Self-Care for Dementia Caregivers

NCT05309577 | Completed Results

• 3 other identifiers: STUDY21060122P30AG024978R41AG069596
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Caregivers; Carers; Alzheimer Disease; Alzheimer Dementia; Dementia; Twenty-Four Hour Rhythm; Geriatrics; Self Care; Circadian Rhythm

Outcome Measures

Primary Outcomes (2)

• Pre/Post Change in Depressive Symptoms

  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.

  Up to 6 weeks

• Pre/Post Change in Insomnia Symptoms

  The 7-item Insomnia Severity Index (ISI) is a self-reported questionnaire to be completed by the participant that assesses severity of insomnia. The ISI will be administered throughout the study to assess changes in insomnia 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 28, indicating more severe impacts to patient health.

  Up to 6 weeks

Study Arms (1)

Caregiver Intervention

EXPERIMENTAL

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

Behavioral: Behavioral Self-Monitoring + Motivational Interviewing

Interventions

Behavioral Self-Monitoring + Motivational Interviewing 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.

Caregiver Intervention

Eligibility Criteria

• Age: 50 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute on Aging (NIA): collaborator
• Activity Rhythm Solutions Corporation: collaborator
• Oregon Health and Science University: collaborator
• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

MeSH Terms

Conditions

Mental Disorders; Sedentary Behavior; Prodromal Symptoms; Alzheimer Disease; Dementia; Chronobiology Disorders

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Limitations and Caveats

Due to cost restraints and the early phase nature of this study, we used a single-arm design. This precludes inference on the extent to which the observed health benefits were due to via real-time RAR monitoring, rather than other aspects of the intervention sessions, or non-specific therapeutic responses. Our sample consisted of adults willing/able to use digital technologies. Feasibility may be lower in adults with lower levels of technology literacy.

Results Point of Contact

• Title: Sarah T. Stahl, PhD
• Organization: University of Pittsburgh

sts80@pitt.edu

4122466003

Study Officials

• Sarah T Stahl, PhD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry and Clinical and Assistant Professor of Translational Science

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 4, 2022
• Study Start: March 7, 2023
• Primary Completion: December 1, 2024
• Study Completion: March 10, 2025
• Last Updated: January 23, 2026
• Results First Posted: January 23, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately following publication. No end date.
• Access Criteria: De-identified individual participant date will be available indefinitely following publication. It may be shared with researchers who provide a methodologically sound proposal for the purpose of achieving the aims in the approved proposal. Proposals should be directed to sts80@pitt.edu. Approved requestors will need to sign a data access management agreement.

Locations

US (1)