Health in Motion- A Pragmatic Clinical Trial

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PROJECT SUMMARY/ ABSTRACT In the US today, the most common non-medical approach to fall prevention is a referral to scientifically validated community-based fall prevention program. These evidence-based programs are well validated, effectively reduce fall risk, provide a significant return on investment, and reduce healthcare utilization. They consist of a fall risk reduction education and balance/strengthening exercises; and they are usually disseminated through faith-based organizations, civic organizations, libraries, affordable housing sites, community centers, and the home. They are typically funded through the Older Americans Act Title IIID. The Problem: While these programs serve an important resource and intervention for older adults at risk for falling, and the benefits of attending the workshops are well established, they are costly, lack scalability, do not address access needs of older adults living outside metropolitan areas, their uptake ranges from low to moderate, they fail to track long-term outcomes, and they do not provide population health metrics that can be used by funders and health insurance providers to ensure the older adults receives the most appropriate fall prevention intervention. The primary objective of this Phase IIB application is to complete two pragmatic clinical trials to demonstrate the effectiveness of our NIH funded Health in Motion Fall Prevention Platform to addresses the limitations of existing programs when deployed in community-centers (study 1) and in the home (study 2). The long-term objective is to obtain approval by the Administration for Community Living as an evidence-based fall prevention program and to reduce falls on a wide-scale basis. If successful, this study will ensure Health in Motion’s commercial success as it would be eligible for Title IIID funding across the U.S. and it will demonstrate our value proposition. Specific Aims: 1) Complete additional development needed for the planned pragmatic clinical trials in Aims 2 and 3. 2) Determine the effectiveness and economic benefit of Health in Motion when disseminated in the community and when used as after community-based fall prevention workshops as a wraparound benefit. 3) Determine the effectiveness and economic benefit of Health in Motion when disseminated in the home. Research Design: For Aim 2, we will complete a 3-month, parallel group, cluster- randomized pragmatic clinical trial (PrCT) with a 9-month non-randomized extension and follow-up study. Participants will attend at least one community-based fall prevention program and will be invited to use the Health in Motion Health Diary to collect information related to falls and healthcare utilization for 9-months post class. For Aim 3, we complete a prospective longitudinal (12-month) observational cohort study. Participants will self-select to complete the home-based Health in Motion-Otago Fall Prevention Program or no program. All participants will complete all assessments using Health in Motion. Health relatedness: This project is directly aligned with the National Institutes on Aging mission to improve the health and well-being of older adults through biomedical, social and behavioral research. This application is written in response to the NIA’s request for solutions that address behavioral interventions for older adults to maintain independence, well-being, and prevent disease/disability.