Supporting Self-employment in Young Adults with Stroke

Not Applicable

Recruiting

• Conditions: Stroke
• Interventions: Other: Self-employment support intervention

• Registration Number: NCT06369051
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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.

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 Timeline

• Study Start: 2023-01-01
• Status Verified: 2024-04
• Study First Submitted: 2024-04-12
• Study First Submitted QC: 2024-04-12
• Study First Posted: 2024-04-16
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 156

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	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.

Primary Outcome Measures

Name	Time	Method
Self-employment rate	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".

Secondary Outcome Measures

Name	Time	Method
Self-efficacy	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).
Life satisfaction	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).
Emotional well-being	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).
Community reintegration	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).

Trial Locations

Locations (1)

Non-government organisations; 🇭🇰 Hong Kong, Hong Kong