Self-Care for Dementia Caregivers (Care2)

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.

Study Overview

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

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.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emilee Croswell, BS; Phone Number: 412-440-8418; Email: Croswellej@upmc.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15260
      • Recruiting
      • University of Pittsburgh
      • Principal Investigator: Sarah T Stahl, PhD
      • Contact: Emilee Croswell, BS; Phone Number: 412-440-8418; Email: Croswellej@upmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Caregiver Intervention; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Sarah T Stahl, PhD, University of Pittsburgh, Assistant Professor of Psychiatry and Clinical and Translational Science

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2023
• Primary Completion (Estimated): February 28, 2024
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: March 24, 2022
• First Submitted That Met QC Criteria: March 24, 2022
• First Posted (Actual): April 4, 2022

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Dementia; Alzheimer Disease; Circadian Rhythm; Caregivers; Geriatrics; Self Care; Alzheimer Dementia; Carers; Twenty-Four Hour Rhythm
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Mental Disorders; Dementia; Alzheimer Disease; Prodromal Symptoms; Chronobiology Disorders
• Other Study ID Numbers: STUDY21090195; P30AG024978 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All individual participant data collected during the trial will be available, after de-identification.
• IPD Sharing Time Frame: Immediately following publication. No end date.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No