N/A
N=21
Self-Care for Dementia Caregivers
Aging · Mental Disorder · Eating, Healthy · Physical Inactivity · Prodromal Symptoms
Bottom Line
View on ClinicalTrials.gov: NCT05309577 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Pre/Post Change in Depressive Symptoms — 2.27 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Behavioral Self-Monitoring + Motivational Interviewing (Behavioral)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pre/Post Change in Depressive Symptoms |
2.27 | — |
| PRIMARY Pre/Post Change in Insomnia Symptoms |
5.64 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05309577). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.