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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stress, Carer Stress Syndrome, Dementia, Alzheimer Disease

Intervention / Treatment
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* Behavioral: Biofeedback Training
* Other: Dementia Education
* Behavioral: Resourcefulness Training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-Management<br> | Behavioral: Biofeedback Training<br>* 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.<br>Behavioral: Resourcefulness Training<br>* 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.<br>|
| Active Comparator: Usual Care<br> | Other: Dementia Education<br>* 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.<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caregiver, Biofeedback, Resourcefulness, Self-Management