Tailored Health Self-Management Interventions for Highly Distressed Caregivers: Family Members of Persons With Dementia
Primary Purpose
Stress, Carer Stress Syndrome, Dementia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biofeedback Training
Dementia Education
Resourcefulness Training
Sponsored by
About this trial
This is an interventional treatment trial for Stress focused on measuring Caregiver, Biofeedback, Resourcefulness, Self-Management
Eligibility Criteria
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
Sites / Locations
- Case Western Reserve University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Self-Management
Usual Care
Arm Description
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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
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
Change in Heart Rate Variability
Change in Heart Rate Variability: time-domain parameters and frequency domain parameters are combined into a single index score
Change in Resourcefulness Scale
Measure of Resourcefulness: 28 items; 6-point scale; Scores range 0-140; higher score indicates more resourcefulness
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
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
Full Information
NCT ID
NCT04247347
First Posted
January 24, 2020
Last Updated
July 18, 2022
Sponsor
Case Western Reserve University
1. Study Identification
Unique Protocol Identification Number
NCT04247347
Brief Title
Tailored Health Self-Management Interventions for Highly Distressed Caregivers: Family Members of Persons With Dementia
Official Title
Tailored Health Self-Management Interventions for Highly Distressed Caregivers: Family Members of Persons With Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
August 29, 2019 (Actual)
Primary Completion Date
June 21, 2022 (Actual)
Study Completion Date
June 21, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Case Western Reserve University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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:
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;
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Carer Stress Syndrome, Dementia, Alzheimer Disease
Keywords
Caregiver, Biofeedback, Resourcefulness, Self-Management
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
311 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Self-Management
Arm Type
Experimental
Arm Title
Usual Care
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Biofeedback Training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Dementia Education
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Resourcefulness Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Global Health - PROMIS (Patient Reported Outcomes Measurement Information System)
Description
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
Time Frame
From T1 (baseline) through T2 (30 days post-intervention)
Title
Change in Health Risk Behavior Scale
Description
Measure of Caregiving Health Risks: 9 items; 3-point scale, Scores range 9-27; higher score indicates greater risk
Time Frame
From T1 (baseline) through T2 (30 days post-intervention)
Secondary Outcome Measure Information:
Title
Change in Involvement Evaluation Questionnaire
Description
Measure of Caregiving Involvement:31 items; four subscales (5-point scale); Scores range 0-124; higher score indicates more involvement
Time Frame
From T1 (baseline) through T2 (30 days post-intervention)
Title
Change in Dementia Knowledge Assessment Scale
Description
Measure of Dementia Knowledge: 25 items; true-false (5-point scale); Scores range 25-125; higher score indicates better knowledge
Time Frame
From T1 (baseline) through T2 (30 days post-intervention)
Title
Change in Heart Rate Variability
Description
Change in Heart Rate Variability: time-domain parameters and frequency domain parameters are combined into a single index score
Time Frame
From T1 (baseline) through T2 (30 days post-intervention)
Title
Change in Resourcefulness Scale
Description
Measure of Resourcefulness: 28 items; 6-point scale; Scores range 0-140; higher score indicates more resourcefulness
Time Frame
From T1 (baseline) through T2 (30 days post-intervention)
Title
Change in Care Recipient Dementia Symptoms / Behaviors
Description
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
Time Frame
From T1 (baseline) through T2 (30 days post-intervention)
Title
Change in Caregiver Reactions
Description
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
Time Frame
From T1 (baseline) through T2 (30 days post-intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Tailored Health Self-Management Interventions for Highly Distressed Caregivers: Family Members of Persons With Dementia
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