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      Optimizing a Technology-Based Body and Mind Intervention to Prevent Falls and Reduce Health Disparities in Low-Income Populations: Protocol for a Clustered Randomized Controlled Trial

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          Abstract

          Background

          The lack of health care coverage, low education, low motivation, and inconvenience remain barriers to participating in fall prevention programs, especially among low-income older adults. Low-income status also contributes to negative aging self-perceptions and is associated with a high perceived barrier to care. Existing fall prevention intervention technologies do not enable participants and practitioners to interact and collaborate, even with technologies that bring viable strategies to maintain independence, prevent disability, and increase access to quality care. Research is also limited on the use of technology to enhance motivation and help individuals align their perception with physiological fall risk. We developed a novel, 8-week Physio-Feedback Exercise Program (PEER), which includes (1) technology-based physio-feedback using a real-time portable innovative technology—the BTrackS Balance Tracking System, which is reliable and affordable, allows for home testing, and provides feedback and tracks balance progression; (2) cognitive reframing using the fall risk appraisal matrix; and (3) peer-led exercises focusing on balance, strength training, and incorporating exercises into daily activities.

          Objective

          This study consists of 3 aims. Aim 1 is to examine the effects of the technology-based PEER intervention on fall risk, dynamic balance, and accelerometer-based physical activity (PA). Aim 2 is to examine the effects of the PEER intervention on fall risk appraisal shifting and negative self-perceptions of aging. Aim 3 is to explore participants’ experiences with the PEER intervention and potential barriers to accessing and adopting the technology-based PEER intervention to inform future research.

          Methods

          This is an intention-to-treat, single-blinded, parallel, 2-arm clustered randomized controlled trial study. We will collect data from 340 low-income older adults at baseline (T1) and measure outcomes after program completion (T2) and follow-up at 3 months (T3) and 6 months (T4). Participants will be enrolled if they meet all the following inclusion criteria: aged ≥60 years, cognitively intact, and able to stand without assistance. Exclusion criteria were as follows: a medical condition precluding exercise or PA, currently receiving treatment from a rehabilitation facility, plan to move within 1 year, hospitalized >3 times in the past 12 months, and does not speak English or Spanish.

          Results

          As of August 2023, the enrollment of participants is ongoing.

          Conclusions

          This study addresses the public health problem by optimizing a customized, technology-driven approach that can operate in low-resource environments with unlimited users to prevent falls and reduce health disparities in low-income older adults. The PEER is a novel intervention that combines concepts of physio-feedback, cognitive reframing, and peer-led exercise by motivating a shift in self-estimation of fall risk to align with physiological fall risk to improve balance, PA, and negative aging self-perception.

          Trial Registration

          ClinicalTrials.gov NCT05778604; https://www.clinicaltrials.gov/ct2/show/study/NCT05778604

          International Registered Report Identifier (IRRID)

          DERR1-10.2196/51899

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          Most cited references122

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          Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support.

          Research electronic data capture (REDCap) is a novel workflow methodology and software solution designed for rapid development and deployment of electronic data capture tools to support clinical and translational research. We present: (1) a brief description of the REDCap metadata-driven software toolset; (2) detail concerning the capture and use of study-related metadata from scientific research teams; (3) measures of impact for REDCap; (4) details concerning a consortium network of domestic and international institutions collaborating on the project; and (5) strengths and limitations of the REDCap system. REDCap is currently supporting 286 translational research projects in a growing collaborative network including 27 active partner institutions.
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            Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups.

            Qualitative research explores complex phenomena encountered by clinicians, health care providers, policy makers and consumers. Although partial checklists are available, no consolidated reporting framework exists for any type of qualitative design. To develop a checklist for explicit and comprehensive reporting of qualitative studies (in depth interviews and focus groups). We performed a comprehensive search in Cochrane and Campbell Protocols, Medline, CINAHL, systematic reviews of qualitative studies, author or reviewer guidelines of major medical journals and reference lists of relevant publications for existing checklists used to assess qualitative studies. Seventy-six items from 22 checklists were compiled into a comprehensive list. All items were grouped into three domains: (i) research team and reflexivity, (ii) study design and (iii) data analysis and reporting. Duplicate items and those that were ambiguous, too broadly defined and impractical to assess were removed. Items most frequently included in the checklists related to sampling method, setting for data collection, method of data collection, respondent validation of findings, method of recording data, description of the derivation of themes and inclusion of supporting quotations. We grouped all items into three domains: (i) research team and reflexivity, (ii) study design and (iii) data analysis and reporting. The criteria included in COREQ, a 32-item checklist, can help researchers to report important aspects of the research team, study methods, context of the study, findings, analysis and interpretations.
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              "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician.

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                Author and article information

                Contributors
                Journal
                JMIR Res Protoc
                JMIR Res Protoc
                ResProt
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                1929-0748
                2023
                3 October 2023
                : 12
                : e51899
                Affiliations
                [1 ] Nursing Systems Department College of Nursing University of Central Florida Orlando, FL United States
                Author notes
                Corresponding Author: Ladda Thiamwong ladda.thiamwong@ 123456ucf.edu
                Author information
                https://orcid.org/0000-0001-8506-5812
                https://orcid.org/0000-0001-9769-8131
                https://orcid.org/0000-0001-7977-3302
                https://orcid.org/0000-0002-8131-8373
                https://orcid.org/0000-0001-5178-2848
                https://orcid.org/0000-0001-6114-1649
                Article
                v12i1e51899
                10.2196/51899
                10582821
                37788049
                16cd6f35-9c68-4c52-a76a-41c02f6cf8d5
                ©Ladda Thiamwong, Rui Xie, Joon-Hyuk Park, Nichole Lighthall, Victoria Loerzel, Jeffrey Stout. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 03.10.2023.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

                History
                : 16 August 2023
                : 18 August 2023
                : 19 August 2023
                : 20 August 2023
                Categories
                Protocol
                Protocol
                Custom metadata
                The proposal for this study was peer-reviewed by: National Institute of Biomedical Imaging and Bioengineering Special Emphasis Panel (National Institutes of Health, USA).

                fall prevention,fear of falling,low income,older adults,exercise,technology

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