Back to resultsA Psychoeducational Intervention for Stroke Family Caregivers
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Psychoeducation
Sponsored by
About this trial
This is an interventional supportive care trial for Stroke focused on measuring Caregiver, stroke, psychoeducation, problem-solving
Eligibility Criteria
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
Sites / Locations
- Prince of Wales Hospital, Shatin Hospital, Tai Po Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Psychoeducational program
Usual care
Arm Description
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
Outcomes
Primary Outcome Measures
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
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
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
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
Secondary Outcome Measures
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
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
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
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
Caregiving-related injuries
End-point between-group differences of the self-reported caregiving related injuries will be analyzed using Chi square statistics
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
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
Full Information
NCT ID
NCT02080910
First Posted
March 4, 2014
Last Updated
July 5, 2018
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT02080910
Brief Title
A Psychoeducational Intervention for Stroke Family Caregivers
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Caregiver, stroke, psychoeducation, problem-solving
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Psychoeducational program
Arm Type
Experimental
Arm Description
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
Arm Title
Usual care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Primary Outcome Measure Information:
Title
Caregivers' change in depressive symptom severity from baseline
Description
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
Time Frame
3 month post intervention
Title
Caregiver's change in perceived mental health from baseline
Description
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
Time Frame
3 months post intervention
Title
Caregiver's change in caregiving burden
Description
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
Time Frame
at immediate post-intervention, 1-month post-intervention, 3-month post-intervention
Title
Caregiver's change in caregiving competence from baseline
Description
Change in caregiving competence, as measured by the Caregiving Competence Scale (Chinese version), will be analyzed by the GEE model
Time Frame
3 months post intervention
Secondary Outcome Measure Information:
Title
Caregiver's change in self-appraised problem-solving abilities from baseline
Description
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
Time Frame
3 months post intervention
Title
Caregiver's change in family functioning from baseline
Description
Change in family functioning, as measured by the McMaster Model of Family Assessment Device (Chinese version), will be analyzed using the GEE model
Time Frame
3 months post intervention
Title
Caregiver's change in perceived social support from baseline
Description
Change in perceived social support, as measured by the Six-item Social Support Questionnaire (Chinese version), will be analyzed using the GEE model
Time Frame
3 months post intervention
Title
Caregiver's change in perceived physical health from baseline
Description
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
Time Frame
3 months post intervention
Title
Caregiving-related injuries
Description
End-point between-group differences of the self-reported caregiving related injuries will be analyzed using Chi square statistics
Time Frame
at immediate post-intervention, 1-month post-intervention, 3-month post-intervention
Title
Stroke-related hospital readmission (stroke survivors)
Description
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
Time Frame
at immediate post-intervention, 1-month post-intervention, 3-month post-intervention
Title
Placement to residential/nursing care home (stroke survivors)
Description
End-point between-group differences of the placement to residential/nursing care home of stroke survivors will be analyzed by the Chi square statistics
Time Frame
at immediate post-intervention, 1-month post-intervention, 3-month post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ho Yu CHENG, PgD (MH), BN
Organizational Affiliation
Nethersole School of Nursing, Chinese University of Hong Kong
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Janita Chau, PhD
Organizational Affiliation
The Nethersole School of Nursing
Official's Role
Study Chair
Facility Information:
Facility Name
Prince of Wales Hospital, Shatin Hospital, Tai Po Hospital
City
Hong Kong SAR
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
34813082
Citation
Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
Results Reference
derived
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A Psychoeducational Intervention for Stroke Family Caregivers
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