NCT06369051

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for not_applicable stroke

Timeline
20mo left

Started Jan 2023

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress68%
Jan 2023Dec 2027

Study Start

First participant enrolled

January 1, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 12, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 16, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

May 11, 2026

Status Verified

May 1, 2026

Enrollment Period

4 years

First QC Date

April 12, 2024

Last Update Submit

May 6, 2026

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Self-efficacy

    Change from baseline level to three months after completion of the intervention

  • Life satisfaction

    Change from baseline level to three months after completion of the intervention

  • Emotional well-being

    Change from baseline level to three months after completion of the intervention

  • Community reintegration

    Change from baseline level to three months after completion of the intervention

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

Usual stroke care services

Interventions

Self-employment support interventionOTHER

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.

Intervention

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Non-government organisations

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Suzanne Lo

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Suzanne Lo

CONTACT

39434485suzannelo@cuhk.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 12, 2024

First Posted

April 16, 2024

Study Start

January 1, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

May 11, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)