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Use of Educational Technology in Inclusive Primary Education: Protocol for a Systematic Review.
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-02-25 DOI: 10.2196/65045
Erica Ranzato, Catherine Holloway, Maryam Bandukda

Background: Educational technology (EdTech) has been instrumental in the last few decades in promoting inclusive education by overcoming various learning barriers and offering tools and opportunities to all students, including those with special educational needs and disabilities (SEND). However, there is limited understanding of current classroom practices and policies and of the effects of the COVID-19 pandemic on EdTech use in the inclusive classroom.

Objective: This systematic review aims to outline the current knowledge on the use of EdTech to support the learning of students with SEND in inclusive primary schools in high-income countries.

Methods: We followed the PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols) and the Generalized Systematic Review Registration Form in reporting the details of this protocol. The inclusion criteria for the systematic review require that studies focus on students with SEND who are attending the primary stage of school in high-income countries. The studies can be qualitative or quantitative and should explore the design and use of EdTech with these students. Eligible studies must be published between 2016 and 2024, be peer-reviewed, and be available in English. We systematically searched the ACM, Directory of Open Access Journals, British Educational Index, ERIC, Google Scholar (first 100 records), IEEE, PsycINFO, Scopus, and Web of Science databases. The titles and abstracts of all records will be screened for relevance according to the inclusion criteria. Following this, the full text of the articles will be screened. To ensure the reliability of the screening process, an independent reviewer will screen a percentage of the records for the first screening round. The data extraction process for this systematic review will start with a pilot stage to validate and eventually update the list of entities to be extracted. Following the pilot stage, the final data extraction will be undertaken. An independent reviewer will extract data from a subsample of the records to ensure the reliability of the data extraction process.

Results: The database search was conducted in July 2024. The database search identified a total of 547 records. It is anticipated that the study findings will be submitted for publication in a peer-reviewed journal by the end of January 2025.

Conclusions: This study will provide up-to-date evidence of the use of EdTech in inclusive primary school settings in high-income countries and will describe the impact of the COVID-19 pandemic on the use of EdTech with students with SEND.

International registered report identifier (irrid): DERR1-10.2196/65045.

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引用次数: 0
Unintended Prolonged Opioid Use: A Case-Control Study.
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-02-24 DOI: 10.2196/72032
W Michael Hooten, Darin J Erickson, Marek Chawarski, Natalie A Scholz, Jennifer F Waljee, Jennifer F Waljee, Chad M Brummett, Molly M Jeffery

Background: Misuse of prescription opioids remains a public health problem. Appropriate short-term use of these medications in opioid-naïve patients is indicated in selected settings, but can result in unintended prolonged opioid use (UPOU), defined as the continuation of opioid therapy beyond the period by which acute pain would have been expected to resolve. Clinical strategies aimed at preventing UPOU are lacking due, in part, to the absence of information about how this poorly-understood clinical phenomenon actually develops.

Objective: In this research project, three Clinical and Translational Science Awards (CTSA) programs (Mayo Clinic, University of Michigan, and Yale University) leveraged the conceptual framework for UPOU to investigate how the patient characteristics, practice environment characteristics, and opioid prescriber characteristics facilitate or impede UPOU. All data management and analyses were conducted at a fourth CTSA program (University of Minnesota). This work was accomplished by pursuing three specific aims.

Methods: In aim 1, opioid-naïve adults receiving an initial opioid prescription were recruited for study participation. Opioid prescriptions were identified longitudinally and patterns of use were categorized as short-term, episodic or long-term utilizing established criteria. Using a prospective case-control design, patients progressing to UPOU were matched 1:1 with patients who did not develop UPOU and differences in patient characteristics were assessed. In aim 2, clinicians who prescribed opioids to patients in aim 1 were identified and recruited for prospective assessments. Institutional and individual practice environments were assessed using a validated self-report survey. In aim 3, structural equation modeling was utilized to evaluate data collected in aims 1 and 2 and identified interactions were further evaluated in a large national administrative claims database.

Results: Patient recruitment began August 1, 2019. However, due to the coronavirus disease of 2019 (COVID-19) pandemic, patient recruitment was slowed and intermittently interrupted over the ensuing 3 year period. As a result of regional variations in the impact of the COVID-19 pandemic on research activities, the majority of patient and clinician recruitment occurred at the Mayo Clinic site.

Conclusions: Following complete data analyses, it is anticipated that electronic health record systems will be leveraged to help clinicians identify at risk patients and to develop direct-to-patient educational materials to raise awareness of the risk factors for developing UPOU.

Clinicaltrial: Trial registration (clinicaltrials.gov): NCT04024397.

