Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000124639
Ethics application status
Approved
Date submitted
9/08/2005
Date registered
10/08/2005
Date last updated
10/08/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
The use of objective measures in assessing driving ability
Scientific title
The validation of objective measures used in return to driving with people with stroke and older drivers in the clinical setting
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke. Older drivers. 212 0
Condition category
Condition code
Stroke 238 238 0 0

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
None
Intervention code [1] 144 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 283 0
On-road assessment of driving ability.
Timepoint [1] 283 0
Primary outcome [2] 284 0
Medical practitioner recommendation related to driving.
Timepoint [2] 284 0
Secondary outcome [1] 628 0
Useful field of vision and stroke driver screening assessment scores.
Timepoint [1] 628 0

Eligibility
Key inclusion criteria
People who drove prior to their stroke and wish to return to driving or older people who are currently driving.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People who have the onset of other medical conditions that may impact on driving.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 297 0
Other
Name [1] 297 0
Flinders Institute for Health Research Grant in Aid
Country [1] 297 0
Australia
Primary sponsor type
Individual
Name
Professor Maria Crotty
Address
Country
Secondary sponsor category [1] 230 0
None
Name [1] 230 0
None
Address [1] 230 0
Country [1] 230 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1165 0
Repatriation General Hospital
Ethics committee address [1] 1165 0
Ethics committee country [1] 1165 0
Australia
Date submitted for ethics approval [1] 1165 0
Approval date [1] 1165 0
Ethics approval number [1] 1165 0
Ethics committee name [2] 1166 0
Flinders University/Flinders Medical Centre
Ethics committee address [2] 1166 0
Ethics committee country [2] 1166 0
Australia
Date submitted for ethics approval [2] 1166 0
Approval date [2] 1166 0
Ethics approval number [2] 1166 0
Ethics committee name [3] 1167 0
The Royal Adelaide Hospital
Ethics committee address [3] 1167 0
Ethics committee country [3] 1167 0
Australia
Date submitted for ethics approval [3] 1167 0
Approval date [3] 1167 0
Ethics approval number [3] 1167 0

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

Contacts
Principal investigator
Name 35806 0
Address 35806 0
Country 35806 0
Phone 35806 0
Fax 35806 0
Email 35806 0
Contact person for public queries
Name 9333 0
Prof. Maria Crotty
Address 9333 0
Department of Rehabilitation and Aged Care
Flinders University
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
Country 9333 0
Australia
Phone 9333 0
+61 8 82751103
Fax 9333 0
+61 8 82751130
Email 9333 0
[email protected]
Contact person for scientific queries
Name 261 0
Prof. Maria Crotty
Address 261 0
Department of Rehabilitation and Aged Care
Flinders University
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
Country 261 0
Australia
Phone 261 0
+61 8 82751103
Fax 261 0
+61 8 82751130
Email 261 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.