Clinical trial NCT06369051: Supporting Self-employment in Young Adults with Stroke
Official title: Supporting Self-employment in Working-age Stroke Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Self-employment rate
timeFrame: Change from baseline level to three months after completion of the intervention
Secondary outcomes:
measure: Self-efficacy
timeFrame: Change from baseline level to three months after completion of the intervention
measure: Life satisfaction
timeFrame: Change from baseline level to three months after completion of the intervention
measure: Emotional well-being
timeFrame: Change from baseline level to three months after completion of the intervention
measure: Community reintegration
timeFrame: Change from baseline level to three months after completion of the intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Non-government organisations
Study officials:
affiliation: Chinese University of Hong Kong
name: Suzanne Lo
role: PRINCIPAL_INVESTIGATOR
References: