NCT04603482

Self-Management Intervention: Considering Needs & Preferences of Dementia Caregivers (Caregiver Career Study)

Self-Management Interventions: Considering Needs & Preferences of Dementia Caregivers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 328 (actual)
• Sponsor: Case Western Reserve University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

How do varying levels of participation in selecting self-management interventions (ranging from no input into the selection to selection based on need or preference) affect health risks and physical and mental health over time in family caregivers of persons with Alzheimer's and other dementia disorders? Caregivers will be randomized to 1) information on diversional activities (attention control); 2) self-management intervention based on need (SM-need); or 3) self-management intervention of their preference (SM-preference).

Detailed description

The study has two aims: The primary aim (A1) is to examine differences across the three groups (attention control, SM-need, and SM-preference) on caregiver health (health risks and mental and physical health) over time. The investigators hypothesize that the caregivers who receive a self-management intervention based on need (SM-need) or preference (SM-preference) will have better health outcomes than those in the attention control. Secondary aims are to: A2) explore whether caregiver baseline need or preference for intervention (i.e. choice) is associated with: a) care recipient's symptoms; b) caregiver reactions; and c) caregiving involvement, and A3) build caregiver profiles from demographic/ contextual factors that are associated with their needs and preferences for the self-management interventions. All caregivers will complete assessment measures and measures of health risks, and physical and mental health at baseline (T1), about 6 months (T2), and about 12 months (T3). Caregivers will be randomly assigned to one of three groups. The attention control group will receive information on diversional activities. The SM-need group will receive a self-management intervention for biofeedback training or resourcefulness training, as determined by baseline cut scores. Caregivers in the SM-preference group will choose one of the two self-management interventions according to their personal preference. Both self-management interventions (biofeedback training, resourcefulness training) and the diversional activities, are delivered over four weeks (between T1 and T2). Caregivers may use the intervention whenever and as often as they wish (i.e. self-tailoring) for the remainder of the study period. These resourcefulness training includes teaching self-help (stress-management, problem-solving) and help-seeking skills, respectively. Biofeedback training consists of the use of a hand-held device that shows the participant their changes in heart rate based on changes in their breathing pattern (as they relax); caregivers who need or prefer the biofeedback will be given a device to use for 28 days. All study participants receiving the intervention will also be asked to keep a journal to record their experience with the intervention.

Conditions

• Stress
• Carer Stress Syndrome
• Dementia
• Alzheimer's Disease
• Bereavement

Interventions

Type	Name	Description
BEHAVIORAL	Resourcefulness training	Resourcefulness training is a cognitive behavioral intervention that consists of teaching and reinforcing personal (self-help) and social (help-seeking) strategies to overcome adversity.
BEHAVIORAL	Biofeedback	Biofeedback training combines teaching slow, deep, paced breathing with real-time tracking to increase an individual's heart rate variability and ultimately improve self-regulation.
BEHAVIORAL	Attention Control	Participants randomly assigned to this intervention will receive suggested Diversional Activities, presented in an audiovisual format.

Timeline

• Start date: 2021-01-08
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2020-10-26
• Last updated: 2025-05-13
• Results posted: 2025-03-18

Locations

1 site across 1 country: United States