Developing a widely-useable wearable Circadian Profiling System to assess 24-hour behavioral rhythm disruption in people with dementia and their family caregivers

开发可广泛使用的可穿戴昼夜节律分析系统，以评估痴呆症患者及其家庭护理人员的 24 小时行为节律紊乱

• 批准号: 10612523
• 负责人: Stephen F Smagula
• 金额: $ 12.79万
• 依托单位: ACTIVITY RHYTHM SOLUTIONS CORPORATION
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-01 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10612523
• 关键词: Address; Adherence; Administrative Supplement; Adverse effects; Affect; Alzheimer' s disease related dementia; Area; Award; Behavior Therapy; Behavior monitoring; Behavioral; COVID-19; COVID-19 pandemic; Caregivers; Cause of Death; Cellular Phone; Circadian Dysregulation; Clinical Trials; Computer software; Contracts; Data; Databases; Dementia; Development; Educational Materials; Elderly; Employee; Enrollment; Ensure; Environment; Family; Family Caregiver; Financial compensation; Funding; Head; Health; Hour; Individual; Industry; Information Technology; Intervention; Investments; Job Description; Medical; Modernization; Monitor; Parents; Participant; Patients; Persons; Positioning Attribute; Process; Provider; Quality of life; Research; Research Institute; SARS-CoV-2 infection; Sampling; Services; Software Engineering; System; Telephone; Testing; Time; Virulent; Wages; Work; base; circadian; design; digital; experience; human subject; improved; multi-site trial; novel; operation; parent project; prototype; recruit; remote delivery; research study; skills; software development; success; tool; user-friendly; viral transmission; virtual; virtual platform; wearable sensor technology

Supplement Project Summary: The parent study (1R41AG069596-01A1) is prototyping and performing initial user testing of a novel wearable-based monitoring system. The system, which we call the Circadian Activity Profiling System (CAPS) for Dementia Management (CAPS-DM) is designed to assess 24-hour behavioral rhythm disruption in people with dementia and their family caregivers. One use of the CAPS is to personalize/ adaptively tailor behavioral interventions for families affected by Alzheimer’s Disease and Related Dementias (ADRDs). The parent award aims to (1) prepare the CAPS prototype for use by families with ADRDs; and (2) evaluate user adherence/potential health effects of use. While we are on track to complete this scope (albeit delayed, see above), the likelihood that user testing will be successful would be substantially increased by directly addressing two challenges that were brought on by the COVID-19 pandemic. These two unanticipated challenges are the aims of this supplement award. We propose Aim 1 to transition our trial of the CAPS to be conducted all remotely/virtually/online. Completing the process of switching to all remote study administration prior to this initial test among ADRD users will increase the likelihood of a successful user test by: (1) ensuring enrollment success in the COVID-19 environment (increase our reach and number of participant screens); and (2) improving the ability of the app to “standalone” (i.e., be useful to ADRD families without substantial aid from in-person/telephone user support). To enable an all remotely conducted study, we propose this supplement to: facilitate online-based recruitment; add online-based research assessments; and make the CAPS App stand- alone through enhancements to both set up and educational materials. The second challenge/Aim 2 of this supplement is to resolve our pending issue related to hiring a single part-time software engineer with an extremely diverse skill set. The market for software engineers has becoming increasing competitive as remote services increased across industries during the COVID-19 pandemic. The parent award included modest support for a part-time software developer, but not sufficient funds to hire a developer with the following unique skills: server-based database analytics and iPhone-based user interface/interaction design. This supplement award would increase our ability to hire qualified software development support by: (1) contracting with an Information Technology staffing service; and (2) re-allocating development work to two part-time developers, thereby no longer requiring the candidate to have skills in distinct work areas (design and server/database analytics). In summary, this supplement award would increase the likelihood that the parent project is successful by ensuring that we are able to recruit the sample of ADRD user-testers; enhancing their user- experience to be on-par with modern software application; and amending job descriptions for our open SBC developer position, plus using a staffing service, to ensure realistic and timely staffing.

补充项目摘要：母研究 (1R41AG069596-01A1) 正在制作原型并执行初步研究 用户测试一种新颖的基于可穿戴设备的监测系统，我们称之为昼夜节律活动。 痴呆症管理分析系统 (CAPS-DM) 旨在评估 24 小时行为 痴呆症患者及其家庭护理人员的节律紊乱是 CAPS 的一种用途。 为受阿尔茨海默病和相关痴呆症影响的家庭适应性定制行为干预措施 (ADRD) 家长奖旨在 (1) 准备 CAPS 原型供患有 ADRD 的家庭使用；以及 (2) 评估用户依从性/使用的潜在健康影响。 延迟，见上文），用户测试成功的可能性将大大增加 直接解决 COVID-19 大流行带来的两个意想不到的挑战。 我们提出的目标 1 将我们的 CAPS 试验转变为挑战。 完成所有远程/虚拟/在线学习管理的转换过程。 在 ADRD 用户中进行此初始测试之前，将通过以下方式增加用户测试成功的可能性：(1) 确保 在 COVID-19 环境中注册成功（扩大我们的覆盖范围和参与者屏幕数量）； (2) 提高应用程序“独立”的能力（即对没有大量援助的 ADRD 家庭有用） 面对面/电话用户支持）。为了实现所有远程进行的研究，我们建议此补充： 促进在线招聘；添加在线研究评估，并使 CAPS 应用程序站起来； 单独通过增强设置和教育材料来解决这个问题的第二个挑战/目标 2。 补充是为了解决我们与雇用一名兼职软件工程师相关的悬而未决的问题 随着远程技术的发展，软件工程师的市场竞争变得越来越激烈。 在 COVID-19 大流行期间，各行业的服务有所增加，其中包括适度的家长奖励。 支持兼职软件开发人员，但没有足够的资金聘请具有以下独特能力的开发人员 技能：基于服务器的数据库分析和基于 iPhone 的用户界面/交互设计本补充。 该奖项将通过以下方式提高我们聘请合格软件开发支持的能力：(1) 与 信息技术人员配备服务；以及 (2) 将开发工作重新分配给两名兼职开发人员， 不再要求候选人具备不同工作领域的技能（设计和服务器/数据库） 总之，该补充奖励将增加父项目的可能性。 通过确保我们能够招募 ADRD 用户测试人员样本来增强他们的用户能力，从而取得成功； 与现代软件应用程序相媲美的经验；并修改我们开放式 SBC 的职位描述 开发人员职位，加上人员配备服务，以确保现实和及时的人员配备。

项目成果

Initial proof of concept that a consumer wearable can be used for real-time rest-activity rhythm monitoring.

消费者可穿戴设备可用于实时休息活动节律监测的初步概念证明。

• 发表时间: 2022-03-14
• 影响因子: 5.6
• 作者: Smagula, Stephen F;Stahl, Sarah T;Krafty, Robert T;Buysse, Daniel J
• 通讯作者: Buysse, Daniel J