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基于互联网的有指导与无指导前庭康复治疗与常规护理对50岁及以上头晕成年人的疗效比较:一项三臂随机试验方案

Guided and unguided internet-based vestibular rehabilitation versus usual care for dizzy adults of 50 years and older: a protocol for a three-armed randomised trial.

作者信息

van Vugt Vincent A, van der Wouden Johannes C, Bosmans Judith E, Smalbrugge Martin, van Diest Willianne, Essery Rosie, Yardley Lucy, van der Horst Henriëtte E, Maarsingh Otto R

机构信息

Department of General Practice & Elderly Care Medicine, Amsterdam Public Health research institute, VU University Medical Center, Amsterdam, The Netherlands.

Department of Health Sciences, Faculty of Earth and Life Sciences, Amsterdam Public Health research institute, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.

出版信息

BMJ Open. 2017 Jan 20;7(1):e015479. doi: 10.1136/bmjopen-2016-015479.

Abstract

INTRODUCTION

Dizziness is a common symptom in general practice with a high prevalence among older adults. The most common cause of dizziness in general practice is peripheral vestibular disease. Vestibular rehabilitation (VR) is a safe and effective treatment for peripheral vestibular disease that entails specific exercises to maximise the central nervous system compensation for the effects of vestibular pathology. An internet-based VR intervention has recently been shown to be safe and effective. Online interventions are low cost and easily accessible, but prone to attrition and non-adherence. A combination of online and face-to-face therapy, known as blended care, may balance these advantages and disadvantages.

METHODS AND ANALYSIS

A single-blind, three-arm, randomised controlled trial among patients aged 50 years and over presenting with dizziness of vestibular origin in general practice will be performed. In this study, we will compare the clinical and cost-effectiveness of stand-alone internet-based VR and internet-based VR with physiotherapeutic support ('blended care') with usual care during 6 months of follow-up. We will use a translated Dutch version of a British online VR intervention. Randomisation will be stratified by dizziness severity. The primary outcome measure is the Vertigo Symptoms Scale-Short Form. Intention-to-treat analysis will be performed, adjusting for confounders. The economic evaluation will be conducted from a societal perspective. We will perform an additional analysis on the data to identify predictors of successful treatment in the same population to develop a clinical decision rule for general practitioners.

ETHICS AND DISSEMINATION

The ethical committee of the VU University Medical Center approved ethics and dissemination of the study protocol. The insights and results of this study will be widely disseminated through international peer-reviewed journals and conference presentations.

TRIAL REGISTRATION NUMBER

Pre-results, NTR5712.

摘要

引言

头晕是全科医疗中的常见症状,在老年人中患病率很高。全科医疗中头晕最常见的原因是外周前庭疾病。前庭康复(VR)是治疗外周前庭疾病的一种安全有效的方法,需要进行特定的锻炼,以使中枢神经系统对前庭病变的影响进行最大程度的代偿。最近一项基于互联网的VR干预已被证明是安全有效的。在线干预成本低且易于获得,但容易出现人员流失和不依从的情况。在线和面对面治疗相结合,即混合护理,可能会平衡这些优缺点。

方法与分析

将对年龄在50岁及以上、因前庭性头晕前来全科医疗就诊的患者进行一项单盲、三臂随机对照试验。在本研究中,我们将比较单纯基于互联网的VR以及基于互联网的VR与物理治疗支持(“混合护理”)与常规护理在6个月随访期间的临床效果和成本效益。我们将使用一个翻译后的荷兰语版本的英国在线VR干预。随机分组将按头晕严重程度进行分层。主要结局指标是眩晕症状量表简表。将进行意向性分析,并对混杂因素进行调整。经济评估将从社会角度进行。我们将对数据进行额外分析,以确定同一人群中成功治疗预测因素,从而为全科医生制定临床决策规则。

伦理与传播

阿姆斯特丹自由大学医学中心伦理委员会批准了本研究方案的伦理和传播事宜。本研究的见解和结果将通过国际同行评审期刊和会议报告广泛传播。

试验注册号

预结果,NTR5712。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/209f/5253547/bb6d0ea9e56e/bmjopen2016015479f01.jpg

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