JMIR Publications

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  RCTs - Protocols/Proposals (eHealth)

  Sep 23, 2020

  The Impact of Previsit Contextual Data Collection on Patient-Provider Communication and Patient Activation: Study Protocol for a Randomized Controlled Trial

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  Authors List:

  • Jeana M Holt  
  • Rachel Cusatis  
  • Aaron Winn  
  • Onur Asan  
  • Charles Spanbauer  
  • Joni S Williams  
  • Kathryn E Flynn  
  • Melek Somai  
  • Purushottam Laud  
  • Bradley H Crotty  

  Abstract:

  Background: Patient-centered care is respectful of and responsive to individual patient preferences, needs, and values. To provide patient-centered care, clinicians need to know and incorporate patients’ context into their communication and care with patients. Patient contextual data (PCD) encompass social determinants of health and patients’ needs, values, goals, and preferences relevant to their care. PCD can be challenging to collect as a routine component of the time-limited primary care visit. Objective: This study aims to determine if patient-provider communication and patient activation are different for patient users and patient nonusers of an electronic health record (EHR)–integrated PCD tool and assess if the impact of using PCD on patient-provider communication and patient activation differs for Black and White patients. Methods: We describe a randomized controlled trial of a prospective cohort of non-Hispanic White and Black patients who receive primary care services at a midwestern academic health care system in the United States. We will evaluate whether providing PCD through a consumer informatics tool enhances patient-provider communication, as measured by the Communication Assessment Tool, and we will evaluate patient activation, as measured by the Patient Activation Measure for PCD tool users and nonusers. Furthermore, owing to racial disparities in care and communication, we seek to determine if the adoption and use of the tool might narrow the differences between patient groups. Results: The trial was funded in November 2017 and received local ethics review approval in February 2019. The study began recruitment in April 2019 and enrollment concluded in October 2019 with 301 participants. The analysis was completed in May 2020, and trial results are expected to be published in winter 2020. Conclusions: Recently, there has been increased attention to the role of health information technology tools to enable patients to collaborate with providers through the sharing of PCD. The adoption of such tools may overcome the barriers of current EHRs by directly engaging patients to submit their contextual data. Effectively, these tools would support the EHR in providing a more holistic understanding of the patient. Research further supports that individuals who have robust digital engagement using consumer informatics tools have higher participation in treatment follow-up and self-care across populations. Therefore, it is critical to investigate interventions that elicit and share patients’ social risks and care preferences with the health care team as a mechanism to improve individualized care and reduce the gap in health outcomes. Clinical Trial: ClinicalTrials.gov NCT03766841; https://clinicaltrials.gov/ct2/show/NCT03766841

  • JMIR Res Protoc 2020;9(9):e20309

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  RCTs - Protocols/Proposals (funded,...

  Sep 23, 2020

  Game-Based Meditation Therapy to Improve Posttraumatic Stress and Neurobiological Stress Systems in Traumatized Adolescents: Protocol for a Randomized...

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  Authors List:

  • Angela A T Schuurmans  
  • Karin S Nijhof  
  • Ron Scholte  
  • Arne Popma  
  • Roy Otten  

  Abstract:

