the age group of 10 to 16 years. They will be equally distributed into 2 groups. The control group will be given Navak Guggulu, and the trial group will be given Vachaharidradi Gana Vati for 90 days. Both groups will be advised of diet restrictions and the daily performance of the Sun Salutation. The study duration is 180 days, with assessment at baseline, followed by every 15 days up to 90 days, and at the end point, that is, after 180 days. Appropriate statistical techniques, such as analysis of covariance paired 2-tailed t test, Wilcoxon signed rank test, Mann-Whitney U test, and multivariate regression analysis, will be used to evaluate the efficacy of the interventions.</p><p><strong>Results: </strong>The study got underway in April 2024. Since participants may begin at any time, our goal is for everyone to be finished by May 2025.</p><p><strong>Conclusions: </strong>This research will be useful to provide new insight into the effectiveness of the Ayurveda pharmacological approach in treating obesity in children. The results will guide evidence-based multimodality in treatments aimed at changing lifestyle behaviors in children with obesity, thus reducing social stigmatization in them.</p><p><strong>Trial registration: </strong>Clinical Trial Registry of India CTRI/2023/03/","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e58838"},"PeriodicalIF":1.5,"publicationDate":"2025-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145238837","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}
引用次数: 0
Promoting Physical Activity and Preventing Falls Among Older Adults in a Nursing Home Setting: Protocol for Development and Implementation of the BeSt Age Mobile App. 在养老院环境中促进老年人的身体活动和预防跌倒:最佳年龄移动应用程序的开发和实施协议。
IF 1.5
JMIR Research Protocols Pub Date : 2025-10-06 DOI: 10.2196/74174
Janina Krell-Roesch, Jonathan Diener, Jelena Krafft, Sabine Rayling, Alexander Woll, Kathrin Wunsch
{"title":"Promoting Physical Activity and Preventing Falls Among Older Adults in a Nursing Home Setting: Protocol for Development and Implementation of the BeSt Age Mobile App.","authors":"Janina Krell-Roesch, Jonathan Diener, Jelena Krafft, Sabine Rayling, Alexander Woll, Kathrin Wunsch","doi":"10.2196/74174","DOIUrl":"10.2196/74174","url":null,"abstract":"<p><strong>Background: </strong>Most nursing home residents do not meet physical activity guidelines. Many interventions to promote physical activity and prevent falls in nursing home residents have low adherence rates, lack a theoretical foundation, or require much time from staff for preparation or delivery.</p><p><strong>Objective: </strong>This study aims to describe the rationale, development, and implementation approach of the BeSt Age app through a cluster randomized controlled trial. We also provide baseline characteristics of the study sample and discuss possible implications for further app developments.</p><p><strong>Methods: </strong>We iteratively developed a novel, tablet-based mobile app (BeSt Age) that enables nursing home staff to deliver individualized physical exercise training to residents with or without motor or cognitive impairments. The app was designed and developed based on an intervention-mapping approach. A needs assessment was performed, followed by defining objectives, theory-based methods, program development, implementation, and evaluation. We took several steps to ensure that the app was based on a sound theoretical background and considered limitations identified in prior research. For implementation and evaluation purposes, we conducted a study among 229 older adults from 19 nursing homes (171 females, 58 males; mean age 85, SD 7 years). Results will be used to examine the effectiveness of the app with regard to different outcomes. Primary outcomes among participating nursing home residents are quality of life, fall risk evaluated through 2 performance-oriented balance tests, and fall incidence. Secondary outcomes include motor performance, cognition, activities of daily living, physical activity behavior, and fall efficacy. In this paper, we examined differences between intervention group (IG) and control group (CG) participants at baseline using the chi-square test, the Mann-Whitney U test, or the t test.</p><p><strong>Results: </strong>The IG (n=137 from 11 nursing homes) received a 12-week intervention with the BeSt Age app in small, homogenous groups of 5-7 nursing home residents, with 2 exercise sessions per week, each lasting 25-30 minutes. The CG (n=92 from 8 nursing homes) received usual care. At baseline, the IG had a statistically significantly larger number of females, participants had a higher BMI, and more participants rated attending physical activity programs as important. There were no further statistically significant differences between the groups. Results with regard to the effectiveness of the BeSt Age app are expected to be published in spring 2026.</p><p><strong>Conclusions: </strong>If proven effective, the BeSt Age app may be a viable solution for physical activity promotion and fall prevention among older adults residing in nursing homes, thereby contributing to maintaining quality of life and overall well-being in this vulnerable population. The app can support nursing home staff in de","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e74174"},"PeriodicalIF":1.5,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12500227/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145238845","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}
引用次数: 0
Assessing Day-to-Day Emotion Dynamics Within the Whole Family: Protocol for a Family-Wide Ecological Momentary Assessment Study (The Family and Child Emotion Study). 评估整个家庭的日常情绪动态:家庭范围内生态瞬间评估研究(家庭和儿童情绪研究)的协议。
IF 1.5
JMIR Research Protocols Pub Date : 2025-10-06 DOI: 10.2196/77364
Natasha Vogel, Linda Sosa-Hernandez, Charlotte Funston, Evelyn Balfour, Kristel Thomassin
{"title":"Assessing Day-to-Day Emotion Dynamics Within the Whole Family: Protocol for a Family-Wide Ecological Momentary Assessment Study (The Family and Child Emotion Study).","authors":"Natasha Vogel, Linda Sosa-Hernandez, Charlotte Funston, Evelyn Balfour, Kristel Thomassin","doi":"10.2196/77364","DOIUrl":"10.2196/77364","url":null,"abstract":"<p><strong>Background: </strong>Families play a pivotal role in shaping children's emotional development through emotion socialization. However, most research has focused on individual or dyadic relationships, such as those between parents and children, overlooking the more complex dynamics that emerge when multiple family members interact simultaneously. This limited perspective fails to capture the full scope of the interconnected emotional processes within family units. A contributing factor to this gap is the limited availability of models suited for capturing and analyzing complex, family-level data.</p><p><strong>Objective: </strong>The Family and Child Emotion Study aims to address this gap by examining family-wide emotion dynamics across all family members-including parents and children-as they naturally unfold in daily life.</p><p><strong>Methods: </strong>This protocol uses a pre-post design and a 7-day ecological momentary assessment period combined with ambulatory monitoring of heart rate and electrodermal activity within whole family units to examine interactions among mothers, fathers, and siblings, providing a comprehensive understanding of family-wide emotion processes. Data will be analyzed using a network analytical approach, specifically multilevel vector autoregressive modeling, to investigate dynamic emotional processes within and between family members.</p><p><strong>Results: </strong>Funding was received in April 2020. Data collection began in September 2022 and will continue until March 2026. As of May 2025, the Family and Child Emotion Study has collected data from 48 eligible families. Data analyses will begin after March 2026, with results expected to be published in Fall 2027.</p><p><strong>Conclusions: </strong>This study introduces an innovative approach for examining emotion dynamics within whole-family systems in naturalistic settings, offering practical guidance for collecting and analyzing complex, multilevel, and nested data. The primary aim is to investigate how family emotion networks contribute to children's emotional functioning and development. A secondary aim is to explore key factors, such as parental psychological functioning and child emotion regulation abilities, that may shape these networks. This protocol serves as a valuable framework for future researchers exploring family-wide emotion dynamics.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/77364.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e77364"},"PeriodicalIF":1.5,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145232802","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}
引用次数: 0
Supporting Individuals With Cognitive Impairment and Family Members in Rural Communities: Protocol for a Mixed Methods Digital Health Study. 支持农村社区认知障碍患者及其家庭成员:混合方法数字健康研究协议
IF 1.5
JMIR Research Protocols Pub Date : 2025-10-06 DOI: 10.2196/77958
