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临床试验/NCT02648750
NCT02648750已完成不适用

A Stroke Self-Management Programme Delivered by Rehabilitation Assistants Within an Early Supported Discharge Service: A Feasibility Randomised Controlled Trial

Jenny Freeman0 个研究点目标入组 15 人开始时间: 2015年6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
已完成
发起方
入组人数
15
主要终点
Change from baseline Stroke Self-Efficacy Scale at 6 weeks

研究概览

简要总结

This feasibility study evaluates whether it is possible to run a larger scale study to investigate the use of a self-management programme with adults who have recently had a stroke. Half of the participants will receive support with self-management from stroke therapists, while the other half will receive it from rehabilitation assistants.

详细描述

Supporting self-management post-stroke is a key priority in healthcare policy, but not yet embedded into the provision of stroke rehabilitation. Barriers to implementation include time and resource. The feasibility of using the Bridges Stroke Self-Management Programme within an Early Supported Discharge Service and delivery by Rehabilitation Assistants is unknown.

The aim of this study was to evaluate key trial parameters to inform the protocol of a future definitive trial into the effectiveness of Bridges delivered by rehabilitation assistants within an Early Supported Discharge Service.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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
否

入选标准

  • •Clinical diagnosis of new stroke
  • •Being referred to the ESD service
  • •Medically stable
  • •Able to give informed consent
  • •Can follow a two-stage command

排除标准

  • •Being discharged to a care home

研究组 & 干预措施

Rehabilitation Assistant

Experimental

Bridges stroke self-management programme. Delivered by rehabilitation assistants. Participants will receive a minimum of 4 sessions over a 4-6 week period.

干预措施: Bridges self-management programme (Behavioral)

Therapist

Active Comparator

Bridges stroke self-management programme. Delivered by registered stroke therapists (Occupational therapists or physiotherapists).

Participants will receive a minimum of 4 sessions over a 4-6 week period.

干预措施: Bridges self-management programme (Behavioral)

结局指标

主要结局

Change from baseline Stroke Self-Efficacy Scale at 6 weeks

时间窗: Baseline and 6 weeks

次要结局

  • Change from baseline PHQ-9 at 6 weeks(Baseline and 6 weeks)
  • Change from baseline Modified Rivermead Mobility Index at 6 weeks(Baseline and 6 weeks)
  • Change from baseline EQ5D at 6 weeks(Baseline and 6 weeks)
  • Change from baseline SIPSO at 6 weeks(Baseline and 6 weeks)

研究者

发起方
Jenny Freeman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jenny Freeman

Reader in Physiotherapy and Rehabilitation

University of Plymouth

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