StrokeNCT05902195
Improving Work Ability of Young Adults With Stroke
A study testing Personal Resource Building and Inclusive Volunteering Intervention (PVI) in people with Stroke, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This project will investigate effects of a novel theory-driven 6-week virtual Personal Resource Building and Inclusive Volunteering Intervention (PVI) on young stroke survivors' work ability, self-efficacy and psychosocial outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Personal Resource Building and Inclusive Volunteering Intervention (PVI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2023to 30 Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-64 years old,
- been clinically diagnosed with a first-ever or recurrent ischaemic or haemorrhagic stroke,
- living at home,
- Montreal Cognitive Assessment score >2nd percentile,
- a Modified Rankin Scale of 4 or below (moderately severe disability),
- able to communicate in Cantonese and read Traditional Chinese,
- a regular paid employment at the time of stroke,
- been unemployed for at least 3 months at the time of recruitment.
Who cannot join
- have been diagnosed with transient ischaemic attack,
- have experienced cerebrovascular events due to tumours,
- have been diagnosed with a mental condition such as depression, schizophrenia or bipolar disorder,
- demonstrate incomprehensible speech or difficulty in comprehending conversations, or
- have or are receiving vocational programmes.
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, 852 3943 4485, suzannelo@cuhk.edu.hk
About this study
Official title: Improving Work Ability of Young Adults With Stroke Through Personal Resource Building and Inclusive Volunteering: A Randomised Controlled Trial
This project will investigate effects of a novel theory-driven 6-week virtual Personal Resource Building and Inclusive Volunteering Intervention (PVI) on young stroke survivors' work ability, self-efficacy and psychosocial outcomes.
It is hypothesised that participants in the intervention group, compared with the control group, will demonstrate the outcomes below at immediately and 3 months post-intervention with respect to baseline: 1) Significant improvement in work ability (primary outcome), 2) Significant improvements in self-efficacy, health-related quality of life (HRQoL), emotional well-being and social skills (secondary outcomes).
Eligible participants will be randomly assigned to receive usual care or PVI with usual care and the control group participants will receive usual stroke care services.
Read the detailed description
Returning to work is a major rehabilitation priority for young stroke survivors. This project will investigate effects of a novel theory-driven 6-week virtual Personal Resource Building and Inclusive Volunteering Intervention (PVI) on young stroke survivors' work ability, self-efficacy and psychosocial outcomes. A 2-arm, assessor-blind, randomised controlled trial will be conducted. Eligible participants will be randomly assigned to receive usual care or PVI with usual care and the control group participants will receive usual stroke care services. Outcomes including work ability, self-efficacy, health-related quality of life, emotional well-being and social skills will be measured at baseline, immediately post-PVI and 3 months post-PVI.
- Conditions
- Stroke
- Being tested
- Personal Resource Building and Inclusive Volunteering Intervention (PVI), Usual care
- Keywords
- Return to work
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personal Resource Building and Inclusive Volunteering Intervention (PVI)Behavioural
PVI is a 6-week virtual programme aimed at building up young stroke survivors' personal resources for work through engaging in inclusive volunteering activities.
Usual careOther
Usual stroke care services include medical and health services offered by the hospitals or community-based organisations.
| Study group | Role | What they receive |
|---|---|---|
| Personal Resource Building and Inclusive Volunteering Intervention (PVI) | Experimental | All participants in the intervention group will receive the intervention (PVI) in addition to usual care. PVI is a 6-week virtual programme aimed at building up young stroke survivors' personal resources for work through engaging in inclusive volunteering activities. Receives: Behavioral: Personal Resource Building and Inclusive Volunteering Intervention (PVI) |
| Control | Active comparator | All participants in the control group will receive usual stroke care services such as medical or health services offered by the hospitals or community-based organisations. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the level of perceived work ability
The Work Ability Index (Chinese version) will assess participants' perceived capability for work. It consists of 7 dimensions about participants' self-reported current work ability compared with the lifetime best. Total score is yielded by summing all items (range: 7-49): poor (7-27), moderate (28-36), good (37-43), and excellent (44-49) work ability.
Measured: Change from baseline level to three months after completion of the intervention
Secondary outcomes (4)
Change in the level of self-efficacy
The 10-item General Self-Efficacy Scale (GSES) (Chinese version) will assess participants' perceived self-efficacy in coping with stressful life events. Each item is rated on a 4-point scale (1=not at all true to 4=exactly true). Total score is yielded by summing all items (range: 10-40). A higher score indicates higher self-efficacy.
Measured: Change from baseline level to three months after completion of the intervention
Change in the level of health-related quality of life
Participants' health-related quality of life (HRQoL) will be measured by the 47-item Stroke-Specific Quality of Life Scale (Chinese version). It has 11 domains on physical to psychosocial and participation. Items are scored from 1 (strongly disagree/cannot do it) to 5 (strongly agree/no trouble). Total score is yielded by summing all items (range 47-235). A higher score indicates higher HRQoL.
Measured: Change from baseline level to three months after completion of the intervention
Change in the level of emotional well-being
The 14-item Hospital Anxiety and Depression Scale (HADS) (Chinese version) will measure participants' emotional well-being. Participants will rate their mood in the past week on a 4-point scale (0=no not at all to 3=yes definitely). It has 2 subscales (anxiety and depression). Subscale score is yielded by summing the relevant item scores (Total=0-21). A higher score indicates higher distress.
