Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000941763
Ethics application status
Approved
Date submitted
7/06/2022
Date registered
4/07/2022
Date last updated
4/07/2022
Date data sharing statement initially provided
4/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
MOVETech: enhancing the coMpetency and confidence of Older drivers in the use of advanced VEhicle TECHnologies
Scientific title
MOVETech: enhancing the coMpetency and confidence of Older drivers in the use of advanced VEhicle TECHnologies
Secondary ID [1] 305913 0
RSIF2-85
Universal Trial Number (UTN)
U1111-1272-0665
Trial acronym
MOVETech
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Road Traffic Crash Involvement 324489 0
Road Traffic Injuries 324492 0
Road Traffic Fatalities 324493 0
Condition category
Condition code
Injuries and Accidents 321975 321975 0 0
Other injuries and accidents
Public Health 322674 322674 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomised to the intervention group will firstly participate in an interactive classroom education session, led by a licensed Driving Instructor and/or Occupational Therapist Driving Assessor, aiming to familiarise older drivers with the benefits, risks and correct use of advanced vehicle technologies (AVT), in groups of 8 to 10 older drivers per session. Classroom training will run for a total of 3 hours, including 30 minutes for morning tea, and will involve input from an older driver already using AVT, and the use of handouts, pamphlets and audio-visual material such as video and photographs. These were designed specifically for the study. Topics discussed include:
1. Ageing and driving – what to look out for
2. Autonomous Vehicle Technology – what are they, and what functions do they perform?
3. Autonomous Vehicle Technology – benefits to drivers?
4. Autonomous Vehicle Technology – risks to drivers?
On a separate day, as soon as possible after the classroom session, each participant will be scheduled to complete a one-hour practical, on-road (naturalistic) training session with a licensed Driving Instructor or Occupational Therapist Driving Assessor to implement their new knowledge and skills from the classroom education session. One hour is considered sufficient timing to experience the range of AVT fitted into the provided dual-controlled vehicle, such as lane departure warnings, road sign recognition and navigation aid. Each on-road driving session will involve on-road instruction in AVT use and broken into three parts:
1. Participant driving on a pre-planned route designed to demonstrate the AVT on board the provided vehicle. For example, narrow and winding roads are more likely to activate lane departure alerts, multiple speed zone changes will result in an alert that the speed zone has changed and a highway section that will demonstrate the following distance of the vehicle, relative to the vehicles in front. This will involve an increase in complexity, where the route will start in an area of low traffic density and move into areas of moderate traffic density.
2. A navigation task using the navigation aid will involve participants being asked to navigate to and from one unfamiliar location to another.
3. A reverse maneuver using a reverse camera and proximity alerts. This task will be performed in a traffic free environment. The design of this task has been informed by the literature on drivers experience with rear parking sensors and will involve the following:
a. Reversing towards an object that cannot be seen in the rear-view mirror
b. Reversing into an area towards an object that can be seen in the rear-view mirror (reverse park)
Further, in-cabin advice in the participant’s own vehicle will also be provided. Session attendance checklists, scheduling data and staff reports will be used to monitor adherence to the intervention.
Intervention code [1] 322308 0
Prevention
Intervention code [2] 322309 0
Behaviour
Comparator / control treatment
A control group of older drivers aged 70 years and over will receive a guide to read, "A Guide to Older Driver Licensing" by Transport for NSW. This guide contains information about older driver licensing options and driving assessments. Control group participants will also be assessed at baseline and 3-month follow up.
At the end of the study, control participants will be invited to attend an optional classroom session of the training program.
Control group
Active

Outcomes
Primary outcome [1] 329720 0
assessor-blinded, in-vehicle assessment of on-road driving performance (P-Drive test-score) (Patomella & Bundy, 2015)
Timepoint [1] 329720 0
3-months post-randomisation
Primary outcome [2] 329721 0
assessor-blinded, in-vehicle assessment of on-road competence on AVT use (test-score)
Timepoint [2] 329721 0
3-months post-randomisation
Secondary outcome [1] 403585 0
vehicle damage of participant's own vehicle (inspection of vehicle)
Timepoint [1] 403585 0
baseline, 3-months post-randomisation
Secondary outcome [2] 403586 0
self-reported driving confidence (Chevalier et al. 2017)
Timepoint [2] 403586 0
baseline, 3-months post-randomisation
Secondary outcome [3] 403587 0
self-reported competence on AVT use, using study-specific telephone questionnaires
Timepoint [3] 403587 0
baseline, 3-months post-randomisation
Secondary outcome [4] 410794 0
vehicle crashes (Owsley et al. 1999)
Timepoint [4] 410794 0
baseline, 3-months post-randomisation
Secondary outcome [5] 410795 0
vehicle citations (Owsley et al. 1999)
Timepoint [5] 410795 0
baseline, 3-months post-randomisation

