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: 10266162
• 负责人: Sheryl Flynn
• 金额: $ 99.22万
• 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 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10266162
• 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 Airway 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; Hispanics; 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.

项目总结/摘要 在今天的美国，预防跌倒最常见的非医学方法是推荐科学验证的 以社区为基础的预防跌倒计划。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。它们包括降低跌倒风险的教育 和平衡/加强活动;这些活动通常通过信仰组织、民间社会组织、 组织、图书馆、经济适用房、社区中心和家庭。它们通常通过以下方式获得资金： 美国老年人法案第三章问题：虽然这些计划是一个重要的资源和干预， 老年人有跌倒的风险，参加研讨会的好处已经得到证实，但成本高昂，缺乏 可扩展性，不能解决居住在大都市地区以外的老年人的接入需求，其吸收范围从低到高， 中度，他们无法跟踪长期结果，他们不提供人口健康指标，可用于 资助者和健康保险提供者，以确保老年人得到最适当的跌倒预防 干预这项IIB期申请的主要目标是完成两项实用的临床试验，以证明 我们的NIH资助的健康运动跌倒预防平台的有效性，以解决现有的限制， 在社区中心（研究1）和家庭（研究2）部署的程序。长期目标是获得 社区生活管理局批准作为一个以证据为基础的跌倒预防计划，并减少福尔斯跌倒， 广泛的基础。如果成功，这项研究将确保健康运动的商业成功，因为它将有资格获得 标题IIID资金在美国各地，它将证明我们的价值主张。具体目标：（1）完成额外 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， 当在社区中传播时，以及当在社区基础上使用时， 预防跌倒研讨会作为一个概括性的好处。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，我们将完成一个为期3个月的，平行组，集群- 随机化实用临床试验（PrCT），9个月非随机化扩展和随访研究。参与者将 参加至少一个以社区为基础的跌倒预防计划，并将被邀请使用健康运动健康日记 收集与福尔斯相关的信息，并在术后9个月内收集医疗保健利用情况。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。参加者将自行选择完成以家庭为基础的 运动健康-奥塔哥跌倒预防计划或没有计划。所有参与者将使用Health 驶动健康相关性：该项目直接与国家老龄化研究所的使命保持一致，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。本应用程序是在 对NIA要求解决老年人行为干预问题的解决方案的回应， 独立、幸福和预防疾病/残疾。