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临床试验/NCT03741842
NCT03741842已完成不适用

"COMBO-KEY" (Coaching Ongoing Momentum Building On stroKe rEcovery journeY) - A Home Visiting and Phone Coaching Programme to Promote Stroke Survivors' Recovery: A Territory-wide Project

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
134
试验地点
1
主要终点
Change in the level of self-efficacy in performing daily functional activities and self management

研究概览

简要总结

Building confidence and capabilities to transfer rehabilitative knowledge and skills into lifestyle-workable strategies for changing health behaviours among stroke survivors are important to optimise health outcomes and reduce risks of recurrent stroke. The aim of this project is to promote stroke survivors' health by building confidence and positive expectations of recovery outcomes, and enabling their engagement in stroke self-management behaviours.

详细描述

A randomised controlled trial will be conducted to determine the effectiveness of a programme "Coaching Ongoing Momentum Building On stroKe rEcovery journeY" ("COMBO-KEY"), a home visiting and phone coaching programme, on community-dwelling stroke survivors' self-efficacy, outcome expectation, and engagement in stroke self-management behaviours. An estimated sample of 134 stroke survivors will be recruited. COMBO-KEY will be underpinned by Bandura's constructs of self-efficacy and outcome expectation. It will be delivered by trained coaches. Outcomes will be measured at baseline and immediately after completion of the programme. Generalised estimating equations model will be used to assess the differential changes in outcome variables from pre-test to post-test between the intervention and control groups with adjustment for their baseline levels.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinically diagnosed with stroke
  • 18 years old or above
  • Community dwelling
  • Have a modified Rankin Scale score equal to or greater than 3 (moderate to severe disability)
  • Have a Montreal Cognitive Assessment score >20

排除标准

  • Have severe dysphasia
  • Are diagnosed with a mental illness

结局指标

主要结局

Change in the level of self-efficacy in performing daily functional activities and self management

时间窗: Change from baseline level to immediately after completion of the intervention

The 13-item Chinese version of the Stroke Self-Efficacy Questionnaire will be used. The items assess the stroke survivors' confidence in performing self-management behaviours over a 0-no confidence to 10-very confident points scale. All item scores are summed (total 0-130). Higher scores indicate higher self-efficacy.

次要结局

  • Level of goal attainment (Participants in the intervention group)(Immediately after completion of the intervention)
  • Change in the level of outcome expectation of stroke self-management behaviours(Change from baseline level to immediately after completion of the intervention)
  • Change in the level of health-related quality of life(Change from baseline level to immediately after completion of the intervention)
  • Change in the level of satisfaction with performance of stroke self-management behaviours(Change from baseline level to immediately after completion of the intervention)
  • Change in the level of community reintegration(Change from baseline level to immediately after completion of the intervention)
  • Satisfaction with the programme (Participants in the intervention group)(Immediately after completion of the intervention)
  • Change in the level of depressive symptoms(Change from baseline level to immediately after completion of the intervention)
  • Usage of the resource package (Participants in the intervention group)(Immediately 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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