Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00350389




Registration number
NCT00350389
Ethics application status
Date submitted
6/07/2006
Date registered
10/07/2006
Date last updated
3/06/2015

Titles & IDs
Public title
VISIBLE Study (Visual Intervention Strategy Incorporating Bifocal & Long-distance Eyewear)
Scientific title
Randomised Controlled Falls Prevention Trial of Plain Distance Glasses in Elderly Multifocal Wearers.
Secondary ID [1] 0 0
350855
Universal Trial Number (UTN)
Trial acronym
VISIBLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Outdoor use of plain distance glasses with counselling

Experimental: 1 - Provision of single lens glasses, glasses aids, counselling, updated multifocal glasses if required

No intervention: 2 - Usual care, updated multifocal glasses if required


BEHAVIORAL: Outdoor use of plain distance glasses with counselling
Provision of single lens glasses, glasses aids, counselling, updated multifocal glasses if required
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Falls rates, Falls diaries
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Quality of life, SF-36
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Instrumental Activities of Daily Living, Adelaide Activities Profile
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
Modified Falls Efficacy Scale
Timepoint [3] 0 0
12 months

Eligibility
Key inclusion criteria
* outdoor use of multifocal glasses 3 or more times per week
* community-dwelling persons aged 65+ years with a recent fall OR persons aged 80+ years regardless of falls history
* Folstein Mini Mental score of 24+
* adequate visual contrast sensitivity (Melbourne Edge Test score of 16+dB)
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* nursing home residents

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2008
Sample size
Target
Accrual to date
Final
606
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Prince of Wales Medical Research Institute - Sydney
Recruitment postcode(s) [1] 0 0
2031 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
The University of New South Wales
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
South Eastern Area Health Service
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Northern Sydney and Central Coast Area Health Service
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephen R Lord, PhD
Address 0 0
University of New South Wales
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00350389