ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Road accidents

Condition category

Condition code

Injuries and Accidents

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]

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]

Incidence of motor vehicle crashes as indicated in police-reported crashes (via licence details)

Timepoint [1]

After 24 weeks (4-week baseline and 20-week intervention)

Secondary outcome [1]

DrivePoints score (i.e., the driving safety score) generated by participants' smartphone app

Timepoint [1]

Baseline, weekly throughout 20-week intervention period, and at 4 weeks post-intervention

Secondary outcome [2]

Crash risk behaviour identified by harsh braking or acceleration, speeding, and drowsy driving through smartphone app (assessed as a composite secondary outcome)

Timepoint [2]

Baseline, weekly throughout 20-week intervention period, and 4 weeks post-intervention

Secondary outcome [3]

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]

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]

Charities/Societies/Foundations

Name [1]

National Health and Medical Research Council (NHMRC)

Address [1]

414 La Trobe St
Melbourne VIC 3000

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

Transport for NSW

Address [2]

Transport for NSW
231 Elizabeth Street
Sydney NSW 2000

Country [2]

Australia

Funding source category [3]

Government body

Name [3]

Transport Accident Commission Victoria

Address [3]

Country [3]

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]

Individual

Name [1]

Avita Streatfield

Address [1]

Melbourne School of Design
University of Melbourne
Parkville VIC 3010

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Melbourne Central Human Research Ethics Committee

Ethics committee address [1]

University of Melbourne
Parkville VIC 3010

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

27/04/2023

Approval date [1]

20/07/2023

Ethics approval number [1]

HREC 023-25244-42050-4

Summary

Brief summary

By 2030, road crashes are predicted to be the fifth leading cause of death globally. Although Australia has made great strides in road injury prevention and safety, road fatality rates have plateaued over the last decade. Of concern is the fact that young drivers are overrepresented in road injury and fatality statistics in Australia - whilst young drivers comprise only 14% of all licence holders, they are involved in about one-fourth of all serious crashes (Australian Transport Council 2011). For young people aged 18-25, driving is a high-risk activity, with the risk of a crash greatest in the first six months of licensure (VicRoads 2005).

In-vehicle telematics presents a promising technological means of reducing road trauma. Telematics technology generates real-time motor vehicle data, such as acceleration and braking information, providing drivers with direct feedback on driving performance. Moreover, linking safety-specific feedback with financial incentives may achieve safer driving behaviours.

This study aims to assess whether personalised safety feedback linked to financial incentives will improve driving behaviour and reduce road crashes among novice drivers.

This study will be the largest trial of personalised transport safety feedback delivered using telematics technology in Australia. Recent aforementioned research highlights that personalised driving feedback and financial incentives shape safer driving behaviours (Mortimer et al. 2006; Stevenson et al. 2018), and this study will extend this important finding by assessing the likely impact that personalised safety feedback and incentives have on reducing the likelihood of road crashes. This study will be a crucial step in advancing scientific knowledge around road safety and enabling large-scale implementation of interventions to reduce road trauma.

A unique element of this trial is that it delivers across the entire state(s). Most technology trials have relied on participants and researchers in close proximity to ensure appropriate installation of the technology in-vehicle, and hence have been wholly delivered in urban environments. This trial, on the other hand, will overcome the underrepresentation of regional and rural young drivers in such studies. This is a significant strength as about two-thirds of serious injuries and fatal crashes occur in regional and rural areas. 

In the past decade, hospitalisations from road crashes in Australia have not declined. As such, the market penetration of technologies like telematics highlights the opportunity to reduce the burden of road traffic injury. Furthermore, this research will provide decision-makers with data in order to guide policymaking. Our research will generate new knowledge that can be directly translated into transport safety policies associated with all newly licensed drivers.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Mark Stevenson

Address

University of Melbourne
Parkville VIC 3010

Country

Australia

Phone

+61 0383447240

Fax

mark.stevenson@unimelb.edu.au

Contact person for public queries

Name

Avita Streatfield

Address

University of Melbourne
Parkville VIC 3010

Country

Australia

Phone

+61 429899062

Fax

avita.streatfield@unimelb.edu.au

Contact person for scientific queries

Name

Mark Stevenson

Address

University of Melbourne
Parkville VIC 3010

Country

Australia

Phone

+61 0383447240

Fax

mark.stevenson@unimelb.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
18676	Informed 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

Source	Title	Year of Publication	DOI
Embase	FEEDBACK trial - A randomised control trial to investigate the effect of personalised feedback and financial incentives on reducing the incidence of road crashes.	2023	https://dx.doi.org/10.1186/s12889-023-16886-z

N.B. These documents automatically identified may not have been verified by the study sponsor.

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