N/A
N=310
Tailored Health Self-Management Interventions for Highly Distressed Family Caregivers
Distress · Caregiver
Bottom Line
View on ClinicalTrials.gov: NCT03023332 ↗Enrolled (actual)
310
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Change in Caregiver Health - Health Risks — 15.53; 14.65; 15.02; 14.80 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Resourcefulness Training (Behavioral); Biofeedback training (Behavioral); Bipolar Education (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Case Western Reserve University
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Caregiver Health - Health Risks |
15.53; 14.65; 15.02; 14.80; 14.84; 15.00 | — |
| PRIMARY Change in Global Health - PROMIS (Patient Reported Outcomes Measurement Information System) |
25.95; 27.77; 26.66; 27.54; 27.45; 27.4 | — |
| SECONDARY Change in Bipolar Knowledge Assessment Scale |
21.90; 22.58; 22.11; 21.48; 22.29; 21.85 | — |
| SECONDARY Change in Heart Rate Variability |
56.64; 50.41; 67.94; 57.07; 63.34; 59.53 | — |
| SECONDARY Change in Resourcefulness |
92.93; 92.78; 93.15; 94.83; 92.82; 93.81 | — |
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 bipolar disorder? Caregivers will be randomized to: 1) a control group (no intervention); 2) education (usual care); 3) self-management intervention based on need (SM-need); or 4) self-management intervention of their preference (SM-preference).
Eligibility Criteria
Inclusion Criteria
- English-speaking
- At least 18 years old
- Have a family member with bipolar disorder
- Have cared/supported them for at least the last 6 months in the last year
- Be capable of performing the informed consent and participate in interventions
Exclusion Criteria
- Does not have family member with bipolar disorder
- Has not cared for family member for at least 6 months in the last year
- Knowledge of another family member in the same household enrolled in the study
- Is pregnant
- Has a pacemaker
- Lives outside of the study area (Cuyahoga, Lake, Geauga, Portage, Summit, Medina, and Lorain counties)
Data sourced from ClinicalTrials.gov (NCT03023332). 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.