TY - JOUR
T1 - Study design and rationale of the AZIMUTH trial: a smartphone, app-based, E-health-integrated model of care for heart failure patients
AU - D'AMARIO, DOMENICO
AU - Restivo, Attilio
AU - Laborante, Renzo
AU - Paglianiti, Donato Antonio
AU - Cesario, Alfredo
AU - Patarnello, Stefano
AU - Kyriazakos, Sofoklis
AU - Luraschi, Alice
AU - Kostopoulou, Konstantina
AU - Iaconelli, Antonio
AU - Incaminato, Enrico
AU - Rizzo, Gaetano
AU - Gorini, Marco
AU - Marcoli, Stefania
AU - Bartoli, Vincenzo
AU - Griffiths, Thomas
AU - Fenici, Peter
AU - Giubilato, Simona
AU - Volterrani, Maurizio
AU - Patti, Giuseppe Rocco Salvatore
AU - Valentini, Vincenzo
AU - Scambia, Giovanni
AU - Crea, Filippo
PY - 2025
Y1 - 2025
N2 - 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.
AB - 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.
KW - Digital Technologies
KW - E-health integrated model of care
KW - Heart failure
KW - Digital Technologies
KW - E-health integrated model of care
KW - Heart failure
UR - https://iris.uniupo.it/handle/11579/223122
U2 - 10.1093/ehjdh/ztaf040
DO - 10.1093/ehjdh/ztaf040
M3 - Article
SN - 2634-3916
VL - 6
SP - 840
EP - 848
JO - European Heart Journal - Digital Health
JF - European Heart Journal - Digital Health
IS - 4
ER -