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NCT04603482 | COMPLETED | Stress


Dementia Caregiver Career Study
Sponsor:

Case Western Reserve University

Information provided by (Responsible Party):

Jaclene A. Zauszniewski

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).

Condition or disease

Stress

Carer Stress Syndrome

Dementia

Alzheimer's Disease

Bereavement

Intervention/treatment

Resourcefulness Training

Biofeedback Training

Diversional Activites

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 328 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : Self-Management Interventions: Considering Needs & Preferences of Dementia Caregivers
Actual Study Start Date : 2021-01-08
Estimated Primary Completion Date : 2024-06-30
Estimated Study Completion Date : 2024-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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

Dementia Caregiver Career Study

Location Details

NCT04603482


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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

United States, Ohio

CWRU School of Nursing

Cleveland, Ohio, United States, 44106

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