Clinical trial NCT02080910: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Caregiver
stroke
psychoeducation
problem-solving
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2014-03-07
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Caregivers' change in depressive symptom severity from baseline
timeFrame: 3 month post intervention
measure: Caregiver's change in perceived mental health from baseline
timeFrame: 3 months post intervention
measure: Caregiver's change in caregiving burden
timeFrame: at immediate post-intervention, 1-month post-intervention, 3-month post-intervention
measure: Caregiver's change in caregiving competence from baseline
timeFrame: 3 months post intervention
Secondary outcomes:
measure: Caregiver's change in self-appraised problem-solving abilities from baseline
timeFrame: 3 months post intervention
measure: Caregiver's change in family functioning from baseline
timeFrame: 3 months post intervention
measure: Caregiver's change in perceived social support from baseline
timeFrame: 3 months post intervention
measure: Caregiver's change in perceived physical health from baseline
timeFrame: 3 months post intervention
measure: Caregiving-related injuries
timeFrame: at immediate post-intervention, 1-month post-intervention, 3-month post-intervention
measure: Stroke-related hospital readmission (stroke survivors)
timeFrame: at immediate post-intervention, 1-month post-intervention, 3-month post-intervention
measure: Placement to residential/nursing care home (stroke survivors)
timeFrame: at immediate post-intervention, 1-month post-intervention, 3-month post-intervention
Other outcomes:
Locations:
city: Hong Kong SAR
country: China
facility: Prince of Wales Hospital, Shatin Hospital, Tai Po Hospital
Study officials:
affiliation: Nethersole School of Nursing, Chinese University of Hong Kong
name: Ho Yu CHENG, PgD (MH), BN
role: PRINCIPAL_INVESTIGATOR
affiliation: The Nethersole School of Nursing
name: Janita Chau, PhD
role: STUDY_CHAIR
References:
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.