- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04560140
Promoting Community Reintegration for Young Adults With Stroke
May 6, 2026 updated by: Suzanne HS Lo, Chinese University of Hong Kong
Promoting Community Reintegration Using Narratives and Skills Building for Young Adults With Stroke
This project will investigate the effects of a Narrative and Skills-building Intervention on young stroke survivors' community reintegration and psychosocial outcomes.
A randomised controlled trial will be conducted.
This is a novel trial to test the short and long-term effects of a theory-based intervention on young stroke survivors' community reintegration.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This project will investigate the effects of a Narrative and Skills-building Intervention on young stroke survivors' community reintegration and psychosocial outcomes.
A randomised controlled trial will be conducted.
Participants will be facilitated to narrate their survival experiences and rebuild core life skills.
Outcomes including community reintegration, depressive symptoms, health-related quality of life, self-efficacy, outcome expectation and satisfaction with performance of self-management behaviours will be measured.
This is a novel trial to test the short and long-term effects of a theory-based intervention on young stroke survivors' community reintegration.
Study Type
Interventional
Enrollment (Estimated)
208
Phase
- 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 Contact
- Name: Suzanne Lo
- Phone Number: 852 39434485
- Email: suzannelo@cuhk.edu.hk
Study Locations
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Hong Kong, Hong Kong
- Recruiting
- Suzanne Lo
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Contact:
- Suzanne Lo
- Phone Number: 39434485
- Email: suzannelo@cuhk.edu.hk
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Contact:
- Suzanne Lo
- Phone Number: 85239434485
- Email: suzannelo@cuhk.edu.hk
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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
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- (1) are 18-64 years of age,
- (2) have a clinical diagnosis of first-ever or recurrent ischaemic or haemorrhagic stroke,
- (3) are living at home after discharge from hospital,
- (4) have a Montreal Cognitive Assessment score >20,
- (5) have a modified Rankin Scale score ≥3,
- (6) can communicate in Cantonese, and
- (7) are able to attend all intervention sessions.
Exclusion Criteria:
- 1) transient ischaemic attack, subdural or epidural haemorrhage,
- 2) experienced cerebrovascular events due to tumours or head trauma,
- 3) mental condition such as depression, schizophrenia, bipolar or personality disorder,
- 4) incomprehensible speech or difficulty in comprehending conversations, or
- 5) have received a self-management programme in the past.
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: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention group
Eligible participants will be randomly assigned to receive usual care with the novel 24-week Narrative and Skills-building Intervention.
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The intervention is grounded in Narrative Theory and Bandura's principles of Self-efficacy and Outcome Expectation.
It will consist of eight individual sessions over six months delivered by a facilitator.
Participants will be facilitated to narrate their survival experiences and rebuild core life skills.
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No Intervention: Usual care group
Participants will receive usual stroke care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in the participants' level of community reintegration
Time Frame: Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention
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The Chinese version of the Reintegration to Normal Living Index (RNIL-C) will be used to assess the participants' level of community reintegration.
It consists of 11 items in eight domains: mobility, self-care, daily work and school activity, recreational and social activities, family roles, personal relationships, presentation of self to others and general coping skills.
Participants are asked to rate the extent to which each item describes their situation on a scale from 1 - 'a small extent' to 5 - 'a great extent'.
The total score is calculated by summation and normalised to give 100 with a total score range of 25 to 100.
A higher score indicates better community reintegration.
The RNIL-C has high internal consistency (Cronbach's alpha=0.92)
and good convergent validity.
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Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in the participants' level of depressive symptoms
Time Frame: Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention
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The Chinese version of the 15-item Geriatric Depression Scale (GDS) will be used to measure participants' depressive symptoms.
Studies support its utility in younger adults (>18 years old), with good diagnostic sensitivity and specificity.
Each item represents symptoms of depression and describes a participant's condition in the preceding week; the participants answer each item with either 'yes' or 'no'.
All items are summed (total score 0-15).
A score of six or greater is a cutoff for depression.
The GDS has a Cronbach's alpha of 0.78.
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Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention
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Change in the participants' level of health-related quality of life
Time Frame: Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention
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Participants' health-related quality of life (HRQoL) will be measured by the Chinese version of the Stroke-Specific Quality of Life Scale (SSQOL-C), which has 47 items with 11 domains ranging from physical to psychosocial and participation.
The items are about the health conditions of the participants and how much difficulty the participants have when doing everyday self-care tasks.
The items are scored from 1 - 'strongly disagree/cannot do it' to 5 - 'strongly agree/no trouble'.
Total score is yielded by summing all item scores (range 47-235): the higher the score, the higher the HRQoL.
It has acceptable internal consistency (Cronbach's alpha: 0.63-0.93)
and convergent validity.
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Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention
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Change in the participants' level of satisfaction with the performance of self-management behaviours
Time Frame: Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention
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The 11-item Chinese version of the Stroke Self-management Behaviours Performance Scale (SSBPS-C) will be adopted to assess participants' satisfaction with the performance of self-management behaviours.
Each item is scored using a range from 0 - 'very dissatisfied' to 10 - 'very satisfied'.
Taking the sum of all item scores yields one total score (range 0-110), and the higher the score, the higher the satisfaction.
This scale has a Cronbach's alpha of 0.93.
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Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention
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Change in the participants' level of self-efficacy
Time Frame: Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention
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The Chinese version of the Stroke Self-Efficacy Questionnaire (SSEQ-C) will be used to measure self-efficacy.
It has 13 items, each is scored using a scale from 0 - 'no confidence' to 10 - 'very confident'.
The items are about the participants' perceived extent of confidence in doing everyday activities and self-management tasks.
A total score is yielded by summing all items (range 0-130).
A higher total score represents higher self-efficacy.
The scale has acceptable internal consistency (Cronbach's alpha=0.92)
and convergent validity.
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Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention
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Change in the participants' level of outcome expectation
Time Frame: Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention
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The Chinese version of the Stroke Self-management Outcome Expectation Scale (SSOES-C) will be used to measure the participants' outcome expectation beliefs.
It has 11 items, each rated using a scale from 0 - 'strongly disagree' to 10 - 'strongly agree'.
The score of each item indicates the participants' confidence in the expected outcomes to occur.
All item scores will be calculated by summation (total score 0-110).
A higher score represents higher outcome expectations.
This scale has good internal consistency (Cronbach's alpha=0.94).
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Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Suzanne Lo, Chinese University of Hong Kong
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.
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
Study Start (Actual)
September 1, 2021
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2028
Study Registration Dates
First Submitted
September 17, 2020
First Submitted That Met QC Criteria
September 17, 2020
First Posted (Actual)
September 23, 2020
Study Record Updates
Last Update Posted (Actual)
May 11, 2026
Last Update Submitted That Met QC Criteria
May 6, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NSI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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