Eric S Cerino, Megan C McCoy, Margarita Martinez, Thomasina J Seaton, Rasheera Dopson, Travis J Anderson, Gillian Porter, Faith R Shannon, Raechel A Livingston, Amanda D Black, Jacqueline Mogle, Louis Lucero, Michael J McCarthy
{"title":"Supporting Individuals With Cognitive Impairment and Family Members in Rural Communities: Protocol for a Mixed Methods Digital Health Study.","authors":"Eric S Cerino, Megan C McCoy, Margarita Martinez, Thomasina J Seaton, Rasheera Dopson, Travis J Anderson, Gillian Porter, Faith R Shannon, Raechel A Livingston, Amanda D Black, Jacqueline Mogle, Louis Lucero, Michael J McCarthy","doi":"10.2196/77958","DOIUrl":"10.2196/77958","url":null,"abstract":"<p><strong>Background: </strong>The health and economic burdens of Alzheimer disease and related dementias (ADRD) are exacerbated for people living in rural social contexts who experience geographic barriers to care. There are currently few resources specifically designed to support socioculturally diverse rural ADRD care dyads, including early detection of potential precursors to ADRD such as mild cognitive impairment (MCI) and subjective cognitive decline (SCD).</p><p><strong>Objective: </strong>The primary objective of the Northern Arizona Memory Study (NAZMS) is to develop culturally informed and scalable resources to identify and support rural families at risk for ADRD. The purpose of this study is to introduce the NAZMS protocol and discuss its role in addressing dementia risk and promoting cognitive health in rural communities.</p><p><strong>Methods: </strong>This dyadic study will use a mixed methods, digital health approach. A sample of rural care dyads with MCI or SCD will be screened and recruited through partnerships with community centers across Northern Arizona. Consenting dyads will complete semistructured interviews to answer questions about technology preferences for monitoring symptoms and engaging in remotely delivered interventions. Next, care dyads will complete separate baseline questionnaires assessing dyadic (eg, experiences with caregiving or care receiving) and health factors. Participants with cognitive impairment will then complete a 14-day mobile protocol of brief end-of-day surveys and cognitive assessments delivered via study-provided smartphones.</p><p><strong>Results: </strong>Data from the qualitative interviews will provide dyad preferences for intervention development. Data from the quantitative protocol will specify for whom (ie, between-person) and on which days (ie, within-person) modifiable factors are related to better cognitive health in everyday life.</p><p><strong>Conclusions: </strong>This study will take a mixed methods, digital health approach to supporting rural families at risk for ADRD by understanding intervention preferences and identifying the modifiable protective and risk factors that influence cognitive health in everyday life. The findings are expected to directly support rural Arizonans and respond to national priorities in ADRD research for the development of community-based disease education programs and the use of digital assessments of cognitive health and well-being.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e77958"},"PeriodicalIF":1.5,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12500224/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145238994","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}
引用次数: 0
Investigating the Role of Coenzyme A Restriction in the Pathophysiology of Preeclampsia: Protocol for a Combined Patient Screening and Laboratory Study. 研究辅酶A限制在子痫前期病理生理中的作用:一项联合患者筛查和实验室研究方案。
IF 1.5
JMIR Research Protocols Pub Date : 2025-10-03 DOI: 10.2196/66202
Reem Al-Jayyousi, Reem K Jan, Alexander D Giddey, Adrian G Stanley, Anagha Parambath, Fadi G Mirza, Rajan Radhakrishnan, William Atiomo, Charlie Hodgman
{"title":"Investigating the Role of Coenzyme A Restriction in the Pathophysiology of Preeclampsia: Protocol for a Combined Patient Screening and Laboratory Study.","authors":"Reem Al-Jayyousi, Reem K Jan, Alexander D Giddey, Adrian G Stanley, Anagha Parambath, Fadi G Mirza, Rajan Radhakrishnan, William Atiomo, Charlie Hodgman","doi":"10.2196/66202","DOIUrl":"10.2196/66202","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Preeclampsia is 1 of the 3 leading causes of maternal mortality worldwide. Unfortunately, its exact pathogenesis is still unclear. Published metabolomic and gene expression analyses point to coenzyme A (CoA) restriction in the placenta as a factor underpinning the observed complications of preeclampsia, but this hypothesis has never been tested.