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

NCT04247347 | Completed Results DMC

• 1 other identifier: 3R01NR01S817-04S1
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stress; Carer Stress Syndrome; Dementia; Alzheimer Disease

Keywords

Caregiver; Biofeedback; Resourcefulness; Self-Management

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change in Dementia Knowledge Assessment Scale

  From T1 (baseline) through T2 (30 days post-intervention)

• Change in Heart Rate Variability

  From T1 (baseline) through T2 (30 days post-intervention)

• Change in Resourcefulness Scale

  From T1 (baseline) through T2 (30 days post-intervention)

Study Arms (3)

Resourcefulness Training

EXPERIMENTAL

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.

Behavioral: Resourcefulness Training

Dementia Education

ACTIVE COMPARATOR

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.

Other: Dementia Education

Biofeedback Training

EXPERIMENTAL

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: Biofeedback Training

Interventions

Biofeedback Training BEHAVIORAL

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.

Biofeedback Training

Dementia Education OTHER

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.

Dementia Education

Resourcefulness Training BEHAVIORAL

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.

Resourcefulness Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Western Reserve University: lead

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Dementia; Alzheimer Disease

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Jaclene Zauszniewski, PhD
• Organization: Case Western Reserve University

jaz@case.edu

216.368.3612

Study Officials

• Jaclene A Zauszniewski, PhD

  Case Western Reserve University - Frances Payne Bolton School of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 24, 2020
• First Posted: January 30, 2020
• Study Start: August 29, 2019
• Primary Completion: June 21, 2022
• Study Completion: June 21, 2022
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Locations

US (1)