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引用次数: 0
Acceptance Factors and Barriers to the Implementation of a Digital Intervention With Older Adults With Dementia or Caregivers: Protocol for an Umbrella Review.
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-02-24 DOI: 10.2196/56584
Ricardo Madeira, Dulce Esteves, Nuno Pinto, Alessandro Vercelli, Maria Vaz Patto

Background: The increase in average life expectancy, aging, and the rise in the number of people living with dementia contribute to growing interest from the scientific community. As the disease progresses, people with dementia may need help with most daily activities and need to be supervised by their carer to ensure their safety. With the help of technology, health care provides new means of self-managing health that support active aging, allowing older people and people with dementia to live independently in their homes for a longer period of time. Although some systematic reviews have revealed some of the impacts of using digital interventions in this area, a broad systematic review that examines the overall results of the effect of this intervention type is mandatory.

Objective: The aim of this review is to further investigate and understand the acceptability and barriers to using technology to monitor and manage health conditions of people living with dementia and their caregivers.

Methods: A review of systematic reviews on acceptability factors and barriers for people with dementia and caregivers was carried out. Interventions that assessed acceptability factors and barriers to the use of technology by people with dementia or their carers were included. Each potentially relevant systematic review was assessed in full text by a member of a team of external experts.

Results: The analysis of the results will be presented in the form of a detailed table of the characteristics of the reviews included. It will also describe the technologies used and factors of acceptability and barriers to their use. The search and preliminary analysis were carried out between May 5, 2023, and August 1, 2024.

Conclusions: This review will play an important role as a comprehensive, evidence-based summary of the barriers and facilitators to the use of digital interventions. This review may help to establish effective policy and clinical guideline recommendations.

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引用次数: 0
Examining the Implementation of the Italian Version of the Teen Online Problem-Solving Program Coupled With Remote Psychological Support: Protocol for a Randomized Controlled Trial.
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-02-21 DOI: 10.2196/64178
Claudia Corti, Marta Papini, Sandra Strazzer, Renato Borgatti, Romina Romaniello, Geraldina Poggi, Fabio Alexander Storm, Cosimo Urgesi, Ashok Jansari, Shari L Wade, Alessandra Bardoni
<p><strong>Background: </strong>Pediatric acquired brain injury (ABI) is frequently associated with cognitive and socioemotional alterations. Therefore, targeted rehabilitation to improve everyday functioning, particularly executive functioning (EF), is needed to limit the possible deterioration of cognitive abilities and behavior over time and the associated social and psychological costs.</p><p><strong>Objective: </strong>In this paper, we present the protocol for a phase-2 randomized controlled trial (RCT) aimed at examining the feasibility and efficacy of a web-based intervention (ie, the Italian version of the Teen Online Problem-Solving [I-TOPS] intervention) to improve problem-solving abilities versus an active-control, web-based intervention (ie, wellness intervention) providing health and wellness content.</p><p><strong>Methods: </strong>A double-blinded, phase-2 RCT will be conducted to guarantee controls on data quality and findings. In total, 42 adolescents will be recruited from a rehabilitation institute and individually randomly assigned in a 1:1 ratio to receive the I-TOPS intervention or the web-based wellness intervention. Both interventions will include 10 core sessions and will be delivered remotely using a web-based platform. Participants allocated to both interventions and their caregivers will independently complete the learning modules in an everyday setting using their computer. The I-TOPS intervention's core sessions will target the EF domain (eg, planning, emotion regulation, and social skills), while all the contents of the wellness intervention will be aimed at providing psychoeducation on ABI sequelae and supporting health and wellness. Participants assigned to the I-TOPS intervention will also receive bimonthly direct training in problem-solving coupled with remote support from a psychologist. Feasibility data and efficacy outcomes on both adolescents' and parents' functioning will be assessed. Cognitive abilities in the EF domain and behavioral and psychological functioning (ie, internalizing and externalizing symptoms) of the adolescents will be evaluated via performance-based measures, administered remotely using the Google Meet platform, and paper-and-pencil questionnaires; parents' well-being will be assessed through paper-and-pencil questionnaires. Efficacy will be evaluated immediately after training and at 6-month follow-up.</p><p><strong>Results: </strong>This study started on February 26, 2021, and ended on February 28, 2023. A total of 42 adolescents were enrolled and randomly assigned to the 2 study groups, 34 (81%) completed the intervention and posttreatment evaluation (I-TOPS: n=19 and wellness intervention: n=15) and 31 performed follow-up evaluation (I-TOPS: n=18 and wellness intervention: n=13). Data analysis on feasibility and efficacy will be performed after protocol publication, and the results will be published in the form of a paper in a relevant journal in 2025.</p><p><strong>Conclusions: </s
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引用次数: 0
Evaluation of Comparative Efficacy of Polyherbal Steam Inhalation Versus Polyherbal Nasal Fumigation (Dhoopana) in Children With Rhinitis (Pratishyaya): Protocol for an Open-Label Randomized Controlled Trial.
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-02-21 DOI: 10.2196/58197
Monika Kakar, Renu Rathi, Deepthi Balakrishnan, Bharat Rathi

