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

Case Western Reserve University

Status: Completed

Conditions: Alzheimer's Disease; Bereavement; Carer Stress Syndrome; Dementia; Stress

Treatments: Behavioral: Attention Control; Behavioral: Biofeedback; Behavioral: Resourcefulness training

Study type: Interventional

Funder types: Other

Identifiers

NCT04603482

R01NR018476

Details and patient eligibility

About

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).

Full 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.

Enrollment: 328 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• At least 18 years old
• Have a living family member or a recently deceased family member diagnosed 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, and have entered that role within the past twelve months; Care Partners whose family member moved into a nursing or assisted living facility within the past twelve months, and must report visiting their care recipient at least once per week; Caretakers (i.e. bereaved) whose family member is deceased within the past twelve months, and are persons with direct oversight of the deceased person's belongings, estate, finances, etc.
• Be capable of performing informed consent and participating in study procedures

Exclusion criteria

• Does not have a family member with Alzheimer's disease or another dementia
• Has not cared for a living family member with dementia within the last 12 months, or the family member has been deceased for more than 12 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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328 participants in 3 patient groups, including a placebo group

Self-management intervention based on Need

Active Comparator group

Description:

Participants randomly assigned to this arm receive a self-management intervention (Resourcefulness Training or Biofeedback) according to baseline data.

Treatment:

Behavioral: Resourcefulness training

Behavioral: Biofeedback

Self-management intervention based on Preference

Active Comparator group

Description:

Participants randomly assigned to this arm receive a self-management intervention (Resourcefulness Training or Biofeedback) according to their preference.

Treatment:

Behavioral: Resourcefulness training

Behavioral: Biofeedback

Attention Control: Diversonal Activities

Placebo Comparator group

Description:

Participants randomly assigned to this arm will be presented with diversional activities.

Treatment:

Behavioral: Attention Control