Application-based coaching for recurrent urinary tract infections in adult women: design of a mixed-methods multicenter randomized controlled trial and process evaluation in the Netherlands

Background Recurrent urinary tract infections (rUTI) healthcare has proven to be a challenge due to different limitations. Digital coaching could provide a solution for these challenges. Earlier, we have developed a digital coach for women with rUTI and pilot-tested this positively. We now aim to assess the clinical effectiveness of this app-based coaching tool, and to support its optimal implementation through a comprehensive process evaluation. This article describes the design of the study. Methods A mixed-methods study will be conducted, consisting of a randomized controlled superiority trial in parallel with an extensive process evaluation. Adult women with rUTI will be randomized to receive care as usual or care as usual with additional mobile coaching, offering interactive education, symptom tracking, lifestyle advice and self-care strategies. The primary outcome of the RCT is UTI frequency during the 12-month follow-up time. Secondary outcomes include antibiotics usage, patient-reported quality of life, healthcare consumption, and cost-effectiveness. The process evaluation will combine surveys, interviews with patients, focus groups with healthcare professionals and log data to assess acceptability and usability of app-based coaching and to explore barriers and facilitators for implementation of this eHealth tool. Conclusion This pragmatic study envisions to explore the additional value of digital coaching to care as usual for women suffering from rUTI through a mixed-methods design in a real-world setting, as well as to establish a more profound understanding of the mechanisms behind implementation and efficacy of app-based coaching. Trial registration The RCT is registered in the ‘Overview of Medical Research in the Netherlands'-register (OMON; NL-005140, date of registration 25 June 2024).