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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a program to enable older, at-risk drivers to stop or limit driving, but maintain mobility
Scientific title
Comparison of the safety and independent mobility of older drivers who complete an educational program about safe driving to older drivers who do not receive a program
Secondary ID [1] 280507 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crashes and near misses defined by a rapid deceleration of the participants vehicle. 286492 0
Driving exposure in kilometers traveled, distance from home and kilometers traveled at night. 286493 0
Community participation using the Keele Assessment of Participation 286494 0
Condition category
Condition code
Injuries and Accidents 286752 286752 0 0
Other injuries and accidents
Public Health 286798 286798 0 0
Other public health

Study type
Description of intervention(s) / exposure
An individual education program delivered over 2 sessions (1 month apart) based on the Knowledge Enhances Your Safety Curriculum (KEYS, Stalvey & Owlsey, Copyright 1998) but adapted for the Australian context.
The sessions will be supervised by an occupational therapist. The first session will run for 2 hours and the content will be individually tailored to the participant's stage of behaviour change according to the Precaution Adoption Process Model (Weinstein et al 1998). The session is conducted in a conversational format and closely follows the educational curriculum in the KEYS program relating to vision but also includes some discussion of cognition, physical abilities and medications. The driving scenes are replaced with scenes relevant to an Australian context. The results of the DriveSafe Drive Aware (Kay, Bundy & Clemson 2009) is also integrated into the discussion. At the outset of the session an inventory of driving and weekly activities is recorded. Information about alternative transport options is provided. A set of goals will be developed during the session and strategies devised to achieve these goals.
Session 2 will be of 30 minutes duration and will involve revising some of the material and discussion of progress towards goals.
Intervention code [1] 284880 0
Intervention code [2] 284912 0
Comparator / control treatment
No program
Control group

Primary outcome [1] 287142 0
Rate of crashes and near misses defined as a rapid deceleration event detected by an accelerometer in an in-vehicle monitoring device installed into the participants' vehicle.
Timepoint [1] 287142 0
Continuous measurement for 12 months
Secondary outcome [1] 297476 0
Driving exposure as measured by Global Positioning System in an in-vehicle monitoring device installed into the participants' vehicle.
Timepoint [1] 297476 0
Continuous measurement for 12 months
Secondary outcome [2] 297477 0
Community participation as measured by the Keele Assessment of Participation
Timepoint [2] 297477 0
Baseline and 12 months

Key inclusion criteria
75 years of age or older
currently hold a NSW drivers license
resident in the Hills Shire, in Sydney Australia
drive at least 5 days per week
have own vehicle
Minimum age
75 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Short Portable Mental Status Questionnaire score of 3 or more errors (adjusted for education)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be a convenience sample of volunteers who meet the eligibility criteria. They will be recruited through seniors groups, flyers, community transport organisation and general medical practitioners. After screening by telephone for eligibility informed consent will be sought and a baseline assessment completed. After assessment the participant will be randomised using a concealed (web-based) process.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation scheme will be generated using an on-line random number generator ( and implemented through the study data base to conceal the randomisation (RedCAP) until baseline assessment is completed.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285273 0
Government body
Name [1] 285273 0
Australian Research Council
Address [1] 285273 0
Level 2, 11 Lancaster Place
Majura Park ACT 2609
Country [1] 285273 0
Funding source category [2] 285274 0
Name [2] 285274 0
University of Sydney NHMRC Equipment Grant
Address [2] 285274 0
The University of Sydney
NSW 2006
Country [2] 285274 0
Funding source category [3] 285275 0
Name [3] 285275 0
IRT Foundation
Address [3] 285275 0
3/77 Market Street
Wollongong NSW 2500
Country [3] 285275 0
Funding source category [4] 293987 0
Government body
Name [4] 293987 0
Transport for NSW
Address [4] 293987 0
Level 4 18 Lee St, Chippendale NSW 2008
Country [4] 293987 0
Primary sponsor type
The George Institute for Global Health, The University of Sydney
321 Kent Street
Sydney NSW 2000
Secondary sponsor category [1] 284135 0
Name [1] 284135 0
NeuroScience Research Australia, The University of New South Wales
Address [1] 284135 0
Hospital Road
Randwick NSW 2031
Country [1] 284135 0
Secondary sponsor category [2] 284157 0
Name [2] 284157 0
Kolling Institute of Medical Research
Address [2] 284157 0
Royal North Shore Hospital
Pacific Hwy
St Leonards NSW 2065
Country [2] 284157 0
Secondary sponsor category [3] 284158 0
Name [3] 284158 0
Discipline of Occupational Therapy, The University of Sydney
Address [3] 284158 0
75 East St
Lidcombe NSW 2141
Country [3] 284158 0
Other collaborator category [1] 260816 0
Name [1] 260816 0
Community Transport Organisation
Address [1] 260816 0
Suite 2, Level 1,
186 Church Street, Parramatta
Country [1] 260816 0

Ethics approval
Ethics application status
Ethics committee name [1] 287288 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 287288 0
Level 6
Jane Foss Russell Building G02
University of Sydney NSW 2006
Ethics committee country [1] 287288 0
Date submitted for ethics approval [1] 287288 0
Approval date [1] 287288 0
Ethics approval number [1] 287288 0

Brief summary
We are using a randomised controlled trial to evaluate a program designed to promote safe mobility for drivers aged 75 years and older. Half of our study participants will be randomly selected to receive an integrated program which includes individual advice about safe driving and promotion of alternative transport delivered over two sessions in the participants own home. All study participants’ cars will be fitted with a monitoring device which transmits GPS location, speed and acceleration patterns during the 12 month study. We will compare driving exposure and incident involvement (crashes and rapid deceleration events) through this objective measurement. Community participation and independent mobility will be assessed with surveys.

The trial will determine if an individual program can improve safety in a group of older drivers. The trial will assess the impact on mobility and evaluate uptake of alternative transport. The study approach is robust using a randomised controlled design and safety outcomes will be measured objectively. Safety of older drivers, is of concern due to increased crash involvement per km travelled and their vulnerability to injury. While there are a number of programs designed to improve safe driving, there is very little evidence about their effectiveness. The results of this trial will contribute high level evidence for policy makers in this area.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 34191 0
A/Prof Lisa Keay
Address 34191 0
The George Institute for Global Health
Level 3, 50 Bridge Street,
Sydney NSW 2000
Country 34191 0
Phone 34191 0
Fax 34191 0
Email 34191 0
Contact person for public queries
Name 17438 0
A/Prof Lisa Keay
Address 17438 0
PO Box M201
Missenden Road NSW 2050
Country 17438 0
Phone 17438 0
61 2 9657 0335
Fax 17438 0
61 2 9657 0301
Email 17438 0
Contact person for scientific queries
Name 8366 0
A/Prof Lisa Keay
Address 8366 0
PO Box M201
Missenden Road NSW 2050
Country 8366 0
Phone 8366 0
61 2 9657 0335
Fax 8366 0
61 2 9657 0301
Email 8366 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary