NCT02080910

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P75+ for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 7, 2014

Completed
Last Updated

July 6, 2018

Status Verified

July 1, 2018

First QC Date

March 4, 2014

Last Update Submit

July 5, 2018

Conditions

Stroke

Keywords

Caregiverstrokepsychoeducationproblem-solving

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (7)

  • Caregiver's change in self-appraised problem-solving abilities from baseline

    3 months post intervention

  • Caregiver's change in family functioning from baseline

    3 months post intervention

  • Caregiver's change in perceived social support from baseline

    3 months post intervention

  • Caregiver's change in perceived physical health from baseline

    3 months post intervention

  • Caregiving-related injuries

    at immediate post-intervention, 1-month post-intervention, 3-month post-intervention

  • +2 more secondary outcomes

Study Arms (2)

Psychoeducational program

EXPERIMENTAL

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

Usual care

NO INTERVENTION

Interventions

PsychoeducationBEHAVIORAL
Psychoeducational program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Family member of stroke survivor
  • Chinese adult
  • Live with stroke survivors
  • Primary caregiver
  • Being able to communicate with the researcher
  • Chinese adult with diagnosis of stroke
  • Live at home after discharge
  • Being able to understand and to give consent

You may not qualify if:

  • History of self-reported doctor-diagnosed psychiatric illness
  • (stroke survivor): being mild to totally independent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital, Shatin Hospital, Tai Po Hospital

Hong Kong SAR, China

Location

Related Publications (1)

  • 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.

    PMID: 34813082DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Ho Yu CHENG, PgD (MH), BN

    Nethersole School of Nursing, Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

  • Janita Chau, PhD

    The Nethersole School of Nursing

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD (Nursing) candidate, BN, PgD (Mental Health), RN

Study Record Dates

First Submitted

March 4, 2014

First Posted

March 7, 2014

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

July 6, 2018

Record last verified: 2018-07

Locations

CN(1)