Clinical trial NCT02704819: Proof of Concept Study of EMBalance Decision Support System to Evaluate Balance Disorders
Official title: A Decision Support System Incorporating a Validated Patient-specific, Multi-scale Balance Hyper Model Towards Early Diagnostic Evaluation and Efficient Management Plan Formulation of Balance Disorders (EMBalance)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dizziness
Vertigo
Keywords: Decision Support System
Dizziness
Vertigo
Balance
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: National and Kapodistrian University of Athens
name: Universiteit Antwerpen
name: University Hospital Freiburg
First posted: 2016-03-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Balance is crucial for an individual's mobility and independence. Human balance is achieved and maintained by a complex set of sensorimotor systems that include sensory input from vision, proprioception and the vestibular system (motion, equilibrium, spatial orientation). This information is then integrated by the brain. This complexity leads to undiagnosed or mistreated patients with balance disorders for long period which can affect their daily activities.

The EMBalance project is a research project funded by the European Union, involving 10 universities across Europe. Its aim is to create a Decision Support System (DSS) to support doctors in diagnosing and treating balance disorders. It will be available to primary and secondary care doctors of different specialties, levels of training and in different parts of the country.

The DSS will:

* Be used by primary and secondary health care professionals
* Assist the doctor on the evaluation and management of dizzy patients
* Predict how the balance disorder may progress
* Reduce patient waiting time and the onward referrals
* Ensure patients receive prompt and efficient treatment plans

The EMBalance randomised clinical trial (RCT) is a proof-of-concept, multicentre, single-blind, and parallel group study, conducted in Belgium, Germany, Greece and United Kingdom. At present, the question that this study aims to answer is whether the algorithms developed for the EMBalance Platform will yield meaningful information and how these algorithms and platform can be improved, performing an offline comparison of the classical diagnostic approach and the outcome of the EMBalance platform, without any consequence for the patient.

Patients who present with balance related symptoms at primary care will be randomised to either intervention group (non-specialist doctor +DSS) or control group (non-specialist doctor -DSS). An overseeing expert will then confirm the diagnosis and management decisions made by the non-specialist doctors in order to determine whether the use of the DSS can help them in a more precise assessment.

Detailed description: Balance is crucial for an individual's mobility and independence. Dizziness and imbalance symptoms are one of the most common reasons for visits to a doctor and affect up to 30-40% of the population by 60 years of age. The healthcare service provision to address vestibular pathology remains inadequate and is regarded as low priority. The complexity of balance control mechanisms, the lack of medical expertise, and the absence of specialised equipment can be contributory factors to the mismanagement of patients suffering balance disorders. However, the mean number for patient visits to their Health Care providers required to establish a correct diagnosis and start appropriate treatment, both in the US and the UK, is 4.5. The overall socio-economic impact of balance disorders on the affected individual, patient's families as well as the burden on society and the health services is considerable.

Advances in computer science and artificial intelligence have allowed the development of computer systems that support clinical diagnosis or therapeutic and treatment decisions based on individualised patient data. However, a review of existing Decision Support Systems used in Medicine demonstrated there are not many successful integrated software systems or standalone tools that address the early diagnosis and effective management of balance disorders.

All this said, the EMBalance DSS has been developed as a supplementary and supportive tool for non-expert physicians faced with the challenge of addressing vestibular disorders.

The current study will assess the effectiveness of the EMBalance Decision Support System (DSS) for diagnosis and management of balance disorders in a feasibility/proof of concept study. Patients who present with balance related symptoms (specifically vertigo or dizziness exacerbated by head movements) in primary care, will be seen by a non-specialist doctor either with or without the support of the DSS, on a ratio 1:1.

Non-specialist doctors in each participating country are defined as follow:

* UK: General Practitioners
* Germany: Neurology residents
* Belgium \& Greece: ENT residents

Overseeing experts in each participating country are defined as follow:

* UK: Consultant in audiovestibular medicine (AVM)
* Germany: Neurologist
* Belgium \& Greece: ENT specialist with \>10 years expertise in AVM/Neuro-otology

It is anticipated 100 participants will be recruited to each of the two treatment groups, giving a total of 200 participants across Europe. Each participating site in Greece, Belgium, Germany and United Kingdom will recruit 50 patients. Allocation will be performed based on randomisation tables that are produced in advance for each centre.

