Health in Motion- A Pragmatic Clinical Trial

运动中的健康——一项务实的临床试验

• 批准号: 10432097
• 负责人: Sheryl Flynn
• 金额: $ 97.89万
• 依托单位: BLUE MARBLE REHAB, INC.
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-01 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10432097
• 关键词: Address; Adoption; Aging; American; Area; Behavior Therapy; Behavioral Research; Caregiver Burden; Caring; Centers for Disease Control and Prevention (U.S.); Cessation of life; Chronic Obstructive Pulmonary Disease; Client; Clinical; Clinical Practice Guideline; Cohort Studies; Communities; Country; County; Course Content; Data; Data Collection; Development; Disease; Dizziness; Economics; Education; Educational workshop; Effectiveness; Elderly; Ensure; Equilibrium; Evidence based program; Exercise; Fall prevention; Follow-Up Studies; Foundations; Funding; Funding Agency; Goals; Health; Health Benefit; Health Diary; Health Insurance; Health Personnel; Hispanic; Home; Hospitals; Housing; Incidence; Injury; Intervention; Investments; Learning Module; Libraries; Life; Living Wills; Measures; Mission; Motion; National Heart, Lung, and Blood Institute; National Institute on Aging; National Institute on Deafness and Other Communication Disorders; Outcome; Participant; Patient Self-Report; Personal Satisfaction; Persons; Phase; Pragmatic clinical trial; Prevention program; Progress Reports; Provider; Public Health; Randomized; Recommendation; Research Design; Resource Allocation; Resources; Risk; Risk Reduction; Secure; Side; Site; Software Tools; Standardization; Testing; Translating; Translations; United States Centers for Medicare and Medicaid Services; United States National Institutes of Health; Validation; Visit; base; commercialization; community center; community living; comparative; cost; digital; disability; effectiveness evaluation; effectiveness study; evidence base; fall risk; falls; fear of falling; group intervention; health care service utilization; health data; heart rate monitor; improved; metropolitan; population health; premature; prevent; preventive intervention; primary outcome; programs; prospective; response; sensor; social; success; tool; uptake; web app

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.

项目概要/摘要 在当今的美国，预防跌倒的最常见的非医疗方法是参考经科学验证的方法 以社区为基础的跌倒预防计划。这些基于证据的计划经过充分验证，有效降低跌倒风险， 提供显着的投资回报，并减少医疗保健利用率。它们包括减少跌倒风险的教育 和平衡/力量练习；它们通常通过信仰组织、民间组织传播 组织、图书馆、经济适用房、社区中心和家庭。他们的资金通常来自 《美国老年人法案》第三章。问题：虽然这些计划为 有跌倒风险的老年人，参加讲习班的好处是众所周知的，但费用昂贵，缺乏 可扩展性，不能满足居住在大都市地区以外的老年人的访问需求，他们的使用范围从低到低 中等，他们无法跟踪长期结果，并且他们不提供可供人们使用的人口健康指标 资助者和健康保险提供者确保老年人获得最适当的跌倒预防 干涉。该IIB期申请的主要目标是完成两项实用临床试验以证明 我们的 NIH 资助的 Health in Motion 跌倒预防平台在解决现有技术的局限性方面的有效性 项目部署在社区中心（研究 1）和家庭（研究 2）。长期目标是获得 经社区生活管理局批准作为基于证据的跌倒预防计划，并减少跌倒 具有广泛的基础。如果成功，这项研究将确保 Health in Motion 的商业成功，因为它将有资格获得 Title IIID 资助遍布美国，它将展示我们的价值主张。具体目标： 1) 完成额外的 目标 2 和 3 中计划的实用临床试验所需的开发。 2) 确定有效性和 Health in Motion 在社区中传播以及在基于社区后使用时的经济效益 预防跌倒研讨会作为一项综合福利。 3) 确定健康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，我们将完成为期 3 个月的平行小组、集群- 随机实用临床试验 (PrCT)，包含 9 个月的非随机扩展和随访研究。参与者将 参加至少一项基于社区的跌倒预防计划，并将受邀使用 Health in Motion 健康日记 收集课后 9 个月内与跌倒和医疗保健利用相关的信息。对于目标 3，我们完成了 前瞻性纵向（12 个月）观察队列研究。参与者将自行选择完成家庭作业 Health in Motion-奥塔哥跌倒预防计划或无计划。所有参与者将使用 Health 完成所有评估 在运动中。健康相关性：该项目与美国国家老龄化研究所的使命直接相关，旨在改善 通过生物医学、社会和行为研究来改善老年人的健康和福祉。这个应用程序是写在 响应 NIA 提出的解决方案的要求，以解决老年人的行为干预问题，以维持 独立、福祉和预防疾病/残疾。