StrokeNCT04560140
Promoting Community Reintegration for Young Adults With Stroke
A study testing Narrative and Skills-building Intervention in people with Stroke, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Stroke
- What is being tested?
- Narrative and Skills-building Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2021to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- (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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Suzanne Lo
Hong Kong
Suzanne Lo, 39434485, suzannelo@cuhk.edu.hk
Suzanne Lo, 85239434485, suzannelo@cuhk.edu.hk
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Narrative and Skills-building Intervention
- Keywords
- Stroke, Community reintegration, Narrative, Skill building
- Medical subject headings
- Stroke, Narration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrative and Skills-building InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Eligible participants will be randomly assigned to receive usual care with the novel 24-week Narrative and Skills-building Intervention. Receives: Behavioral: Narrative and Skills-building Intervention |
| Usual care group | No intervention | Participants will receive usual stroke care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the participants' level of community reintegration
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.
Measured: Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention
Secondary outcomes (5)
Change in the participants' level of depressive symptoms
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.
Measured: Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention
Change in the participants' level of health-related quality of life
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.
Measured: Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention
Change in the participants' level of satisfaction with the performance of self-management behaviours
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.
Measured: Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention
Change in the participants' level of self-efficacy
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.
Measured: Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention
Change in the participants' level of outcome expectation
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).
Measured: Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start1 Sep 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suzanne HS Lo, Chinese University of Hong Kong
- Investigators
- Suzanne Lo, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560140
- Sponsor's protocol ID
- NSI
- Status last verified
- May 2026
- First submitted
- 17 Sep 2020
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lo SHS, Chau JPC, Choi KC, Shum EWC, Yeung JHM, Li SH. Promoting community reintegration using narratives and skills building for young adults with stroke: a protocol for a randomised controlled trial. BMC Neurol. 2021 Jan 4;21(1):3. doi: 10.1186/s12883-020-02015-5.
PubMed 33397316
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Community Reintegration Using Narratives and Skills Building for Young Adults With Stroke
- ClinicalTrials.gov ID
- NCT04560140
- Acronym / sponsor ID
- NSI
- Conditions
- Stroke
- Keywords
- Stroke, Community reintegration, Narrative, Skill building
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 23 Sep 2020 (actual)
- 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 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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Narrative and Skills-building InterventionEligible participants will be randomly assigned to receive usual care with the novel 24-week Narrative and Skills-building Intervention. |
| Usual care group | No intervention | –Participants will receive usual stroke care. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- (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,
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Narrative and Skills-building InterventionThe 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. | Behavioural | Intervention group |
Primary outcome
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
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.
5 secondary outcomes
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Derived from this study: PubMed 33397316Lo SHS, Chau JPC, Choi KC, Shum EWC, Yeung JHM, Li SH. Promoting community reintegration using narratives and skills building for young adults with stroke: a protocol for a randomised controlled trial. BMC Neurol. 2021 Jan 4;21(1):3. doi: 10.1186/s12883-020-02015-5.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Brain-Machine Interface With Virtual Reality and Neuromuscular Electrical Stimulation for Upper Limb Rehabilitation After Stroke
Ischemic Stroke
Recruiting
Understanding and Enhancing Human Health and Movement
Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Not yet recruitingObservational study
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
Stroke, Ischemic Stroke
RecruitingObservational study
Stroke Hemiplegic Shoulder Pain: Ultrasound Findings and VAS (Cross-Sectional)
Hemiplegic Shoulder Pain, Stroke
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.
Suzanne Lo principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrative and Skills-building Intervention in people with Stroke, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 11 May 2026. 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 Hong Kong. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suzanne Lo (852 39434485, suzannelo@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 NCT04560140, 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 11 May 2026.