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Table 1 Trial registration data from the World Health Organization Trial Registration Data Set

From: Tailored multifactorial intervention to improve dizziness symptoms and quality of life, balance and gait in dizziness sufferers aged over 50 years: protocol for a randomised controlled trial

Data category Information
Primary registry and trial identifying number anzctr.org.au ACTRN12612000379819
Date of registration in primary registry 3 April 2012
Secondary identifying numbers N/A
Source(s) of monetary or material support Australian National Health and Medical Research Council
Primary sponsor Professor Stephen Lord, Neuroscience Research Australia
Secondary sponsor Dr Jasmine Menant, Neuroscience Research Australia
Contact for public queries Professor Stephen Lord, DSc [S.Lord@neura.edu.au]
Contact for scientific queries Professor Stephen Lord, DSc Neuroscience Research Australia, Randwick Sydney, Australia
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
Countries of recruitment Australia
Health condition(s) or problem(s) studied Dizziness in older people
Intervention(s) Active comparator: Multifaceted tailored intervention including a home exercise program, a vestibular rehabilitation program, a booklet-based cognitive behavioural therapy, and/or a comprehensive geriatric assessment and medication review.
Placebo comparator: usual care, no intervention
Key inclusion and exclusion criteria Ages eligible for study: ≥50 years Sexes eligible for study: both Accepts healthy volunteers: yes
Inclusion criteria: adult patient (≥50 years), 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.
Exclusion criteria: presence of a diagnosed degenerative neurological condition or severe cognitive impairment (GP-Cog score equal or below 4).
Study type Interventional
Allocation: randomized intervention model. Parallel assignment masking: single blind (investigator, outcomes assessor)
Primary purpose: prevention
Phase III
Date of first enrolment August 2012
Target sample size 300
Recruitment status Completed
Primary outcome(s) • Frequency and duration of dizziness episodes experienced in the 6-months period between baseline and re-test. • Dizziness-related quality of life recorded using a validated questionnaire, the Dizziness Handicap Inventory • Choice stepping reaction time: a composite measure of reaction time, strength and balance. Time points for all outcomes: baseline and 6 months post-baseline (i-e at the end of the intervention period)
Key secondary outcomes • Tilt table test of orthostatic hypotension • Coordinated Stability - a test of leaning balance • Geriatric depression scale - 15 items: a questionnaire to assess depression disorders Time points for all outcomes: baseline and 6 months post-baseline (i-e at the end of the intervention period)