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This pilot study aims to discover evidence supporting the CoA-restriction hypothesis through 2 avenues. The first of these involves developing a procedure for the quantitative determination of metabolites to discover if harmful metabolites are elevated in patients with preeclampsia, while the second seeks to emulate the onset of CoA restriction in cultured cells.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This manuscript provides a rationale and a protocol for a clinical study and laboratory experiments to test the hypothesis. The methods have 3 key aspects. Phase 1 comprises optimization of assays of 5 key metabolites arising from CoA restriction, namely L-leucine, ketoisovalerate, ketodeoxycholate, oleic acid, and sphingosine-1-phosphate. Phase 2 comprises recruitment of patients to obtain serum samples to measure the metabolites, and phase 3 comprises culturing and treating trophoblast cells to induce CoA restriction and test the effects of the metabolites on the cells. Patients with preeclampsia and healthy controls will be recruited based on World Health Organization criteria for preeclampsia. Exclusion criteria include multiple pregnancies, premature rupture of membranes, and various medical complications. Blood samples will be collected and analyzed using high-performance liquid chromatography/mass spectrometry (HPLC/MS) to quantify key metabolites associated with CoA restriction. For trophoblast cell studies, BeWo cells will be cultured under conditions likely to induce CoA restriction, including hypoxia and human chorionic gonadotropin supplementation, and will also be treated with the key metabolites to determine what effect they might have. Cell viability, apoptosis, energy metabolism, and gene expression (focusing on genes involved in CoA synthesis and metabolism) will be assessed. Statistical analysis will involve 2-tailed t tests or Mann-Whitney U tests to compare metabolite concentrations between patients with preeclampsia and controls. A correlation matrix will be used to explore associations between metabolite levels and patient characteristics.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Institutional review board ethics approval has been obtained for this study. Patient recruitment started April 1, 2025. The 5 metabolites have been purchased in synthetic form and used to optimize the HPLC/MS assays in preparation for receiving blood samples. The trophoblast cell-line culture is being optimized.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;The findings of this study will demonstrate that key metabolite concentrations can be quantified using HPLC/MS and i","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e66202"},"PeriodicalIF":1.5,"publicationDate":"2025-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145212762","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}
引用次数: 0
Frailty Trajectories and Influencing Factors in Patients With Non-Hodgkin Lymphoma During Chemotherapy: Protocol for a Longitudinal Mixed Methods Study. 化疗期间非霍奇金淋巴瘤患者的衰弱轨迹和影响因素:一项纵向混合方法研究方案。
IF 1.5
JMIR Research Protocols Pub Date : 2025-10-03 DOI: 10.2196/76628
Ruofei Du, Ying Zhang, Huimin Yang, Yating Du, Jin Li, Bingyan Zhang
{"title":"Frailty Trajectories and Influencing Factors in Patients With Non-Hodgkin Lymphoma During Chemotherapy: Protocol for a Longitudinal Mixed Methods Study.","authors":"Ruofei Du, Ying Zhang, Huimin Yang, Yating Du, Jin Li, Bingyan Zhang","doi":"10.2196/76628","DOIUrl":"10.2196/76628","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;High-intensity chemotherapy for non-Hodgkin lymphoma (NHL) has been shown to improve survival outcomes. However, its substantial toxicity may induce or exacerbate patient frailty, which is strongly associated with treatment interruptions, increased adverse effects, and reduced survival rates. Despite this, the dynamic progression of frailty and its specific contributing factors among patients with NHL undergoing chemotherapy remain poorly understood.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aims to investigate the heterogeneity of frailty trajectories and explore their risk factors in patients with NHL. We seek to generate insights into the dynamic relationship between frailty and disease course. The findings may offer health care professionals dynamic insights into frailty progression and could help inform strategies for the early identification of high-risk populations through the systematic assessment of key factors. Ultimately, this work seeks to contribute to the evidence base for developing interventions that could mitigate or prevent frailty.