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Trial record 2 of 4 for:    15755945 [PUBMED-IDS]

Proof of Concept Study of EMBalance Decision Support System to Evaluate Balance Disorders (EMBalance)

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ClinicalTrials.gov Identifier: NCT02704819
Recruitment Status : Completed
First Posted : March 10, 2016
Last Update Posted : October 26, 2016
Sponsor:
Collaborators:
National and Kapodistrian University of Athens
Universiteit Antwerpen
University Hospital Freiburg
Information provided by (Responsible Party):
University College, London

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.


Condition or disease Intervention/treatment Phase
Dizziness Vertigo Other: Decision Support System (DSS) Other: Specialist Audiovestibular Consultation Other: DSS Customised Vestibular Physiotherapy Other: Standard Physiotherapy Practice Other: Follow-up Not Applicable

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)


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
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 Start Date : March 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Non-specialist doctor +DSS

Patients allocated to +DSS group will receive the following intervention:

  • V1: appointment with a non-specialist doctor with the support of the DSS
  • V2: appointment with an overseeing expert
  • V3: DSS Customised Vestibular Physiotherapy
  • V4: follow-up visit with the overseeing expert
Other: Decision Support System (DSS)

The EMBalance DSS is a program which summarises and structures clinical information. The structuring of medical information is based on algorithms that have been developed and are employed via the DSS platform. The non-specialist doctors who use the DSS will be asked to exercise their clinical judgement in order to come up with a diagnosis or management plan. The DSS use has the following characteristics:

  1. Doctors can pace the process anyway they see fit (e.g. by switching from history taking to examination, stopping at any point, or going back to medical history) or by stopping the process entirely.
  2. Although the EMBalance platform will propose 2-3 diagnosis (with probability estimation for each), doctors will be asked to either choose one of these or discard and choose their own.
Other Name: Decision Making Software

Other: Specialist Audiovestibular Consultation
After the initial appointment with the non-specialist doctor, all patients will be invited to attend a specialist neuro-otology clinic where they will be seen by an overseeing expert in order to undergo a "Gold Standard" diagnostic process, and determine the management plan appropriate to the diagnosis, which will be compared to the management plan previously advised by the non-specialist doctor. The overseeing expert will review investigations carried out, results assessed by the non-specialist doctor.

Other: DSS Customised Vestibular Physiotherapy

Customised vestibular exercise programme suggested by the DSS. Such exercises are based on the eye, head, and postural exercises that provoke a patient's symptoms.

  1. Adaptation exercises incorporating gaze fixation and head movements and postural exercises are prescribed to promote recovery of the vestibule-ocular reflex (VOR) and vestibulo-spinal reflex function. Up to 5 exercises will be practised by the patient at home for approximately 1-2 minutes each, twice daily initially at a slow speed which gradually increases as symptoms improve.
  2. Patients presenting vestibular migraine will perform a maximum of three exercises. These exercises will be chosen by the DSS from a range of established exercises and chosen according to the patient's symptoms when performing the exercise/type of movement.
Other Name: Vestibular Rehabilitation

Other: Follow-up
All patients will be reviewed after three months follow-up by the overseeing expert.

Active Comparator: Non-specialist doctor -DSS

Patients allocated to -DSS group will receive the following intervention:

  • V1: appointment with a non-specialist doctor without the support of the DSS
  • V2: appointment with an overseeing expert
  • V3: Standard Physiotherapy Practice
  • V4: follow-up visit with the overseeing expert
Other: Specialist Audiovestibular Consultation
After the initial appointment with the non-specialist doctor, all patients will be invited to attend a specialist neuro-otology clinic where they will be seen by an overseeing expert in order to undergo a "Gold Standard" diagnostic process, and determine the management plan appropriate to the diagnosis, which will be compared to the management plan previously advised by the non-specialist doctor. The overseeing expert will review investigations carried out, results assessed by the non-specialist doctor.

Other: Standard Physiotherapy Practice
Patient will be referred to a local physiotherapy service by his/her non-specialist doctor within 18 weeks from referral. Standard vestibular rehabilitation practice consists of a customised exercise programme, this is service dependent and tailored for patient's symptoms. The rehabilitation programme might include lifestyle advice and education, sometimes accompanied by a leaflet.
Other Name: Standard Rehabilitation Practice

Other: Follow-up
All patients will be reviewed after three months follow-up by the overseeing expert.




Primary Outcome Measures :
  1. Percentage of diagnosis agreement [ Time Frame: Through study completion, an average of 8 months ]
    Agreement between the diagnosis established by the non-specialist doctors (using the DSS and not using DSS) and the "Gold Standard" as determined by an overseeing expert and according to current evidence based guidelines for the diagnosis/management of these disorders.

  2. Percentage of management plan agreement [ Time Frame: Through study completion, an average of 8 months ]
    Agreement between the management plan established by the non-specialist doctors (using the DSS and not using DSS) and the "Gold Standard" as recommended by an overseeing expert and according to current evidence based guidelines for the diagnosis/management of these disorders.


Secondary Outcome Measures :
  1. Number of initial diagnoses changed after investigations proposed [ Time Frame: Through study completion, an average of 8 months ]
  2. Number of referrals to secondary care needed [ Time Frame: Through study completion, an average of 8 months ]
  3. Name of investigations required for an accurate diagnosis [ Time Frame: Through study completion, an average of 8 months ]
  4. Overall improvement according to the patient (Better, stable, worse) [ Time Frame: Change from baseline at 3 months (follow-up) ]
  5. Overall improvement according to overseeing expert (Better, stable, worse) [ Time Frame: Change from baseline at 3 months (follow-up) ]
  6. Severity of symptoms (Visual Analogue Scale from 1-10 (VAS)) [ Time Frame: Change from baseline at 3 months (follow-up) ]
  7. Difficulties regarding dizziness (Dizziness Handicap Inventory questionnaire (DHI)) [ Time Frame: Change from baseline at 3 months (follow-up) ]
  8. Quality of life (EQ-5D-3L Questionnaire) [ Time Frame: Change from baseline at 3 months (follow-up) ]
  9. Number of patients not enrolled and/or withdrawn from the trial [ Time Frame: Through study completion, an average of 8 months ]
  10. Reason for exclusion to the trial [ Time Frame: Through study completion, an average of 8 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02704819


Locations
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Belgium
Antwerp University Hospital
Edegem, Belgium, 2650
Germany
Freiburg University Medical Center
Freiburg, Germany, 79106
Greece
Hippocrateio Hospital
Athens, Greece, 115 27
Sponsors and Collaborators
University College, London
National and Kapodistrian University of Athens
Universiteit Antwerpen
University Hospital Freiburg
Investigators
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Principal Investigator: Doris-Eva Bamiou, MD MSc FRCP PhD University College, London
Study Director: Linda M Luxon, CBE BSc FRCP FRCPE Royal College of Physicians

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02704819     History of Changes
Other Study ID Numbers: 13/0336
610454 ( Other Grant/Funding Number: EU Seventh Framework Programme )
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University College, London:
Decision Support System
Dizziness
Vertigo
Balance

Additional relevant MeSH terms:
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Vertigo
Dizziness
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sensation Disorders