The Effects of a Psychoeducational Intervention on Stroke Family Caregiver Outcomes and the Use of Health and Social Services Among Stroke Survivors: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 128
- Locations
- 1
- Primary Endpoint
- Caregivers' change in depressive symptom severity from baseline
Study Overview
Brief Summary
This is a randomized controlled trial with a 3-month psychoeducational program as intervention, followed by a 3 month observational period. The purpose of this study was to examine whether a psychoeducational program focusing on equipping caregivers with problem-solving skills would improve caregiver's problem-solving abilities, their psychological responses and caregiving resources, and would minimize the use of health and social services among stroke survivors.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Caregivers' change in depressive symptom severity from baseline
Time Frame: 3 month post intervention
Change in depressive symptoms severity, as measured by the 10-item Center for Epidemiological Studies Depression (Chinese version), will be analyzed by the GEE model
Caregiver's change in caregiving competence from baseline
Time Frame: 3 months post intervention
Change in caregiving competence, as measured by the Caregiving Competence Scale (Chinese version), will be analyzed by the GEE model
Caregiver's change in perceived mental health from baseline
Time Frame: 3 months post intervention
Change in perceived mental health, as measured by the Chinese (Hong Kong) Medical Outcomes Study 12-item Short Form Health Survey version 2 (SF-12v2), its mental component summary score will be analyzed by the GEE model
Caregiver's change in caregiving burden
Time Frame: at immediate post-intervention, 1-month post-intervention, 3-month post-intervention
End-point between-group differences of the caregiving burden, as measured by the Caregiving Strain Index (Chinese version), will be analyzed by multiple regression analysis
Secondary Outcomes
- Caregiver's change in family functioning from baseline(3 months post intervention)
- Placement to residential/nursing care home (stroke survivors)(at immediate post-intervention, 1-month post-intervention, 3-month post-intervention)
- Caregiving-related injuries(at immediate post-intervention, 1-month post-intervention, 3-month post-intervention)
- Caregiver's change in self-appraised problem-solving abilities from baseline(3 months post intervention)
- Stroke-related hospital readmission (stroke survivors)(at immediate post-intervention, 1-month post-intervention, 3-month post-intervention)
- Caregiver's change in perceived social support from baseline(3 months post intervention)
- Caregiver's change in perceived physical health from baseline(3 months post intervention)
Investigators
Ho Yu CHENG
PhD (Nursing) candidate, BN, PgD (Mental Health), RN
Chinese University of Hong Kong