Self-Care for Dementia Caregivers: User-Centered Design

Sponsor

University of Pittsburgh (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05309577

Collaborator

National Institute on Aging (NIA) (NIH)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The Self-Care for Dementia Caregivers research study is a pilot randomized control trial (RCT) to develop and evaluate the feasibility of a behavioral intervention that uses technology and motivational health coaching to optimize caregivers' sleep, exercise, and social activities. Caregivers of family members with Alzheimer's Disease (AD) and AD-related dementias often experience disruptions of their biological or behavioral time cues, placing them at higher risk for adverse health outcomes. The investigators hypothesize that targeting the stability of sleep, exercise, and social activities will improve stability of the biological clock, improve caregiver health and wellbeing, and improve their ability to provide care.

Condition or Disease	Intervention/Treatment	Phase
Aging Mental Disorder Eating, Healthy Physical Inactivity Prodromal Symptoms Sleep Alzheimer Disease Dementia Circadian Rhythm Disorders	Behavioral: Behavioral Self-Monitoring + Motivational Interviewing Behavioral: Enhanced Usual Care	N/A

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. 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 be randomly assigned to 6 weeks of the caregiver intervention or enhanced usual care arm. Objective actigraphic measures of the 24-hour pattern of sleep and daytime activity - known as the rest-activity rhythm (RAR) - will be measured for 7 days at the start and end of the assigned intervention procedures 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 Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Optimizing Dementia Caregivers' Biological Clock Through Lifestyle Change

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Caregiver Intervention Behavioral self-monitoring of daily physical activity, dietary, and sleep behaviors for 6 weeks, into an electronic tablet or device; and behavioral self monitoring + motivational interviewing health coaching.	Behavioral: Behavioral Self-Monitoring + Motivational Interviewing Participants randomized to the self-monitoring arm (n=10) will record the timing of sleep, social activities and exercise twice daily using a diary-like Qualtrics website, for 6 weeks. The steps of behavioral self-monitoring include: (1) selecting a goal, (2) paying attention to some aspect of behavior, and (3) recording some details of that behavior in a daily diary. 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.
Active Comparator: Enhanced Usual Care Participants randomized to this condition will receive the written education provided to all participants, along with weekly check-in calls.	Behavioral: Enhanced Usual Care In the enhanced usual care group (n=10), participants will be provided with the same educational information as the caregiver intervention arm, but without the tailored advice, motivational health coaching, or digital feedback (e.g. Qualtrics website/daily diary; lifestyle log) that participants in the caregiver intervention arm will receive. Enhanced usual care participants will have the same assessment schedule as caregiver intervention participants. They will also receive weekly calls from a staff member.

Arm

Intervention/Treatment

Active Comparator: Caregiver Intervention

Behavioral self-monitoring of daily physical activity, dietary, and sleep behaviors for 6 weeks, into an electronic tablet or device; and behavioral self monitoring + motivational interviewing health coaching.

Behavioral: Behavioral Self-Monitoring + Motivational Interviewing

Participants randomized to the self-monitoring arm (n=10) will record the timing of sleep, social activities and exercise twice daily using a diary-like Qualtrics website, for 6 weeks. The steps of behavioral self-monitoring include: (1) selecting a goal, (2) paying attention to some aspect of behavior, and (3) recording some details of that behavior in a daily diary. 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.

Active Comparator: Enhanced Usual Care

Participants randomized to this condition will receive the written education provided to all participants, along with weekly check-in calls.

Behavioral: Enhanced Usual Care

In the enhanced usual care group (n=10), participants will be provided with the same educational information as the caregiver intervention arm, but without the tailored advice, motivational health coaching, or digital feedback (e.g. Qualtrics website/daily diary; lifestyle log) that participants in the caregiver intervention arm will receive. Enhanced usual care participants will have the same assessment schedule as caregiver intervention participants. They will also receive weekly calls from a staff member.

Outcome Measures

Primary Outcome Measures

Change from baseline in Caregiver Burden throughout research study [Up to 4.5 months]
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.

Secondary Outcome Measures

Change from baseline in depressive symptoms throughout research study [Up to 4.5 months]
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.
Change from baseline in anxiety symptoms throughout research study [Up to 4.5 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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 > 3 on either the PHQ-2 or GAD-2 and/or score > 48 on the Zarit Burden Interview.)