Self-Care for Dementia Caregivers

NCT ID: NCT05309577

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-07
• Study Completion Date: 2025-03-10

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 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.

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, up to 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 circadian 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. Initially our plan was to focus an intervention on promoting self-care and reducing caregiving burden. However, in designing the trial, we switched the focus to the circadian-informed, behavioral activation-based approach that aimed to improve sleep and mood in caregivers. Therefore, the two main outcomes of interest were measures of depression symptom severity and insomnia symptom severity.

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

Conditions

Aging; Mental Disorder; Eating, Healthy; Physical Inactivity; Prodromal Symptoms; Sleep; Alzheimer Disease; Dementia; Circadian Rhythm Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Caregiver Intervention

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

Group Type: EXPERIMENTAL

Behavioral Self-Monitoring + Motivational Interviewing

Intervention Type: BEHAVIORAL

Participants (n=20) will wear a iWatch to continuously measure their objective sleep-wake activity. The iWatch data sync to the new myRhythmWatch app, where participants will monitor their behavioral rhythm. Participants will also interact with a 'health coach' about their recorded behaviors weekly. This health coach will use motivational interviewing to enhance older adult caregivers' confidence and intrinsic motivation to engage in regular self-care.

Interventions

Behavioral Self-Monitoring + Motivational Interviewing

Participants (n=20) will wear a iWatch to continuously measure their objective sleep-wake activity. The iWatch data sync to the new myRhythmWatch app, where participants will monitor their behavioral rhythm. Participants will also interact with a 'health coach' about their recorded behaviors weekly. This health coach will use motivational interviewing to enhance older adult caregivers' confidence and intrinsic motivation to engage in regular self-care.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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

• 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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Activity Rhythm Solutions Corporation

UNKNOWN

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Sarah T. Stahl, PhD

Associate Professor of Psychiatry and Clinical and Assistant Professor of Translational Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sarah T Stahl, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

P30AG024978

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R41AG069596

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY21060122

Identifier Type: -

Identifier Source: org_study_id