Overview of the study design
deaths
ADVERSE EVENTS, EVENTS
The FEEDBACK trial is a two-arm parallel group, superiority randomised controlled trial. The study was approved by the Human Research Ethics Committee of the University of Melbourne (HREC 023-25244-42050-4), the Queensland University of Technology Research Governance and Integrity team (Project ID: 7478) and the University of Western Australia (2023/ET000616). It was funded by the National Health and Medical Research Council Australia Partnership Grant (NHMRC; Grant number: 2,015,470). The trial was prospectively registered with Australian New Zealand Clinical Trials Registry (ANZCTR; ACTRN12623000387628p).The trial was designed to comply with Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) [Following NHMRC guidelines, a trial Data Safety and Monitoring Committee (DSMC) will be established. The DSMC will be a multidisciplinary group who will have no involvement in the trial nor any conflicts of interest. It will include individuals with scientific expertise in transport safety research, statistics, and a consumer representative to ensure end-user representation and engagement during the trial. The committee will convene once per year to monitor the efficacy and safety of the trial. The responsibility of the committee will be to consider reasons for ineligibility and non-participation, adherence to protocol, intervention fidelity, study events, adverse events (those perceived to be related to the devices such as smartphones), withdrawals and deaths, and provide recommendations to the chief investigator about continuing, modifying, or stopping the trial. There are no planned interim analyses or stopping guidelines.