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Self-Care Training for Dementia Caregivers (Care2 Trial)

N/A
Recruiting
Led By Sarah T Stahl, PhD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
50 years old or older
Be older than 18 years old
Must not have
Under 50 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4.5 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will develop and evaluate a behavioral intervention to help caregivers of family members with Alzheimer's disease or related dementias improve their sleep, exercise, and social activities.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
There are no direct medical side effects as this is not a drug trial; however, participants may experience increased awareness of personal habits which could lead to temporary emotional discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 50 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am younger than 50 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4.5 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4.5 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in Caregiver Burden throughout research study
Secondary study objectives
Change from baseline in anxiety symptoms throughout research study
Change from baseline in depressive symptoms throughout research study

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Caregiver InterventionExperimental Treatment1 Intervention
Behavioral self-monitoring of sleep and activity up to 6 weeks, using the myRhythmWatch app, and motivational health coaching.

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,776 Previous Clinical Trials
16,353,375 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,774 Previous Clinical Trials
28,185,505 Total Patients Enrolled
Sarah T Stahl, PhDPrincipal InvestigatorUniversity of Pittsburgh, Assistant Professor of Psychiatry and Clinical and Translational Science

Media Library

Behavioral Self-Monitoring + Motivational Interviewing Clinical Trial Eligibility Overview. Trial Name: NCT05309577 — N/A
Circadian Rhythm Disorder Research Study Groups: Caregiver Intervention
Circadian Rhythm Disorder Clinical Trial 2023: Behavioral Self-Monitoring + Motivational Interviewing Highlights & Side Effects. Trial Name: NCT05309577 — N/A
Behavioral Self-Monitoring + Motivational Interviewing 2023 Treatment Timeline for Medical Study. Trial Name: NCT05309577 — N/A
~0 spots leftby Nov 2024
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