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临床试验/NCT04560140
NCT04560140招募中不适用

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

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 208 人开始时间: 2021年9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
208
试验地点
1
主要终点
Change in the participants' level of community reintegration

研究概览

简要总结

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.

详细描述

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.

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)

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • (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.

排除标准

  • 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.

研究组 & 干预措施

Usual care group

No Intervention

Participants will receive usual stroke care.

Intervention group

Experimental

Eligible participants will be randomly assigned to receive usual care with the novel 24-week Narrative and Skills-building Intervention.

干预措施: Narrative and Skills-building Intervention (Behavioral)

结局指标

主要结局

Change in the participants' level of community reintegration

时间窗: Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) after completion of the intervention

The Chinese version of the Reintegration to Normal Living Index (RNIL-C) will be used to assess the participants' level of community reintegration. It consists of 11 items in eight domains: mobility, self-care, daily work and school activity, recreational and social activities, family roles, personal relationships, presentation of self to others and general coping skills. Participants are asked to rate the extent to which each item describes their situation on a scale from 1 - 'a small extent' to 5 - 'a great extent'. The total score is calculated by summation and normalised to give 100 with a total score range of 25 to 100. A higher score indicates better community reintegration. The RNIL-C has high internal consistency (Cronbach's alpha=0.92) and good convergent validity.

次要结局

  • Change in the participants' level of self-efficacy(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(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(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(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 depressive symptoms(Change from baseline (T0) to immediately (T1), 6 months (T2) and 12 months (T3) 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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