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Trial registered on ANZCTR


Registration number
ACTRN12612000379819
Ethics application status
Approved
Date submitted
30/03/2012
Date registered
3/04/2012
Date last updated
20/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Treating dizziness in older people
Scientific title
A randomised controlled trial of dizziness interventions based on a multidisciplinary assessment in older people: towards the development of a multiple profile assessment of dizziness – the MPA-D
Secondary ID [1] 280230 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dizziness in older people 286177 0
Condition category
Condition code
Neurological 286372 286372 0 0
Other neurological disorders
Cardiovascular 286425 286425 0 0
Other cardiovascular diseases
Mental Health 286426 286426 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Multifaceted tailored intervention during a 6 month-period targeting the potential cause(s) of dizziness identified during a baseline multidisciplinary assessment. Established interventions will include the Otago home exercise program (strength and balance training exercises for 30min 3 times weekly and 2 walks of 30min weekly for 6 months; the program will involve home visits and phone contact with an exercise physiologist) to target poor balance, a vestibular rehabilitation program (over 8 weeks (within the 6months period) with a vestibular physiotherapist; the duration of the session will be about 30min) to target vestibular asymmetry, a booklet-based cognitive behavioral therapy (5 lessons including a weekly homework assignment (approximately 4 hours per week) over 8 weeks (within the 6-months intervention period) and telephone support by a clinical psychologist) to target depression disorders, comprehensive geriatric assessment and medication review with a geriatrician.
Intervention code [1] 284563 0
Treatment: Other
Intervention code [2] 284612 0
Rehabilitation
Intervention code [3] 284613 0
Behaviour
Intervention code [4] 285448 0
Other interventions
Comparator / control treatment
the control group will receive no intervention. However, as part of our duty of care, if significant vestibular, postural hypotension, mental illness or high-fall risk problems are identified in control group participants at the fortnightly case conference meetings we will immediately provide the control participants (and their GPs with participant permission) with reports of these findings
Control group
Active

Outcomes
Primary outcome [1] 286827 0
Frequency and duration of dizziness episodes experienced in the 6-months period between baseline and re-test - using the Vertigo Symptom Scale
Timepoint [1] 286827 0
at baseline and 6 months post baseline (i-e at the end of the intervention period)
Primary outcome [2] 286828 0
dizziness-related quality of life recorded using a validated questionnaire, the Dizziness Handicap Inventory
Timepoint [2] 286828 0
at baseline and 6 months post baseline (i-e at the end of the intervention period)
Primary outcome [3] 286829 0
Choice stepping reaction time, a composite measure of reaction time, strength and balance. This is measured using a 'dance-mat' which displays 4 pressure-sensitive arrows (front left, front right, left, right) and is connected to a computer screen displaying the same arrows' arrangement. In this test the participant is required to step as fast as possible on the arrow on the mat which corresponds to the arrow lighting up on the computer screen. The participant performs 20 trials with the arrows displayed in a random order.
Timepoint [3] 286829 0
at baseline and 6 months post baseline (i-e at the end of the intervention period)
Secondary outcome [1] 296758 0
Tilt table test of orthostatic hypotension: a decrease in systolic blood pressure greater than 20 mmHg, or a decrease in diastolic blood pressure greater than 10 mmHg or a decrease of systolic blood pressure to less than 90 mmHg after 3min of 70degrees head up tilt compared to lying, defines orthostatic hypotension whether or not symptoms.
Timepoint [1] 296758 0
at baseline and 6 months post baseline (i-e at the end of the intervention period)
Secondary outcome [2] 296759 0
Coordinated Stability - a test of leaning balance
Timepoint [2] 296759 0
at baseline and 6 months post baseline (i-e at the end of the intervention period)
Secondary outcome [3] 349752 0
Patient-Health Questionnaire -9 items - a questionnaire to assess depression disorders
Timepoint [3] 349752 0
at baseline and at re-assessment (6 months later marking the end of the study)

