Self-Care Training for Dementia Caregivers

(Care2 Trial)

Overseen By Ada Lopaczynski, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Age, No ADRD diagnosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

21 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 self-care. 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 psychological distress and caregiver burden.

Who Is on the Research Team?

Sarah T Stahl, PhD

Principal Investigator

University of Pittsburgh, Assistant Professor of Psychiatry and Clinical and Translational Science

Are You a Good Fit for This Trial?

This trial is for family caregivers over 50 who provide at least 8 hours of care per week to a relative with dementia and live in the same household. They should be struggling with self-care, particularly sleep, exercise, or social activities, and have mild psychological distress. Those planning to institutionalize their loved one within a year or living in nursing homes cannot join.

Inclusion Criteria

I struggle with self-care activities like sleeping, exercising, or socializing.

I am a spouse, child, or considered family to the person needing care.

I am 50 years old or older.

Exclusion Criteria

Living in a nursing home

Does not live in the same household as the care recipient

I plan to place a loved one in a care facility within the next year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants use the myRhythmWatch app and receive motivational health coaching for self-care

6 weeks

Weekly health coaching calls

Follow-up

Participants are monitored for changes in depressive symptoms, anxiety symptoms, and caregiver burden

3 months

Post-intervention assessment and 3-month follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral Self-Monitoring + Motivational Interviewing
• Enhanced Usual Care

Trial Overview The study tests a behavioral health intervention combining digital monitoring via an Apple Watch app that tracks sleep-wake rhythms and weekly motivational calls from health coaches for six weeks. The aim is to help caregivers establish regular self-care routines to reduce stress and burden.

How Is the Trial Designed?

Group I: Caregiver Intervention Experimental Treatment 1 Intervention

Behavioral self-monitoring of sleep and activity up to 6 weeks, using the myRhythmWatch app, and motivational health coaching.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Activity Rhythm Solutions Corporation

Collaborator

Trials

1

Recruited

20+

Oregon Health and Science University

Collaborator

Trials

1,024

Recruited

7,420,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+