Study design and rationale of the AZIMUTH trial: a smartphone, app-based, E-health-integrated model of care for heart failure patients

Aims Despite advancements in disease-modifying therapies, the rate of hospitalizations in patients with heart failure (HF) remains high, with an increased risk of future adverse events and healthcare costs. In this context, the AZIMUTH study aims to evaluate the large-scale applicability of a smartphone app-based model of care to improve the quality of care and clinical outcomes of HF patients. Methods The AZIMUTH trial is a multicentre, prospective, pragmatic, interventional, single-cohort study enrolling HF patients. Three and results hundred patients will be recruited from four different sites. For comparative analyses, historical data from participating hospitals for the 6 months before enrolment and propensity-matching score analyses from GENERATOR HF DataMart, will be used. The estimated duration of the study is 6 months. During the whole observational period, the patients are asked to provide information regarding their clinical status, transmit remote clinical parameters, and periodically answer validated questionnaires, the Kansas City Cardiomyopathy Questionnaire Health and Morisky Medication Adherence Scale 8-item, on a mobile application, through which healthcare providers implement therapeutic adjustments and remote clinical assessments. The primary objective of this study is to evaluate the feasibility, usability, and perceived benefits for key stakeholders (patients and clinical staff) of the AZIMUTH digital platform in the enrolled patients when compared to standard of care. Secondary endpoints will be the description of the rate of hospital readmissions, ambulatory visits and prescribed therapy in the 6 months following enrolment in the experimental group compared to both the historical and propensity-matched cohorts. Conclusion The AZIMUTH aims to enhance HF management by leveraging digital technologies to support the care process and enhance monitoring, engagement, and personalized treatment for HF patients.