Measured: Change from baseline level to three months after completion of the intervention
Change in the level of social skills
The 12-item Social Skills subscale of Work Personality Profile (Chinese version) will measure participants' interpersonal behaviours as applied to work. Item are rated on a 4-point scale (1=a problem area to 4=a definite strength). Total score is yielded by summing all items (range: 12-48). A higher score indicates greater proficiency in social skills at work.
Measured: Change from baseline level to three months 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 posted13 Jun 2023
- Study start1 Jan 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- A 2-arm, assessor-blind, randomised controlled trial will be conducted.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 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
- NCT05902195
- Sponsor's protocol ID
- PVI
- Status last verified
- May 2026
- First submitted
- 5 Jun 2023
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The dataset will become available upon completion of the study upon written request made to the Principal Investigator.
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
- Improving Work Ability of Young Adults With Stroke Through Personal Resource Building and Inclusive Volunteering: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05902195
- Acronym / sponsor ID
- PVI
- Conditions
- Stroke
- Keywords
- Return to work
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 13 Jun 2023 (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 effects of a novel theory-driven 6-week virtual Personal Resource Building and Inclusive Volunteering Intervention (PVI) on young stroke survivors' work ability, self-efficacy and psychosocial outcomes.
It is hypothesised that participants in the intervention group, compared with the control group, will demonstrate the outcomes below at immediately and 3 months post-intervention with respect to baseline: 1) Significant improvement in work ability (primary outcome), 2) Significant improvements in self-efficacy, health-related quality of life (HRQoL), emotional well-being and social skills (secondary outcomes).
Eligible participants will be randomly assigned to receive usual care or PVI with usual care and the control group participants will receive usual stroke care services.
Detailed description
Returning to work is a major rehabilitation priority for young stroke survivors. This project will investigate effects of a novel theory-driven 6-week virtual Personal Resource Building and Inclusive Volunteering Intervention (PVI) on young stroke survivors' work ability, self-efficacy and psychosocial outcomes. A 2-arm, assessor-blind, randomised controlled trial will be conducted. Eligible participants will be randomly assigned to receive usual care or PVI with usual care and the control group participants will receive usual stroke care services. Outcomes including work ability, self-efficacy, health-related quality of life, emotional well-being and social skills will be measured at baseline, immediately post-PVI and 3 months post-PVI.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A 2-arm, assessor-blind, randomised controlled trial will be conducted.
| Arm | Type | Receives |
|---|---|---|
| Personal Resource Building and Inclusive Volunteering Intervention (PVI) | Experimental | Behavioral: Personal Resource Building and Inclusive Volunteering Intervention (PVI)All participants in the intervention group will receive the intervention (PVI) in addition to usual care. PVI is a 6-week virtual programme aimed at building up young stroke survivors' personal resources for work through engaging in inclusive volunteering activities. |
| Control | Active comparator | Other: Usual careAll participants in the control group will receive usual stroke care services such as medical or health services offered by the hospitals or community-based organisations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18-64 years old,
- been clinically diagnosed with a first-ever or recurrent ischaemic or haemorrhagic stroke,
- living at home,
- Montreal Cognitive Assessment score >2nd percentile,
- a Modified Rankin Scale of 4 or below (moderately severe disability),
Key exclusion criteria (5 listed)
- have been diagnosed with transient ischaemic attack,
- have experienced cerebrovascular events due to tumours,
- have been diagnosed with a mental condition such as depression, schizophrenia or bipolar disorder,
- demonstrate incomprehensible speech or difficulty in comprehending conversations, or
- have or are receiving vocational programmes.
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 |
|---|---|---|
| Personal Resource Building and Inclusive Volunteering Intervention (PVI)PVI is a 6-week virtual programme aimed at building up young stroke survivors' personal resources for work through engaging in inclusive volunteering activities. | Behavioural | Personal Resource Building and Inclusive Volunteering Intervention (PVI) |
| Usual careUsual stroke care services include medical and health services offered by the hospitals or community-based organisations. | Other | Control |
Primary outcome
Change in the level of perceived work ability
Time frame: Change from baseline level to three months after completion of the intervention
The Work Ability Index (Chinese version) will assess participants' perceived capability for work. It consists of 7 dimensions about participants' self-reported current work ability compared with the lifetime best. Total score is yielded by summing all items (range: 7-49): poor (7-27), moderate (28-36), good (37-43), and excellent (44-49) work ability.
4 secondary outcomes
Change in the level of self-efficacy
Time frame: Change from baseline level to three months after completion of the intervention
Change in the level of health-related quality of life
Time frame: Change from baseline level to three months after completion of the intervention
Change in the level of emotional well-being
Time frame: Change from baseline level to three months after completion of the intervention
Change in the level of social skills
Time frame: Change from baseline level to three months 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.
- Individual participant dataSharing planned: Yes. The dataset will become available upon completion of the study upon written request made to the Principal Investigator.
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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.
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 Personal Resource Building and Inclusive Volunteering Intervention (PVI) 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 8 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 3943 4485, 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 level of perceived work ability (time frame: Change from baseline level to three months 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?
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.