Self-Care for Dementia Caregivers

Not Applicable

Completed

• Conditions: Aging; Eating, Healthy; Alzheimer Disease; Circadian Rhythm Disorders; Mental Disorder; Sleep; Dementia; Physical Inactivity; Prodromal Symptoms
• Interventions: Behavioral: Behavioral Self-Monitoring + Motivational Interviewing

• Registration Number: NCT05309577
• Lead Sponsor: University of Pittsburgh

Brief 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 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.

Detailed Description

Caregivers of family members with Alzheimer's Disease (AD) and AD-related dementias (ADRD) experience high rates of psychological stress, physical impairments, and often, disruptions in normal daily activities. Caregivers must be alert both at night and during the day, and often on an inconsistent schedule. As a result, caregivers are less likely to sleep, exercise, and be socially active on a regular schedule. Disruptions of these biological and behavioral time cues, or "zeitgebers", in turn decrease the stability of the body's biological clock, placing caregivers at high risk for adverse health outcomes related to an out-of-sync biological clock (e.g. diabetes, cardiovascular disease, and depression, among others). Caregivers of individuals with ADRD experience worse health outcomes compared with other types of caregivers, likely due to more heavily or frequently disrupted schedules.

For this research study, 25 individuals aged 50 and older who are providing care for a family member with mild-to-moderate dementia will be included. Data from 5 participants will be used for the development of an intervention manual (NIH Stage Model IA). A small pilot study will be conducted (NIH Stage Model IB) in which 20 participants will use a new mobile app - my rhythm watch - for up to 6 weeks. Objective actigraphic measures of the 24-hour pattern of sleep and daytime activity - known as the rest-activity rhythm (RAR) - will be measured continuously via the apple watch to evaluate circadian rhythms as a potential intervention target/mechanism of action. The investigators will measure the regularity, timing, and amplitude of behavioral patterns over a 24-hour period. Participants will be assessed at baseline, post-intervention, and 3-months post-intervention.

The study as described in the original registration (April 2022) never proceeded. The registration has been revised to reflect the study as modified after securing a technology partner (per funding requirements) and prior to study initiation

Study Timeline

• Study First Submitted: 2022-03-24
• Study First Submitted QC: 2022-03-24
• Study First Posted: 2022-04-04
• Study Start: 2023-03-07
• Primary Completion: 2024-12-01
• Status Verified: 2025-03
• Study Completion: 2025-03-10
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Caregiver Intervention	Behavioral Self-Monitoring + Motivational Interviewing	Behavioral self-monitoring of sleep and activity up to 6 weeks, using the myRhythmWatch app, and motivational health coaching.

Primary Outcome Measures

Name	Time	Method
Change from baseline in Caregiver Burden throughout research study	Up to 6 weeks	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. 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.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in depressive symptoms throughout research study	Up to 6 weeks	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. 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.
Change from baseline in anxiety symptoms throughout research study	Up to 6 weeks	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. 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.

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States