Clinical trial NCT04247347: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Carer Stress Syndrome
Dementia
Alzheimer Disease
Keywords: Caregiver
Biofeedback
Resourcefulness
Self-Management
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

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

Primary outcomes:
measure: Change in Global Health - PROMIS (Patient Reported Outcomes Measurement Information System)
timeFrame: From T1 (baseline) through T2 (30 days post-intervention)
measure: Change in Health Risk Behavior Scale
timeFrame: From T1 (baseline) through T2 (30 days post-intervention)
Secondary outcomes:
measure: Change in Dementia Knowledge Assessment Scale
timeFrame: From T1 (baseline) through T2 (30 days post-intervention)
measure: Change in Heart Rate Variability
timeFrame: From T1 (baseline) through T2 (30 days post-intervention)
measure: Change in Resourcefulness Scale
timeFrame: From T1 (baseline) through T2 (30 days post-intervention)
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
Study officials:
affiliation: Case Western Reserve University - Frances Payne Bolton School of Nursing
name: Jaclene A Zauszniewski, PhD
role: PRINCIPAL_INVESTIGATOR
References: