Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000543886
Ethics application status
Approved
Date submitted
18/05/2012
Date registered
22/05/2012
Date last updated
4/07/2016
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
Nil
Universal Trial Number (UTN)
U1111-1130-8834
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

Intervention/exposure
Study type
Interventional
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
Behaviour
Intervention code [2] 284912 0
Prevention
Comparator / control treatment
No program
Control group
Active

Outcomes
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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
Yes
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 (http://www.randomization.com/) 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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2012
Actual
2/07/2012
Date of last participant enrolment
Anticipated
28/06/2013
Actual
31/10/2013
Date of last data collection
Anticipated
Actual
31/10/2014
Sample size
Target
380
Accrual to date
Final
380
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 285273 0
Government body
Name [1] 285273 0
Australian Research Council
Country [1] 285273 0
Australia
Funding source category [2] 285274 0
University
Name [2] 285274 0
University of Sydney NHMRC Equipment Grant
Country [2] 285274 0
Australia
Funding source category [3] 285275 0
Charities/Societies/Foundations
Name [3] 285275 0
IRT Foundation
Country [3] 285275 0
Australia
Funding source category [4] 293987 0
Government body
Name [4] 293987 0
Transport for NSW
Country [4] 293987 0
Australia
Primary sponsor type
University
Name
The George Institute for Global Health, The University of Sydney
Address
321 Kent Street
Sydney NSW 2000
Country
Australia
Secondary sponsor category [1] 284135 0
University
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
Australia
Secondary sponsor category [2] 284157 0
University
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
Australia
Secondary sponsor category [3] 284158 0
University
Name [3] 284158 0
Discipline of Occupational Therapy, The University of Sydney
Address [3] 284158 0
75 East St
Lidcombe NSW 2141
AUSTRALIA
Country [3] 284158 0
Australia
Other collaborator category [1] 260816 0
Charities/Societies/Foundations
Name [1] 260816 0
Community Transport Organisation
Address [1] 260816 0
Suite 2, Level 1,
186 Church Street, Parramatta
Country [1] 260816 0
Australia

Ethics approval
Ethics application status
Approved
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
Australia
Date submitted for ethics approval [1] 287288 0
Approval date [1] 287288 0
01/11/2011
Ethics approval number [1] 287288 0
14235

Summary
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
nil
Trial related presentations / publications
nil
Public notes

Contacts
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
Australia
Phone 34191 0
+61296570335
Fax 34191 0
+61296570301
Email 34191 0
[email protected]
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
Australia
Phone 17438 0
61 2 9657 0335
Fax 17438 0
61 2 9657 0301
Email 17438 0
[email protected]
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
Australia
Phone 8366 0
61 2 9657 0335
Fax 8366 0
61 2 9657 0301
Email 8366 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.