N/A
N=85
Tailored Health Self-Management Interventions for Highly Distressed Caregivers: Family Members of Persons With Dementia
Stress · Carer Stress Syndrome · Dementia · Alzheimer Disease
Bottom Line
View on ClinicalTrials.gov: NCT04247347 ↗Enrolled (actual)
85
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Change in Global Health - PROMIS (Patient Reported Outcomes Measurement Information System) — 27.23; 27.13; 27.52; 27.23 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Biofeedback Training (Behavioral); Dementia Education (Other); Resourcefulness Training (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Case Western Reserve University
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Global Health - PROMIS (Patient Reported Outcomes Measurement Information System) |
27.23; 27.13; 27.52; 27.23; 28.63; 28.20 | — |
| PRIMARY Change in Health Risk Behavior Scale |
15.9; 14.74; 14.58; 14.80; 15.33; 14.52 | — |
| SECONDARY Change in Dementia Knowledge Assessment Scale |
31.71; 28.96; 33.52; 33.04; 32.25; 36.28 | — |
| SECONDARY Change in Heart Rate Variability |
70.60; 86.67; 79.03; 55.81; 43.85; 54.53 | — |
| SECONDARY Change in Resourcefulness Scale |
91.81; 87.67; 97.20; 93.81; 91.08; 95.68 | — |
Summary
How do different health self-management interventions (resourcefulness training or biofeedback training) compare to usual care (dementia education) in affecting the health risks, and physical and mental health, of family caregivers of people with dementia? And, how do those health outcomes compare with similar measures for family caregivers of people with bipolar disorder? This one-year supplement study will exam these two aims as part of a larger four-year parent grant (NCT03023332). Caregivers enrolled in the study will be randomized to one of the three self-management interventions, with two data collections time points pre- and post-intervention.
Eligibility Criteria
Inclusion Criteria
- At least 18 years old
- Have a living family member 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 for at least the last 6 months. Caregivers whose family member lives within a facility: must report visiting their care recipient at least once per week for at least the last 6 months.
- Be capable of performing informed consent and participating in study procedures
Exclusion Criteria
- Does not have family member with Alzheimer's disease or another dementia
- Has not cared for a living family member for at least the last 6 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 (NCT04247347). 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.