Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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
ACTRN12623000387628
Ethics application status
Approved
Date submitted
30/03/2023
Date registered
17/04/2023
Date last updated
15/04/2024
Date data sharing statement initially provided
17/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
FEEDBACK trial: Investigating the effect of a personalised feedback intervention on the incidence of road crashes
Scientific title
FEEDBACK trial: Investigating the effect of using telematics, direct feedback, and financial incentives on reducing the incidence of road crashes
Secondary ID [1] 309249 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Road accidents 329407 0
Condition category
Condition code
Injuries and Accidents 326353 326353 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants include drivers aged 18-20 who have obtained their provisional (P1) drivers' licence. Once a participant has consented to participate, they will complete an online questionnaire around demographics, driving attitudes, and road pricing attitudes. All participants will then download a telematics technology-enabled smartphone app (developed specifically for this study) that will be able to track their driving behaviour during car trips.

Driving behaviour will be monitored for a 4-week baseline period during which they will not receive feedback. Participants will then be randomly assigned to either an intervention group or a control group. Over 20 weeks, intervention group will receive daily driving feedback and a personalised weekly driving score which will be linked to a financial incentive, all via the app. Participants will not be asked to interact with the app other than to review their weekly driving scores. The app will provide driving scores based on crash risk behaviour such as harsh braking, speeding, and drowsy driving. The app will not provide any other educational materials other than these scores.

Intervention group participants will begin with a starting amount of $120 (deposited into a 'safe driving account') and monthly deductions of $24 may occur if participants receive poor driving scores.

There will then be a 4-week post-intervention period, and participants will complete an abridged post-trial questionnaire. Participants' licensing details will also be captured in order to verify if any police-reported crashes occurred during the trial.

Both the intervention and control group participants will also be entered into a weekly draw for a $100 e-voucher. Draw winners will be chosen randomly, and participants will receive weekly SMS updates about the draw. As long as participants have location services enabled for the app, they will be eligible for the draw.

App analytics will be access in order to monitor adherence to the intervention. If the app analytics data indicate that participants are not adhering to the intervention (including disabling location services for the app), participants will be contacted via SMS or email to encourage adherence.
Intervention code [1] 325687 0
Behaviour
Comparator / control treatment
The control group participants will also complete the pre-trial questionnaire upon consenting to participate. They will then download the same telematics-enabled app, and driving behaviour will be monitored during the 4-week baseline period. However, once participants are randomly assigned to the intervention or control group, the control group will not receive feedback via the app, but will instead be eligible for the weekly draw for a $100 e-voucher.
Control group
Active

Outcomes
Primary outcome [1] 334209 0
Incidence of motor vehicle crashes as indicated in police-reported crashes (via licence details)
Timepoint [1] 334209 0
After 24 weeks (4-week baseline and 20-week intervention)
Secondary outcome [1] 419838 0
DrivePoints score (i.e., the driving safety score) generated by participants' smartphone app
Timepoint [1] 419838 0
Baseline, weekly throughout 20-week intervention period, and at 4 weeks post-intervention
Secondary outcome [2] 419839 0
Crash risk behaviour identified by harsh braking or acceleration, speeding, and drowsy driving through smartphone app (assessed as a composite secondary outcome)
Timepoint [2] 419839 0
Baseline, weekly throughout 20-week intervention period, and 4 weeks post-intervention
Secondary outcome [3] 420617 0
Incidence of 'at-fault' crashes self-reported by drivers in post-trial questionnaire (resulting in damage to either the driver's vehicle or another person's vehicle). This questionnaire has been designed specifically for this study
Timepoint [3] 420617 0
After 20-week intervention period and again after 4-week post-intervention period

Eligibility
Key inclusion criteria
Participants must:
1. Be 18-20 years old
2. Hold a P1 provisional licence from the licensing agencies in New South Wales, Victoria, Western Australia, or Queensland
3. Be the sole driver of a motor vehicle
4. Own and use a smartphone
5. Speak English at a sufficient level to understand the instructions for downloading and understanding the feedback from the smartphone app
Minimum age
18 Years
Maximum age
20 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Central randomisation will be done by computer. Participants will be de-identified and assigned participant IDs, and then electronically randomised by ID number.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
3068
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC

Funding & Sponsors
Funding source category [1] 313441 0
Charities/Societies/Foundations
Name [1] 313441 0
National Health and Medical Research Council (NHMRC)
Country [1] 313441 0
Australia
Funding source category [2] 313445 0
Government body
Name [2] 313445 0
Transport for NSW
Country [2] 313445 0
Australia
Funding source category [3] 316303 0
Government body
Name [3] 316303 0
Transport Accident Commission Victoria
Country [3] 316303 0
Australia
Primary sponsor type
Individual
Name
Prof Mark Stevenson
Address
Melbourne School of Design
University of Melbourne
Parkville VIC 3010
Country
Australia
Secondary sponsor category [1] 315211 0
Individual
Name [1] 315211 0
Avita Streatfield
Address [1] 315211 0
Melbourne School of Design
University of Melbourne
Parkville VIC 3010
Country [1] 315211 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312647 0
University of Melbourne Central Human Research Ethics Committee
Ethics committee address [1] 312647 0
Ethics committee country [1] 312647 0
Australia
Date submitted for ethics approval [1] 312647 0
27/04/2023
Approval date [1] 312647 0
20/07/2023
Ethics approval number [1] 312647 0
HREC 023-25244-42050-4

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

Contacts
Principal investigator
Name 125414 0
Prof Mark Stevenson
Address 125414 0
University of Melbourne
Parkville VIC 3010
Country 125414 0
Australia
Phone 125414 0
+61 0383447240
Fax 125414 0
Email 125414 0
[email protected]
Contact person for public queries
Name 125415 0
Avita Streatfield
Address 125415 0
University of Melbourne
Parkville VIC 3010
Country 125415 0
Australia
Phone 125415 0
+61 429899062
Fax 125415 0
Email 125415 0
[email protected]
Contact person for scientific queries
Name 125416 0
Mark Stevenson
Address 125416 0
University of Melbourne
Parkville VIC 3010
Country 125416 0
Australia
Phone 125416 0
+61 0383447240
Fax 125416 0
Email 125416 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18676Informed consent form    385589-(Uploaded-23-03-2023-11-25-59)-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
SourceTitleYear of PublicationDOI
EmbaseFEEDBACK trial - A randomised control trial to investigate the effect of personalised feedback and financial incentives on reducing the incidence of road crashes.2023https://dx.doi.org/10.1186/s12889-023-16886-z
N.B. These documents automatically identified may not have been verified by the study sponsor.