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Идёт набор NCT04560140

Promoting Community Reintegration for 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: Narrative and Skills-building Intervention.
Кому может быть актуально
Состояния в реестре: Stroke. Базовые параметры: 18 лет — 64 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Promoting Community Reintegration Using Narratives and Skills Building for Young Adults With Stroke

Обзор

This project will investigate the effects of a Narrative and Skills-building Intervention on young stroke survivors' community reintegration and psychosocial outcomes. A randomised controlled trial will be conducted. This is a novel trial to test the short and long-term effects of a theory-based intervention on young stroke survivors' community reintegration.

Подробное описание

This project will investigate the effects of a Narrative and Skills-building Intervention on young stroke survivors' community reintegration and psychosocial outcomes. A randomised controlled trial will be conducted. Participants will be facilitated to narrate their survival experiences and rebuild core life skills. Outcomes including community reintegration, depressive symptoms, health-related quality of life, self-efficacy, outcome expectation and satisfaction with performance of self-management behaviours will be measured. This is a novel trial to test the short and long-term effects of a theory-based intervention on young stroke survivors' community reintegration.

Вмешательства

  • Поведенческое Narrative and Skills-building Intervention
    The intervention is grounded in Narrative Theory and Bandura's principles of Self-efficacy and Outcome Expectation. It will consist of eight individual sessions over six months delivered by a facilitator. Participants will be facilitated to narrate their survival experiences and rebuild core life skills.

Первичные конечные точки

  • Change in the participants' level of community reintegration [Срок оценки: Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention]
Вторичные конечные точки (5)
  • Change in the participants' level of depressive symptoms [Срок оценки: Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention]
  • Change in the participants' level of health-related quality of life [Срок оценки: Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention]
  • Change in the participants' level of satisfaction with the performance of self-management behaviours [Срок оценки: Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention]
  • Change in the participants' level of self-efficacy [Срок оценки: Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention]
  • Change in the participants' level of outcome expectation [Срок оценки: Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention]

Критерии участия

Критерии включения

  • (1) are 18-64 years of age,
  • (2) have a clinical diagnosis of first-ever or recurrent ischaemic or haemorrhagic stroke,
  • (3) are living at home after discharge from hospital,
  • (4) have a Montreal Cognitive Assessment score >20,
  • (5) have a modified Rankin Scale score ≥3,
  • (6) can communicate in Cantonese, and
  • (7) are able to attend all intervention sessions.

Критерии исключения

  • 1\) transient ischaemic attack, subdural or epidural haemorrhage,
  • 2\) experienced cerebrovascular events due to tumours or head trauma,
  • 3\) mental condition such as depression, schizophrenia, bipolar or personality disorder,
  • 4\) incomprehensible speech or difficulty in comprehending conversations, or
  • 5\) have received a self-management programme in the past.

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

Публикации

  • Lo SHS, Chau JPC, Choi KC, Shum EWC, Yeung JHM, Li SH. Promoting community reintegration using narratives and skills building for young adults with stroke: a protocol for a randomised controlled trial. BMC Neurol. 2021 Jan 4;21(1):3. doi: 10.1186/s12883-020-02015-5. PMID 33397316

Идентификаторы

NCT: NCT04560140 · NSI

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