Evidence map›Paper›PMID 23965236›Full record

Trial reportJournal of medical Internet research2013

The MOnitoring Resynchronization dEvices and CARdiac patiEnts (MORE-CARE) randomized controlled trial: phase 1 results on dynamics of early intervention with remote monitoring.

Giuseppe Boriani, Antoine Da Costa, Renato Pietro Ricci, Aurelio Quesada, Stefano Favale, Saverio Iacopino, Francesco Romeo, Arnaldo Risi, Lorenza Mangoni di S Stefano, Xavier Navarro and 4 more

Registry-linked trialAbstract readClinical Trial, Phase IMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of medical Internet research, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00885677 (MOnitoring REsynchronization deviCes and cARdiac patiEnts), which is not on this map. Cited by 43 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00885677 naterminatednot on this map

MOnitoring REsynchronization deviCes and cARdiac patiEnts

TypeinterventionalSponsorMedtronic Cardiac Rhythm and Heart FailureRan2009 to 2016Enrolled918ConditionsHeart FailureArmsMedtronic CareLink® Network
3 · Its place in the literature

Who cites it

43 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Knowledge Update on the Economic Evaluation of Pacemaker Telemonitoring Systems.International journal of environmental research and public health · 2021
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  6. REmote SUpervision to Decrease HospitaLization RaTe. Unified and integrated platform for data collected from devices manufactured by different companies: Design and rationale of the RESULT study.Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc · 2017
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  16. 2023 HRS/EHRA/APHRS/LAHRS Expert Consensus Statement on Practical Management of the Remote Device Clinic.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2023
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  17. Article
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  20. What do we do about atrial high rate episodes?European heart journal supplements : journal of the European Society of Cardiology · 2020
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Giuseppe BorianiInstitute of Cardiology, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, S Orsola-Malpighi University Hospital, Bologna, Italy. giuseppe.boriani@unibo.it
Antoine Da Costa
Renato Pietro Ricci
Aurelio Quesada
Stefano Favale
Saverio Iacopino
Francesco Romeo
Arnaldo Risi
Lorenza Mangoni di S Stefano
Xavier Navarro
Mauro Biffi
Massimo Santini
Haran Burri
MORE-CARE Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRemote 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.

objectiveThe 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.

methodsIn 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.

resultsThe median delay from device-detected events to clinical decisions was considerably shorter in the Remote group compared to the Control group: 2 (25(th)-75(th) percentile, 1-4) days vs 29 (25(th)-75(th) 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).

conclusionsRM 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 registrationClinicaltrials.gov NCT00885677; http://clinicaltrials.gov/show/NCT00885677 (Archived by WebCite at http://www.webcitation.org/6IkcCJ7NF).

Indexed as

ElectronicsHumansMonitoring, PhysiologicTelemedicinealertscardiac resynchronization therapyheart failureremote monitoringtelemedicine

Identifiers

PMID23965236
PMCPMC3758044

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.