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Improving Work Ability of Young Adults With Stroke

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Personal Resource Building and Inclusive Volunteering Intervention (PVI)
Usual care
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stroke focused on measuring Return to work

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Suzanne LoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Personal Resource Building and Inclusive Volunteering Intervention (PVI)

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 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 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 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.

Full Information

First Posted
June 5, 2023
Last Updated
June 5, 2023
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05902195
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Return to work

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A 2-arm, assessor-blind, randomised controlled trial will be conducted.
Masking
Outcomes Assessor
Masking Description
Assessor-blinded.
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Personal Resource Building and Inclusive Volunteering Intervention (PVI)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Personal Resource Building and Inclusive Volunteering Intervention (PVI)
Intervention Description
PVI is a 6-week virtual programme aimed at building up young stroke survivors' personal resources for work through engaging in inclusive volunteering activities.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Usual stroke care services include medical and health services offered by the hospitals or community-based organisations.
Primary Outcome Measure Information:
Title
Change in the level of perceived work ability
Description
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.
Time Frame
Change from baseline level to three months after completion of the intervention
Secondary Outcome Measure Information:
Title
Change in the level of self-efficacy
Description
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.
Time Frame
Change from baseline level to three months after completion of the intervention
Title
Change in the level of health-related quality of life
Description
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.
Time Frame
Change from baseline level to three months after completion of the intervention
Title
Change in the level of emotional well-being
Description
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.
Time Frame
Change from baseline level to three months after completion of the intervention
Title
Change in the level of social skills
Description
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.
Time Frame
Change from baseline level to three months after completion of the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suzanne Lo
Phone
852 3943 4485
Email
suzannelo@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Lo
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Suzanne Lo
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzanne Lo
Phone
852 3943 4485
Email
suzannelo@cuhk.edu.hk

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The dataset will become available upon completion of the study upon written request made to the Principal Investigator.
IPD Sharing Time Frame
The data will become available upon completion of the study upon written request made to the Principal Investigator and for one year.
IPD Sharing Access Criteria
The data will become available upon completion of the study upon written request made to the Principal Investigator.

Learn more about this trial

Improving Work Ability of Young Adults With Stroke

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