Clinical trial NCT05309577: Self-Care for Dementia Caregivers
Official title: Self-Care for Dementia Caregivers Using the myRhythmWatch
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Activity Rhythm Solutions Corporation
name: Oregon Health and Science University
First posted: 2022-04-04
Enrollment: 21
Sex: ALL
Minimum age (years): 50
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

Eligibility criteria: Eligibility criteria for ADRD patients are: 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.

Eligibility criteria for ADRD caregivers are: 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.

Participants of this study may enroll as care givers or recipient-caregiver dyads.

Exclusion criteria for ADRD patients are: 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 caregivers are: 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.

Primary outcomes:
measure: Change from baseline in Caregiver Burden throughout research study
timeFrame: Up to 6 weeks
Secondary outcomes:
measure: Change from baseline in depressive symptoms throughout research study
timeFrame: Up to 6 weeks
measure: Change from baseline in anxiety symptoms throughout research study
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh, Assistant Professor of Psychiatry and Clinical and Translational Science
name: Sarah T Stahl, PhD
role: PRINCIPAL_INVESTIGATOR
References: