Improving Work Ability of Young Adults With Stroke

NCT05902195 | Recruiting DMC

• 1 other identifier: PVI
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Return to work

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in the level of self-efficacy

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

• Change in the level of health-related quality of life

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

• Change in the level of emotional well-being

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

• Change in the level of social skills

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

Study Arms (2)

Personal Resource Building and Inclusive Volunteering Intervention (PVI)

EXPERIMENTAL

All participants in the intervention group will receive the intervention (PVI) in addition to usual care. PVI is a 6-week virtual programme aimed at building up young stroke survivors' personal resources for work through engaging in inclusive volunteering activities.

Behavioral: Personal Resource Building and Inclusive Volunteering Intervention (PVI)

Control

ACTIVE COMPARATOR

All participants in the control group will receive usual stroke care services such as medical or health services offered by the hospitals or community-based organisations.

Other: Usual care

Interventions

Usual care OTHER

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

Control

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.

Personal Resource Building and Inclusive Volunteering Intervention (PVI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Suzanne Lo

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Suzanne Lo

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suzanne Lo

CONTACT

852 3943 4485; suzannelo@cuhk.edu.hk

Study Design

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

Model Details: A 2-arm, assessor-blind, randomised controlled trial will be conducted.

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 13, 2023
• Study Start: January 1, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: The data will become available upon completion of the study upon written request made to the Principal Investigator and for one year.
• Access Criteria: The data will become available upon completion of the study upon written request made to the Principal Investigator.

Locations

HK (1)