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Идёт набор NCT05902195

Improving Work Ability of Young Adults With Stroke

Без фазы С лечением Stroke

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Personal Resource Building and Inclusive Volunteering Intervention (PVI), Usual care.
Кому может быть актуально
Состояния в реестре: Stroke. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Гонконг
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

  • Change in the level of perceived work ability [Срок оценки: Change from baseline level to three months after completion of the intervention]
Вторичные конечные точки (4)
  • Change in the level of self-efficacy [Срок оценки: Change from baseline level to three months after completion of the intervention]
  • Change in the level of health-related quality of life [Срок оценки: Change from baseline level to three months after completion of the intervention]
  • Change in the level of emotional well-being [Срок оценки: Change from baseline level to three months after completion of the intervention]
  • Change in the level of social skills [Срок оценки: Change from baseline level to three months after completion of the intervention]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Организация здравоохранения

Центры проведения

Гонконг · 1 центр
  • Suzanne Lo — Гонконг

Идентификаторы

NCT: NCT05902195 · PVI

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