Clinical trial NCT04603482: Self-Management Intervention: Considering Needs & Preferences of Dementia Caregivers (Caregiver Career Study)
Official title: Self-Management Interventions: Considering Needs & Preferences of Dementia Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Carer Stress Syndrome
Dementia
Alzheimer's Disease
Bereavement
Keywords: Caregiver
Biofeedback
Resourcefulness
Self-Management
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
First posted: 2020-10-26
Enrollment: 328
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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Caregiver's Perceived Stress Scale
timeFrame: From T1 (baseline) to T2 (6 months) through T3 (one year)
measure: Change in Caregiver's Negative Emotions Checklist
timeFrame: From T1 (baseline) to T2 (6 months) through T3 (one year)
measure: Change in Caregiver's Depressive Cognitions Scales
timeFrame: From T1 (baseline) to T2 (6 months) through T3 (one year)
measure: Change in Global Health - Physical Health: PROMIS (Patient Reported Outcomes Measurement Information System)
timeFrame: From T1 (baseline) to T2 (6 months) through T3 (one year)
measure: Change in Caregiver Global Health - Mental Health: PROMIS (Patient Reported Outcomes Measurement Information System)
timeFrame: From T1 (baseline) to T2 (6 months) through T3 (one year)
measure: Change in Caregiver's Health Risk Behavior Scale
timeFrame: From T1 (baseline) to T2 (6 months) through T3 (one year)
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: CWRU School of Nursing
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Jaclene A Zauszniewski, PhD
role: PRINCIPAL_INVESTIGATOR
References: