StrokeNCT02080910
A Psychoeducational Intervention for Stroke Family Caregivers
A study testing Psychoeducation in people with Stroke, run by Chinese University of Hong Kong at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- Start not givento Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of self-reported doctor-diagnosed psychiatric illness
- (stroke survivor): being mild to totally independent
Trial locations and contacts
1 site in 1 country.
China1 site
Prince of Wales Hospital, Shatin Hospital, Tai Po Hospital
Hong Kong SAR
About this study
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
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.
- Conditions
- Stroke
- Being tested
- Psychoeducation
- Keywords
- Caregiver, stroke, psychoeducation, problem-solving
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychoeducationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Psychoeducation |
| Usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 3 months post intervention
Secondary outcomes (7)
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
Measured: 3 months post intervention
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
Measured: 3 months post intervention
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
Measured: 3 months post intervention
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
Measured: 3 months post intervention
Caregiving-related injuries
End-point between-group differences of the self-reported caregiving related injuries will be analyzed using Chi square statistics
Measured: at immediate post-intervention, 1-month post-intervention, 3-month post-intervention
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
Measured: at immediate post-intervention, 1-month post-intervention, 3-month post-intervention
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
Measured: at immediate post-intervention, 1-month post-intervention, 3-month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ho Yu CHENG, Chinese University of Hong Kong
- Investigators
- Ho Yu CHENG, PgD (MH), BN, Principal investigator, Nethersole School of Nursing, Chinese University of Hong KongJanita Chau, PhD, Study chair, The Nethersole School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080910
- Sponsor's protocol ID
- CRE-2012.185-T
- Status last verified
- Jul 2018
- First submitted
- 4 Mar 2014
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34813082
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02080910
- Acronym / sponsor ID
- CRE-2012.185-T
- Conditions
- Stroke
- Keywords
- Caregiver, stroke, psychoeducation, problem-solving
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 7 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychoeducational program | Experimental | Behavioral: PsychoeducationPsychoeducational 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 |
| Usual care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Family member of stroke survivor
- Chinese adult
- Live with stroke survivors
- Primary caregiver
- Being able to communicate with the researcher
Key exclusion criteria (2 listed)
- History of self-reported doctor-diagnosed psychiatric illness
- (stroke survivor): being mild to totally independent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychoeducation | Behavioural | Psychoeducational program |
Primary outcome
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
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
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
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
7 secondary outcomes
Caregiver's change in self-appraised problem-solving abilities from baseline
Time frame: 3 months post intervention
Caregiver's change in family functioning from baseline
Time frame: 3 months post intervention
Caregiver's change in perceived social support from baseline
Time frame: 3 months post intervention
Caregiver's change in perceived physical health from baseline
Time frame: 3 months post intervention
Caregiving-related injuries
Time frame: 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
Placement to residential/nursing care home (stroke survivors)
Time frame: at immediate post-intervention, 1-month post-intervention, 3-month post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Derived from this study: PubMed 34813082Crocker 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ho Yu CHENG, PgD (MH), BN principal investigator
Nethersole School of Nursing, Chinese University of Hong Kong
Janita Chau, PhD study chair
The Nethersole School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation in people with Stroke, run by Chinese University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregivers' change in depressive symptom severity from baseline (time frame: 3 month post intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02080910, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2018.