Improving Work Ability of Young Adults With Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05902195
• Other study ID #: PVI
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: June 2024
• Source: Chinese University of Hong Kong
• Contact: Suzanne Lo
• Phone: 852 3943 4485
• Email: suzannelo[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Personal Resource Building and Inclusive Volunteering Intervention (PVI)
PVI is a 6-week virtual programme aimed at building up young stroke survivors' personal resources for work through engaging in inclusive volunteering activities.

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

Locations

Country	Name	City	State
Hong Kong	Suzanne Lo	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the level of perceived work ability	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.	Change from baseline level to three months after completion of the intervention
Secondary	Change in the level of self-efficacy	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.	Change from baseline level to three months after completion of the intervention
Secondary	Change in the level of health-related quality of life	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.	Change from baseline level to three months after completion of the intervention
Secondary	Change in the level of emotional well-being	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.	Change from baseline level to three months after completion of the intervention
Secondary	Change in the level of social skills	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.	Change from baseline level to three months after completion of the intervention