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This longitudinal mixed methods study will recruit 250 patients newly diagnosed with NHL from multicenter hospitals in China. Quantitative data will be collected at 3 time points: before chemotherapy, during the third cycle of chemotherapy, and at the end of chemotherapy. We will use validated questionnaires (ie, the Tilburg Frailty Indicator) to gather information on sociodemographics, frailty, cognition, physical condition, health literacy, anxiety, and nutrition. Qualitative data will be collected via semistructured interviews and observations at the end of chemotherapy. The growth mixture model and logistic regression analysis will be used to analyze quantitative data, and the diachronic analysis method and the directed content analysis method will be used for the qualitative data. Both types of data will be analyzed in parallel and separately. Finally, we will integrate the datasets to identify areas of confirmation, complementation, or discordance.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The research protocol and informed consent form were approved by the Medical Ethics Committee of the First Affiliated Hospital of Henan University of Science and Technology (2024-03-K171). Recruitment began in January 2025, with 168 participants enrolled as of September 2025. The data collection and analysis processes are expected to be finalized by March 2026. Data management is still ongoing; therefore, data analysis has not yet been conducted.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;As a pilot trial, this research is primarily designed to assess the feasibility of our methods and generate preliminary data on frailty progression. The findings could offer initial insights and help inform the development of future strategies for the early identification of high-risk populations through systematic screening, with the ultimate goal of informing interventions ","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e76628"},"PeriodicalIF":1.5,"publicationDate":"2025-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12494358/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145225352","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}
引用次数: 0
A Dual In-Person and Remote Assessment Approach to Developing Digital End Points Relevant to Autism and Co-Occurring Conditions: Protocol for a Multisite Observational Study. 开发与自闭症和并发疾病相关的数字终点的双重面对面和远程评估方法:一项多地点观察研究方案。
IF 1.5
JMIR Research Protocols Pub Date : 2025-10-03 DOI: 10.2196/71145
Isabel Yorke, Charlotte A Boatman, Akash Roy Choudhury, Bethany Oakley, Pauline Conde, Heet Sankesara, Yatharth Ranjan, Zulqarnain Rashid, Judith Dineley, Johnny Downs, Christopher H Chatham, Nicholas Cummins, Amos Folarin, Eva Loth, Jan Buitelaar, Declan Murphy, Richard Dobson, Emily Simonoff
{"title":"A Dual In-Person and Remote Assessment Approach to Developing Digital End Points Relevant to Autism and Co-Occurring Conditions: Protocol for a Multisite Observational Study.","authors":"Isabel Yorke, Charlotte A Boatman, Akash Roy Choudhury, Bethany Oakley, Pauline Conde, Heet Sankesara, Yatharth Ranjan, Zulqarnain Rashid, Judith Dineley, Johnny Downs, Christopher H Chatham, Nicholas Cummins, Amos Folarin, Eva Loth, Jan Buitelaar, Declan Murphy, Richard Dobson, Emily Simonoff","doi":"10.2196/71145","DOIUrl":"https://doi.org/10.2196/71145","url":null,"abstract":"<p><strong>Background: </strong>Research priorities for autistic people include developing effective interventions for the numerous challenges affecting their daily living, for example, mental health problems, sleep difficulties, and social well-being. However, clinical research progress is limited by a lack of validated objective measures that represent target outcomes for improvement. Digital technologies, including wearable devices and smartphone apps, provide opportunities to develop novel measures that may reflect everyday experience and complement key clinical assessments. However, little is known about the acceptability and feasibility of implementing digital data collection in this population.</p><p><strong>Objective: </strong>The primary objective of this study is to evaluate the usability, acceptability, adherence, and feasibility of a dual in-person and remote (ie, at-home) protocol. Secondarily, we aim to explore the properties of certain resulting data with a view to developing novel digital end points for key target outcomes, including social communication, sleep, and mental health.