Decentralised Trials for Hearing and Tinnitus Therapies: Lessons from the Digital Therapy for Improved Tinnitus Care (DEFINE) Randomised Controlled Trial

Randomised Controlled Trials (RCTs) are the gold standard for evaluating the efficacy of interventions; yet, traditional methods involving multiple recruitment sites often involve significant logistical and financial challenges. The DEFINE trial demonstrates the feasibility of a decentralised approach to RCTs by comparing smartphone-delivered self-guided tinnitus therapy against one-to-one therapist-facilitated treatment for tinnitus. This trial was conducted entirely remotely, leveraging digital technologies for remote recruitment, data collection, and intervention delivery. A total of 210 participants were recruited through social media platforms over a five-month period. Participants were screened and enrolled by a central trial team remotely, who utilised hearing test smartphone applications and electronic consent forms. Baseline and follow-up assessments were conducted using electronic data capture (EDC) platforms, with high retention rates observed at each time point. The trial successfully recruited and retained participants, demonstrating the efficiency and cost-effectiveness of remotely managed trials. Key findings include a high engagement rate from social media ads, with 151,978 impressions leading to 4,997 clicks (3.3%), with a direct advertising spend of £880. 912 individuals self-screened for eligibility online. The median age of participants was 58.3 years, in line with comparable traditionally-recruiting tinnitus studies, with good geographical distribution across the UK. The trial's adaptability allowed for protocol adjustments, and real-time monitoring of data quality and completeness. The DEFINE trial demonstrates that decentralised RCTs can offer a viable alternative to traditional RCTs for some hearing and tinnitus research, potentially increasing participant diversity and reducing the burden of research on participants, while maintaining rigorous standards of data collection and participant safety. Increasing clinical use of remote audiological assessment, and hearing implant programming provide increasing opportunities for the adoption of entirely remote or hybrid studies in hearing and tinnitus conditions.