一项针对多发性硬化症患者的基于在线群组的跌倒预防自我管理计划——[计划名称]的有效性：一项随机对照试验方案

Effectiveness of , an online group-based self-management fall prevention programme for people with multiple sclerosis: protocol of a randomised controlled trial.

作者信息

Tuvemo Johnson Susanna, Flink Maria, Gottberg Kristina, Walker Peterson Elizabeth, Meijer Ulrika, Bylinder Johanna, Kierkegaard Marie, Ytterberg Charlotte

机构信息

Department of Neurobiology, Care Science and Society, Karolinska Institutet, Stockholm, Sweden

Department of Women's and Childrens Health, Uppsala University, Uppsala, Sweden.

出版信息

BMJ Open. 2025 Jan 6;15(1):e089217. doi: 10.1136/bmjopen-2024-089217.

DOI:10.1136/bmjopen-2024-089217

PMID:39762097

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11749722/

Abstract

INTRODUCTION

is a manualised self-management fall prevention programme co-developed for and with ambulatory and non-ambulatory people with multiple sclerosis (PwMS). Findings from a feasibility study indicate the necessity of a full-scale randomised controlled trial (RCT).

METHODS AND ANALYSIS

A parallel-group RCT with a mixed methods process evaluation as well as a cost-effectiveness evaluation will be conducted. We aim to recruit 240 PwMS, who will be stratified by ambulation level and randomised 1:1 in blocks of eight to intervention or control. The group-based self-management fall prevention intervention involves eight 2-hour online synchronous sessions (approximately eight participants/group) facilitated by a licensed healthcare professional and home assignments to be completed by participants between sessions. The setting is online, and participants can be located anywhere in Sweden. The control and intervention groups will also receive a brochure on fall risk factors and fall prevention in addition to their standard MS care and rehabilitation. Data collection will be performed at baseline and 3, 6 and 12 months after the start of the intervention. Falls will be monitored via a short message service every week during 1 year from the start of the intervention. The primary outcome is fall frequency (falls/person/year). Secondary outcomes include injurious falls, falls control, fear of falling, falls self-efficacy, activity curtailment, perceived effect of MS, self-rated health and cost-effectiveness.

ETHICS AND DISSEMINATION

Ethical approval has been obtained from the Swedish Ethical Review Authority (registration numbers 2022-06667-01 and 2023-07723-02). The RCT will adhere to the Declaration of Helsinki. Written consent to participate will be obtained from all participants. Study-related information about participants will be stored securely at Karolinska Institutet. The results will be presented in peer-reviewed journals, through the patient organisation Neuro Sweden, at conferences, and in social media.

TRIAL REGISTRATION NUMBER

ClinicalTrials.gov, NCT05789225.

摘要

介绍

是一项为患有多发性硬化症的非卧床和卧床患者共同开发并与之合作的手动自我管理跌倒预防计划。一项可行性研究的结果表明有必要进行全面的随机对照试验（RCT）。

方法与分析

将进行一项平行组随机对照试验，同时进行混合方法过程评估以及成本效益评估。我们的目标是招募240名患有多发性硬化症的患者，他们将根据行走能力水平进行分层，并以1:1的比例随机分成每组8人的小组，分别接受干预或对照。基于小组的自我管理跌倒预防干预包括由持牌医疗保健专业人员主持的八次2小时的在线同步课程（每组约八名参与者），以及参与者在课程之间要完成的家庭作业。活动地点为在线，参与者可以位于瑞典的任何地方。除了标准的多发性硬化症护理和康复外，对照组和干预组还将收到一份关于跌倒风险因素和预防跌倒的手册。数据收集将在基线以及干预开始后的3、6和12个月进行。从干预开始的1年内，每周通过短信服务监测跌倒情况。主要结果是跌倒频率（跌倒次数/人/年）。次要结果包括伤害性跌倒、跌倒控制、跌倒恐惧、跌倒自我效能感、活动减少、多发性硬化症的感知影响、自评健康状况和成本效益。

伦理与传播

已获得瑞典伦理审查局的伦理批准（注册号2022 - 06667 - 01和2023 - 07723 - 02）。该随机对照试验将遵循《赫尔辛基宣言》。将获得所有参与者的书面知情同意。有关参与者的与研究相关信息将安全存储在卡罗林斯卡学院。研究结果将在同行评审期刊上发表，通过患者组织瑞典神经协会、在会议上以及在社交媒体上公布。