Improving Work Ability of Young Adults With Stroke

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Recruiting
CT.gov ID
NCT05902195
Collaborator
(none)
160
1
2
29.9
5.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Personal Resource Building and Inclusive Volunteering Intervention (PVI)
  • Other: Usual care
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A 2-arm, assessor-blind, randomised controlled trial will be conducted.A 2-arm, assessor-blind, randomised controlled trial will be conducted.
Masking:
Single (Outcomes Assessor)
Masking Description:
Assessor-blinded.
Primary Purpose:
Health Services Research
Official Title:
Improving Work Ability of Young Adults With Stroke Through Personal Resource Building and Inclusive Volunteering: A Randomised Controlled Trial
Actual Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Jun 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Personal Resource Building and Inclusive Volunteering Intervention (PVI)

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

Active Comparator: Control

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

Outcome Measures

Primary Outcome Measures

  1. Change in the level of perceived work ability [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 Outcome Measures

  1. Change in the level of self-efficacy [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Suzanne Lo Hong Kong Hong Kong

Sponsors and Collaborators

  • Chinese University of Hong Kong

Investigators

  • Principal Investigator: Suzanne Lo, Chinese University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Suzanne HS Lo, Assistant Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT05902195
Other Study ID Numbers:
  • PVI
First Posted:
Jun 13, 2023
Last Update Posted:
Jun 13, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Suzanne HS Lo, Assistant Professor, Chinese University of Hong Kong
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 13, 2023