Evaluation of an Organizational Model for Remote Monitoring of Pacemaker and Implantable Cardioverter Defibrillator Recipients

Pacemaker Clinical Trial

Official title:

Prospective Registry for the Evaluation of an Organizational Model for Remote Monitoring of Pacemaker and Implantable Cardioverter Defibrillator (ICD) Recipients in the Clinical Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01459874
• Other study ID #: HomeGuide
• Status: Completed
• Phase: N/A
• First received: October 24, 2011
• Last updated: March 26, 2013
• Start date: March 2008
• Est. completion date: December 2011

Study information

• Verified date: March 2013
• Source: San Filippo Neri General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeItaly: National Institute of Health
• Study type: Observational

Clinical Trial Summary

The purpose of the registry is to evaluate an organizational model fixing roles and behaviors of subjects involved in the remote monitoring of patients implanted with pacemakers and defibrillators.

The evaluation will estimate the clinical efficiency and the impact on health service resources of the organizational model when this is implemented in the daily clinical practice.

Description:

After a number of studies which assessed technical reliability and clinical implications of remote monitoring systems, a further step should approach the issue of how remote monitoring can be implemented as a part of routine activities of a cardiology outpatient clinic. A clear definition of roles and workflow to timely manage information and properly react to adverse events is required. The HomeGuide Registry proposes an organizational model specifying roles and procedures for outpatient clinics using a specific remote monitoring system in routine follow-up. The HomeGuide model is essentially based on an interaction between one or more allied professionals (expert and trained nurses or technicians) and a responsible physician. The main objective of the HomeGuide Registry is to evaluate:

1. Clinical efficiency of remote patient management;

2. Health service resources required by a remote patient management.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1650
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients implanted with a BIOTRONIK pacemaker or ICD with Home Monitoring (HM) technology

• Ability to utilize the HM system throughout the study

• Ability to give informed consent

• Ability to return for regular follow-ups for two years

Exclusion Criteria:

• Patients who do not fulfill all inclusion criteria

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Implantable Cardioverter Defibrillator
• Pacemaker

Intervention

Behavioral:
• Organizational model for remote monitoring
An organizational model defining roles and behaviors of subjects involved in the remote monitoring of pacemaker and defibrillator recipients

Locations

Country	Name	City	State
Italy	Umberto I Hospital	Altamura	Bari
Italy	G.M. Lancisi Hospital	Ancona
Italy	I.N.R.C.A.	Ancona
Italy	S. Donato di Arezzo Hospital	Arezzo
Italy	Presidio Ospedale di Ariano Irpino	Ariano Irpino	Avellino
Italy	Policlinico - Card. Universitaria	Bari
Italy	Policlinico - Cardiologia Ospedaliera	Bari
Italy	Policlinico - Cardiologia Ospedaliera	Benevento
Italy	AO Spedali Civili	Brescia
Italy	Congreg. Ancelle della Carità Poliambulanza	Brescia
Italy	A. Perrino Hospital	Brindisi
Italy	Cardarelli Hospital	Campobasso
Italy	S. Cuore University	Campobasso
Italy	Carrara Civil Hospital	Carrara
Italy	PO Francesco Ferrari	Casarano	Lecce
Italy	Sant'Anna e San Sebastiani Hospital	Caserta
Italy	San Leonardo	Castellammare di Stabia	Napoli
Italy	Ferrarotto Hospital	Catania
Italy	ULSS n. 14	Chioggia	Venezia
Italy	Ulss n. 7	Conegliano	Treviso
Italy	Ospedale di Circolo	Desio	Monza e Brianza
Italy	AO Arcispedale S. Anna	Ferrara
Italy	A.O.U. Careggi S.O.D. Aritmologia	Firenze
Italy	S. Giovanni di Dio Hospital	Firenze
Italy	S. Maria Annunziata Hospital	Firenze
Italy	S. Maria Nuova Hospital	Firenze
Italy	P.O. Di Gorizia	Gorizia
Italy	F. Veneziale Hospital	Isernia
Italy	Vito Fazzi Hospital	Lecce
Italy	Mater Salutis Hospital	Legnago	Verona
Italy	P.O. Giannuzzi	Manduria	Taranto
Italy	Paolo Borsellino Hospital	Marsala	Trapani
Italy	P. O. Villa D'Agri	Marsicovetere	Potenza
Italy	Piemonte Hospital	Messina
Italy	Dell'Angelo Hospital	Mestre	Venezia
Italy	Sacco Hospital	Milano
Italy	P.O.G. Fogliani	Milazzo	Messina
Italy	Mirano Hospital	Mirano	Venezia
Italy	Montebelluna Hospital	Montebelluna	Treviso
Italy	F.B.F.	Napoli
Italy	Federico II Hospital	Napoli
Italy	Monaldi Hospital - Gruppo Sun	Napoli
Italy	Monaldi Hospital, U.O. Aritmologia	Napoli
Italy	Policlinico Federico II	Napoli
Italy	G. B. Grassi	Ostia	Roma
Italy	Policlinico Universitario di Padova	Padova
Italy	ARNAS Civico	Palermo
Italy	Cervello Hospital	Palermo
Italy	Santa Maria della Misericordia Hospital	Perugia
Italy	SS. Cosimo e Damiano Hospital	Pescia	Pistoia
Italy	Guglielmo da Saliceto Civil Hospital	Piacenza
Italy	Santa Maria degli Angeli Hospital	Pordenone
Italy	Portogruaro Hospital	Portogruaro	Venezia
Italy	Santa Maria Nuova Hospital	Reggio Emilia
Italy	Degli Infermi Hospital	Rimini
Italy	Casa di Cura Villa Pia	Roma
Italy	Policlinico Casilino	Roma
Italy	Policlinico Tor Vergata	Roma
Italy	Policlinico Umberto I	Roma
Italy	San Filippo Neri Hospital	Rome
Italy	San Giovanni di Dio e Ruggi D'Aragona Hospital	Salerno
Italy	San Donà di Piave Hospital	San Donà di Piave
Italy	Teresa Masselli Mascia Hospital	San Severo
Italy	Senigallia Civil Hospital	Senigallia	Ancona
Italy	Santa Maria Della Misericordia Hospital	Sorrento	Salerno
Italy	P.O. SS. Annunziata	Taranto
Italy	Michele Sarcone Hospital	Terlizzi	Bari
Italy	Sant'Antonio Abate Hospital	Trapani
Italy	Ca' Foncello Hospital	Treviso
Italy	Di Circolo Hospital	Varese
Italy	Macchi Hospital	Varese
Italy	SS. Giovanni e Paolo Hospital	Venezia
Italy	Guizzardi Hospital	Vittoria	Ragusa
Italy	Volterra Hospital	Volterra	Pisa

Sponsors (2)

Lead Sponsor	Collaborator
San Filippo Neri General Hospital	Biotronik Italia

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Ricci RP, Morichelli L, D'Onofrio A, Calò L, Vaccari D, Zanotto G, Curnis A, Buja G, Rovai N, Gargaro A. Effectiveness of remote monitoring of CIEDs in detection and treatment of clinical and device-related cardiovascular events in daily practice: the Hom — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity, positive predictive value and expected utility of the organizational model	Sensitivity, positive predictive value and expected utility in the detection of all cardiovascular and device-related events of the proposed organizational model	Up to two years	No
Secondary	Manpower of the organizational model	Health care source consumption required to implement the organizational model for the remote management of patients	Up to two years	No