Statistical data analysis will be performed by the National and Kapodistrian University of Athens. The statistical analysis has been developed by the National and Kapodistrian University of Athens and reviewed by the Institute of Communication and Computer Science (Greece).

Quality and ethical assurance are supervised by the Trial Steering Committee (TSC) and Trial Management Group (TMG)

Eligibility criteria: Inclusion Criteria:

* Be capable of understanding the information provided
* Absence of dementia/uncontrolled psychiatric disorder
* Vertigo or chronic dizziness exacerbated by head movements (\<12 months)
* Sub-acute presentation of dizziness (up to 3 months) without presenting to emergency services

Exclusion Criteria:

* Subjects with learning disability or dementia
* Patients with uncontrolled psychiatric disorders
* Pregnant and breastfeeding women
* Patients' incapable or unwilling to give informed consent.
* Patients with acute vestibular disorders (present at Accident and Emergency).

Primary outcomes:
measure: Percentage of diagnosis agreement
timeFrame: Through study completion, an average of 8 months
measure: Percentage of management plan agreement
timeFrame: Through study completion, an average of 8 months
Secondary outcomes:
measure: Number of initial diagnoses changed after investigations proposed
timeFrame: Through study completion, an average of 8 months
measure: Number of referrals to secondary care needed
timeFrame: Through study completion, an average of 8 months
measure: Name of investigations required for an accurate diagnosis
timeFrame: Through study completion, an average of 8 months
measure: Overall improvement according to the patient (Better, stable, worse)
timeFrame: Change from baseline at 3 months (follow-up)
measure: Overall improvement according to overseeing expert (Better, stable, worse)
timeFrame: Change from baseline at 3 months (follow-up)
measure: Severity of symptoms (Visual Analogue Scale from 1-10 (VAS))
timeFrame: Change from baseline at 3 months (follow-up)
measure: Difficulties regarding dizziness (Dizziness Handicap Inventory questionnaire (DHI))
timeFrame: Change from baseline at 3 months (follow-up)
measure: Quality of life (EQ-5D-3L Questionnaire)
timeFrame: Change from baseline at 3 months (follow-up)
measure: Number of patients not enrolled and/or withdrawn from the trial
timeFrame: Through study completion, an average of 8 months
measure: Reason for exclusion to the trial
timeFrame: Through study completion, an average of 8 months
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
city: Freiburg
country: Germany
facility: Freiburg University Medical Center
city: Athens
country: Greece
facility: Hippocrateio Hospital
Study officials:
affiliation: University College, London
name: Doris-Eva Bamiou, MD MSc FRCP PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal College of Physicians
name: Linda M Luxon, CBE BSc FRCP FRCPE
role: STUDY_DIRECTOR
References:
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citation: Bamiou DE, Kikidis D, Bibas T, Koohi N, Macdonald N, Maurer C, Wuyts FL, Ihtijarevic B, Celis L, Mucci V, Maes L, Van Rompaey V, Van de Heyning P, Nazareth I, Exarchos TP, Fotiadis D, Koutsouris D, Luxon LM. Diagnostic accuracy and usability of the EMBalance decision support system for vestibular disorders in primary care: proof of concept randomised controlled study results. J Neurol. 2022 May;269(5):2584-2598. doi: 10.1007/s00415-021-10829-7. Epub 2021 Oct 20.
citation: Rammazzo L, Kikidis D, Anwer A, Macdonald N, Kyrodimos E, Maurer C, Wuyts F, Luxon L, Bibas A, Bamiou DE. EMBalance - validation of a decision support system in the early diagnostic evaluation and management plan formulation of balance disorders in primary care: study protocol of a feasibility randomised controlled trial. Trials. 2016 Sep 5;17(1):435. doi: 10.1186/s13063-016-1568-x.