Background: Rhinitis is a condition characterized by inflammation of the nasal mucosa. It causes obstruction and congestion in the nasal cavity. Clinically, it resembles pratishyaya (rhinitis) in Ayurveda, which is caused by accumulation and downward movement of the tridoshas (3 elements, named vata, pitta, and kapha) in the nasal cavity. Rhinitis is one of the most common diseases among children. There is no role for antibiotics in rhinitis, and nasal decongestants have also not been found to be effective in its management. In Ayurveda, dhoopana (nasal fumigation) is mentioned in the pratishyaya treatment protocol. However, we have found no previous study regarding its efficacy. The efficacy of tulsi, vasa, nirgundi, and nilgiri is already proven when they are used for steam inhalation in respiratory tract infections. Therefore, in this study, a dhoopana of a polyherbal formulation containing tulsi, vasa, nirgundi, and nilgiri will be compared with the inhalation of steam containing arka (a liquid obtained by distillation) of tulsi, vasa, nirgundi, and nilgiri leaves in children with pratishyaya.

Objective: We aim to evaluate the efficacy of polyherbal steam inhalation as a standard control against dhoopana in children aged 7 to 14 years with pratishyaya.

Methods: A total of 70 participants fulfilling the inclusion criteria were selected and distributed into 2 groups of 35 each. The intervention group received dhoopana and the control group received polyherbal steam inhalation, both twice daily for 7 days. The primary outcome measure was the change in Total Nasal Symptom Score and a modified cold spatula test. At the same time, the association between prakriti (body constitution) and the prevalence of pratishyaya in children was analyzed as a secondary outcome. Assessments were performed on days 3, 5, and 7, with a follow-up time of 28 days. Appropriate descriptive and inferential statistics will be used for data analysis.

Results: As of November 2024, we have completed our enrollment of 70 patients, with 35 patients in each group. Data analysis will be completed by February 2025, and we expect results to be published in March 2025.

Conclusions: We anticipate that polyherbal nasal fumigation will be found to be equally as effective as polyherbal steam inhalation in the management of acute rhinitis in the pediatric population. This study may provide a standardized, herbal, safe, and cost-effective treatment for rhinitis in children in the form of dhoopana.

International registered report identifier (irrid): DERR1-10.2196/58197.

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引用次数: 0
Tablet- and Group-Based Multicomponent Cognitive Stimulation for Older Adults With Mild Cognitive Impairment: Single-Group Pilot Study and Protocol for Randomized Controlled Trial.
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-02-21 DOI: 10.2196/64465
Khanitin Jornkokgoud, Pattrawadee Makmee, Peera Wongupparaj, Alessandro Grecucci

Background: Cognitive stimulation therapy is a group-based psychological treatment for people with dementia as well as those with mild cognitive impairment (MCI) and is shown to improve both cognition and quality of life. Previous studies have indicated the potential to benefit from the use of technological devices in group interventions.

Objective: The pilot study aimed to assess the effectiveness of a tablet- and group-based multicomponent cognitive stimulation therapy (MCST) for enhancing cognitive functions among older adults with MCI. The following study aims to report the protocol for a trial evaluating whether the MCST program is affecting individuals with MCI.

Methods: In the first study, 30 individuals with MCI participated in 10 sessions of the tablet- and group-based MCST group. A subsequent protocol study will compare tablet-based MCST, tablet-based cognitive stimulation therapy, and control groups among 93 individuals with MCI. All participants will be recruited from older adults living in semiurban communities. Intervention groups will be facilitated by trained therapists, nurses, or psychologists. The study will be assessed by a pre- and posttest evaluation, including computer-based neuropsychological tests and electroencephalography assessment. The effects of several indicators, such as cognitive functions, behavioral, and emotional, will be analyzed as being indexed by their neurophysiological data.

Results: The pilot study showed significant cognitive improvement (P<.001), reduced depression (P=.002), and decreased state anxiety (P=.001) post intervention. Quality of life remained unchanged (P=.18). The randomized controlled trial study was funded in March 2023. Enrolling began in August 2023 and was completed in December 2023. The data analysis was started, and the results are expected to be published by mid- to late-2025.

Conclusions: The study is the first tablet-group-based MCST for older adults with MCI in middle-income countries. It will provide deeper insight into participants' neuropsychological data, thus identifying specific processes underlying physiologically measured positive outcomes. Furthermore, the project will deliver solid and integrative results to mental health professionals in terms of knowledge and guidance for implementing the tablet- and group-based MCST in people with MCI.

Trial registration: Thai Clinical Trials Registry TCTR20230829004; https://tinyurl.com/3wuaue3e.