  Background: Many adolescents in residential care have been exposed to prolonged traumatic experiences such as violence, neglect, or abuse. Consequently, they suffer from posttraumatic stress. This not only negatively affects psychological and behavioral outcomes (eg, increased anxiety, depression, and aggression) but also has adverse effects on physiological outcomes, in particular on their neurobiological stress systems. Although current evidence-based treatment options are effective, they have their limitations. An alternative to traditional trauma treatment is meditation-based treatment that focuses on stress regulation and relaxation. Muse is a game-based meditation intervention that makes use of adolescents’ intrinsic motivation. The neurofeedback element reinforces relaxation abilities. Objective: This paper describes the protocol for a randomized controlled trial in which the goal is to examine the effectiveness of Muse (InteraXon Inc) in reducing posttraumatic stress and normalizing neurobiological stress systems in a sample of traumatized adolescents in residential care. Methods: This will be a multicenter, multi-informant, and multimethod randomized controlled trial. Participants will be adolescents (N=80), aged 10 to 18 years, with clinical levels of posttraumatic symptoms, who are randomized to receive either the Muse therapy sessions and treatment as usual (intervention) or treatment as usual alone (control). Data will be collected at 3 measurement instances: pretest (T1), posttest (T2), and at 2-month follow-up. Primary outcomes will be posttraumatic symptoms (self-report and mentor report) and stress (self-report) at posttest. Secondary outcomes will be neurobiological stress parameters under both resting and acute stress conditions, and anxiety, depression, and aggression at posttest. Secondary outcomes also include all measures at 2-month follow-up: posttraumatic symptoms, stress, anxiety, depression aggression, and neurobiological resting parameters. Results: The medical-ethical committee Arnhem-Nijmegen (NL58674.091.16) approved the trial on November 15, 2017. The study was registered on December 2, 2017. Participant enrollment started in January 2018, and the results of the study are expected to be published in spring or summer 2021. Conclusions: Study results will demonstrate whether game-based meditation therapy improves posttraumatic stress and neurobiological stress systems, and whether it is more effective than treatment as usual alone for traumatized adolescents. Trial Registration: Netherlands Trial Register NL6689 (NTR6859); https://www.trialregister.nl/trial/6689

  • JMIR Res Protoc 2020;9(9):e19881

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  RCTs - Protocols/Proposals (eHealth)

  Sep 23, 2020

  Telomerase Activation to Reverse Immunosenescence in Elderly Patients With Acute Coronary Syndrome: Protocol for a Randomized Pilot Trial

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  Authors List:

  • Rebecca Maier  
  • Bilal Bawamia  
  • Karim Bennaceur  
  • Sarah Dunn  
  • Leanne Marsay  
  • Roland Amoah  
  • Adetayo Kasim  
  • Andrew Filby  
  • David Austin  
  • Helen Hancock  
  • Ioakim Spyridopoulos  

  Abstract:

  Background: Inflammation plays a key role in the pathophysiology of coronary heart disease (CHD) and its acute manifestation, acute coronary syndrome (ACS). Aging is associated with a decline of the immune system, a process known as immunosenescence. This is characterized by an increase in highly proinflammatory T cells that are involved in CHD progression, plaque destabilization, and myocardial ischemia–reperfusion injury. Telomere dysfunction has been implicated in immunosenescence of T lymphocytes. Telomerase is the enzyme responsible for maintaining telomeres during cell divisions. It has a protective effect on cells under oxidative stress and helps regulate flow-mediated dilation in microvasculature. Objective: The TACTIC (Telomerase ACTivator to reverse Immunosenescence in Acute Coronary Syndrome) trial will investigate whether a telomerase activator, TA-65MD, can reduce the proportion of senescent T cells in patients with ACS with confirmed CHD. It will also assess the effect of TA-65MD on decreasing telomere shortening, reducing oxidative stress, and improving endothelial function. Methods: The study was designed as a single-center, randomized, double-blind, parallel-group, placebo-controlled phase II trial. Recruitment started in January 2019. A total of 90 patients, aged 65 years or older, with treated ACS who have had CHD confirmed by angiography will be enrolled. They will be randomized to one of two groups: TA-65MD oral therapy (8 mg twice daily) or placebo taken for 12 months. The primary outcome is the effect on immunosenescence determined by a decrease in the proportion of CD8+ TEMRA (T effector memory cells re-expressing CD45RA [CD45 expressing exon A]) cells at 12 months. Secondary outcomes include leukocyte telomere length, endothelial function, cardiac function as measured by echocardiography and NT-proBNP (N-terminal fragment of the prohormone brain-type natriuretic peptide), systemic inflammation, oxidative stress, and telomerase activity. Results: The study received National Health Service (NHS) ethics approval on August 9, 2018; Medicines and Healthcare products Regulatory Agency approval on October 19, 2018; and NHS Health Research Authority approval on October 22, 2018. The trial began recruiting participants in January 2019 and completed recruitment in March 2020; the trial is due to report results in 2021. Conclusions: This pilot trial in older patients with CHD will explore outcomes not previously investigated outside in vitro or preclinical models. The robust design ensures that bias has been minimized. Should the results indicate reduced frequency of immunosenescent CD8+ T cells as well as improvements in telomere length and endothelial function, we will plan a larger, multicenter trial in patients to determine if TA-65MD is beneficial in the treatment of CHD in elderly patients. Trial Registration: ISRCTN Registry ISRCTN16613292; http://www.isrctn.com/ISRCTN16613292 and European Union Drug Regulating Authorities Clinical Trials Database (EudraCT), European Union Clinical Trials Register 2017-002876-26; https://tinyurl.com/y4m2so8g

