CompletedNot Applicable

Self-Care for Dementia Caregivers

United States21 participantsStarted 2023-03-07

Plain-language 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.

Who can participate

Age range

50 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pre/Post Change in Depressive Symptoms

Timeframe: Up to 6 weeks

Pre/Post Change in Insomnia Symptoms

Timeframe: Up to 6 weeks

Trial details

NCT IDNCT05309577

SponsorUniversity of Pittsburgh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-01

Results submitted2025-11-20

View on ClinicalTrials.gov More Aging trials