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

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

doi:10.1136/bmjopen-2016-015479

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

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

Health Economics and Health Technology Assessment

Research output: Contribution to Journal › Article › Academic › peer-review

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.

Original language	English
Article number	e015479
Pages (from-to)	e015479
Journal	BMJ Open
Volume	7
Issue number	1
DOIs	https://doi.org/10.1136/bmjopen-2016-015479
Publication status	Published - 20 Jan 2017

Funding

This study was funded by ZonMw (programma Kwaliteit van Zorg: Versnellen, verbreden, vernieuwen; grant number 839110015). The results of the study will be submitted for publication to peer-reviewed scientific journals. There are no restrictions placed on publication by ZonMw.

Funders	Funder number
Economic and Social Research Council	ES/F029624/1
ZonMw	839110015

Keywords

Aged
Aged, 80 and over
Clinical Protocols
Dizziness
Exercise Therapy
Female
Humans
Internet
Journal Article
Male
Middle Aged
Physical Therapy Modalities
Postural Balance
Randomized Controlled Trial
Research Design
Research Support, Non-U.S. Gov't
Treatment Outcome
Vertigo
Vestibular Diseases
Vestibule, Labyrinth

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1136/bmjopen-2016-015479

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Cite this

van Vugt, V. A., van der Wouden, J. C., Bosmans, J. E., Smalbrugge, M., van Diest, W., Essery, R., Yardley, L., van der Horst, H. E., & Maarsingh, O. R. (2017). 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. BMJ Open, 7(1), e015479. Article e015479. https://doi.org/10.1136/bmjopen-2016-015479

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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.",

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author = "{van Vugt}, {Vincent A} and {van der Wouden}, {Johannes C} and Bosmans, {Judith E} and Martin Smalbrugge and {van Diest}, Willianne and Rosie Essery and Lucy Yardley and {van der Horst}, {Henri{\"e}tte E} and Maarsingh, {Otto R}",

note = "Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.",

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van Vugt, VA, van der Wouden, JC, Bosmans, JE, Smalbrugge, M, van Diest, W, Essery, R, Yardley, L, van der Horst, HE & Maarsingh, OR 2017, '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', BMJ Open, vol. 7, no. 1, e015479, pp. e015479. https://doi.org/10.1136/bmjopen-2016-015479

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. / van Vugt, Vincent A; van der Wouden, Johannes C; Bosmans, Judith E et al.
In: BMJ Open, Vol. 7, No. 1, e015479, 20.01.2017, p. e015479.

Research output: Contribution to Journal › Article › Academic › peer-review

TY - JOUR

T1 - Guided and unguided internet-based vestibular rehabilitation versus usual care for dizzy adults of 50 years and older

T2 - a protocol for a three-armed randomised trial

AU - van Vugt, Vincent A

AU - van der Wouden, Johannes C

AU - Bosmans, Judith E

AU - Smalbrugge, Martin

AU - van Diest, Willianne

AU - Essery, Rosie

AU - Yardley, Lucy

AU - van der Horst, Henriëtte E

AU - Maarsingh, Otto R

N1 - Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

PY - 2017/1/20

Y1 - 2017/1/20

N2 - 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.

AB - 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.

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KW - Aged, 80 and over

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KW - Dizziness

KW - Exercise Therapy

KW - Female

KW - Humans

KW - Internet

KW - Journal Article

KW - Male

KW - Middle Aged

KW - Physical Therapy Modalities

KW - Postural Balance

KW - Randomized Controlled Trial

KW - Research Design

KW - Research Support, Non-U.S. Gov't

KW - Treatment Outcome

KW - Vertigo

KW - Vestibular Diseases

KW - Vestibule, Labyrinth

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