  • JMIR Res Protoc 2020;9(9):e19456

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  RCTs - Protocols/Proposals (eHealth)

  Sep 23, 2020

  School-Based Multicomponent Intervention to Promote Physical Activity and Reduce Sedentary Time of Disadvantaged Children Aged 6-10 Years: Protocol for a...

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  Authors List:

  • Caroline Maite Marie Bernal  
  • Lena Lhuisset  
  • Nicolas Fabre  
  • Julien Bois  

  Abstract:

  Background: In our modern society, physical activity (PA) is decreasing and sedentary time (ST) is increasing, especially for children from disadvantaged neighborhoods. School-based interventions to promote PA and decrease ST are therefore required among this population in order to change children’s lifestyle habits. Moreover, attentional capacities and academic achievement can be enhanced by chronic PA during childhood. The relationships between these variables have been poorly studied with this population. Objective: The objective of this study is to present the rationale and methods for a randomized controlled trial among 6-10-year-old children with low socioeconomic status that will (1) evaluate the effectiveness of a school-based intervention designed to promote PA and reduce ST and (2) study the relationships between PA, ST, motor skills, attentional capacities, and academic achievement. Methods: A randomized controlled trial was conducted in 2 eligible primary schools. During academic year 2016-2017, 1 school was randomly assigned as the experiment one and the other was assigned as the control one. Five assessments times were used: baseline (T1 [November 2016] to T2 [June 2017]), follow-up (T3 [November 2017] to T4 [June 2018]), and final assessment (T5 [June 2019]). The school-based intervention included various components on different levels of the socioecological model: (1) curriculum-based program for children; (2) sensitization workshops and newsletters for parents; (3) training workshops for teachers; (4) environmental adaptation of playgrounds and reorganization of recess time; (5) time adaptation of lunch breaks; and (6) collaboration with political groups. PA, ST, motor skills, and attentional capacities were evaluated and academic achievement was recorded. Results: The presented intervention and its different assessments have been successfully implemented. In order to achieve the 2 objectives of this randomized controlled trial, data analyses are about to be completed. Conclusions: The implementation of this randomized controlled trial can help to determine effective strategies to promote PA in the context of increasing prevalence of physical inactivity among children with sedentary lifestyle which will be useful for researchers, stakeholders, and public policy makers. Trial Registration: ClinicalTrials.gov NCT03983447; https://clinicaltrials.gov/ct2/show/NCT03983447

  • JMIR Res Protoc 2020;9(9):e17815

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  Scoping Review Protocols

  Sep 23, 2020

  The Impact of Brexit on the Pharmaceutical Supply Chain of the United Kingdom: Scoping Review Protocol

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  Authors List:

  • Madison Milne-Ives  
  • Ching Lam  
  • Michelle van Velthoven  
  • Edward Meinert  

  Abstract:

  Background: The continuing uncertainty around Brexit has caused concern in the pharmaceutical industry and among health care professionals and patients. The exact consequences of Brexit on the pharmaceutical supply chain in the United Kingdom will depend on whether a deal is reached and what it entails, but it is likely to be affected by the withdrawal of the United Kingdom from the European Union. Regulatory issues and delays in supply have the potential to negatively affect the ability of UK residents to receive an adequate and timely supply of necessary medicines. Objective: The purpose of this protocol is to provide an overview and critical analysis of current perspectives on the effect of Brexit on the UK pharmaceutical supply chain. Methods: The PRISMA-ScR (Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews) guidelines will be used to structure this protocol. A systematic search of MEDLINE, EMBASE, PsycINFO, Healthcare Management Information Consortium (HMIC), Cochrane, Web of Science, Business Source Complete, EconLit, and Economist Intelligence Unit will be conducted, as well as a Google and Nexis.UK search for grey literature such as reports, opinion pieces, and press releases. Two reviewers will independently screen the titles and abstracts of identified references and select studies according to the eligibility criteria. Any discrepancies will then be discussed and resolved. One reviewer will extract data from the included studies into a standardized form, which will be validated by a second reviewer. Risk of bias will be assessed using the Cochrane Collaboration Risk of Bias tool for any randomized controlled trials; quality will be assessed using the relevant Critical Appraisal Skills Programme (CASP) checklists; and grey literature will be assessed using the Authority, Accuracy, Coverage, Objectivity, Date, Significance (AACODS) checklist. Outcomes include the agreement between sources on the potential, likelihood, and severity of the consequences of Brexit on the UK pharmaceutical supply chain. Results: Results will be included in the scoping review, which will be published in 2020. Conclusions: This scoping review will summarize the currently expected consequences of Brexit on the UK pharmaceutical supply chain.

