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: 10569134
• 负责人: Mark McInnis
• 金额: $ 164.44万
• 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 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10569134
• 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; Theory of Change; 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; two way texting; 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。它在大脑中默默地开始了几十年 在失忆开始之前。据估计，有4600万美国人受到第一个症状前期的影响。 阿尔茨海默病(AD)。这一阶段是解决风险因素的机会之窗，这些风险因素可能 延缓痴呆症的进展。不幸的是，大多数人没有意识到生活方式的改变 可以显著延缓认知能力的下降。此外，很少有人能够接触到专门研究AD风险的医生 减少，大多数AD患者生活在低收入社区，获得医疗保健的机会有限。 几项随机试验发现，多领域干预可以维持认知。以审判为首的 我们研究小组的两名成员的研究表明，个性化的生活方式干预可以显著减少 广告风险和提高认知度。为了在这项工作的基础上再接再厉，Retain Health，Inc.开发了一个跨平台的“移动- 第一次申请降低AD风险。Retory是一种数字治疗工具，旨在评估 个人和应用行为修改技术，以提供基于证据的、个性化的 建议。我们的系统促进饮食、体育锻炼、睡眠、社交等方面的行为改变 参与、认知参与、血管危险因素(例如，血压)、肥胖、戒烟、 和压力管理。Retain使用双向短信短信来创建虚拟对话。AS 96%的美国人拥有手机，自动短信通信可以经济高效地服务于缺乏 获得大规模护理的机会。重要的是，Retain建立在我们之前7年的研究基础上，使用基于Web的 与学术界合作开展教育，奠定了实质性的基础。 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 风险指数。我们还将探索在改善认知和生活质量方面的有效性。然后，我们将评估 降低风险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 一项为期六个月的基于网络的三臂随机对照试验，有860名AD风险受试者参加。一如既往 在我们之前的研究中，我们将使用有针对性的网络广告来快速和经济地招聘 这是一个多元化的群体。ARM 1将包括个性化的、基于网络的AD风险因素教育以及常规 个性化双向短信短信交流。ARM 2将包括个性化的基于网络的AD风险因素 教育没有个性化的短信文本。ARM 3(控制)将包括全面的AD教育，包括 统计、公共政策和护理，以及关于这些主题的定期短信交流。 该项目的成功实施将带来第一个自动化数字解决方案，以提供 针对AD高危人群的多域个性化管理。这也将导致一种产品准备就绪 市场和解决国家阿尔茨海默氏症项目法的目标，到2025年预防和有效治疗阿尔茨海默病。