Internet-based vestibular rehabilitation for older dizzy adults: does it work? A single blind, three arm, randomised controlled trial in general practice

Dizziness is a common symptom with a high prevalence among older adults. Most
patients are managed in primary care, mainly by reassurance and symptomatic
drugs. Vestibular rehabilitation (VR) is a safe and effective treatment for
peripheral vestibular disease that entails specific exercises with the aim of
maximizing central nervous system compensation for vestibular pathology.
Despite the evidence for VR, the majority of GPs in The Netherlands never uses
VR.

In this study we want to investigate the clinical and cost-effectiveness of
internet-based VR, with and without physiotherapeutic support, for older dizzy
patients in general practice in comparison with usual care. Furthermore, we
want to identify predictors of successful treatment in older dizzy patients
receiving internet-based VR and investigate the experiences of these patients
with internet-based VR.

Firstly, we will perform a single blind, three arm, randomised controlled trial
among patients aged 50 years and over presenting with dizziness in general
practice. 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 six months of follow-up. During
randomisation, patients will be stratified by dizziness severity. Previously,
the effectiveness and safety of internet-based VR was investigated by Yardley
et al. of the University of Southampton. With permission of the NHS Research
Ethics Committee, the study showed internet-based VR to be effective without
serious adverse events. Our study will take place in close collaboration with
professor Yardley and the University of Southampton. We will use a translated
Dutch version of the British online intervention. Secondly, we will perform an
additional analysis on the data to identify predictors of successful treatment
in the same population. Thirdly, we will perform a qualitative study among a
random sample of 20-30 dizzy patients aged 50 years and over by performing
semi-structured face-to-face interviews to investigate patients* experiences of
internet-based VR (with and without physiotherapeutic support).

Patients in the first trial arm will receive stand-alone internet-based VR.
This intervention is a translated Dutch version of the British intervention
that showed to be safe and effective. The intervention entails six sessions
across a 6-week intervention period. In each session, the patient will receive
an individualized set of exercises. Patients are asked to carry out the
exercises for 10 minutes twice a day. In the next session, patients provide the
online intervention with feedback about the exercises. A tailored set of
exercises for the coming week can be created by using this feedback. Patients
in the second trial arm will receive internet-based VR as described above,
completed with two sessions by a trained physiotherapist. The physiotherapist
will provide information about the background of dizziness and VR, elicit and
address doubts and concerns about dizziness and VR. He/she will also teach the
patient how to use the online intervention, describe and take the patient
through a set of VR exercises and provide support while encouraging adherence.
Internet-based VR will be offered to patients in the first and second group in
addition to usual GP care. Patients in the third trial arm will solely receive
usual care delivered by their GPs, which consists of treatment of dizziness
according to the guideline of the Dutch College of GPs.

All patients will be asked to complete a questionnaire at baseline, 3 months
follow-up, and 6 months follow-up. The time required to fill out these
questionnaires will be approximately 35 minutes per questionnaire. The data of
this research project will be collected online, using the software of
LifeGuide. Several successful internet-based intervention trials using
LifeGuide have been performed and published in high-impact scientific journals.
LifeGuide has been proven to be a safe and reliable instrument. Privacy
settings ensure that all data is coded and only accessible to the research team
((https://www.lifeguideonline.org/publications/index) ( see Williams, S.,
Yardley, L., Weal, M. and Wills, G (2010) Introduction to LifeGuide:
Open-source Software for Creating Online Interventions for Health Care, Health
Promotion and Training. In
proceedings Med-e-tel: Global Telemedicine and eHealth Updates: Knowledge
Resources.Luxembourg,LU, 187-190.). Patients in the first and second trial arm
(n=200) are asked to perform exercises (shake their head; shake their head with
eyes closed; shake their head while staring at a fixed point in front of them;
nod; nod with their eyes closed; nod while staring at a fixed point in front of
them) twice a day for 10 minutes, and note how dizzy each exercise makes them
feel. Through automatic feedback a tailored set of exercises is created. To
collect this feedback, patients are asked to log in to LifeGuide once a week
during the 6 week intervention period. The second trial arm will receive a
physiotherapeutic session in week one and three of the 6-week intervention
period, which will last for 45 minutes each. In these sessions patients will
practice the exercises together with the physiotherapist. In addition to this,
concerns about VR will be discussed and patients will be encouraged to continue
the exercises. A small group of patients from the first (n=10-15) and second
(n=10-15) trial arm will be asked to participate in a semi-structured
face-to-face interview. All 300 patients will receive usual GP care; care will
not be restricted in any way. There are no major medical health risks for
participants in this study. Earlier trials for vestibular rehabilitation were
approved by different ethics committees and demonstrated no serious adverse
events. More specifically, no serious adverse events were reported during the
trial of Yardley et al, i.e. the English version of the online intervention we
will investigate. Vestibular rehabilitation can be regarded as a safe treatment
for this target population. The experimental group (trial arm 1 and 2) might
benefit from the intervention by a reduction of impairment due to dizziness
and/or a decrease in dizziness frequency. Patients in the control group (trial
arm 3) will be offered access to the online intervention after completing the
follow-up period (6 months). By doing so, they might also benefit from the same
reduction of dizziness symptoms.