</p><p><strong>Methods: </strong>Eligible autistic and nonautistic in the AIMS Longitudinal European Autism Project were invited to participate in a digitally augmented in-person Autism Diagnostic Observation Schedule-2 (ADOS-2) and a 28-day remote measurement (RM) protocol involving wearing a Fitbit device, downloading a passive smartphone data collection app, and using 2 active reporting apps.</p><p><strong>Results: </strong>The first AIMS Longitudinal European Autism Project study participants were enrolled in September 2021 (in-person component) and March 2022 (RM component). To date, 190 participants have taken part in the digitally augmented ADOS-2 component, and 86 participants have been enrolled for the RM protocol. Recruitment is now complete with some RM data collection ongoing until August 2025. Data analysis has commenced, including qualitative framework analysis of feedback interview data coproduced with autism community members, exploration of acceptability and feasibility metrics, pipeline development for ADOS-2 speech analysis, and RM sleep measures.</p><p><strong>Conclusions: </strong>This study lays important groundwork in understanding the acceptability and feasibility of in-person and remotely implemented digital measurement procedures to capture meaningful outcomes in domains important to improving everyday life for autistic people.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/71145.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e71145"},"PeriodicalIF":1.5,"publicationDate":"2025-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145225323","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}
引用次数: 0
Medication Management Using Technology-Based Interventions in Older People at Home Care Settings: Protocol for a Scoping Review. 在家庭护理环境中使用基于技术干预的老年人药物管理:范围审查方案。
IF 1.5
JMIR Research Protocols Pub Date : 2025-10-03 DOI: 10.2196/75200
Shiji Thomas, Beth Fylan, Jonathan Silcock, Md Shafiqur Rahman Jabin
{"title":"Medication Management Using Technology-Based Interventions in Older People at Home Care Settings: Protocol for a Scoping Review.","authors":"Shiji Thomas, Beth Fylan, Jonathan Silcock, Md Shafiqur Rahman Jabin","doi":"10.2196/75200","DOIUrl":"10.2196/75200","url":null,"abstract":"<p><strong>Background: </strong>Older adults with complex care needs and polypharmacy are at risk of experiencing medication-related problems such as administration errors and adverse drug events. These problems lead to increased use of emergency care and hospital admissions. Technology-based interventions have been introduced to address some of these problems. This review aims to establish key concepts and address the gaps in the evidence base to improve the use of technology-based interventions and reduce medication management-associated problems in home care settings.</p><p><strong>Objective: </strong>This scoping review aims to understand the extent and type of evidence regarding the management of medications for older people in home care settings using technology-based interventions.</p><p><strong>Methods: </strong>The review will follow the Joanna Briggs Institute (JBI) methodology. The published studies will be searched through MEDLINE, CINAHL, Scopus, Web of Science, Embase, IEEE Xplore, and ACM digital library, and the unpublished studies through the EBSCO Open Dissertations database. Studies published in all languages will be considered. A broad scope of evidence, including quantitative, qualitative, text, and opinion studies, will be considered. This review will include studies of older adults (aged 60 years or older) living in home care settings and receiving formal or informal social care support for medication management. Studies that focus on the application of the technology for medication management will be included. The titles and abstracts will be reviewed initially for relevance, and then, the full text will be reviewed for in-depth analysis. The results of the search and inclusion process will be presented in a Preferred Reporting Items for Systematic Review and Meta-Analysis extension for Scoping Reviews (PRISMA-ScR) flow diagram. Data will be extracted from the included studies using a data extraction tool developed for this study.</p><p><strong>Results: </strong>A draft charting table will be developed as a data extraction tool. Results will be presented in a graph, diagram, or table, accompanied by a narrative summary.