RETAIN: A digital therapeutic for Alzheimer's risk reduction

RETAIN：降低阿尔茨海默病风险的数字疗法

• 批准号: 10256502
• 负责人: Mark McInnis
• 金额: $ 43.07万
• 依托单位: RETAIN HEALTH INC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-05-01 至 2022-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10256502
• 关键词: Academia; Address; Advertising; Affect; Alzheimer disease prevention; Alzheimer' s Disease; Alzheimer' s disease risk; American; Area; Behavior Therapy; Behavioral; Blood Pressure; Brain; Caring; Cellular Phone; Centers for Disease Control and Prevention (U.S.); Chronic Disease; Clinical Management; Clinical Trials; Cognition; Cognitive; Collaborations; Communication; Communities; Computer software; Dementia; Devices; Diabetes Mellitus; Diet; Disease; Drops; Education; Effectiveness; Elderly; Feedback; Foundations; Fright; Goals; Habits; Health; Health Services Accessibility; Health Technology; Impaired cognition; Individual; Internet; Intervention; Knowledge; Lead; Life Style; Low income; Measures; Memory; Memory Loss; Methods; Monitor; Obesity; Online Systems; Outcome; Pathologic; Patients; Persons; Pharmaceutical Preparations; Phase; Physical Exercise; Physicians; Population; Populations at Risk; Prevention; Public Health; Public Policy; Publishing; Quality of life; Randomized Controlled Trials; Recommendation; Research; Resources; Risk; Risk Assessment; Risk Factors; Risk Reduction; Sleep; System; Techniques; Testing; Text; Text Messaging; Time; Translating; United States; Work; arm; base; behavior change; cardiovascular disorder risk; care delivery; caregiving; clinical care; clinical practice; cognitive function; cohort; comparative effectiveness trial; cost; cost effective; design; diabetes prevention program; dietary; digital; digital treatment; effective therapy; effectiveness evaluation; evidence base; experience; handheld mobile device; health care availability; improved; indexing; intervention cost; lifestyle intervention; mHealth; medication compliance; member; mobile application; mobile computing; multimodality; personalized management; pre-clinical; prevent; prototype; randomized trial; recruit; satisfaction; screening; smoking cessation; social engagement; statistics; stress management; three-arm study; tool; usability; vascular risk factor; virtual; web app

Alzheimer's is the most expensive disease in the United States. It starts silently in the brain decades before memory loss begins. An estimated 46 million Americans are affected by the first pre-symptomatic phase of Alzheimer’s disease (AD). This stage represents a window of opportunity to address risk factors which can delay progression to dementia. Unfortunately, the majority of this population is unaware that lifestyle changes can significantly delay cognitive decline. In addition, few have access to physicians specializing in AD risk reduction and most people with AD live in low-income communities with limited healthcare access. Several randomized trials have found that multi-domain interventions can maintain cognition. A trial led by two members of our study team showed that individualized lifestyle interventions can significantly reduce AD risk and improve cognition. To build on this work, RETAIN Health, Inc developed a cross platform “mobile- first” application for AD risk reduction. RETAIN is a digital therapeutic designed to assess the risk of an individual and apply behavioral modification techniques to deliver evidence-based, personalized recommendations. Our system promotes behavior change in the areas of diet, physical exercise, sleep, social engagement, cognitive engagement, vascular risk factors (e.g., blood pressure), obesity, smoking cessation, and stress management. RETAIN uses bi-directional SMS text messaging to create a virtual conversation. As 96% of Americans own cell phones, automated text communication can cost-effectively serve people who lack access to care on a large scale. Importantly, RETAIN builds off 7 years of our prior research using web-based education in collaboration with academia, establishing a substantive foundation. We aim to improve the user experience of our software through both qualitative and quantitative user experience testing. We will then evaluate whether RETAIN is effective in reducing AD risk using a validated risk index. We will also explore effectiveness in improving cognition and quality of life. We will then assess the associated costs to the user of the risk reduction interventions and evaluate user satisfaction. We will conduct a six-month, web-based, three-arm randomized controlled trial of 860 subjects at risk for AD. As was accomplished in our prior studies, we will use targeted internet advertising to rapidly and cost-effectively recruit a diverse cohort. Arm 1 will include personalized, web-based AD risk factor education plus regular personalized bi-directional SMS text communication. Arm 2 will include personalized web-based AD risk factor education without personalized SMS text. Arm 3 (control) will include generalized AD education covering statistics, public policy, and caregiving, along with regular SMS text communication about these topics. Successful implementation of this project will result in the first automated digital solution to provide multi-domain individualized management for people at risk for AD. It will also result in a product ready for market and address goals of the National Alzheimer's Project Act to prevent and effectively treat AD by 2025.

阿尔茨海默氏症是美国最昂贵的疾病。它在大脑中悄然开始数十年 在记忆开始丧失之前。据估计，有 4600 万美国人受到第一个症状前阶段的影响 阿尔茨海默病（AD）。这一阶段代表了解决风险因素的机会之窗，这些风险因素可以 延缓痴呆的进展。不幸的是，大多数人并没有意识到生活方式的改变 可以显着延缓认知能力下降。此外，很少有人能够接触到专门从事 AD 风险的医生 减少，并且大多数 AD 患者生活在医疗保健机会有限的低收入社区。 多项随机试验发现，多领域干预可以维持认知。一项试验导致 我们研究小组的两名成员表明，个性化的生活方式干预可以显着减少 AD 风险并提高认知能力。为了在这项工作的基础上，RETAIN Health, Inc 开发了一个跨平台“移动- “第一个”降低 AD 风险的应用程序。RETAIN 是一种数字疗法，旨在评估 AD 风险 个人并应用行为矫正技术来提供基于证据的、个性化的 建议。我们的系统促进饮食、体育锻炼、睡眠、社交等领域的行为改变 参与度、认知参与度、血管危险因素（例如血压）、肥胖、戒烟、 和压力管理。 RETAIN 使用双向短信来创建虚拟对话。作为 96% 的美国人拥有手机，自动文本通信可以经济高效地为缺乏手机的人们提供服务 获得大规模护理。重要的是，RETAIN 建立在我们之前 7 年的研究基础上，使用基于网络的 与学术界合作进行教育，建立实质性基础。 我们的目标是通过定性和定量的用户来改善我们软件的用户体验 体验测试。然后，我们将使用经过验证的方法来评估 RETAIN 是否能有效降低 AD 风险。 风险指数。我们还将探索改善认知和生活质量的有效性。然后我们将评估 风险降低干预措施的用户的相关成本并评估用户满意度。我们将进行 这是一项为期 6 个月、基于网络的三臂随机对照试验，对 860 名有 AD 风险的受试者进行了试验。一如既往 根据我们之前的研究成果，我们将使用有针对性的互联网广告来快速且经济有效地招募 一个多元化的群体。第 1 组将包括基于网络的个性化 AD 风险因素教育以及定期教育 个性化双向短信文本通信。 Arm 2 将包含基于网络的个性化 AD 风险因素 没有个性化短信的教育。第 3 组（控制）将包括广义 AD 教育，涵盖 统计数据、公共政策和护理，以及有关这些主题的定期短信通信。 该项目的成功实施将产生第一个自动化数字解决方案，以提供 针对 AD 风险人群的多领域个性化管理。它还将导致产品准备好 市场并实现《国家阿尔茨海默病项目法》的目标，即到 2025 年预防和有效治疗 AD。