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.

补充项目总结：母研究（1 R41 AG 069596 - 01 A1）正在进行原型设计并进行初始研究 一种新型可穿戴式监测系统的用户测试。我们称之为昼夜活动的系统 痴呆症管理分析系统（CAPS）（CAPS-DM）旨在评估24小时行为 痴呆症患者及其家庭照顾者的节律紊乱。CAPS的一个用途是个性化/ 为受阿尔茨海默病和相关痴呆症影响的家庭提供适应性的行为干预措施 （ADRD）。家长奖旨在（1）准备CAPS原型供ADRD家庭使用;以及（2） 评价用户依从性/使用的潜在健康影响。虽然我们正在完成这个范围（尽管 延迟，见上文），用户测试成功的可能性将大大增加， 直接应对COVID-19疫情带来的两大挑战。这两个意想不到的 挑战是这个补充奖的目的。我们建议目标1将我们的CAPS试验过渡到 远程/虚拟/在线进行。完成切换到所有远程研究管理的过程 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环境下成功注册（增加我们的覆盖范围和参与者筛选数量）;以及 (2)提高应用程序“独立”的能力（即，对ADRD家庭有用，而无需实质性的援助， 现场/电话用户支持）。为了能够进行远程研究，我们建议将本补充文件用于： 促进在线招聘;增加在线研究评估;并使CAPS应用程序 仅通过加强设置和教育材料。第二个挑战/目标2 补充是为了解决我们的悬而未决的问题有关雇用一个兼职软件工程师与 非常多样化的技能软件工程师的市场竞争越来越激烈， 在COVID-19疫情期间，各行业的服务增加。父母奖包括适度的 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。这种补充剂 该奖项将通过以下方式提高我们雇用合格软件开发支持的能力：（1）与 信息技术人员配置服务;以及（2）将开发工作重新分配给两名兼职开发人员， 从而不再要求候选人具有不同工作领域（设计和服务器/数据库）的技能 分析）。总之，这一补充奖励将增加母项目被 通过确保我们能够招募ADRD用户测试人员样本，提高他们的用户- 与现代软件应用程序相媲美的经验;以及修改我们开放式SBC的职位描述 开发人员的位置，加上使用人员配置服务，以确保现实和及时的人员配置。

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。

• DOI: 10.1093/sleep/zsab288
• 发表时间: 2022
• 期刊: Sleep
• 影响因子: 5.6
• 作者: Smagula,StephenF;Stahl,SarahT;Krafty,RobertT;Buysse,DanielJ
• 通讯作者: Buysse,DanielJ