Tailored Health Self-Management Interventions for Highly Distressed Caregivers: Family Members of Persons With Dementia

How do different health self-management interventions (resourcefulness training or biofeedback training) compare to usual care (dementia education) in affecting the health risks, and physical and mental health, of family caregivers of people with dementia? And, how do those health outcomes compare with similar measures for family caregivers of people with bipolar disorder? This one-year supplement study will exam these two aims as part of a larger four-year parent grant (NCT03023332). Caregivers enrolled in the study will be randomized to one of the three self-management interventions, with two data collections time points pre- and post-intervention.

Study Overview

• Status: Completed
• Conditions: Carer Stress Syndrome; Stress; Dementia; Alzheimer Disease
• Intervention / Treatment: Behavioral: Biofeedback Training; Behavioral: Resourcefulness Training; Other: Dementia Education

Detailed Description

With every passing minute, a family member in the United States becomes an informal caregiver for an elder with Alzheimer's disease or another related dementia, which can be highly distressing and adversely affect the caregiver's mental and physical health. Similar to caregivers of persons with bipolar disorder, who are currently participating in the parent study for which this supplement is proposed, caregivers of persons with Alzheimer's or related dementia have been found to experience greater distress than caregivers of persons with other chronic conditions. They have significantly more mental and physical health problems than the general population, leading to greater use of mental health and primary care services and resulting in their inability to continue to provide care for their family members. Thus, although the trajectories of the two conditions (bipolar disorder versus dementia) may differ, we propose that caregivers of persons with dementia may benefit similarly from tailored health self-management interventions, including resourcefulness skills or biofeedback training, more than the educational materials or programs they are typically offered. Therefore, the caregivers of persons with Alzheimer's disease or related dementia to be sampled in this administrative supplement will comprise an additional study arm for the randomized controlled trial constituting the parent study. They will be randomized to: 1) usual care (education program), 2) resourcefulness training, or 3) biofeedback. Three outcomes (health risk, mental health, and physical health) will be assessed at baseline and post-intervention.

Study aims are to:

1. Examine the effectiveness of resourcefulness training and biofeedback versus usual care (education program) in family caregivers of persons with Alzheimer's disease or related dementia;
2. Compare the effects of usual care, resourcefulness training, and biofeedback obtained in caregivers of persons with dementia with those of the caregivers of persons with bipolar disorder from the parent study; and
3. Explore differences between the two types of caregivers on their needs (determined by their lowest baseline cut score on measures of knowledge, resourcefulness, and heart rate variability) and preferences (determined by asking which intervention they would have chosen) among education, resourcefulness training, or biofeedback.

Repeated measures analyses and descriptive statistics will address the study aims. Our findings will generate new scientific knowledge about the effectiveness of novel, easy to use, independently performed interventions that can be individualized and self-tailored to promote the health of Alzheimer's caregivers and other comparably distressed family caregivers.

• Study Type: Interventional
• Enrollment (Actual): 311
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Case Western Reserve University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• At least 18 years old
• Have a living family member with Alzheimer's disease or another dementia
• Identify self as a primary caregiver
• In-home caregivers: must be currently providing a minimum of 4 hours per day of supervision/direct care for at least the last 6 months. Caregivers whose family member lives within a facility: must report visiting their care recipient at least once per week for at least the last 6 months.
• Be capable of performing informed consent and participating in study procedures

Exclusion Criteria:

• Does not have family member with Alzheimer's disease or another dementia
• Has not cared for a living family member for at least the last 6 months.
• Has knowledge of another family member in the same household enrolled in the study
• Currently pregnant
• Has a pacemaker
• Lives outside of the study area

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Usual Care	Other: Dementia Education; An educational program designed to teach family caregivers about the characteristics, types, causes, and risk factors of dementia, as well as teach about health promotion, the stages of dementia, behavior changes, communicating with a family member with dementia, and caring for oneself. The content to be presented within an audiovisual format using a tablet computer follows recommendations and guidelines developed through research and by the Alzheimer's Association and the National Institute on Aging.
EXPERIMENTAL: Self-Management	Behavioral: Biofeedback Training; Use of a heart-rate variability (HRV) tracking device to enable one to learn to alter physiology to improve health. Devices are used to measure physiological activity, e.g., breathing and heart function, and provide rapid, accurate "feedback" to the user, thereby enabling desired physiological changes that can endure over time without continued use of the device and to continue to influence behavior.; Behavioral: Resourcefulness Training; A cognitive-behavioral intervention presented within an audiovisual format using a tablet computer that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Global Health - PROMIS (Patient Reported Outcomes Measurement Information System)	Measure of Caregiver's Global Health: 5 items - physical health; 5 items - mental health; 5-point scale; Scores range 0-40; higher score indicates better health	From T1 (baseline) through T2 (30 days post-intervention)
Change in Health Risk Behavior Scale	Measure of Caregiving Health Risks: 9 items; 3-point scale, Scores range 9-27; higher score indicates greater risk	From T1 (baseline) through T2 (30 days post-intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Involvement Evaluation Questionnaire	Measure of Caregiving Involvement:31 items; four subscales (5-point scale); Scores range 0-124; higher score indicates more involvement	From T1 (baseline) through T2 (30 days post-intervention)
Change in Dementia Knowledge Assessment Scale	Measure of Dementia Knowledge: 25 items; true-false (5-point scale); Scores range 25-125; higher score indicates better knowledge	From T1 (baseline) through T2 (30 days post-intervention)
Change in Heart Rate Variability	Change in Heart Rate Variability: time-domain parameters and frequency domain parameters are combined into a single index score	From T1 (baseline) through T2 (30 days post-intervention)
Change in Resourcefulness Scale	Measure of Resourcefulness: 28 items; 6-point scale; Scores range 0-140; higher score indicates more resourcefulness	From T1 (baseline) through T2 (30 days post-intervention)
Change in Care Recipient Dementia Symptoms / Behaviors	Measure of Revised Memory and Behaviors Checklist: 24 items; subscale measuring frequency (5-point scale) of behaviors; Scores range 0-120; higher score indicates more symptoms / behaviors	From T1 (baseline) through T2 (30 days post-intervention)
Change in Caregiver Reactions	Measure of Revised Memory and Behaviors Checklist: 24 items; subscale measuring reaction (5-point scale) of behaviors; Scores range 0-120; higher score indicates greater reaction	From T1 (baseline) through T2 (30 days post-intervention)

Collaborators and Investigators

• Sponsor: Case Western Reserve University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 29, 2019
• Primary Completion (ACTUAL): June 21, 2022
• Study Completion (ACTUAL): June 21, 2022

Study Registration Dates

• First Submitted: January 24, 2020
• First Submitted That Met QC Criteria: January 28, 2020
• First Posted (ACTUAL): January 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Caregiver; Self-Management; Biofeedback; Resourcefulness
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Dementia; Alzheimer Disease
• Other Study ID Numbers: 3R01NR01S817-04S1

Drug and device information, study documents

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