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

Primary Purpose

Dizziness, Vertigo

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Decision Support System (DSS)
Specialist Audiovestibular Consultation
DSS Customised Vestibular Physiotherapy
Standard Physiotherapy Practice
Follow-up
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dizziness focused on measuring Decision Support System, Dizziness, Vertigo, Balance

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Antwerp University Hospital
  • Freiburg University Medical Center
  • Hippocrateio Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Non-specialist doctor +DSS

Non-specialist doctor -DSS

Arm Description

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

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

Outcomes

Primary Outcome Measures

Percentage of diagnosis agreement
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.
Percentage of management plan agreement
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

Number of initial diagnoses changed after investigations proposed
Number of referrals to secondary care needed
Name of investigations required for an accurate diagnosis
Overall improvement according to the patient (Better, stable, worse)
Overall improvement according to overseeing expert (Better, stable, worse)
Severity of symptoms (Visual Analogue Scale from 1-10 (VAS))
Difficulties regarding dizziness (Dizziness Handicap Inventory questionnaire (DHI))
Quality of life (EQ-5D-3L Questionnaire)
Number of patients not enrolled and/or withdrawn from the trial
Reason for exclusion to the trial

Full Information

First Posted
February 29, 2016
Last Updated
October 25, 2016
Sponsor
University College, London
Collaborators
National and Kapodistrian University of Athens, Universiteit Antwerpen, University Hospital Freiburg
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1. Study Identification

Unique Protocol Identification Number
NCT02704819
Brief Title
Proof of Concept Study of EMBalance Decision Support System to Evaluate Balance Disorders
Acronym
EMBalance
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

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London
Collaborators
National and Kapodistrian University of Athens, Universiteit Antwerpen, University Hospital Freiburg

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dizziness, Vertigo
Keywords
Decision Support System, Dizziness, Vertigo, Balance

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-specialist doctor +DSS
Arm Type
Experimental
Arm Description
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
Arm Title
Non-specialist doctor -DSS
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Decision Support System (DSS)
Other Intervention Name(s)
Decision Making Software
Intervention Description
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: 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. 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.
Intervention Type
Other
Intervention Name(s)
Specialist Audiovestibular Consultation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
DSS Customised Vestibular Physiotherapy
Other Intervention Name(s)
Vestibular Rehabilitation
Intervention Description
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. 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. 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.
Intervention Type
Other
Intervention Name(s)
Standard Physiotherapy Practice
Other Intervention Name(s)
Standard Rehabilitation Practice
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Follow-up
Intervention Description
All patients will be reviewed after three months follow-up by the overseeing expert.
Primary Outcome Measure Information:
Title
Percentage of diagnosis agreement
Description
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.
Time Frame
Through study completion, an average of 8 months
Title
Percentage of management plan agreement
Description
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.
Time Frame
Through study completion, an average of 8 months
Secondary Outcome Measure Information:
Title
Number of initial diagnoses changed after investigations proposed
Time Frame
Through study completion, an average of 8 months
Title
Number of referrals to secondary care needed
Time Frame
Through study completion, an average of 8 months
Title
Name of investigations required for an accurate diagnosis
Time Frame
Through study completion, an average of 8 months
Title
Overall improvement according to the patient (Better, stable, worse)
Time Frame
Change from baseline at 3 months (follow-up)
Title
Overall improvement according to overseeing expert (Better, stable, worse)
Time Frame
Change from baseline at 3 months (follow-up)
Title
Severity of symptoms (Visual Analogue Scale from 1-10 (VAS))
Time Frame
Change from baseline at 3 months (follow-up)
Title
Difficulties regarding dizziness (Dizziness Handicap Inventory questionnaire (DHI))
Time Frame
Change from baseline at 3 months (follow-up)
Title
Quality of life (EQ-5D-3L Questionnaire)
Time Frame
Change from baseline at 3 months (follow-up)
Title
Number of patients not enrolled and/or withdrawn from the trial
Time Frame
Through study completion, an average of 8 months
Title
Reason for exclusion to the trial
Time Frame
Through study completion, an average of 8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doris-Eva Bamiou, MD MSc FRCP PhD
Organizational Affiliation
University College, London
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Linda M Luxon, CBE BSc FRCP FRCPE
Organizational Affiliation
Royal College of Physicians
Official's Role
Study Director
Facility Information:
Facility Name
Antwerp University Hospital
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Freiburg University Medical Center
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Hippocrateio Hospital
City
Athens
ZIP/Postal Code
115 27
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
8023718
Citation
Colledge NR, Wilson JA, Macintyre CC, MacLennan WJ. The prevalence and characteristics of dizziness in an elderly community. Age Ageing. 1994 Mar;23(2):117-20. doi: 10.1093/ageing/23.2.117.
Results Reference
background
Citation
Royal College of Physicians, Hearing and Balance Disorders, Report of a working party (2007) Available at: https://www.rcplondon.ac.uk/sites/default/files/documents/hearing-and-balance-disorders.pdf. [Accessed 29 September 2008]
Results Reference
background
PubMed Identifier
17538212
Citation
Pavlou M, Davies RA, Bronstein AM. The assessment of increased sensitivity to visual stimuli in patients with chronic dizziness. J Vestib Res. 2006;16(4-5):223-31.
Results Reference
background
PubMed Identifier
18955641
Citation
Neuhauser HK, Radtke A, von Brevern M, Lezius F, Feldmann M, Lempert T. Burden of dizziness and vertigo in the community. Arch Intern Med. 2008 Oct 27;168(19):2118-24. doi: 10.1001/archinte.168.19.2118. Erratum In: Arch Intern Med. 2009 Jan 12;169(1):89.
Results Reference
background
PubMed Identifier
12933783
Citation
Scuffham P, Chaplin S, Legood R. Incidence and costs of unintentional falls in older people in the United Kingdom. J Epidemiol Community Health. 2003 Sep;57(9):740-4. doi: 10.1136/jech.57.9.740.
Results Reference
background
Citation
Keen, P. & Morton, M. S. (1978). Decision Support Systems: An Organizational Perspective, Addison-Wesley
Results Reference
background
Citation
Eom, S. & Kim, E. A survey of decision support system applications. Journal of the Operational Research Society. 2006, 57(15): 1264-1278
Results Reference
background
PubMed Identifier
15755945
Citation
Garg AX, Adhikari NK, McDonald H, Rosas-Arellano MP, Devereaux PJ, Beyene J, Sam J, Haynes RB. Effects of computerized clinical decision support systems on practitioner performance and patient outcomes: a systematic review. JAMA. 2005 Mar 9;293(10):1223-38. doi: 10.1001/jama.293.10.1223.
Results Reference
background
PubMed Identifier
34669009
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.
Results Reference
derived
PubMed Identifier
27596486
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.
Results Reference
derived
Links:
URL
https://twitter.com/em_balance
Description
EMBalance Twitter account

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

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