Eligibility
Key inclusion criteria
1. Aged 70 years and older
2. Has an active and valid NSW Driver’s license (Class C)
3. Regular driver (at least 2-3 times per week) of a vehicle with at least Level 1 AVT (driver assistance such as collision or lane departure warnings, lane keep assist, cruise control)
4. Able to travel to sites/driving centres for study visits
5. Consent to use your personal vehicle to perform a driving assessment in the presence of an Occupational Therapy Driving Assessor (OTDA) and/or licensed driving instructor (DI)
6. Consent to drive an unfamiliar vehicle
7. Able to meet the time commitment of the study (approx. 3.5 to 7.5 hours across several days)
8. Able to understand conversational English
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Has a modified driver license which restricts attendance or completion of study activities, e.g. can only travel restricted distances from home by which the study sites or driving assessment route is not included

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)
A computer-generated allocation sequence will be used to allocate participants to either the intervention or control arm of the study. Randomisation will occur when participants present for their in-person baseline visit (visit 1).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation sequence will be prepared using a blocked randomisation model (block size of 4) by a researcher with no involvement in the trial and uploaded to REDCap.
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
Sample size: Building on the development and pilot testing of this training program, a study of approximately 100 older drivers will be required to evaluate the impact of the training program on driving performance. This sample size will have >90% power to measure a meaningful difference in driving safety (1.5 points on a 0-10 scale) with 5% level of significance, based on the distribution of scores in a population of older drivers in Australia on average 76 years of age. A total of 120 older drivers will be randomised to allow for 15% dropout.
Statistical Analysis Plan: The outcome measures will be compared between groups using linear regression for the continuous outcomes. Continuous outcomes include the dual primary outcomes, on-road driving performance and competence on AVT use, and secondary outcomes, self-reported driving confidence and perceived AVT competence. Count data (secondary outcomes, vehicle damage and crash involvement) will be analysed using negative binomial regression models. All analyses will be on an intent to treat basis and will be reported in line with the consort statement.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/07/2022
Actual
Date of last participant enrolment
Anticipated
28/02/2023
Actual
Date of last data collection
Anticipated
28/04/2023
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 37737 0
2444 - Port Macquarie
Recruitment postcode(s) [2] 37738 0
2430 - Taree
Recruitment postcode(s) [3] 37739 0
2428 - Forster
Recruitment postcode(s) [4] 37740 0
2164 - Wetherill Park

Funding & Sponsors
Funding source category [1] 310263 0
Government body
Name [1] 310263 0
Office of Road Safety
Country [1] 310263 0
Australia
Primary sponsor type
University
Name
University of New South Wales Sydney
Address
Level 3, Rupert Myers Building South Wing, Gate 14 Barker Street Entrance
University of New South Wales NSW 2052
Country
Australia
Secondary sponsor category [1] 311363 0
None
Name [1] 311363 0
Address [1] 311363 0
Country [1] 311363 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309935 0
UNSW HREC Committee A
Ethics committee address [1] 309935 0
Ethics committee country [1] 309935 0
Australia
Date submitted for ethics approval [1] 309935 0
22/11/2021
Approval date [1] 309935 0
11/02/2022
Ethics approval number [1] 309935 0
HC210969

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

Contacts
Principal investigator
Name 115898 0
Prof Lisa Keay
Address 115898 0
School of Optometry and Vision Science
North Wing Rupert Myers Building
Barker Street
UNSW Sydney NSW 2052 Australia
Country 115898 0
Australia
Phone 115898 0
+61 2 9385 5372
Fax 115898 0
Email 115898 0
l.keay@unsw.edu.au
Contact person for public queries
Name 115899 0
Kerrie Ren
Address 115899 0
School of Optometry and Vision Science
North Wing Rupert Myers Building
Barker Street
UNSW Sydney NSW 2052 Australia
Country 115899 0
Australia
Phone 115899 0
+61 2 9065 3857
Fax 115899 0
Email 115899 0
kerrie.ren@unsw.edu.au
Contact person for scientific queries
Name 115900 0
Kerrie Ren
Address 115900 0
School of Optometry and Vision Science
North Wing Rupert Myers Building
Barker Street
UNSW Sydney NSW 2052 Australia
Country 115900 0
Australia
Phone 115900 0
+61 2 9065 3857
Fax 115900 0
Email 115900 0
kerrie.ren@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All individual participant data collected from participants during the trial will be shared in a de-identified format.
When will data be available (start and end dates)?
Data will be made available at the end of the study, with no end date.
Available to whom?
De-identified data will be available to researchers who have received ethics approval to access the data, and only for participants who have provided consent to have their de-identified data shared.
Available for what types of analyses?
Systematic reviews and meta-analyses
How or where can data be obtained?
A copy of the ethics approval from the other researcher will need to be received prior to sharing the de-identified data for secondary research purposes. The researcher will maintain a copy of the other researchers' ethics approval for their records. The researchers will transfer the data to other researchers by sharing a link to a secure UNSW OneDrive folder.


What supporting documents are/will be available?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14246Study protocol    383210-(Uploaded-15-02-2022-13-06-20)-Study-related document.pdf
14248Ethical approval    383210-(Uploaded-15-02-2022-13-06-45)-Study-related document.Pdf


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14246Study protocol    383210-(Uploaded-25-06-2024-12-15-36)-MOVETech_Project Description_2024.03.04.docx
14248Ethical approval    383210-(Uploaded-15-02-2022-13-06-45)-Study-related document.Pdf

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.