Alzheimer Disease Clinical Trial
— Care2Official title:
Self-Care for Dementia Caregivers
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 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.
Status | Recruiting |
Enrollment | 25 |
Est. completion date | November 1, 2024 |
Est. primary completion date | November 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years to 99 Years |
Eligibility | Inclusion Criteria: - 50 years old or older - family member of the care recipient (spouse, child, or fictive kin) - Provides at least 8 hours of care/ week - Lives in same household as the care recipient - Difficulty engaging in self-care practices including sleep, exercise, and/or social activity with others - Mild level of psychological distress (defined by a score > 5 on the PHQ-9) Exclusion Criteria: - Living in a nursing home - intent to institutionalize loved one in near future (12 months) - Under 50 years of age - Does not live in the same household as care recipient |
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | National Institute on Aging (NIA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in Caregiver Burden throughout research study | The Zarit Burden Interview is a self-reported questionnaire that assesses caregiver burnout. Caregiver Burden will be assessed throughout the study, namely pre- and post-intervention and at 3-month follow-up. A score of 0-10 indicates mild to no burden and a score of 20 or higher indicates a high level of burden, or worse result. | Up to 4.5 months | |
Secondary | Change from baseline in depressive symptoms throughout research study | The 9-item Patient Health Questionnaire (PHQ-9) scale is a self-reported questionnaire to be completed by the participant that assesses severity of depression. The PHQ-9 will be administered throughout the study to assess changes in depressive symptoms pre- and post-intervention, and at the 3-month follow-up visit. A minimum score on this metric is a 0, indicating no impact to patient health, and ranges up to a maximum score of 27, indicating more severe impacts to patient health. | Up to 4.5 months | |
Secondary | Change from baseline in anxiety symptoms throughout research study | The 7-item Generalized Anxiety Disorder Scale (GAD-7) will be administered throughout the study to assess changes in anxiety symptoms pre and post-intervention, and at 3-month follow-up visit. The whole scale score can range from 0 to 21, with severity increasing as values increase. The threshold of 5 or higher indicates mild anxiety symptoms, 10 or higher indicates moderate anxiety symptoms, and 15 or higher indicates severe anxiety symptoms. | Up to 4.5 months |
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