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BACKGROUND Inflammatory bowel diseases (IBD) are chronic inflammatory conditions of the gastrointestinal tract often requiring long-term medical therapy. While adherence to IBD therapies is associated with improved clinical outcomes, overall adherence is poor with reports demonstrating adherence rates ranging from 40% to 80%. Consequently, there is a critical need to develop interventions that monitor adherence in-real time and identify reasons for non-adherence to support clinical teams in initiating effective interventions. Recently, electronic- and virtual-based platforms have been developed to routinely monitor adherence and guide appropriate interventions. A novel remote therapeutic monitoring (RTM) technology, the TapptTM digital health system, has been developed to monitor real-time medication adherence patterns through smart label technologies, capture patient reported outcomes (PROs) and barriers to care, and process patient data through algorithms that trigger personalized digital and human touchpoints between clinical visits. Such digital health solution enables care teams to proactively identify and mitigate nonadherence and worsening clinical outcomes. OBJECTIVE We propose a 12-month, multicenter, randomized, controlled trial to assess the effectiveness of TapptTM digital health system on adherence, clinical outcomes, and healthcare utilization among patients diagnosed with IBD starting a new oral or subcutaneous therapy. METHODS Specifically, we will (Aim 1) compare adherence as measured by the Medication Possession Ratio (MPR) in participants using the RTM compared to standard of care and (Aim 2) compare clinical outcomes and healthcare utilization in participants using the RTM compared to standard of care. RESULTS We anticipate starting recruitment in August 2022. CONCLUSIONS Effective medication adherence monitoring and intervention programs need to be cost-efficient, pose little to no burden to the patient, be unobtrusive, record reliable data in real-time, and provide actionable insights to the healthcare team. We anticipate the TapptTM digital health system to improve the MPR, clinical outcomes, and healthcare utilization compared to standard of care. CLINICALTRIAL NCT05316584 |