International registered report identifier (irrid): DERR1-10.2196/64465.

{"title":"Tablet- and Group-Based Multicomponent Cognitive Stimulation for Older Adults With Mild Cognitive Impairment: Single-Group Pilot Study and Protocol for Randomized Controlled Trial.","authors":"Khanitin Jornkokgoud, Pattrawadee Makmee, Peera Wongupparaj, Alessandro Grecucci","doi":"10.2196/64465","DOIUrl":"https://doi.org/10.2196/64465","url":null,"abstract":"<p><strong>Background: </strong>Cognitive stimulation therapy is a group-based psychological treatment for people with dementia as well as those with mild cognitive impairment (MCI) and is shown to improve both cognition and quality of life. Previous studies have indicated the potential to benefit from the use of technological devices in group interventions.</p><p><strong>Objective: </strong>The pilot study aimed to assess the effectiveness of a tablet- and group-based multicomponent cognitive stimulation therapy (MCST) for enhancing cognitive functions among older adults with MCI. The following study aims to report the protocol for a trial evaluating whether the MCST program is affecting individuals with MCI.</p><p><strong>Methods: </strong>In the first study, 30 individuals with MCI participated in 10 sessions of the tablet- and group-based MCST group. A subsequent protocol study will compare tablet-based MCST, tablet-based cognitive stimulation therapy, and control groups among 93 individuals with MCI. All participants will be recruited from older adults living in semiurban communities. Intervention groups will be facilitated by trained therapists, nurses, or psychologists. The study will be assessed by a pre- and posttest evaluation, including computer-based neuropsychological tests and electroencephalography assessment. The effects of several indicators, such as cognitive functions, behavioral, and emotional, will be analyzed as being indexed by their neurophysiological data.</p><p><strong>Results: </strong>The pilot study showed significant cognitive improvement (P<.001), reduced depression (P=.002), and decreased state anxiety (P=.001) post intervention. Quality of life remained unchanged (P=.18). The randomized controlled trial study was funded in March 2023. Enrolling began in August 2023 and was completed in December 2023. The data analysis was started, and the results are expected to be published by mid- to late-2025.</p><p><strong>Conclusions: </strong>The study is the first tablet-group-based MCST for older adults with MCI in middle-income countries. It will provide deeper insight into participants' neuropsychological data, thus identifying specific processes underlying physiologically measured positive outcomes. Furthermore, the project will deliver solid and integrative results to mental health professionals in terms of knowledge and guidance for implementing the tablet- and group-based MCST in people with MCI.</p><p><strong>Trial registration: </strong>Thai Clinical Trials Registry TCTR20230829004; https://tinyurl.com/3wuaue3e.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/64465.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e64465"},"PeriodicalIF":1.4,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143472492","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
Combining Ecological Momentary Assessment and Social Network Analysis to Study Youth Physical Activity and Environmental Influences: Protocol for a Mixed Methods Feasibility Study.
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-02-21 DOI: 10.2196/68667
Tyler Prochnow, Genevieve F Dunton, Kayla de la Haye, Keshia M Pollack Porter, Chanam Lee

Background: Physical activity (PA) is crucial for youth health, but up to 74% of adolescents fail to meet recommended levels, especially during summer when structured supports associated with school are not available. The social and built environments significantly influence youth PA; yet, their complex interactions remain poorly understood. This study aims to evaluate the feasibility of combining ecological momentary assessment (EMA) and social network analysis to examine bidirectional influences among youth PA, built environments, and social networks during summer.

Objective: The objectives are to (1) evaluate the feasibility and acceptability of the combined EMA and Social Network Analysis protocol, and (2) identify phenotypes using person-level, microtemporal, and dynamic overlap between social and built environments.

Methods: This mixed methods feasibility study with an exploratory observational component will recruit 120 youth aged 12 years to 15 years from an urban school district in Central Texas, US. Participants will first complete a baseline survey to report their general social network patterns and environmental perceptions. Then participants will wear an ActiGraph LEAP accelerometer and respond to EMA prompts via smartphone for 7 days. EMA will assess real-time perceptions of social networks and surrounding built environments, which will be time-matched with accelerometer-assessed PA data. GPS coordinates will be collected with each EMA prompt to assess features of the built environment. Follow-up semistructured interviews will assess protocol acceptability.

Results: This study has been funded by the National Heart, Lung, and Blood Institute. Data collection is expected in the summers of 2025, 2026, and 2027.

Conclusions: This innovative approach combines EMA, SNA, accelerometry, and GPS data to provide unprecedented insights into the dynamic interplay between social networks, built environments, and youth PA during summer. Findings will inform the development of more targeted, effective interventions to promote PA among youth. While limitations include potential participant burden and generalizability, the study's strengths in capturing real-time, contextualized data make it a valuable contribution to understanding youth PA determinants.

