The Self-care for Dementia Caregivers Study is a behavioral health intervention that uses digital monitoring tools and motivational health coaching to help caregivers of persons with dementia engage in a regular routine of sleep and activity. Participants wear an apple watch for the objective collection of sleep-wake rhythms. They receive personalized feedback on their sleep-wake rhythms via a new app. Health coaches call participants weekly, for up to 6 weeks to help participants meet their health/sleep goals and promote self-knowledge of regular routines. Participants will help the study team improve the design elements and content of the mobile app. The goal of this intervention is to reduce depressive and insomnia symptoms.

Caregivers of family members with Alzheimer's Disease (AD) and AD-related dementias (ADRD) experience high rates of psychological stress, physical impairments, and often, disruptions in normal daily activities. Caregivers must be alert both at night and during the day, and often on an inconsistent schedule. As a result, caregivers are less likely to sleep, exercise, and be socially active on a regular schedule. Disruptions of these biological and behavioral time cues, or "zeitgebers", in turn decrease the stability of the body's biological clock, placing caregivers at high risk for adverse health outcomes related to an out-of-sync biological clock (e.g. diabetes, cardiovascular disease, and depression, among others). Caregivers of individuals with ADRD experience worse health outcomes compared with other types of caregivers, likely due to more heavily or frequently disrupted schedules.

For this research study, up to 25 individuals aged 50 and older who are providing care for a family member with mild-to-moderate dementia will be included. Data from 5 participants will be used for the development of an intervention manual (NIH Stage Model IA). A small pilot study will be conducted (NIH Stage Model IB) in which 20 participants will use a new mobile app - my rhythm watch - for up to 6 weeks. Objective actigraphic measures of the 24-hour pattern of sleep and daytime activity - known as the circadian rest-activity rhythm (RAR) - will be measured continuously via the apple watch to evaluate circadian rhythms as a potential intervention target/mechanism of action. The investigators will measure the regularity, timing, and amplitude of behavioral patterns over a 24-hour period. Participants will be assessed at baseline, post-intervention, and 3-months post-intervention. Initially our plan was to focus an intervention on promoting self-care and reducing caregiving burden. However, in designing the trial, we switched the focus to the circadian-informed, behavioral activation-based approach that aimed to improve sleep and mood in caregivers. Therefore, the two main outcomes of interest were measures of depression symptom severity and insomnia symptom severity.

The study as described in the original registration (April 2022) never proceeded. The registration has been revised to reflect the study as modified after securing a technology partner (per funding requirements) and prior to study initiation

Inclusion criteria for ADRD patients include:

• being ≥60 years
• having been diagnosed with Alzheimer's disease, vascular dementia, mixed Alzheimer's/vascular dementia, or frontotemporal dementia
• living with their caregiver
• being willing to wear the watch and participate in assessments and calls

Inclusion criteria for ADRD caregivers include:

• being a primary caregiver for an ADRD patient
• being ≥50 years
• experiencing stress/strain related to caregiving
• the person being cared for has problems with sleep or keeping a consistent routine
• scoring ≥5 on the PHQ-9 (experiencing depression symptoms)
• living with their care recipient
• being willing to try the app and participate in assessments and calls

Exclusion criteria for ADRD patients include:

• being less than 60 years
• not having a diagnosis of ADRD
• not living with their caregiver
• not being willing to wear the watch and participate in assessments and calls

Exclusion criteria for ADRD caregivers include:

• being less than 50 years
• not experiencing stress/strain related to caregiving
• the person being cared for does not have problems with sleep or keeping a consistent routine
• scoring <5 on the PHQ-9
• not living with their care recipient
• not being willing to try the app and participate in assessments and calls

Participants of this study may enroll as care givers or recipient-caregiver dyads.

All individual participant data collected during the trial will be available, after de-identification.

Immediately following publication. No end date.

De-identified individual participant date will be available indefinitely following publication. It may be shared with researchers who provide a methodologically sound proposal for the purpose of achieving the aims in the approved proposal. Proposals should be directed to sts80@pitt.edu. Approved requestors will need to sign a data access management agreement.

Health outcomes were based on data from 15 dementia caregivers

From enrollment until end of follow-up, up to 3 months

We monitored all caregivers (n=15) for self-reported adverse events (AEs) using an AE reporting form. AEs were subsequently rated for severity and their relationship to study participation and coded using the NIH categorization of adverse events.

Due to cost restraints and the early phase nature of this study, we used a single-arm design. This precludes inference on the extent to which the observed health benefits were due to via real-time RAR monitoring, rather than other aspects of the intervention sessions, or non-specific therapeutic responses. Our sample consisted of adults willing/able to use digital technologies. Feasibility may be lower in adults with lower levels of technology literacy.