A Psychoeducational Intervention for Stroke Family Caregivers

July 5, 2018 updated by: Ho Yu CHENG, Chinese University of Hong Kong

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong SAR, China
        • Prince of Wales Hospital, Shatin Hospital, Tai Po Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual care
Experimental: Psychoeducational program
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 month post intervention
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
3 months post intervention
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
at immediate post-intervention, 1-month post-intervention, 3-month post-intervention
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
3 months post intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caregiver's change in self-appraised problem-solving abilities from baseline
Time Frame: 3 months post intervention
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
Time Frame: 3 months post intervention
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
Time Frame: 3 months post intervention
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
Time Frame: 3 months post intervention
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
Time Frame: at immediate post-intervention, 1-month post-intervention, 3-month post-intervention
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)
Time Frame: at immediate post-intervention, 1-month post-intervention, 3-month post-intervention
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)
Time Frame: at immediate post-intervention, 1-month post-intervention, 3-month post-intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Ho Yu CHENG, PgD (MH), BN, Nethersole School of Nursing, Chinese University of Hong Kong
  • Study Chair: Janita Chau, PhD, The Nethersole School of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

March 4, 2014

First Submitted That Met QC Criteria

March 5, 2014

First Posted (Estimate)

March 7, 2014

Study Record Updates

Last Update Posted (Actual)

July 6, 2018

Last Update Submitted That Met QC Criteria

July 5, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE-2012.185-T

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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