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护士主导的同伴支持干预对脑卒中幸存者影响的随机对照试验方案。

Effects of a nurse-led peer support intervention for stroke survivors: protocol for a randomised controlled trial.

机构信息

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

School of Nursing, Yangzhou University, Yangzhou, China.

出版信息

BMJ Open. 2022 Jun 10;12(6):e062531. doi: 10.1136/bmjopen-2022-062531.

Abstract

INTRODUCTION

Many stroke survivors have unmet psychosocial needs during the recovery phase following a stroke. There is emerging evidence that peer support interventions may play a valuable role in managing stroke. However, evidence regarding the effectiveness of peer support interventions on the psychosocial outcomes of stroke survivors is uncertain. This study aims to develop a nurse-led peer support intervention for stroke survivors based on the Person-Environment-Occupation-Performance Model and evaluate its effects on the psychosocial outcomes of stroke survivors.

METHODS AND ANALYSIS

This is an assessor-blinded two-arm randomised controlled trial. A convenience sample of 120 stroke survivors will be recruited from two community centres and one rehabilitation unit in Yangzhou, a medium-sized city in eastern China, with 60 participants each in the intervention and control groups. The participants allocated to the intervention group will receive the nurse-led peer support intervention, which includes 6 weekly peer support sessions facilitated by a nurse and at least one peer facilitator. Participants randomised to the control group will receive the same dose of interpersonal interaction as intervention participants, including weekly individual face-to-face session for 6 weeks. The primary outcomes are social participation and participation self-efficacy. The secondary outcomes are psychosocial distress, social support, stigma towards disease, self-efficacy in managing chronic conditions and quality of life. Data will be collected at baseline, immediately after the intervention and 3 months after the intervention. A process evaluation will be conducted qualitatively and quantitively to examine the mechanism by which the intervention impacts the psychosocial outcomes of stroke survivors. All outcomes will be analysed following the intention to treat principle. Generalised Estimation Equation models will be used to assess the intervention effect.

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.: 2021.196-T). All participants will be required to provide written informed consent. Results of the study will be disseminated through publication in peer-reviewed journals and presentation at local or international conferences.

TRIAL REGISTRATION NUMBER

ChiCTR2100050853.

摘要

简介

许多中风幸存者在中风后康复阶段存在未满足的心理社会需求。有新证据表明,同伴支持干预措施可能在管理中风方面发挥重要作用。然而,关于同伴支持干预对中风幸存者心理社会结局的有效性的证据尚不确定。本研究旨在基于人-环境-作业-表现模型为中风幸存者制定一项护士主导的同伴支持干预,并评估其对中风幸存者心理社会结局的影响。

方法和分析

这是一项评估者盲法、双臂随机对照试验。将从中国东部中等城市扬州的两个社区中心和一个康复病房招募 120 名中风幸存者的便利样本,每组 60 名参与者,分别为干预组和对照组。分配到干预组的参与者将接受护士主导的同伴支持干预,包括由护士和至少一名同伴促进者主持的 6 次每周同伴支持会议。随机分配到对照组的参与者将接受与干预组相同剂量的人际互动,包括 6 周每周一次的个人面对面会议。主要结局是社会参与和参与自我效能感。次要结局是心理困扰、社会支持、疾病污名化、管理慢性病的自我效能感和生活质量。数据将在基线、干预后立即和干预后 3 个月收集。将进行定性和定量的过程评估,以检验干预对中风幸存者心理社会结局影响的机制。所有结局都将按照意向治疗原则进行分析。广义估计方程模型将用于评估干预效果。

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:2021.196-T)的批准。所有参与者都将被要求提供书面知情同意。研究结果将通过发表在同行评议的期刊和在当地或国际会议上的演讲来传播。

试验注册号

ChiCTR2100050853。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7285/9189841/b22e34d6a05e/bmjopen-2022-062531f01.jpg

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