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NCT Number: NCT05902195

Improving Work Ability of Young Adults With Stroke

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Personal Resource Building and Inclusive Volunteering Intervention (PVI)

Behavioral

PVI is a 6-week virtual programme aimed at building up young stroke survivors' personal resources for work through engaging in inclusive volunteering activities.

Usual Care

Other

Usual stroke care services include medical and health services offered by the hospitals or community-based organisations.

Primary outcomes

  1. Change in the level of perceived work ability

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

    The Work Ability Index (Chinese version) will assess participants' perceived capability for work. It consists of 7 dimensions about participants' self-reported current work ability compared with the lifetime best. Total score is yielded by summing all items (range: 7-49): poor (7-27), moderate (28-36), good (37-43), and excellent (44-49) work ability.

Secondary outcomes

  1. Change in the level of self-efficacy

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

    The 10-item General Self-Efficacy Scale (GSES) (Chinese version) will assess participants' perceived self-efficacy in coping with stressful life events. Each item is rated on a 4-point scale (1=not at all true to 4=exactly true). Total score is yielded by summing all items (range: 10-40). A higher score indicates higher self-efficacy.

  2. Change in the level of health-related quality of life

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

    Participants' health-related quality of life (HRQoL) will be measured by the 47-item Stroke-Specific Quality of Life Scale (Chinese version). It has 11 domains on physical to psychosocial and participation. Items are scored from 1 (strongly disagree/cannot do it) to 5 (strongly agree/no trouble). Total score is yielded by summing all items (range 47-235). A higher score indicates higher HRQoL.

  3. Change in the level of emotional well-being

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

    The 14-item Hospital Anxiety and Depression Scale (HADS) (Chinese version) will measure participants' emotional well-being. Participants will rate their mood in the past week on a 4-point scale (0=no not at all to 3=yes definitely). It has 2 subscales (anxiety and depression). Subscale score is yielded by summing the relevant item scores (Total=0-21). A higher score indicates higher distress.

  4. Change in the level of social skills

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

    The 12-item Social Skills subscale of Work Personality Profile (Chinese version) will measure participants' interpersonal behaviours as applied to work. Item are rated on a 4-point scale (1=a problem area to 4=a definite strength). Total score is yielded by summing all items (range: 12-48). A higher score indicates greater proficiency in social skills at work.

Study contacts

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

Suzanne Lo

CONTACT

[email protected]

852 3943 4485

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Improving Work Ability of Young Adults With Stroke Through Personal Resource Building and Inclusive Volunteering: A Randomised Controlled Trial

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Jun 13, 2023
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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