International registered report identifier (irrid): PRR1-10.2196/68667.

{"title":"Combining Ecological Momentary Assessment and Social Network Analysis to Study Youth Physical Activity and Environmental Influences: Protocol for a Mixed Methods Feasibility Study.","authors":"Tyler Prochnow, Genevieve F Dunton, Kayla de la Haye, Keshia M Pollack Porter, Chanam Lee","doi":"10.2196/68667","DOIUrl":"https://doi.org/10.2196/68667","url":null,"abstract":"<p><strong>Background: </strong>Physical activity (PA) is crucial for youth health, but up to 74% of adolescents fail to meet recommended levels, especially during summer when structured supports associated with school are not available. The social and built environments significantly influence youth PA; yet, their complex interactions remain poorly understood. This study aims to evaluate the feasibility of combining ecological momentary assessment (EMA) and social network analysis to examine bidirectional influences among youth PA, built environments, and social networks during summer.</p><p><strong>Objective: </strong>The objectives are to (1) evaluate the feasibility and acceptability of the combined EMA and Social Network Analysis protocol, and (2) identify phenotypes using person-level, microtemporal, and dynamic overlap between social and built environments.</p><p><strong>Methods: </strong>This mixed methods feasibility study with an exploratory observational component will recruit 120 youth aged 12 years to 15 years from an urban school district in Central Texas, US. Participants will first complete a baseline survey to report their general social network patterns and environmental perceptions. Then participants will wear an ActiGraph LEAP accelerometer and respond to EMA prompts via smartphone for 7 days. EMA will assess real-time perceptions of social networks and surrounding built environments, which will be time-matched with accelerometer-assessed PA data. GPS coordinates will be collected with each EMA prompt to assess features of the built environment. Follow-up semistructured interviews will assess protocol acceptability.</p><p><strong>Results: </strong>This study has been funded by the National Heart, Lung, and Blood Institute. Data collection is expected in the summers of 2025, 2026, and 2027.</p><p><strong>Conclusions: </strong>This innovative approach combines EMA, SNA, accelerometry, and GPS data to provide unprecedented insights into the dynamic interplay between social networks, built environments, and youth PA during summer. Findings will inform the development of more targeted, effective interventions to promote PA among youth. While limitations include potential participant burden and generalizability, the study's strengths in capturing real-time, contextualized data make it a valuable contribution to understanding youth PA determinants.</p><p><strong>International registered report identifier (irrid): </strong>PRR1-10.2196/68667.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e68667"},"PeriodicalIF":1.4,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143472488","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
Enhancing Text Message Support With Media Literacy and Financial Incentives for Vaping Cessation in Young Adults: Protocol for a Pilot Randomized Controlled Trial.
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-02-21 DOI: 10.2196/60527
Tzeyu Michaud, Troy Puga, Rex Archer, Elijah Theye, Cleo Zagurski, Paul Estabrooks, Hongying Daisy Dai

Background: The persistent high prevalence of e-cigarette use among young adults remains a significant public health concern, with limited evidence and guidance on effective vaping cessation programs targeting this population.

Objective: This study aims to outline the study design and protocol of a pilot randomized controlled trial aimed at investigating feasibility and assessing whether media literacy education or financial incentives enhance the effectiveness of evidence-based text message support in promoting vaping abstinence among young adult e-cigarette users.

Methods: The pilot study uses a 4-arm (1:1:1:1) randomized controlled trial design to assess the potential impact of different combinations of media literacy education, financial incentives, and text message support on vaping abstinence over a 3-month period. The first month serves as a preparatory phase for quitting, followed by 2 months focused on abstinence. A total of 80 individuals, aged 19-29 years, who have used e-cigarettes within the past 30 days, have internet access, and express interest in quitting vaping within the next 30 days, will be enrolled. Eligible individuals will be randomized into one of the four study groups: (1) Text Message, (2) Media Literacy, (3) Financial Incentive, and (4) Combined. All participants, regardless of group assignment, will receive text message support. Participants will be followed for 12 weeks, with abstinence status assessed at week 12, as well as during remote check-ins at weeks 6, 8, and 10. Feasibility measures include recruitment rate, reach, engagement, and retention. Other outcomes of interest include self-reported 7-day abstinence and changes in nicotine dependence and media literacy scores. Exit interviews will be conducted with those who complete the study to explore facilitators of and barriers to participation and engagement in vaping cessation, which will inform future program refinement and uptake.

Results: Recruitment for the study commenced in December 2023 and concluded in August 2024. A total of 40 participants were randomized into these groups: 9 for Text Message, 11 for Media Literacy, 10 for Financial Incentive, and 10 for the Combined group. The final assessment was completed in November 2024, and analyses are currently ongoing.

Conclusions: The findings from this trial could provide valuable insights into the design and uptake of vaping cessation strategies among the young adult population.