</p><p><strong>Conclusions: </strong>This review will identify and synthesize evidence associated with applying technology-based medication management interventions to older people in home care settings and the strategies to overcome those identified challenges. This review will identify knowledge gaps, clarify concepts, and make recommendations for future research on technology-based medication management interventions.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e75200"},"PeriodicalIF":1.5,"publicationDate":"2025-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12494106/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145225432","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}
引用次数: 0
The National Study of Daily Experiences: Protocol for Assessments of Daily Stress, Well-Being, Health, and Salivary Biomarkers in a Longitudinal Cohort. 国家日常经验研究:纵向队列中日常压力、幸福感、健康和唾液生物标志物评估方案。
IF 1.5
JMIR Research Protocols Pub Date : 2025-10-02 DOI: 10.2196/76453
David M Almeida, Susan T Charles, Jennifer R Piazza, Robert S Stawski, Kelly E Cichy, Eric S Cerino, Jonathan Rush, Jody S Nicholson, Jennie C Holmberg, Natalie Cramer, Jacqueline Mogle
{"title":"The National Study of Daily Experiences: Protocol for Assessments of Daily Stress, Well-Being, Health, and Salivary Biomarkers in a Longitudinal Cohort.","authors":"David M Almeida, Susan T Charles, Jennifer R Piazza, Robert S Stawski, Kelly E Cichy, Eric S Cerino, Jonathan Rush, Jody S Nicholson, Jennie C Holmberg, Natalie Cramer, Jacqueline Mogle","doi":"10.2196/76453","DOIUrl":"https://doi.org/10.2196/76453","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Modern psychology has long recognized that understanding human behavior requires knowledge about a person's current context, which is often examined through daily diary studies. These studies offer ecologically valid insights into how everyday experiences-particularly stressors-affect health and well-being. The National Study of Daily Experiences (NSDE) addresses a critical gap by applying this approach in a large, longitudinal, and publicly accessible study that captures daily life across adulthood.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The NSDE is the largest and longest-running publicly accessible daily diary study in the United States. The purpose of this paper is to provide a guide for researchers interested in initiating similar naturalistic studies and to facilitate research using the existing NSDE data.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The NSDE includes 3510 adults (aged 24-97 years), yielding over 42,000 days of information to capture how daily life changes with age, over time, and across different cohorts, and how these daily experiences predict later health and well-being. This intensive longitudinal dataset includes an 8-day daily diary collected via phone survey, spans more than 20 years, and consists of 2 longitudinal datasets. During the daily phone interviews, participants provide reports of their experiences regarding daily events, including their stressors (Daily Inventory of Stressful Events), as well as their physical health indices, emotional experiences, and cognitive health. In addition, saliva is collected concurrently with days 2-5 of the daily phone interviews (4 collections per day for 4 consecutive days) and is used to measure biomarkers such as cortisol and alpha amylase.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Recruitment began in 1995, with data collection occurring every 9-10 years. The most recent data collection is ongoing through 2027. All NSDE data are housed under the Midlife in the United States (MIDUS) study umbrella, with archived and updated datasets made available to the public on the online portal, MIDUS Colectica.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Results from the NSDE have refined our understanding of daily stress processes. The study's timescale has provided insight into daily life for hundreds of studies, yet much more can be learned from using these data. Microlongitudinal measures and combinations of factors provide for new avenues of research and promise for better understanding of health and aging. Moreover, NSDE data can be combined with datasets from neuroscience, biomarker, and macrolongitudinal subprojects from MIDUS to examine health-related processes. In addition to offering information on how to use the NSDE, this protocol serves as a resource for secondary data analyses and an outline for investigators wishing to replicate an intensive assessment design to other populations and research questions to continue to refine our understanding of how daily stress processes in","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e76453"},"PeriodicalIF":1.5,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145212678","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}