  • JMIR Res Protoc 2020;9(9):e17684

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  RCTs - Protocols/Proposals (funded,...

  Sep 23, 2020

  Optimizing an Acceptance and Commitment Therapy Microintervention Via a Mobile App With Two Cohorts: Protocol for Micro-Randomized Trials

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  Authors List:

  • Emily B Kroska  
  • Sydney Hoel  
  • Amanda Victory  
  • Susan A Murphy  
  • Melvin G McInnis  
  • Zachary N Stowe  
  • Amy Cochran  

  Abstract:

  Background: Given gaps in the treatment of mental health, brief adaptive interventions have become a public health imperative. Transdiagnostic interventions may be particularly appropriate given high rates of medical comorbidity and the broader reach of transdiagnostic therapies. One such approach utilized herein is acceptance and commitment therapy (ACT), which is focused on increasing engagement with values, awareness, and openness to internal experiences. ACT theory posits that experiential avoidance is at the center of human suffering, regardless of diagnosis, and, as such, seeks to reduce unworkable experiential avoidance. Objective: Our objective is to provide the rationale and protocol for examining the safety, feasibility, and effectiveness of optimizing an ACT-based intervention via a mobile app among two disparate samples, which differ in sociodemographic characteristics and symptom profiles. Methods: Twice each day, participants are prompted via a mobile app to complete assessments of mood and activity and are then randomly assigned to an ACT-based intervention or not. These interventions are questions regarding engagement with values, awareness, and openness to internal experiences. Participant responses are recorded. Analyses will examine completion of assessments, change in symptoms from baseline assessment, and proximal change in mood and activity. A primary outcome of interest is proximal change in activity (eg, form and function of behavior and energy consumed by avoidance and values-based behavior) following interventions as a function of time, symptoms, and behavior, where we hypothesize that participants will focus more energy on values-based behaviors. Analyses will be conducted using a weighted and centered least squares approach. Two samples will run concurrently to assess the capacity of optimizing mobile ACT in populations that differ widely in their clinical presentation and sociodemographic characteristics: individuals with bipolar disorder (n=30) and distressed first-generation college students (n=50). Results: Recruitment began on September 10, 2019, for the bipolar sample and on October 5, 2019, for the college sample. Participation in the study began on October 18, 2019. Conclusions: This study examines an ACT-based intervention among two disparate samples. Should ACT demonstrate feasibility and preliminary effectiveness in each sample, a large randomized controlled trial applying ACT across diagnoses and demographics would be indicated. The public health implications of such an approach may be far-reaching. Trial Registration: ClinicalTrials.gov NCT04098497; https://clinicaltrials.gov/ct2/show/NCT04098497; ClinicalTrials.gov NCT04081662; https://clinicaltrials.gov/ct2/show/NCT04081662

  • JMIR Res Protoc 2020;9(9):e17086

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  Non-randomized Protocols and Methods...

