Health in Motion- A Pragmatic Clinical Trial

项目摘要/摘要 在今天的美国，最常见的预防跌倒的非医学方法是转诊到经过科学验证的 以社区为基础的跌倒预防计划。这些基于证据的计划得到了很好的验证，有效地降低了跌倒的风险， 提供显著的投资回报，并降低医疗保健利用率。它们包括减少跌倒风险的教育 和平衡/加强练习；它们通常通过以信仰为基础的组织、民间组织 组织、图书馆、经济适用房站点、社区中心和家庭。它们的资金通常是通过 《老年美国人法案》第三章。问题：虽然这些项目为以下方面提供了重要的资源和干预 老年人有跌倒的风险，参加研讨会的好处是确定的，他们是昂贵的，缺乏 可扩展性，没有解决居住在大都市以外的老年人的接入需求，他们的接受范围从低到 中等，它们无法跟踪长期结果，也没有提供可供以下人员使用的人口健康指标 资助者和医疗保险提供者确保老年人获得最适当的预防跌倒 干预。这一IIB期应用的主要目标是完成两项实用的临床试验，以证明 NIH资助的Health in Motion跌倒预防平台的有效性，以解决现有 在社区中心(研究1)和家庭(研究2)部署的方案。长期目标是获得 社区生活管理局批准以证据为基础的预防跌倒计划和减少跌倒 一个大范围的基础。如果成功，这项研究将确保Health in Motion的商业成功，因为它将有资格 标题IIID在全美范围内提供资金，它将展示我们的价值主张。具体目标：1)完成附加 AIMS 2和3.2中计划的实用临床试验所需的开发确定了有效性和 运动中的健康在社区内传播和在社区使用时的经济效益 作为综合福利的预防跌倒研讨会。3)确定卫生保健的有效性和经济效益 在家中传播时的运动。研究设计：对于目标2，我们将完成一个为期3个月的平行分组-- 随机实用临床试验(PRCT)，非随机延长和随访研究9个月。参与者将 至少参加一个基于社区的跌倒预防计划，并将被邀请使用Health in Motion健康日记 收集9个月课后与跌倒和医疗保健利用有关的信息。对于目标3，我们完成一个 前瞻性纵向(12个月)观察性队列研究。参与者将自行选择完成以家庭为基础的 运动中的健康-奥塔哥预防跌倒计划或不计划。所有参与者将使用Health完成所有评估 在运动中。与健康相关：该项目直接与国家老龄研究院的使命保持一致，以改善 通过生物医学、社会和行为研究促进老年人的健康和福祉。此应用程序是用以下语言编写的 对NIA提出的解决方案的要求做出回应，以解决老年人的行为干预问题 独立、幸福和预防疾病/残疾。

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.