Supporting Self-employment in Young Adults With Stroke

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: Stroke
• Intervention / Treatment: Other: Self-employment support intervention

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

• Study Contact: Name: Suzanne Lo; Phone Number: 39434485; Email: suzannelo@cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Non-government organisations
    • Contact: Suzanne Lo; Phone Number: 85239434485; Email: suzannelo@cuhk.edu.hk

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

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	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	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	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	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	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

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

Study record dates

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: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• 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