Clinical trial NCT05902195: Improving Work Ability of Young Adults With Stroke
Official title: Improving Work Ability of Young Adults With Stroke Through Personal Resource Building and Inclusive Volunteering: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Return to work
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-06-13
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A 2-arm, assessor-blind, randomised controlled trial will be conducted.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This project will investigate effects of a novel theory-driven 6-week virtual Personal Resource Building and Inclusive Volunteering Intervention (PVI) on young stroke survivors' work ability, self-efficacy and psychosocial outcomes.

It is hypothesised that participants in the intervention group, compared with the control group, will demonstrate the outcomes below at immediately and 3 months post-intervention with respect to baseline: 1) Significant improvement in work ability (primary outcome), 2) Significant improvements in self-efficacy, health-related quality of life (HRQoL), emotional well-being and social skills (secondary outcomes).

Eligible participants will be randomly assigned to receive usual care or PVI with usual care and the control group participants will receive usual stroke care services.

Detailed description: Returning to work is a major rehabilitation priority for young stroke survivors. This project will investigate effects of a novel theory-driven 6-week virtual Personal Resource Building and Inclusive Volunteering Intervention (PVI) on young stroke survivors' work ability, self-efficacy and psychosocial outcomes. A 2-arm, assessor-blind, randomised controlled trial will be conducted. Eligible participants will be randomly assigned to receive usual care or PVI with usual care and the control group participants will receive usual stroke care services. Outcomes including work ability, self-efficacy, health-related quality of life, emotional well-being and social skills will be measured at baseline, immediately post-PVI and 3 months post-PVI.

Eligibility criteria: Inclusion Criteria:

* 18-64 years old,
* been clinically diagnosed with a first-ever or recurrent ischaemic or haemorrhagic stroke,
* living at home,
* Montreal Cognitive Assessment score \>2nd percentile,
* a Modified Rankin Scale of 4 or below (moderately severe disability),
* able to communicate in Cantonese and read Traditional Chinese,
* a regular paid employment at the time of stroke,
* been unemployed for at least 3 months at the time of recruitment.

Exclusion Criteria:

* have been diagnosed with transient ischaemic attack,
* have experienced cerebrovascular events due to tumours,
* have been diagnosed with a mental condition such as depression, schizophrenia or bipolar disorder,
* demonstrate incomprehensible speech or difficulty in comprehending conversations, or
* have or are receiving vocational programmes.

Primary outcomes:
measure: Change in the level of perceived work ability
timeFrame: Change from baseline level to three months after completion of the intervention
Secondary outcomes:
measure: Change in the level of self-efficacy
timeFrame: Change from baseline level to three months after completion of the intervention
measure: Change in the level of health-related quality of life
timeFrame: Change from baseline level to three months after completion of the intervention
measure: Change in the level of emotional well-being
timeFrame: Change from baseline level to three months after completion of the intervention
measure: Change in the level of social skills
timeFrame: Change from baseline level to three months after completion of the intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Suzanne Lo
Study officials:
affiliation: Chinese University of Hong Kong
name: Suzanne Lo
role: PRINCIPAL_INVESTIGATOR
References: