Supporting Self-employment in Young Adults With Stroke

May 6, 2026 updated by: Suzanne HS Lo, Chinese University of Hong Kong

Supporting Self-employment in Working-age Stroke Survivors

This project will investigate the effects of an 8-week theory-driven online/hybrid Self-employment Skill Building Intervention on the rate of self-employment, self-efficacy, life satisfaction, and psychosocial outcomes among working-age stroke survivors.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A 2-arm randomised controlled trial will be conducted. Individuals aged 18-65 years old, with a first-ever/recurrent ischaemic/haemorrhagic stroke, and unemployed for at least 6 months will be recruited. Eligible participants will be randomly assigned to receive usual care or a new intervention with usual care. The intervention is aimed at assisting survivors in becoming self-employed by developing entrepreneurial skills. Outcomes including self-employment rate, self-efficacy, life satisfaction, emotional well-being, and community reintegration at baseline, immediately and 3 months after completing the intervention. Semi-structured interviews will be conducted with participants to elicit feedback on SSI.

Study Type

Interventional

Enrollment (Estimated)

156

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

Study Locations

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18-65 years old at the time of recruitment
  • been clinically diagnosed with a first-ever/recurrent ischaemic/haemorrhagic stroke
  • a Montreal Cognitive Assessment score (MoCA) >2nd percentile
  • a paid job (full-time/part-time) at the recent onset of stroke
  • been unemployed (not in paid, full-time/part-time job) for ≥6 months at the time of recruitment
  • able to communicate in Cantonese and read Traditional Chinese.

Exclusion Criteria:

  • diagnosed with transient ischaemic attack
  • cerebrovascular events due to tumour
  • diagnosed with a mental condition for example depression or schizophrenia
  • incomprehensible speech
  • receiving or awaiting to receive vocational programmes
  • self-employed at the time of recruitment or planning to retire

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
Experimental: Intervention
A new intervention developed to assist stroke survivors in becoming self-employed by developing entrepreneurial skills. It consists of one home visit, three online individual sessions, and four online group sessions held once a week for eight weeks.
Other: Self-employment support intervention
A new intervention developed to assist stroke survivors in becoming self-employed by developing entrepreneurial skills. It consists of one home visit, three online individual sessions, and four online group sessions held once a week for eight weeks.
No Intervention: Control
Usual stroke care services

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-employment rate
Time Frame: Change from baseline level to three months after completion of the intervention
Self-employment work is defined as the active production of goods and/or services on one's own or with a small group for personal gains, including income, and is not performed for wages by employers. Work done by housewives, students, and volunteers is not included. A minimum of 10 hours per week should be committed to the work (25% of full-time work).(2,3) The participant's response will be rated as "Yes" or "No".
Change from baseline level to three months after completion of the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-efficacy
Time Frame: Change from baseline level to three months after completion of the intervention
Participants' self-efficacy in coping with stressful life events will be assessed by the 10-item General Self-Efficacy Scale (GSES) (Chinese version). Each item is rated on a 4-point scale (1=not at all true to 4=exactly true).
Change from baseline level to three months after completion of the intervention
Life satisfaction
Time Frame: Change from baseline level to three months after completion of the intervention
Participants' satisfaction with life will be measured by the Satisfaction with Life Scale (Chinese version). It contains 5 items that ask participants to rate their agreement with each statement on a 7-point scale (1=strongly disagree to 7=strongly agree).
Change from baseline level to three months after completion of the intervention
Emotional well-being
Time Frame: Change from baseline level to three months after completion of the intervention
Participants' emotional well-being will be measured by the 14-item Hospital Anxiety and Depression Scale (Chinese version). It has 2 subscales (anxiety and depression), and participants will rate their mood in the previous week on a 4-point scale (0=no not at all to 3=yes definitely). Summation of relevant item scores yields the subscale score (total=0-21).
Change from baseline level to three months after completion of the intervention
Community reintegration
Time Frame: Change from baseline level to three months after completion of the intervention
The 11-item Reintegration to Normal Living Index (Chinese version) will be used to assess participants' level of community reintegration.(44) It has 8 domains (mobility, daily self-care and work/activities, roles in family, relationships with others, presentation of self to others, coping skills). Participants will rate how well each item describes their situation (1=a small extent to 5=a great extent). Summation produces a total score that is normalised to 100 (range 25-100).
Change from baseline level to three months after completion of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Suzanne Lo, Chinese University of Hong Kong

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)

January 1, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

April 12, 2024

First Submitted That Met QC Criteria

April 12, 2024

First Posted (Actual)

April 16, 2024

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

  • YSEmploy

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

product manufactured in and exported from the U.S.

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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