Self-Care for Dementia Caregivers (Care2)

University of Pittsburgh

Status

Completed

Conditions

Aging

Eating, Healthy

Alzheimer Disease

Physical Inactivity

Mental Disorder

Prodromal Symptoms

Circadian Rhythm Disorders

Dementia

Sleep

Treatments

Behavioral: Behavioral Self-Monitoring + Motivational Interviewing

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT05309577

R41AG069596 (U.S. NIH Grant/Contract)

STUDY21060122

P30AG024978 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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

Enrollment

21 patients

Sex

All

Ages

50 to 99 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria for ADRD patients include:

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

Inclusion criteria for ADRD caregivers include:

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 for ADRD patients include:

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

Exclusion criteria for ADRD caregivers include:

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.