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临床试验/NCT05902195
NCT05902195招募中不适用

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

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2023年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
160
试验地点
1
主要终点
Change in the level of perceived work ability

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

Assessor-blinded.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

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.

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

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.

干预措施: Usual care (Other)

结局指标

主要结局

Change in the level of perceived work ability

时间窗: 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.

次要结局

  • 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 social skills(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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Suzanne HS Lo

Assistant Professor

Chinese University of Hong Kong

研究点 (1)

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