引用次数: 0
Comparative Effectiveness of Titanium Platelet-Rich Fibrin and Connective Tissue Graft Harvested from the Tuberosity Area Via Modified Vestibular Incision Supraperiosteal Tunnel Access for Managing Gingival Recession: Protocol for a Randomized Controlled Trial. 富血小板纤维蛋白钛和结缔组织经改良前庭切口髌上隧道通道从结节区移植治疗牙龈萎缩的比较效果:一项随机对照试验方案。
IF 1.5
JMIR Research Protocols Pub Date : 2025-10-02 DOI: 10.2196/67168
Sanehi Punse, Prasad Dhadse
{"title":"Comparative Effectiveness of Titanium Platelet-Rich Fibrin and Connective Tissue Graft Harvested from the Tuberosity Area Via Modified Vestibular Incision Supraperiosteal Tunnel Access for Managing Gingival Recession: Protocol for a Randomized Controlled Trial.","authors":"Sanehi Punse, Prasad Dhadse","doi":"10.2196/67168","DOIUrl":"https://doi.org/10.2196/67168","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Periodontal surgery has traditionally relied on connective tissue grafts (CTGs) obtained from the tuberosity site to correct gingival recession abnormalities. However, there are challenges to be addressed, including insufficient graft quantity and patient susceptibility. Consequently, titanium-prepared platelet-rich fibrin, or T-PRF, has emerged as a competitive alternative. By combining T-PRF with the modified vestibular incision supraperiosteal tunnel access (M-VISTA) approach, a more conservative way is provided, which may improve the course of treatment.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The objective of this study is to compare the effectiveness of T-PRF and CTGs from the tuberosity area in managing gingival recession defects using the M-VISTA technique. The study aims to evaluate improvements in clinical outcomes, including pocket probing depth (PPD), clinical attachment level (CAL), relative gingival margin level (RGML), recession depth (RD), and width of keratinized gingiva (WKG), as well as plaque and bleeding indices.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The proposed methodology entails conducting a randomized clinical trial over 2 years with 24 participants, each presenting with multiple gingival recessions (&gt;2 mm, Miller's Class I or II) on the buccal or labial aspects of teeth in the maxilla or mandible. Participants will be randomly allocated into 2 groups: the test group and the control group. The M-VISTA technique will be used for root coverage using T-PRF in the test group and tuberosity CTG in the control group as regenerative materials. Their effectiveness will be compared by evaluating PPD, CAL, RGML, RD, and WKG. Additionally, the plaque index will be calculated by dividing the total plaque index score of all teeth by the number of teeth examined, and the papillary bleeding index will be assessed using a periodontal probe with scores evaluated on a scale of 0-4 based on bleeding potential. Data will be analyzed using Student paired and unpaired t tests to compare results from baseline to 3 and 6 months for each group.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Recruitment, participant selection, baseline data collection, and randomization of groups concluded in September 2024, and the intervention phase is scheduled to end in December 2025. The study is expected to be completed by July 2026, with final evaluation, data analysis, and publication preparation taking place between June and July 2026.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Based on existing evidence, we anticipate that the M-VISTA technique with T-PRF will provide superior root coverage compared to tuberosity CTG because no second surgical site is involved. Evidence suggests that T-PRF may offer comparable clinical benefits to CTG, particularly in clinical attachment gain, RD reduction, and gingival thickness, supporting the advancement of minimally invasive periodontal plastic surgery.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial registration: &lt;/strong&gt;Clinical Trials Regist","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e67168"},"PeriodicalIF":1.5,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145212601","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}
引用次数: 0
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