  Sep 22, 2020

  Online Navigation for Pre-Exposure Prophylaxis via PleasePrEPMe Chat for HIV Prevention: Protocol for a Development and Use Study

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  Authors List:

  • Shannon Weber  
  • Laura Lazar  
  • Alan McCord  
  • Charlie Romero  
  • Judy Tan  

  Abstract:

  Background: Pre-exposure prophylaxis is an HIV medication taken by an individual who is HIV-negative to prevent infection before exposure to the virus. Numerous clinical studies in various communities have shown high rates of effectiveness when pre-exposure prophylaxis is taken as prescribed. Since FDA (US Food and Drug Administration) approval of the first product for pre-exposure prophylaxis in 2012, uptake has been lower than the estimated 1.1 million US adults who could benefit from its use, with an estimated 70,394 individuals on pre-exposure prophylaxis in 2017. Of these, only 11% were Black and 13% were Hispanic despite Black and Hispanic individuals comprising two-thirds of individuals who could benefit, highlighting racial and ethnic disparities in pre-exposure prophylaxis uptake. Patient navigators have been shown to be effective in improving the linkage and retention in care outcomes of people living with HIV across the HIV treatment cascade and can be used throughout the pre-exposure prophylaxis care continuum to assist decision making and connect potential users to pre-exposure prophylaxis services. Objective: PleasePrEPMe Chat was designed as a novel online strategy aimed at improving engagement in pre-exposure prophylaxis care services with pre-exposure prophylaxis–eligible populations in California via free HIV-prevention information and health care navigation services. Methods: Visitors connected with navigators via online bilingual (English, Spanish) chat. During the chat, navigators helped locate pre-exposure prophylaxis services through the PleasePrEPMe provider directory, provided links to HIV-prevention resources, and supported uninsured, insured, and undocumented visitors with benefits navigation. Data such as date, time, type of encounter, visitor type, key demographics, discussion topics, insurance, and other relevant information were collected via a chat log and through the HealthEngage chat platform. Results: From April 2017 to December 2019, PleasePrEPMe completed 2191 online chats. Mean interaction time was 16 minutes, with 68% of chats covering more than one topic. Conversation topics included health care navigation (1104/2191, 50.39%), provider identification (954/2191, 43.54%), pre-exposure prophylaxis information (773/2191, 35.28%), post-exposure prophylaxis information (318/2191, 14.91%), and the California Pre-Exposure Prophylaxis Assistance Program (232/2191, 10.59%). Referrals to pre-exposure prophylaxis– or non pre-exposure prophylaxis–related resources included directory updates, HIV testing and treatment, undetectable=untransmittable, reproductive health, sexually transmitted infections, and other prevention methods. A total of 368 chat visitors completed a voluntary satisfaction scale rating the quality and helpfulness of the service provided, producing a mean rating of 4.7 out of 5. Conclusions: Online chat is a method for reaching people not already engaged in HIV-prevention services, supporting HIV-prevention decision making, and linking people seeking information online with in-person services. Additional research to evaluate online sexual health information services and understand how social determinants of health influence online engagement is needed to better understand how to reach priority populations not well served by current HIV-prevention services.

  • JMIR Res Protoc 2020;9(9):e20187

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  RCTs - Protocols/Proposals (funded,...

  Sep 22, 2020

  Mobile-Enhanced Prevention Support Study for Men Who Have Sex With Men and Transgender Women Leaving Jail: Protocol for a Randomized Controlled Trial

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  Authors List:

  • Gabriel G Edwards  
  • Cathy J Reback  
  • William E Cunningham
  • Charles L Hilliard  
  • Charles McWells  
  • Sukrit Mukherjee  
  • Robert E Weiss  
  • Nina T Harawa  

  Abstract:

  Background: Men who have sex with men (MSM) and transgender women, particularly those who have experienced criminal justice involvement, have particularly high HIV burdens, and a majority of those in jail have substance use disorders (SUDs). MSM and transgender women also experience elevated rates of incarceration. Once community re-entry occurs, individuals are in a critical period for addressing potential risks of HIV and sexually transmitted infection (STI) acquisition and negative sequelae of substance use. Further, the impact experienced by one’s social and sexual networks experienced at the time of detention and release have important health implications for MSM and transgender women. Objective: The purpose of this study is to test a new intervention—Mobile-Enhanced Prevention Support (MEPS)—that involves a GPS-based mobile app called GeoPassport (referred to as GeoPass in practice), incentives, and peer support for promoting HIV prevention, substance use treatment, and use of related services. Methods: A two-arm, unblinded, randomized controlled trial will seek to enroll 300 HIV-negative MSM and transgender women, aged 18-49 years, with SUDs, who are either in jail or have recently left jail. Participants will be enrolled by study staff and randomized to the MEPS intervention group or usual care group. The intervention group will receive customized wellness goals in addition to GeoPass, cash incentives, and the support of a trained peer mentor for 6 months. Data collection will consist of a baseline survey and three follow-up surveys at 3, 6, and 9 months postenrollment, either in person or by phone or videoconference when necessary. The primary outcomes include establishing a primary care provider; being prescribed and adhering to pre-exposure prophylaxis (PrEP) for HIV; screening for HIV, STIs, and hepatitis C virus; and engagement in recommended treatment for SUDs. Secondary outcomes include obtaining treatment for any identified infections and avoiding recidivism. Results: Enrollment began in November 2019 and study completion is expected in 2023. Conclusions: This study will advance our knowledge base on patient navigation and peer mentor interventions. Peer navigation services have been studied for the treatment of HIV, but less often in the context of HIV and STI prevention among sexual and gender minority populations at the time of re-entry into the community from jail. The MEPS study will examine the acceptability and feasibility of combining peer mentor services with a mobile app to facilitate service utilization and participant–peer mentor communication. MEPS will assess patterns of PrEP uptake and utilization in MSM and transgender women leaving jail. The study will provide heretofore unavailable data from persons leaving jail regarding HIV PrEP, STI screening, substance abuse treatment, and service utilization patterns and experiences, including geocoded data for those in the intervention arm. Trial Registration: ClinicalTrials.gov (NCT04036396); https://www.clinicaltrials.gov/ct2/show/NCT04036396

  • JMIR Res Protoc 2020;9(9):e18106

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  Non-randomized Protocols and Methods...

  Sep 21, 2020

  Assessing the Effectiveness of Policies Relating to Breastfeeding Promotion, Protection, and Support in Southeast Asia: Protocol for a Mixed Methods Study

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  Authors List:

  • Tuan T Nguyen  
  • Amy Weissman  
  • Jennifer Cashin  
  • Tran T Ha  
  • Paul Zambrano  
  • Roger Mathisen  

  Abstract:

  Background: Despite its well-known benefits, breastfeeding practices remain suboptimal worldwide, including in Southeast Asia. Many countries in the region have thus enacted policies, such as maternity protection and the World Health Assembly International Code of Marketing of Breast-milk Substitutes (the Code), that protect, promote, and support breastfeeding. Yet the impact of such national legislation on breastfeeding practices is not well understood. Objective: This study aims to review the content, implementation, and potential impact of policies relating to maternity protection and the Code in Myanmar, the Philippines, Thailand, and Vietnam. Methods: This mixed methods study includes a desk review, trend and secondary data analyses, and quantitative and qualitative data collection. Desk reviews will examine and compare the contents, implementation strategies, coverage, monitoring, and enforcement of national policies focusing on maternity protection and the Code in each country with global standards. Trend and secondary data analyses will examine the potential impact of these policies on relevant variables such as breast milk substitute (BMS) sales and women’s workforce participation. Quantitative data collection and analysis will be conducted to examine relevant stakeholders’ and beneficiaries’ perceptions about these policies. In each country, we will conduct up to 24 in-depth interviews (IDI) with stakeholders at national and provincial levels and 12 employers or 12 health workers. Per country, we will survey approximately 930 women who are pregnant or have a child aged 0-11 months, of whom approximately 36 will be invited for an IDI; 12 partners of the interviewed mothers or fathers of children from 0-11 months will also be interviewed. Results: This study, funded in June 2018, was approved by the Institutional Review Boards of the relevant organizations (FHI 360: April 16, 2019 and May 18, 2020; and Hanoi University of Public Health: December 6, 2019). The dates of data collection are as follows: Vietnam: November and December 2019, May and June 2020; the Philippines: projected August 2020; Myanmar and Thailand: pending based on permissions and funding. Results are expected to be published in January 2021. As of July 2020, we had enrolled 1150 participants. We will present a comparison of key contents of the policies across countries and against international standards and recommendations and a comparison of implementation strategies, coverage, monitoring, and enforcement across countries. We will also present findings from secondary data and trend data analyses to propose the potential impact of a new or amended policy. For the surveys with women, we will present associations between exposure to maternity protection or BMS promotion on infant and young child feeding practices and their determinants. Findings from IDIs will highlight relevant stakeholders’ and beneficiaries’ perceptions. Conclusions: This study will increase the understanding of the effectiveness of policy interventions to improve breastfeeding, which will be used to advocate for stronger policy adoption and enforcement in study countries and beyond.

