%0 Journal Article
%@ 14388871
%I JMIR Publications Inc.
%V 15
%N 8
%P e167
%T The MOnitoring Resynchronization dEvices and CARdiac patiEnts (MORE-CARE) Randomized Controlled Trial: Phase 1 Results on Dynamics of Early Intervention With Remote Monitoring
%A Boriani,Giuseppe
%A Da Costa,Antoine
%A Ricci,Renato Pietro
%A Quesada,Aurelio
%A Favale,Stefano
%A Iacopino,Saverio
%A Romeo,Francesco
%A Risi,Arnaldo
%A Mangoni di S Stefano,Lorenza
%A Navarro,Xavier
%A Biffi,Mauro
%A Santini,Massimo
%A Burri,Haran
%A ,
%+ Institute of Cardiology, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, S Orsola-Malpighi University Hospital, Via Massarenti, 9, Bologna, , Italy, 39 051 349858, giuseppe.boriani@unibo.it
%K cardiac resynchronization therapy
%K heart failure
%K alerts
%K remote monitoring
%K telemedicine
%D 2013
%7 21.08.2013
%9 Original Paper
%J J Med Internet Res
%G English
%X Background: Remote monitoring (RM) in patients with advanced heart failure and cardiac resynchronization therapy defibrillators (CRT-D) may reduce delays in clinical decisions by transmitting automatic alerts. However, this strategy has never been tested specifically in this patient population, with alerts for lung fluid overload, and in a European setting. Objective: The main objective of Phase 1 (presented here) is to evaluate if RM strategy is able to reduce time from device-detected events to clinical decisions. Methods: In this multicenter randomized controlled trial, patients with moderate to severe heart failure implanted with CRT-D devices were randomized to a Remote group (with remote follow-up and wireless automatic alerts) or to a Control group (with standard follow-up without alerts). The primary endpoint of Phase 1 was the delay between an alert event and clinical decisions related to the event in the first 154 enrolled patients followed for 1 year. Results: The median delay from device-detected events to clinical decisions was considerably shorter in the Remote group compared to the Control group: 2 (25th-75th percentile, 1-4) days vs 29 (25th-75th percentile, 3-51) days respectively, P=.004. In-hospital visits were reduced in the Remote group (2.0 visits/patient/year vs 3.2 visits/patient/year in the Control group, 37.5% relative reduction, P<.001). Automatic alerts were successfully transmitted in 93% of events occurring outside the hospital in the Remote group. The annual rate of all-cause hospitalizations per patient did not differ between the two groups (P=.65). Conclusions: RM in CRT-D patients with advanced heart failure allows physicians to promptly react to clinically relevant automatic alerts and significantly reduces the burden of in-hospital visits. Trial Registration: Clinicaltrials.gov NCT00885677; http://clinicaltrials.gov/show/NCT00885677 (Archived by WebCite at http://www.webcitation.org/6IkcCJ7NF). 
%M 23965236
%R 10.2196/jmir.2608
%U http://www.jmir.org/2013/8/e167/
%U https://doi.org/10.2196/jmir.2608
%U http://www.ncbi.nlm.nih.gov/pubmed/23965236