AZIMUTH trial: a smartphone, app-based, E-health-integrated model of care for heart failure patients

Background

Despite advancements, the rate of hospitalizations in patients with heart failure (HF) remains high, with high risk of adverse events. 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 regardless of LVEF. For comparative analyses, both historical data from participating hospitals, along with propensity-matching score analyses from GENERATOR HF DataMart, have been implemented as control group. During the observational period (12 months), the patients were asked to provide information regarding their clinical status, transmit clinical parameters, and periodically answer validated questionnaires such as KCCQ and Morisky Medication Adherence Scale 8-item, on a mobile application, through which healthcare providers implement therapeutic adjustments and remote clinical assessments. User Experience Questionnaire (UEQ-S) and the Friends and Family Test (FFT) were also implemented.

Aims

The primary objective was to evaluate the feasibility, usability and perceived benefits of the AZIMUTH digital platform when compared to standard of care. Secondary endpoints were the description of the rate of hospital readmissions, ambulatory visits and prescribed therapy in the 6 months following enrollment in the experimental group compared to both the historical and propensity-matched cohorts.

Results

Our ehealth-empowered approach was successfully tested in a cohort of 300 consecutive HF patients (mean age 77 ± 12 years, mean LVEF 47 ± 13 %, mean NYHA class 2 ± 0.5). After a median follow-up of 11 months, all patients completed the study.

The engagement was very high: 75% of opened the app at least once a day, showing a remarkable willingness to share additional data, consisting in 15531 "patient-reported outcome measures" (PROM). The average adherence to mandatory tasks was 70.8% whereas the adherence to medication reporting was 84.2%. The median result of the UEQ was "excellent" and the FFT revealed a "very positive" experience. A significant decrease in the rate of re-hospitalization and unplanned visits were observed at 12 months when compared with the same period before the implementation of the AZIMUTH model of care (1±0.2 vs 3±0.3 p<0.01) and was accompanied with a significant increase in the perceived quality of life (KCCQ overall score 71.2±20.7vs78.5±23.5; clinical score 77.4±20.1vs82.6±21.5 p<0.05). The adherence to drug regimens rate was significantly higher in the patients using the solution (82.1% vs 62.4% p<00.1).

Conclusion

The AZIMUTH ehealth-integrated HF care is feasibile, user-friendly, scalable with high adherence. The clinical findings suggest that the AZIMUTH digital platform may improve the quality of life, generate savings in health expenditures and impact patient's outcome.