Eligibility
Key inclusion criteria
Having experienced one or more episode(s) of dizziness in the past year and not being currently treated for it; living independently in the community or retirement village; able to understand English.
Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
presence of a diagnosed degenerative neurological condition or severe cognitive impairment (GP-Cog score equal or below 4).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed and will be done by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised via a computer-generated list (www.randomization.com).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 284989 0
Government body
Name [1] 284989 0
National Health and Medical Research Council
Address [1] 284989 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 284989 0
Australia
Primary sponsor type
Individual
Name
Prof Stephen Lord
Address
Falls and Balance Research Group
Neuroscience Research Australia
Barker st
Randwick 2031 NSW
Country
Australia
Secondary sponsor category [1] 283851 0
Individual
Name [1] 283851 0
Dr Jasmine Menant
Address [1] 283851 0
Falls and Balance Research Group
Neuroscience Research Australia
Barker st
Randwick 2031 NSW
Country [1] 283851 0
Australia
Secondary sponsor category [2] 283852 0
Individual
Name [2] 283852 0
Dr Americo Migliaccio
Address [2] 283852 0
Vision and Vestibular laboratory
Neuroscience Research Australia
Barker st
Randwick 2031 NSW
Country [2] 283852 0
Australia
Secondary sponsor category [3] 283853 0
Individual
Name [3] 283853 0
A/Prof Jacqueline Close
Address [3] 283853 0
Falls and Injury Research Group
Neuroscience Research Australia
Barker st
Randwick 2031 NSW
Country [3] 283853 0
Australia
Secondary sponsor category [4] 283854 0
Individual
Name [4] 283854 0
A/Prof Nickolai Titov
Address [4] 283854 0
Department of Psychology
Macquarie University
NSW 2109
Country [4] 283854 0
Australia
Secondary sponsor category [5] 283855 0
Individual
Name [5] 283855 0
Dr Kim Delbaere
Address [5] 283855 0
Falls and Balance Research Group
Neuroscience Research Australia
Barker st
Randwick 2031 NSW
Country [5] 283855 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286996 0
Human Research Ethics Comittee of the University of New South Wales
Ethics committee address [1] 286996 0
Ethics Secretariat
UNSW Grants Management Office
Rupert Myers Building, Level 3, South Wing
The University of New South Wales
SYDNEY NSW 2052
Ethics committee country [1] 286996 0
Australia
Date submitted for ethics approval [1] 286996 0
03/04/2012
Approval date [1] 286996 0
30/08/2012
Ethics approval number [1] 286996 0
HC12152

Summary
Brief summary
Brief summary: Between 10-30% of older community-living population report dizziness often leading to functional disability and psychological distress. The multifactorial aetiology of dizziness combined with a lack of validated diagnostic tests, and a tendency of clinicians to rely on poorly described symptoms and familiar assessments, are significant barriers to objectively establishing a successful diagnosis and implementing effective interventions. Thus, despite effective treatments being available, up to 40% of older people with reported dizziness remain undiagnosed and untreated. A multidisciplinary assessment battery, with new validated assessments of vestibular impairments is required for diagnosing and treating older people with dizziness. This project will aim to conduct a randomized control trial of a multifaceted dizziness intervention based on a multidisciplinary assessment. We hypothesize that a multidisciplinary assessment (tests of balance, inner ear function, blood pressure, mental health etc) followed by a tailored intervention (exercise program, vestibular rehabilitation, comprehensive geriatric assessment and medication review) will improve diagnosis, reduce self-reported dizziness, enhance postural stability and improve quality of life in older people suffering from dizziness.
Trial website
Trial related presentations / publications
Menant JC, Migliaccio AA, Sturnieks DL, Hicks C, Lo J, Ratanapongleka M, et al. Reducing the burden of dizziness in middle-aged and older people: A multifactorial, tailored, single-blind randomized controlled trial. PLoS Med, in press (accepted 22/06/2018).
Public notes

Contacts
Principal investigator
Name 33988 0
Prof Stephen Lord
Address 33988 0
Falls and Balance Research Group, Neuroscience Research Australia, Barker st, Randwick, 2031, NSW, Australia
Country 33988 0
Australia
Phone 33988 0
+61293991061
Fax 33988 0
Email 33988 0
s.lord@neura.edu.au
Contact person for public queries
Name 17235 0
Dr Jasmine Menant
Address 17235 0
Falls and Balance Research Group
Neuroscience Research Australia
Barker st
Randwick 2031 NSW
Country 17235 0
Australia
Phone 17235 0
+61 2 9399 1267
Fax 17235 0
Email 17235 0
j.menant@neura.edu.au
Contact person for scientific queries
Name 8163 0
Dr Jasmine Menant
Address 8163 0
Falls and Balance Research Group
Neuroscience Research Australia
Barker st
Randwick 2031 NSW
Country 8163 0
Australia
Phone 8163 0
+61 2 9399 1267
Fax 8163 0
Email 8163 0
j.menant@neura.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary