A Psychoeducational Intervention for Stroke Family Caregivers

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: Psychoeducation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (caregiver): Family member of stroke survivor Chinese adult Live with stroke survivors Primary caregiver Being able to communicate with the researcher Inclusion Criteria (stroke survivor): Chinese adult with diagnosis of stroke Live at home after discharge Being able to understand and to give consent Exclusion Criteria (caregiver and stroke survivor): History of self-reported doctor-diagnosed psychiatric illness (stroke survivor): being mild to totally independent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychoeducational program<br>Psychoeducational program consisted of (1) two inpatient sessions of face-to-face education on stroke and its caregiving; (2) six biweekly problem-solving training via telephone contacts after the discharge of stroke survivors | Behavioral: Psychoeducation<br> <br> |
| No Intervention: Usual care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caregivers' change in depressive symptom severity from baseline | 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 | 3 month post intervention | 
| Caregiver's change in perceived mental health from baseline | 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 | 3 months post intervention | 
| Caregiver's change in caregiving burden | 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 | at immediate post-intervention, 1-month post-intervention, 3-month post-intervention | 
| Caregiver's change in caregiving competence from baseline | Change in caregiving competence, as measured by the Caregiving Competence Scale (Chinese version), will be analyzed by the GEE model | 3 months post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caregiver's change in self-appraised problem-solving abilities from baseline | Change in self-appraised problem-solving abilities, as measured by the Problem Solving Inventory (Chinese version), will be analyzed using the Generalized Estimating Equations (GEE) model | 3 months post intervention | 
| Caregiver's change in family functioning from baseline | Change in family functioning, as measured by the McMaster Model of Family Assessment Device (Chinese version), will be analyzed using the GEE model | 3 months post intervention | 
| Caregiver's change in perceived social support from baseline | Change in perceived social support, as measured by the Six-item Social Support Questionnaire (Chinese version), will be analyzed using the GEE model | 3 months post intervention | 
| Caregiver's change in perceived physical health from baseline | Change in perceived physical health, as measured by the Chinese (Hong Kong) SF-12v2 (Physical Component Summary Score), will be analyzed by the GEE model | 3 months post intervention | 
| Caregiving-related injuries | End-point between-group differences of the self-reported caregiving related injuries will be analyzed using Chi square statistics | at immediate post-intervention, 1-month post-intervention, 3-month post-intervention | 
| Stroke-related hospital readmission (stroke survivors) | End-point between-group differences of the self-reported stroke-related hospital readmission, such as falls, recurrent stroke, will be analyzed using Chi square statistics | at immediate post-intervention, 1-month post-intervention, 3-month post-intervention | 
| Placement to residential/nursing care home (stroke survivors) | End-point between-group differences of the placement to residential/nursing care home of stroke survivors will be analyzed by the Chi square statistics | at immediate post-intervention, 1-month post-intervention, 3-month post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caregiver, stroke, psychoeducation, problem-solving