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NCT Number: NCT06369051

Supporting Self-employment in Young Adults With Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-employment support intervention

Other

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 outcomes

  1. 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".

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Suzanne Lo

CONTACT

[email protected]

39434485

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Supporting Self-employment in Working-age Stroke Survivors

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Apr 16, 2024
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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