Study design of the InTakeCare Trial: a digital health solution to monitor and improve medication adherence in hypertensive patients

Abstract Objective The InTakeCare Trial aims to develop, implement, and clinically validate a novel digital health solution (DHS) to improve medication adherence in patients with arterial hypertension. This initiative responds to the global issue of poor medication adherence (MA) to long-term pharmacological treatments, compromising patient outcomes and increasing healthcare costs. Methods This study is structured as a multidisciplinary, single-centre, randomized, open, blinded-endpoint clinical trial. In the preliminary phase, focus groups and a survey are conducted to develop patient Personas, fictional archetypes that represent real people in the development of interventions, informing the personalization of a mobile application for patients and a web dashboard for physicians. The developed DHS is designed to deliver tailored reminders, health messages, and real-time monitoring of MA. After a pilot usability phase, 206 hypertensive patients will be randomized to standard care or active intervention for a 3-month period, followed by a 2-month observational phase to assess the persistence of intervention effects on adherence. MA is measured via direct (e.g., plasma drug levels) and indirect (e.g., self-reports) methods, alongside ambulatory blood pressure monitoring and behavioral engagement scales. Discussion This study offers a novel, theory-informed framework for the design of personalized DHS in chronic disease management. Leveraging user-centered design and machine learning-driven Persona classification, InTakeCare introduces a scalable, evidence-based solution that addresses individual variability in adherence behaviors. The trial’s findings are expected to generate insights into the efficacy, usability, and acceptability of personalized DHS in routine clinical practice, providing a replicable model for future DHS in other chronic conditions.