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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
128

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese University of Hong Kong

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 6, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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