  • JMIR Res Protoc 2020;9(9):e21286

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  Participatory Research Protocols and...

  Sep 21, 2020

  Awareness of and Attitudes Toward User Involvement in Research on Aging and Health: Protocol for a Quantitative Large-Scale Panel Study

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  Authors List:

  • Maya Kylén  
  • Steven M Schmidt  
  • Oskar Jonsson  
  • Björn Slaug  
  • Susanne Iwarsson  

  Abstract:

  Background: User involvement is a requirement of most research funders. There is a growing body of literature exploring the benefits and challenges of user involvement in research, but such studies are scarce in the field of aging and health. Moreover, the majority of such research is qualitative, which limits the generalizability of results. The UserAge panel study will be instrumental in expanding knowledge that will benefit the quality and impact of user involvement in future research. Objective: The aim of this study is to determine the awareness and understanding of and attitudes toward user involvement in research among different categories of knowledge users and researchers over time. Methods: A panel study will be implemented with 3 different categories of knowledge users (people aged 60 years and older, informal carers, and professionals in health care and architecture) and researchers in aging and health. A professional survey company will collect data from all samples in parallel. Potential participants will be asked to complete the survey via telephone or online, or participants can request a paper survey to be sent to them in the post. A draft set of questions on attitudes and behavioral patterns related to research utilization and user involvement in research was compiled based on existing literature and input from the research team. Using a participatory approach, we engaged a user forum, where 8 older people and 3 researchers jointly refined the survey for time/length to complete, terminology, readability, and context. Data collected via the internet or telephone will be automatically processed, and data collected on paper forms will be entered in machine-readable forms. The survey company will store all data and deliver the quality-controlled database to the university for further storage. Analyses of frequencies and measures of central tendency will be used for descriptive purposes. To compare groups, state-of-the art statistical analyses will be used. Results: Data collection for the first study wave started in September 2019 and will be completed in spring 2020. Data will be ready for analysis following cleaning and quality control, which started during summer 2020 and will be completed autumn 2020. We anticipate the data collection for the second study wave to start in September 2021. Conclusions: This is the first quantitative large-scale panel study focusing on trends in attitudes toward, awareness of, and knowledge about user involvement in research on aging and health in Sweden. The results will generate new and important knowledge to advance the understanding of user needs and preferences as well as the relevance of user involvement in research on aging and health.

  • JMIR Res Protoc 2020;9(9):e17759

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  RCTs - Protocols/Proposals (funded,...

  Sep 18, 2020

  Promoting Health and Well-Being Through Mobile Health Technology (Roadmap 2.0) in Family Caregivers and Patients Undergoing Hematopoietic Stem Cell...

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  Authors List:

  • Michelle Rozwadowski  
  • Manasa Dittakavi  
  • Amanda Mazzoli  
  • Afton L Hassett  
  • Thomas Braun  
  • Debra L Barton  
  • Noelle Carlozzi  
  • Srijan Sen  
  • Muneesh Tewari  
  • David A Hanauer  
  • Sung Won Choi  

  Abstract:

