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