A Psychoeducational Intervention for Stroke Family Caregivers

Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02080910
• Other study ID #: CRE-2012.185-T
• Status: Completed
• Phase: N/A
• Est. completion date: March 2014

Study information

• Verified date: July 2018
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Psychoeducation

Locations

Country	Name	City	State
China	Prince of Wales Hospital, Shatin Hospital, Tai Po Hospital	Hong Kong SAR

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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