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虚拟多学科卒中护理诊所对社区居住卒中幸存者和照护者的效果和成本效益:一项随机对照试验方案。

Effectiveness and cost-effectiveness of a virtual multidisciplinary stroke care clinic for community-dwelling stroke survivors and caregivers: a randomised controlled trial protocol.

机构信息

The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong.

School of Pharmacy, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong.

出版信息

BMJ Open. 2019 May 10;9(5):e026500. doi: 10.1136/bmjopen-2018-026500.

Abstract

INTRODUCTION

The virtual multidisciplinary stroke care clinic (VMSCC) is the first nurse-led clinic developed to offer support to community-dwelling stroke survivors and caregivers, and to promote poststroke recovery. This two-arm randomised controlled trial will evaluate its effectiveness on survivors' self-efficacy (SE), survivors' and caregivers' health-related quality of life (HRQoL) and cost-effectiveness on emergency admissions and length of readmission hospital stay.

METHODS AND ANALYSIS

A consecutive sample of 384 stroke survivor-caregiver dyads will be recruited from four hospitals. An online platform that embraces readily accessible and reliable information will be developed. Participants randomly assigned to the intervention group will receive usual care plus the VMSCC service. The service includes access to a tablet containing 30 videos demonstrating appropriate self-care strategies, communication with a registered nurse monthly through video and telephone calls and regular blood pressure monitoring. Primary outcomes include survivors' SE in self-management and survivors' and caregivers' HRQoL. Secondary outcomes include survivors' performance of self-management behaviours, depression and social participation; and caregivers' coping strategies, satisfaction with caring and depression. Data will be collected at baseline, and at 3 and 6 months after commencing the intervention. Survivors' and caregivers' satisfaction with the service will be assessed at 6-month follow-up. Multivariable regressions and generalised estimating equations model will be conducted. Survivors' emergency admissions and length of hospital stay will be evaluated during the 6-month follow-up period. Cost-effectiveness analysis will be performed on the average total cost incurred.

DISCUSSION

The results will inform stakeholders about incorporating the VMSCC service into current stroke rehabilitation service.

ETHICS AND DISSEMINATION

This protocol was approved by the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (CREC Ref. No.: 2017.660). All participants will provide written informed consent. Results will be disseminated through scientific publications, and presentations at local and international conferences.

TRIAL REGISTRATION NUMBER

ChiCTR1800016101; Pre-results.

摘要

简介

虚拟多学科卒中护理诊所(VMSCC)是首个由护士主导的诊所,旨在为社区居住的卒中幸存者及其照护者提供支持,并促进卒中后康复。本项两臂随机对照试验将评估其对幸存者自我效能(SE)、幸存者及其照护者健康相关生活质量(HRQoL)的影响,以及对急诊入院和再入院住院时间的成本效益。

方法和分析

将从四家医院连续招募 384 例卒中幸存者-照护者对。将开发一个在线平台,包含易于获取和可靠的信息。随机分配至干预组的参与者将接受常规护理加 VMSCC 服务。该服务包括使用平板电脑观看 30 个视频,演示适当的自我护理策略,每月通过视频和电话与注册护士进行一次交流,以及定期监测血压。主要结局包括幸存者自我管理中的 SE 和幸存者及其照护者的 HRQoL。次要结局包括幸存者自我管理行为、抑郁和社会参与情况;以及照护者的应对策略、照护满意度和抑郁情况。将在基线、干预开始后 3 个月和 6 个月收集数据。在 6 个月随访时评估幸存者及其照护者对服务的满意度。将进行多变量回归和广义估计方程模型分析。将在 6 个月随访期间评估幸存者的急诊入院和住院时间。将对所产生的平均总成本进行成本效益分析。

讨论

结果将为利益相关者提供有关将 VMSCC 服务纳入当前卒中康复服务的信息。

伦理和传播

本方案已获得香港中文大学-新界东联网临床研究伦理委员会(CREC 编号:2017.660)批准。所有参与者将提供书面知情同意。结果将通过科学出版物以及在本地和国际会议上的演讲进行传播。

试验注册号

ChiCTR1800016101;预注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cbbe/6530406/0bc05954c443/bmjopen-2018-026500f01.jpg

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