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

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.PROJECT NARRATIVE: Circadian Activity Rhythm (CAR) disruption is highly prevalent in people with dementia, lowering quality of life for patients and caregivers alike. This proposal is to develop, validate, and perform user-acceptability testing of the world’s first, user-friendly, wearable system for assessing and monitoring CARs. If successful, this project will set the stage for a clinical trial testing a new digital tool that allows providers to precisely target and tailor circadian-based interventions to reduce the adverse effects of circadian disruption in families affected by dementia.