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

March 26, 2013 updated by: Renato Pietro Ricci, San Filippo Neri General Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

1650

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cardiac Implantable Device recipients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cardiac Implantable Device recipients
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
Other Names:
  • Biotronik Home Monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity, positive predictive value and expected utility of the organizational model
Time Frame: Up to two years
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Manpower of the organizational model
Time Frame: Up to two years
Health care source consumption required to implement the organizational model for the remote management of patients
Up to two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Filippo Neri General Hospital

Collaborators

Biotronik Italia

Investigators

  • Principal Investigator: Renato Pietro Ricci, San Filippo Neri Hospital, Rome, Italy
  • Study Chair: Loredana Morichelli, San Filippo Neri Hospital, Rome, Italy
  • Study Chair: Gianfranco Buja, Policlinico universitario, University of Padua, Italy
  • Study Chair: Leonardo Calò, Policlinico Casilino, Rome, Italy
  • Study Chair: Antonio Curnis, Spedali Civili, University of Brescia, Italy
  • Study Chair: Antonio D'Onofrio, Monaldi Hospital, Italy
  • Study Chair: Diego Vaccari, Montebelluna Hospital, Italy
  • Study Chair: Gabriele Zanotto, Legnago Hospital, Verona, Italy
  • Study Chair: Alessio Gargaro, Biotronik Italia
  • Study Chair: Nicola Rovai, Biotronik Italia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

October 24, 2011

First Submitted That Met QC Criteria

October 25, 2011

First Posted (Estimate)

October 26, 2011

Study Record Updates

Last Update Posted (Estimate)

March 28, 2013

Last Update Submitted That Met QC Criteria

March 26, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HomeGuide

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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