Trial registration: ClinicalTrials.gov NCT05586308; https://clinicaltrials.gov/study/NCT05586308.

International registered report identifier (irrid): DERR1-10.2196/60527.

{"title":"Enhancing Text Message Support With Media Literacy and Financial Incentives for Vaping Cessation in Young Adults: Protocol for a Pilot Randomized Controlled Trial.","authors":"Tzeyu Michaud, Troy Puga, Rex Archer, Elijah Theye, Cleo Zagurski, Paul Estabrooks, Hongying Daisy Dai","doi":"10.2196/60527","DOIUrl":"https://doi.org/10.2196/60527","url":null,"abstract":"<p><strong>Background: </strong>The persistent high prevalence of e-cigarette use among young adults remains a significant public health concern, with limited evidence and guidance on effective vaping cessation programs targeting this population.</p><p><strong>Objective: </strong>This study aims to outline the study design and protocol of a pilot randomized controlled trial aimed at investigating feasibility and assessing whether media literacy education or financial incentives enhance the effectiveness of evidence-based text message support in promoting vaping abstinence among young adult e-cigarette users.</p><p><strong>Methods: </strong>The pilot study uses a 4-arm (1:1:1:1) randomized controlled trial design to assess the potential impact of different combinations of media literacy education, financial incentives, and text message support on vaping abstinence over a 3-month period. The first month serves as a preparatory phase for quitting, followed by 2 months focused on abstinence. A total of 80 individuals, aged 19-29 years, who have used e-cigarettes within the past 30 days, have internet access, and express interest in quitting vaping within the next 30 days, will be enrolled. Eligible individuals will be randomized into one of the four study groups: (1) Text Message, (2) Media Literacy, (3) Financial Incentive, and (4) Combined. All participants, regardless of group assignment, will receive text message support. Participants will be followed for 12 weeks, with abstinence status assessed at week 12, as well as during remote check-ins at weeks 6, 8, and 10. Feasibility measures include recruitment rate, reach, engagement, and retention. Other outcomes of interest include self-reported 7-day abstinence and changes in nicotine dependence and media literacy scores. Exit interviews will be conducted with those who complete the study to explore facilitators of and barriers to participation and engagement in vaping cessation, which will inform future program refinement and uptake.</p><p><strong>Results: </strong>Recruitment for the study commenced in December 2023 and concluded in August 2024. A total of 40 participants were randomized into these groups: 9 for Text Message, 11 for Media Literacy, 10 for Financial Incentive, and 10 for the Combined group. The final assessment was completed in November 2024, and analyses are currently ongoing.</p><p><strong>Conclusions: </strong>The findings from this trial could provide valuable insights into the design and uptake of vaping cessation strategies among the young adult population.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05586308; https://clinicaltrials.gov/study/NCT05586308.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/60527.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e60527"},"PeriodicalIF":1.4,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143472489","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
High-Intensity Interval Training for Individuals With Isolated Impaired Fasting Glucose: Protocol for a Proof-of-Concept Randomized Controlled Trial.
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-02-20 DOI: 10.2196/59842
Sathish Thirunavukkarasu, Thomas R Ziegler, Mary Beth Weber, Lisa Staimez, Felipe Lobelo, Mindy L Millard-Stafford, Michael D Schmidt, Aravind Venkatachalam, Ram Bajpai, Farah El Fil, Maria Prokou, Siya Kumar, Robyn J Tapp, Jonathan E Shaw, Francisco J Pasquel, Joe R Nocera
<p><strong>Background: </strong>Standard lifestyle interventions have shown limited efficacy in preventing type 2 diabetes among individuals with isolated impaired fasting glucose (i-IFG). Hence, tailored intervention approaches are necessary for this high-risk group.</p><p><strong>Objective: </strong>This study aims to (1) assess the feasibility of conducting a high-intensity interval training (HIIT) study and the intervention acceptability among individuals with i-IFG, and (2) investigate the preliminary efficacy of HIIT in reducing fasting plasma glucose levels and addressing the underlying pathophysiology of i-IFG.</p><p><strong>Methods: </strong>This study is a 1:1 proof-of-concept randomized controlled trial involving 34 physically inactive individuals (aged 35-65 years) who are overweight or obese and have i-IFG. Individuals will undergo a 3-step screening procedure to determine their eligibility: step 1 involves obtaining clinical information from electronic health records, step 2 consists of completing questionnaires, and step 3 includes blood tests. All participants will be fitted with continuous glucose monitoring devices for approximately 80 days, including 10 days prior to the intervention, the 8-week intervention period, and 10 days following the intervention. Intervention participants will engage in supervised HIIT sessions using stationary "spin" cycle ergometers in groups of 5 or fewer. The intervention will take place 3 times a week for 8 weeks at the Aerobic Exercise Laboratory in the Rehabilitation Hospital at Emory University. Control participants will be instructed to refrain from engaging in intense physical activities during the study period. All participants will receive instructions to maintain a eucaloric diet throughout the study. Baseline and 8-week assessments will include measurements of weight, blood pressure, body composition, waist and hip circumferences, as well as levels of fasting plasma glucose, 2-hour plasma glucose, and fasting insulin. Primary outcomes include feasibility parameters, intervention acceptability, and participants' experiences, perceptions, and satisfaction with the HIIT intervention, as well as facilitators and barriers to participation. Secondary outcomes comprise between-group differences in changes in clinical measures and continuous glucose monitoring metrics from baseline to 8 weeks. Quantitative data analysis will include descriptive statistics, correlation, and regression analyses. Qualitative data will be analyzed using framework-driven and thematic analyses.