N/A
N=308
Self-Management Intervention: Considering Needs & Preferences of Dementia Caregivers (Caregiver Career Study)
Stress · Carer Stress Syndrome · Dementia · Alzheimer's Disease · Bereavement
Bottom Line
View on ClinicalTrials.gov: NCT04603482 ↗Enrolled (actual)
308
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Change in Caregiver's Perceived Stress Scale — 19.73; 21.01; 19.84; 19.21 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Resourcefulness training (Behavioral); Biofeedback (Behavioral); Attention Control (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Case Western Reserve University
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Caregiver's Perceived Stress Scale |
19.73; 21.01; 19.84; 19.21; 17.34; 16.95 | — |
| PRIMARY Change in Caregiver's Negative Emotions Checklist |
6.80; 7.19; 6.19; 5.98; 5.97; 5.74 | — |
| PRIMARY Change in Caregiver's Depressive Cognitions Scales |
8.48; 10.22; 8.74; 10.00; 7.33; 7.4 | — |
| PRIMARY Change in Global Health - Physical Health: PROMIS (Patient Reported Outcomes Measurement Information System) |
14.80; 14.23; 14.10; 14.29; 14.67; 14.68 | — |
| PRIMARY Change in Caregiver Global Health - Mental Health: PROMIS (Patient Reported Outcomes Measurement Information System) |
12.31; 11.57; 12.44; 12.56; 12.90; 13.06 | — |
| PRIMARY Change in Caregiver's Health Risk Behavior Scale |
15.97; 16.67; 16.19; 15.89; 15.54; 15.10 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT04603482). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.