  Background: Cancer patients who undergo allogeneic hematopoietic stem cell transplantation are among the most medically fragile patient populations with extreme demands for caregivers. Indeed, with earlier hospital discharges, the demands placed on caregivers continue to intensify. Moreover, an increased number of allogeneic hematopoietic stem cell transplantations are being performed worldwide, and this expensive procedure has significant economic consequences. Thus, the health and well-being of family caregivers have attracted widespread attention. Mobile health technology has been shown to deliver flexible, and time- and cost-sparing interventions to support family caregivers across the care trajectory. Objective: This protocol aims to leverage technology to deliver a novel caregiver-facing mobile health intervention named Roadmap 2.0. We will evaluate the effectiveness of Roadmap 2.0 in family caregivers of patients undergoing hematopoietic stem cell transplantation. Methods: The Roadmap 2.0 intervention will consist of a mobile randomized trial comparing a positive psychology intervention arm with a control arm in family caregiver-patient dyads. The primary outcome will be caregiver health-related quality of life, as assessed by the PROMIS Global Health scale at day 120 post-transplant. Secondary outcomes will include other PROMIS caregiver- and patient-reported outcomes, including companionship, self-efficacy for managing symptoms, self-efficacy for managing daily activities, positive affect and well-being, sleep disturbance, depression, and anxiety. Semistructured qualitative interviews will be conducted among participants at the completion of the study. We will also measure objective physiological markers (eg, sleep, activity, heart rate) through wearable wrist sensors and health care utilization data through electronic health records. Results: We plan to enroll 166 family caregiver-patient dyads for the full data analysis. The study has received Institutional Review Board approval as well as Code Review and Information Assurance approval from our health information technology services. Owing to the COVID-19 pandemic, the study has been briefly put on hold. However, recruitment began in August 2020. We have converted all recruitment, enrollment, and onboarding processes to be conducted remotely through video telehealth. Consent will be obtained electronically through the Roadmap 2.0 app. Conclusions: This mobile randomized trial will determine if positive psychology-based activities delivered through mobile health technology can improve caregiver health-related quality of life over a 16-week study period. This study will provide additional data on the effects of wearable wrist sensors on caregiver and patient self-report outcomes. Trial Registration: ClinicalTrials.gov NCT04094844; https://www.clinicaltrials.gov/ct2/show/NCT04094844

  • JMIR Res Protoc 2020;9(9):e19288

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  Non-randomized Protocols and Methods...

  Sep 18, 2020

  Impacts of Motion-Based Technology on Balance, Movement Confidence, and Cognitive Function Among People With Dementia or Mild Cognitive Impairment: Protocol...

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  Authors List:

  • Erica Dove  
  • Rosalie Wang  
  • Karl Zabjek  
  • Arlene Astell  

  Abstract:

  Background: While exercise can benefit the health and well-being of people with dementia or mild cognitive impairment, many exercise programs offered to this population are passive, unengaging, and inaccessible, resulting in poor adherence. Motion-based technologies are increasingly being explored to encourage exercise participation among people with dementia or mild cognitive impairment. However, the impacts of using motion-based technologies with people with dementia or mild cognitive impairment on variables including balance, movement confidence, and cognitive function have yet to be determined. Objective: The purpose of this study is to examine the impacts of a group motion-based technology intervention on balance, movement confidence, and cognitive function among people with dementia or mild cognitive impairment. Methods: In this quasi-experimental pre- and posttest design, we will recruit 24 people with dementia or mild cognitive impairment from 4 adult day programs and invite them to play Xbox Kinect bowling in a group setting, twice weekly for 10 weeks. We will require participants to speak and understand English, be without visual impairment, and be able to stand and walk. At pretest, participants will complete the Mini-Balance Evaluation Systems Test (Mini-BESTest) and the Montreal Cognitive Assessment (MoCA). We will video record participants during weeks 1, 5, and 10 of the intervention to capture behavioral indicators of movement confidence (eg, fluency of motion) through coding. At posttest, the Mini-BESTest and MoCA will be repeated. We will analyze quantitative data collected through the Mini-BESTest and the MoCA using an intent-to-treat analysis, with study site and number of intervention sessions attended as covariates. To analyze the videos, we will extract count and percentage data from the coded recordings. Results: This study will address the question of whether a group motion-based technology intervention, delivered in an adult day program context, has the potential to impact balance, movement confidence, and cognitive function among people with dementia or mild cognitive impairment. The project was funded in 2019 and enrollment was completed on February 28, 2020. Data analysis is underway and the first results are expected to be submitted for publication in 2021. Conclusions: This study will assess the feasibility and potential benefits of using motion-based technology to deliver exercise interventions to people with dementia or mild cognitive impairment. This work can also be used as the basis for developing specific software and future exercise programs using motion-based technology for people with dementia or mild cognitive impairment, as well as understanding some of the conditions in which these programs can be delivered.

  • JMIR Res Protoc 2020;9(9):e18209

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