</p><p><strong>Results: </strong>Recruitment for the study is scheduled to begin in February 2025, with follow-up expected to be completed by the end of September 2025. We plan to publish the study findings by the end of 2025.</p><p><strong>Conclusions: </strong>The study findings are expected to guide the design and execution of an adequately powered randomized controlled trial for evaluating HIIT efficacy in preventing type 2 d
{"title":"High-Intensity Interval Training for Individuals With Isolated Impaired Fasting Glucose: Protocol for a Proof-of-Concept Randomized Controlled Trial.","authors":"Sathish Thirunavukkarasu, Thomas R Ziegler, Mary Beth Weber, Lisa Staimez, Felipe Lobelo, Mindy L Millard-Stafford, Michael D Schmidt, Aravind Venkatachalam, Ram Bajpai, Farah El Fil, Maria Prokou, Siya Kumar, Robyn J Tapp, Jonathan E Shaw, Francisco J Pasquel, Joe R Nocera","doi":"10.2196/59842","DOIUrl":"https://doi.org/10.2196/59842","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Standard lifestyle interventions have shown limited efficacy in preventing type 2 diabetes among individuals with isolated impaired fasting glucose (i-IFG). Hence, tailored intervention approaches are necessary for this high-risk group.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aims to (1) assess the feasibility of conducting a high-intensity interval training (HIIT) study and the intervention acceptability among individuals with i-IFG, and (2) investigate the preliminary efficacy of HIIT in reducing fasting plasma glucose levels and addressing the underlying pathophysiology of i-IFG.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This study is a 1:1 proof-of-concept randomized controlled trial involving 34 physically inactive individuals (aged 35-65 years) who are overweight or obese and have i-IFG. Individuals will undergo a 3-step screening procedure to determine their eligibility: step 1 involves obtaining clinical information from electronic health records, step 2 consists of completing questionnaires, and step 3 includes blood tests. All participants will be fitted with continuous glucose monitoring devices for approximately 80 days, including 10 days prior to the intervention, the 8-week intervention period, and 10 days following the intervention. Intervention participants will engage in supervised HIIT sessions using stationary \"spin\" cycle ergometers in groups of 5 or fewer. The intervention will take place 3 times a week for 8 weeks at the Aerobic Exercise Laboratory in the Rehabilitation Hospital at Emory University. Control participants will be instructed to refrain from engaging in intense physical activities during the study period. All participants will receive instructions to maintain a eucaloric diet throughout the study. Baseline and 8-week assessments will include measurements of weight, blood pressure, body composition, waist and hip circumferences, as well as levels of fasting plasma glucose, 2-hour plasma glucose, and fasting insulin. Primary outcomes include feasibility parameters, intervention acceptability, and participants' experiences, perceptions, and satisfaction with the HIIT intervention, as well as facilitators and barriers to participation. Secondary outcomes comprise between-group differences in changes in clinical measures and continuous glucose monitoring metrics from baseline to 8 weeks. Quantitative data analysis will include descriptive statistics, correlation, and regression analyses. Qualitative data will be analyzed using framework-driven and thematic analyses.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Recruitment for the study is scheduled to begin in February 2025, with follow-up expected to be completed by the end of September 2025. We plan to publish the study findings by the end of 2025.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;The study findings are expected to guide the design and execution of an adequately powered randomized controlled trial for evaluating HIIT efficacy in preventing type 2 d","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e59842"},"PeriodicalIF":1.4,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143468163","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
Social Determinants of Health Screening Tools for Adults in Primary Care: Protocol for a Scoping Review.
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2025-02-19 DOI: 10.2196/68668
Julia Martínez-Alfonso, Fernando Sebastian-Valles, Vicente Martinez-Vizcaino, Nuria Jimenez-Olivas, Antonio Cabrera-Majada, Iván De Los Mozos-Hernando, Shkelzen Cekrezi, Héctor Martínez-Martínez, Arthur Eumann Mesas
<p><strong>Background: </strong>Social determinants of health (SDH) have been shown to be predictors of health outcomes. Integrating SDH screening tools into primary care may help identify individuals or groups with a greater burden of social vulnerability and promote health equity.</p><p><strong>Objective: </strong>This study aimed (1) to identify the existing screening tools to assess social deprivation in adults in primary care settings; (2) to describe the characteristics of these tools and, where appropriate, their psychometric properties; (3) to describe their validity and reliability in those scales in which validation processes have been conducted; and (4) to identify evidence gaps and provide recommendations for future research.</p><p><strong>Methods: </strong>This study protocol was structured according to the Joanna Briggs Institute methodology for scoping reviews and reported according to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) guidelines. Furthermore, since not all SDH assessment tools are published as scientific papers, we will use a slightly modified form of the scoping review framework to retrieve specific information about specific tools for screening SDH in primary care contexts. The following electronic databases will be searched by 2 reviewers: MEDLINE (via PubMed), CINAHL Plus, Web of Science, and Scopus. In addition, the following sources will also be searched for gray literature: DART-Europe E-thesis Portal, OpenGrey, and Google Scholar. After the revision of inclusion and exclusion criteria, the titles, abstracts, and full text of the included studies will be separately screened by 2 reviewers. A PRISMA-ScR flowchart will be used to depict the sources of evidence screened, and data charting will be used to gain in-depth knowledge. The findings of the scoping review will be presented in both narrative and tabular formats, summarizing the existing literature on tools used for SDH in primary care settings. A critical analysis will be undertaken to address the variability in tool validation, cultural adaptability, and integration into different health care systems. Finally, key gaps in the existing evidence will be explored, and research priorities will be proposed, emphasizing the need for screening tools that are culturally sensitive, scalable, and easily integrated into primary care workflows. This critically appraised information may be useful for implementing SDH screening tools in primary care settings and may contribute to future research addressing feasibility and validation studies in different primary health care systems.</p><p><strong>Results: </strong>The study began in July 2024. Data collection is expected to be completed in April 2025, with publication expected in October 2025.</p><p><strong>Conclusions: </strong>This scoping review will provide a comprehensive and critical description of the available tools aimed at screening SDH in prima
{"title":"Social Determinants of Health Screening Tools for Adults in Primary Care: Protocol for a Scoping Review.","authors":"Julia Martínez-Alfonso, Fernando Sebastian-Valles, Vicente Martinez-Vizcaino, Nuria Jimenez-Olivas, Antonio Cabrera-Majada, Iván De Los Mozos-Hernando, Shkelzen Cekrezi, Héctor Martínez-Martínez, Arthur Eumann Mesas","doi":"10.2196/68668","DOIUrl":"10.2196/68668","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Social determinants of health (SDH) have been shown to be predictors of health outcomes. Integrating SDH screening tools into primary care may help identify individuals or groups with a greater burden of social vulnerability and promote health equity.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aimed (1) to identify the existing screening tools to assess social deprivation in adults in primary care settings; (2) to describe the characteristics of these tools and, where appropriate, their psychometric properties; (3) to describe their validity and reliability in those scales in which validation processes have been conducted; and (4) to identify evidence gaps and provide recommendations for future research.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This study protocol was structured according to the Joanna Briggs Institute methodology for scoping reviews and reported according to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) guidelines. Furthermore, since not all SDH assessment tools are published as scientific papers, we will use a slightly modified form of the scoping review framework to retrieve specific information about specific tools for screening SDH in primary care contexts. The following electronic databases will be searched by 2 reviewers: MEDLINE (via PubMed), CINAHL Plus, Web of Science, and Scopus. In addition, the following sources will also be searched for gray literature: DART-Europe E-thesis Portal, OpenGrey, and Google Scholar. After the revision of inclusion and exclusion criteria, the titles, abstracts, and full text of the included studies will be separately screened by 2 reviewers. A PRISMA-ScR flowchart will be used to depict the sources of evidence screened, and data charting will be used to gain in-depth knowledge. The findings of the scoping review will be presented in both narrative and tabular formats, summarizing the existing literature on tools used for SDH in primary care settings. A critical analysis will be undertaken to address the variability in tool validation, cultural adaptability, and integration into different health care systems. Finally, key gaps in the existing evidence will be explored, and research priorities will be proposed, emphasizing the need for screening tools that are culturally sensitive, scalable, and easily integrated into primary care workflows. This critically appraised information may be useful for implementing SDH screening tools in primary care settings and may contribute to future research addressing feasibility and validation studies in different primary health care systems.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The study began in July 2024. Data collection is expected to be completed in April 2025, with publication expected in October 2025.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This scoping review will provide a comprehensive and critical description of the available tools aimed at screening SDH in prima","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"14 ","pages":"e68668"},"PeriodicalIF":1.4,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143449086","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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