Self-Care for Dementia Caregivers Using the myRhythmWatch
Phase: NA
Conditions: Aging, Mental Disorder, Eating, Healthy, Physical Inactivity, Prodromal Symptoms, Sleep, Alzheimer Disease, Dementia, Circadian Rhythm Disorders
Sponsor: University of Pittsburgh

STUDY PROTOCOL 
ClinicalTrials.gov Identifier: NCT05309577 
Self-Care for Dementia Caregivers Using the myRhythmWatch 
Organization's Unique Protocol ID: STUDY21060122 
Study Type: Interventional 
11/21/2025 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PARTICIPANTS 
Participants enrolled as caregiver singletons or caregiver-care recipient dyads. Eligibility criteria 
for caregivers included 1) aged 50+ years; 2) being a primary caregiver for a patient with 
Alzheimer’s Disease (AD) or a related dementia (ADRD); 3) experiencing stress/strain related to 
caregiving; 4) the person being cared for had problems with sleep or keeping a consistent 
routine; 5) experiencing depression symptoms, defined as a score ≥5 on the PHQ-9; 6) living 
with their care recipient; and 7) being willing to try the app and participate in assessments and 
calls. Eligibility criteria for care recipients included 1) 60+ years; 2) having been diagnosed with 
Alzheimer’s disease, vascular dementia, mixed Alzheimer’s/vascular dementia, or 
frontotemporal dementia; 3) living with their caregiver; and 4) being willing to wear the watch 
and participate in assessments and calls. The requirement of at least mild depression symptoms 
was added after the study began, based on stakeholder feedback that the program worked was 
most appropriate for caregivers with at least some depression symptoms.  
 
PROCEDURES 
This single-arm pilot trial enrolled participants between March 2023 and April 2024 in 
Pittsburgh, PA. The University of Pittsburgh Institutional Review Board approved all procedures 
(STUDY21060122) and the trial was registered with ClinicalTrials.gov (NCT05309577). 
Participants were recruited from university-affiliated research registries (ctsi.pitt.edu) at the 
University of Pittsburgh. Participants provided electronic consent in REDCap. To include 
individuals representative of the population of PWD, we allowed individuals who did not have 
the capacity to give informed consent to enroll, provided they gave verbal assent and proxy 
consent signed by a legally authorized representative.  

 
After enrollment, participants received one-on-one technology training with a research staff 
person on wearing the Apple Watch and using the myRW app. Participants were provided a 
Apple Watch Series 8 and asked to wear it over the six-week trial, except when they were 
bathing/showering, when we asked them to charge the watch. As needed, we also followed up 
with participants two days after the technology training visit to troubleshoot any issues that 
arose. Eleven of the 15 caregivers also completed pre-
and post-treatment assessments and were included in the 
health outcome analysis.  
 
Intervention: The myRW system uses raw accelerometry 
data from the Apple Watch to compute standard RAR 
metrics which are displayed to users on their mobile 
phone (Figure 1). Therapists accessed information on 
participant’s RARs via a HIPPA-compliant clinician 
dashboard, which displayed participant’s RAR metric 
data and graphs including raw accelerometer data plots. 
Therapists used this information in six sessions, one per 
week, each lasting about 30-45 minutes. Caregivers 
facilitated sessions for themselves and for their care 
recipients, and when care recipients were involved, the 
sessions were approximately 60 minutes.  
 

In each session, therapists used the RAR monitoring results and motivational interviewing 
techniques to identify targets and plan activities, with the overall goal of adhering to 4 Rules for 
Healthy Rhythms: (1) get up at the same time every day; (2) engage in rewarding morning 
activity (preferably with exposure to sunlight and physical activity); (3) limit naps to less than 30 
minutes and ending before 4:00pm; and (4) maintain active periods of around 15-16 hours per 
day. In the first session, and as needed thereafter, therapists reviewed standardized educational 
materials about circadian rhythms. In subsequent sessions, therapists reviewed participant’s daily 
routine, progress/challenges with their activity plans, developed ideas about areas to target, and 
made future activity plans focused on optimizing rhythms.  
 
Feasibility and acceptability measures: Feasibility was assessed with process outcomes 
including the (1) proportion of users providing sufficient data for assessing RARs (i.e., ≥3 
consecutive valid days defined as days with at least 20 hours of data); (2) the total number of 
valid days of accelerometer data collected; and (3) the number of completed health coaching 
sessions. Acceptability was assessed with open-ended questions that asked participants to 
describe their likes and dislikes of the myRW app and intervention procedures. Participants also 
rated satisfaction with intervention components on a 5-point Likert scale, ranging from “very 
dissatisfied” (1) to “very satisfied” (5). Scores ≥4 indicate adequate levels of intervention 
acceptability. 
 
Mood and Sleep: 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 (described above) that aimed to 

improve sleep and mood in caregivers. Therefore the two main outcomes of interest were 
measures of (1) depression symptom severity assessed using the Patient-Health Questionnaire 
(PHQ-9)  and (2) insomnia symptom severity assessed using the Insomnia Severity Index (ISI).