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Trial registered on ANZCTR


Registration number
ACTRN12615000994583
Ethics application status
Approved
Date submitted
10/09/2015
Date registered
22/09/2015
Date last updated
19/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised Controlled Trial of an Intervention to enhance skills in older drivers.
Scientific title
For older drivers with at-risk driving behaviour, will individually tailored driving lessons lead to improved driving performance, in the short and long-term, compared to only receiving an in-class road rules refresher session?
Secondary ID [1] 287028 0
Nil
Universal Trial Number (UTN)
U1111-1171-7558
Trial acronym
ANU Better Driving Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ageing associated driving impairment 295493 0
Condition category
Condition code
Injuries and Accidents 295747 295747 0 0
Other injuries and accidents
Physical Medicine / Rehabilitation 295748 295748 0 0
Occupational therapy
Neurological 295749 295749 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Tailored Driving Instruction:
Participants allocated to the intervention group will attend a 2-hour Road Rules refresher course (prior to randomisation) - see control treatment for details.

After randomisation, they will complete two one hour driver training sessions with a qualified driving instructor. The lessons will be conducted between 1 and 14 days apart. The instructor will use the skill profile indicated by the baseline on-road assessment to tailor the driving instruction.

The first session will also include video-footage assisted feedback from the baseline on-road session, instructor assisted adjustment of seat, mirrors, etc. More complex modifications such as steering wheel spinner knobs or hand controls will not be fitted as this will introduce significant variation to learning rate across participants. The first session will be conducted in a dual-break vehicle. The second session will be in the participant's own vehicle. Each session will include instructor guided driving practice, using routes within or near the participant's usual driving range that includes opportunity for training the specific skills requiring improvement (e.g., uncontrolled intersections, lane changes etc.).
Intervention code [1] 292236 0
Other interventions
Comparator / control treatment
Control participants will only attend a 2-hour Road Rules refresher course (prior to randomisation). The road rules session will be conducted by a qualified driving instructor, and will include information on age-related changes and its effects on driving, information on adapting the car to optimise visibility and mobility, an update on road rules, safety tips and how to apply them to everyday driving etc. The session will be conducted in room with audio-visual facilities, and will adhere to a pre-defined course structure and content incorporating similar topics as other published in class driver education for seniors. All participants will be encouraged to use the information and apply it to their own driving during the course of the study. The information provided will be general, rather than specific to individual needs. All participants are advised not to undertake outside driver lessons for the duration of the trial.
Control group
Active

Outcomes
Primary outcome [1] 295639 0
On-Road Driving Performance as assessed by the On-Road Test Safety Score
Timepoint [1] 295639 0
Baseline and 7 weeks after intervention
Secondary outcome [1] 316071 0
Driving Performance under naturalistic conditions as assessed by the Dash Camera footage Safety Score
Timepoint [1] 316071 0
Baseline, 7 weeks and 6 months after intervention
Secondary outcome [2] 316072 0
Visual attention and speed of processing as measured by Useful Field of View Test (UFOV)
Timepoint [2] 316072 0
Baseline and 7 weeks after intervention
Secondary outcome [3] 316073 0
Driving safety risk as measured by Multi-D battery (reaction time, sensitivity to visual motion, postural balance)
Timepoint [3] 316073 0
Baseline and 7 weeks after intervention

Eligibility
Key inclusion criteria
Aged 65 years and over. Current drivers license with no restrictions on driving area, current driver, plans to continue driving for the next 12 months. Has not engaged in driver education in the past 6 months.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Aged below 65 years. Area restricted license or no valid license. Valid license but no longer driving. Plans to cease driving within the next 12 months. Has done a driver education course in the past 6 months.

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)
Once participants have given informed consent to be involved in the study, the Trial Coordinator schedules them for baseline lab-based session and an on-road session, followed by a class-based Road Rules refresher session. Participants also have a dash camera fitted to their car for baseline 2-week recording prior to the Road Rules session. Once participants have completed the Road Rules session, the Trial Coordinator receives from the Statistician the follow-up information packs each marked with participant ID and group allocation. The Trial Coordinator then contacts and schedules the participants for driving lessons (if allocated to that condition) and follow-up lab-based and on-road sessions.

