Supporting Self-employment in Young Adults With Stroke

Stroke Clinical Trial

Official title:

Supporting Self-employment in Working-age Stroke Survivors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06369051
• Other study ID #: YSEmploy
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Chinese University of Hong Kong
• Contact: Suzanne Lo
• Phone: 39434485
• Email: suzannelo[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	Non-government organisations	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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