Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000144617
Ethics application status
Approved
Date submitted
9/08/2005
Date registered
15/08/2005
Date last updated
15/08/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving vision to prevent falls: a randomized trial
Scientific title
A randomized phase III trial to evaluate the effect of vision assessment and treatment among people aged 70 years and over to prevent falls
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Accidental falls 234 0
Condition category
Condition code
Injuries and Accidents 265 265 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group:
Vision and eye testing by an optometrist, with arrangement for any necessary treatments (including new glasses, cataract surgery, OT home modifications).
Intervention code [1] 150 0
Prevention
Comparator / control treatment
Control group: usual care
Control group
Active

Outcomes
Primary outcome [1] 315 0
Falls during 12 months of follow-up.
Timepoint [1] 315 0
Secondary outcome [1] 703 0
Vision-related quality of life.
Timepoint [1] 703 0

Eligibility
Key inclusion criteria
Age 70 years or over, living in the community (not a hostel or nursing home), no cataract surgery in previous 3 months, no new glasses in previous 3 months.
Minimum age
70 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealed until after assignment ot study groups. Randomisation list held centrally by researcher with no contact with study subjects.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A published table of random numbers was used to generate the random allocation sequence. Randomisation was in blocks, stratified by falls history, sex and recruitment site.stratified by falls history, sex and recruitment site.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The control receives usual care.
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 322 0
Government body
Name [1] 322 0
National Health and Medical Research Council of Australia
Country [1] 322 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 253 0
None
Name [1] 253 0
None
Address [1] 253 0
Country [1] 253 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1233 0
University of Sydney
Ethics committee address [1] 1233 0
Ethics committee country [1] 1233 0
Australia
Date submitted for ethics approval [1] 1233 0
Approval date [1] 1233 0
Ethics approval number [1] 1233 0
Ethics committee name [2] 1234 0
Central Sydney Area Health Service-RPAH Zone
Ethics committee address [2] 1234 0
Ethics committee country [2] 1234 0
Australia
Date submitted for ethics approval [2] 1234 0
Approval date [2] 1234 0
Ethics approval number [2] 1234 0
Ethics committee name [3] 1235 0
Central Sydney Area Health Service-Concord Hospital Zone
Ethics committee address [3] 1235 0
Ethics committee country [3] 1235 0
Australia
Date submitted for ethics approval [3] 1235 0
Approval date [3] 1235 0
Ethics approval number [3] 1235 0

Summary
Brief summary
Poor vision is a risk factor for falls among older people but it is not known whether improving vision prevents falls. In this study, subjects in the intervention group have a comprehensive eye examination and receive appropriate treatment. It is hoped that this will result in fewer falls over the next 12 months than in an untreated control group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36270 0
Address 36270 0
Country 36270 0
Phone 36270 0
Fax 36270 0
Email 36270 0
Contact person for public queries
Name 9339 0
Robert G Cumming
Address 9339 0
Centre for Education and Research on Ageing
Concord Hospital
C25
Concord NSW 2139
Country 9339 0
Australia
Phone 9339 0
+61 2 97676818
Fax 9339 0
+61 2 97675419
Email 9339 0
[email protected]
Contact person for scientific queries
Name 267 0
Robert G Cumming
Address 267 0
Centre for Education and Research on Ageing
Concord Hospital
C25
Concord NSW 2139
Country 267 0
Australia
Phone 267 0
+61 2 97676818
Fax 267 0
Email 267 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.