The sequence and assignment will be concealed from all researchers except for the Trial coordinator responsible for enrolling, obtaining consent and scheduling participants. The allocation sequence will be revealed to the Trial Coordinator only after each batch of participants complete their baseline assessments (Lab-Based, On-road, Dash Cam) and attend the class-based Road Rules refresher course. The Statistician will assemble two separate sets of letters inside opaque envelopes marked confidential. Half the envelopes will contain letters about the post-intervention assessments only, the other half will contain letters about the post-intervention assessments and driving lessons. To prevent subversion of the allocation sequence, the Statistician will mark each envelope and its contents with the participant ID as per the allocation sequence and deliver these to the Trial Coordinator. The Trial Coordinator will then use the IDs to match contact details in a separate database, attach address labels to the envelopes, phone and schedule each participant for either post-intervention assessments only (control group) or two lessons and post-intervention assessments as per the envelope contents.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The study Statistician, who is independent from recruitment, enrolment, assessment, or allocation implementation, will use a computer generated randomisation list to assign group allocations to participant identification codes with a 1:1 ratio. The allocation sequence will be stratified by age group (young: 65 to 75 years; older: 76 years and up) and gender (male, female). The stratification variables were selected on the basis of knowledge that age is correlated with driving safety, that driving patterns differ across genders, and that females are generally underrepresented in driving studies. The blocked randomisation list will be generated using Stata version 12 and will allocate participants to equally sized (ratio 1:1) groups.

Prior to commencing the study, the Statistician will develop a list of 60 random Participant ID numbers for de-identifying participant data. These unique IDs will be given to the Trial Coordinator as participants are enrolled into the study. When the allocation is to be assigned, the Trial coordinator will provide the Statistician with a list of enrolled participants’ IDs along with age group and gender. This list will be used by the Statistician to allocate groups as above.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A convenience sample is used for the present study. Previous studies show that a sample of 18 per group is sufficient to detect a difference of 0.78 standard deviations in on-road assessment in a three arm RCT design (Porter et al 2013) and a sample of 29 per group was sufficient to detect a change of 0.60 standard deviations in a multi-site RCT design (Bedard et al, 2008). Based on this and our ongoing study showing the likely sample baseline mean on-road score would be 5.65 with a SD of 1.86, a sample of 20 per group would provide 80% power (and two-sided type 1 error rate of 5%) to detect a 1.11 point change (or 0.60 standard deviations) on our On-Road Safety Rating Scale (1-10). A change of 1 point or more on the 10-point on-road safety scale constitutes a noticeable and clinically meaningful change. With an expected attrition rate of 17%, a sample of 30 per group (or 60 for a trial using 2 groups) would provide sufficient power to detect change in on-road performance.

The primary endpoint is change in on-road safety rating during the seven week intervention period in the intention-to-treat population. The on-road safety rating consists of a scale with a range from 1 to 10 with 1 representing very poor driving and 10 excellent skills. Generalised linear models will be used to examine the primary endpoint for evidence of superiority of tailored driving lessons plus class-based education relative to class-based education alone. The secondary outcome measure (on-road safety score based on video footage of naturalistic driving), and lab-based measures of driving safety – specifically the UFOV and the Multi-D, will be analysed in the same way.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/08/2015
Actual
21/08/2015
Date of last participant enrolment
Anticipated
6/11/2015
Actual
7/01/2016
Date of last data collection
Anticipated
Actual
29/07/2016
Sample size
Target
60
Accrual to date
Final
57
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 291696 0
Other
Name [1] 291696 0
NRMA ACT Road Safety Trust
Country [1] 291696 0
Australia
Primary sponsor type
University
Name
The Australian National University
Address
Centre for Research on Ageing, Health and Wellbeing
54 Mills Road
The Australian National University
Acton, Canberra
ACT, 0200
Country
Australia
Secondary sponsor category [1] 290372 0
None
Name [1] 290372 0
Address [1] 290372 0
Country [1] 290372 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293505 0
ANU Human Research Ethics Committee
Ethics committee address [1] 293505 0
Ethics committee country [1] 293505 0
Australia
Date submitted for ethics approval [1] 293505 0
15/07/2015
Approval date [1] 293505 0
20/08/2015
Ethics approval number [1] 293505 0
2015/432

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

Contacts
Principal investigator
Name 58530 0
Prof Kaarin Anstey
Address 58530 0
Centre for Research on Ageing, Health and Wellbeing
54 Mills Road
Australian National University
Acton, Canberra
ACT, 0200
Country 58530 0
Australia
Phone 58530 0
+61 02 62151480
Fax 58530 0
Email 58530 0
kaarin.anstey@anu.edu.au
Contact person for public queries
Name 58531 0
Ranmalee Eramudugolla
Address 58531 0
Centre for Research on Ageing, Health and Wellbeing
54 Mills Road
Australian National University
Acton, Canberra
ACT, 0200
Country 58531 0
Australia
Phone 58531 0
+61 02 61251456
Fax 58531 0
Email 58531 0
ranmalee.eramudugolla@anu.edu.au
Contact person for scientific queries
Name 58532 0
Ranmalee Eramudugolla
Address 58532 0
Centre for Research on Ageing, Health and Wellbeing
54 Mills Road
Australian National University
Acton, Canberra
ACT, 0200
Country 58532 0
Australia
Phone 58532 0
+61 02 61251456
Fax 58532 0
Email 58532 0
ranmalee.eramudugolla@anu.edu.au

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.