Health Economic Evaluation of Remote Follow up for Implantable Cardioverter Defibrillator (ICD) Patients

NCT01075516 | Completed Results

• 1 other identifier: CR 09 021 IT RC
• Study Type: observational
• Target: 209
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of the study is to define the economic value of implantable cardioverter defibrillator (ICD) remote monitoring for hospitals, third payers and patients in Italy. Aims of the study are to develop a hospital cost minimization analysis and a cost effectiveness analysis based on direct estimation of costs and quality of life deriving from remote follow-up (performed with Merlin@home and Merlin.net) compared to standard follow-up in the management of ICD implanted patients.

Conditions

Complication of Cardiac Defibrillator

Keywords

Remote Monitoring; ICD patients; EQ-5D questionnaire; remote follow up

Outcome Measures

Primary Outcomes (1)

• Economic Impact of Remote Monitoring on Hospitals and Patients

  Costs analysis of remote monitoring using Merlin@home and Merlin.net compared to standard follow-up in an Italian real-life setting. Overall mean annual cost per patient: Health Care System (HCS) perspective.

  12 months follow-up

Secondary Outcomes (2)

• Impact of Remote Monitoring on Procedural Costs for the Italian Health Economic System (SSN)

  1 year

• Impact of Remote Monitoring on Patients' Quality of Life

  baseline, 12 months

Study Arms (2)

Standard Follow Up

ICD patients followed through periodic in-hospital visits

Remote Follow Up

ICD patients followed with remote transmitters (Merlin@Home) that periodically communicate correct system functioning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients implanted with ICD according to current guidelines and with the possibility to use Merlin@home transmitters

You may qualify if:

• Patients already implanted with ICD
• Patients able to be followed in the same centre during all the study
• Patients with age \> 18
• Patients able to understand and to answer to EuroQoL Group 5-Dimension (EQ-5D) Questionnaire

You may not qualify if:

• Patients pregnant
• Patients unable to connect Merlin@home transmitters with Website Merlin.net (i.e.without telephonic analogic line or Global System for Mobile Communication (GSM)/Universal Mode Telecommunication System (UMTS) connection)

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (6)

Azienda Ospedaliera S.Gerardo

Monza, Monza (MB), 20052, Italy

Location

Casa di Cura Pederzoli

Peschiera del Garda, VR, Italy

Location

Ospedale Careggi

Florence, Italy

Location

Ospedale Luigi Sacco

Milan, Italy

Location

Ospedale Monaldi

Napoli, Italy

Location

Ospedale San Filippo Neri

Roma, 00135, Italy

Location

Related Publications (11)

• Wilkoff BL, Auricchio A, Brugada J, Cowie M, Ellenbogen KA, Gillis AM, Hayes DL, Howlett JG, Kautzner J, Love CJ, Morgan JM, Priori SG, Reynolds DW, Schoenfeld MH, Vardas PE; Heart Rhythm Society; European Heart Rhythm Association; American College of Cardiology; American Heart Association; European Society of Cardiology; Heart Failure Association of ESC; Heart Failure Society of America. HRS/EHRA expert consensus on the monitoring of cardiovascular implantable electronic devices (CIEDs): description of techniques, indications, personnel, frequency and ethical considerations. Heart Rhythm. 2008 Jun;5(6):907-25. doi: 10.1016/j.hrthm.2008.04.013. No abstract available.

  PMID: 18551743 BACKGROUND

• Morichelli L, Ricci RP. Remote monitoring of implantable devices: the European experience. Heart Rhythm. 2009 Jul;6(7):1077-80. doi: 10.1016/j.hrthm.2009.02.030. Epub 2009 Feb 24. No abstract available.

  PMID: 19560096 BACKGROUND

• Ricci RP, Morichelli L, Santini M. Remote control of implanted devices through Home Monitoring technology improves detection and clinical management of atrial fibrillation. Europace. 2009 Jan;11(1):54-61. doi: 10.1093/europace/eun303. Epub 2008 Nov 16.

  PMID: 19011260 BACKGROUND

• Marzegalli M, Lunati M, Landolina M, Perego GB, Ricci RP, Guenzati G, Schirru M, Belvito C, Brambilla R, Masella C, Di Stasi F, Valsecchi S, Santini M. Remote monitoring of CRT-ICD: the multicenter Italian CareLink evaluation--ease of use, acceptance, and organizational implications. Pacing Clin Electrophysiol. 2008 Oct;31(10):1259-64. doi: 10.1111/j.1540-8159.2008.01175.x.

  PMID: 18811805 BACKGROUND

• Ricci RP, Morichelli L, Santini M. Home monitoring remote control of pacemaker and implantable cardioverter defibrillator patients in clinical practice: impact on medical management and health-care resource utilization. Europace. 2008 Feb;10(2):164-70. doi: 10.1093/europace/eum289. Epub 2008 Jan 16.

  PMID: 18199570 BACKGROUND

• Seto E. Cost comparison between telemonitoring and usual care of heart failure: a systematic review. Telemed J E Health. 2008 Sep;14(7):679-86. doi: 10.1089/tmj.2007.0114.

  PMID: 18817497 BACKGROUND

• Clark RA, Inglis SC, McAlister FA, Cleland JG, Stewart S. Telemonitoring or structured telephone support programmes for patients with chronic heart failure: systematic review and meta-analysis. BMJ. 2007 May 5;334(7600):942. doi: 10.1136/bmj.39156.536968.55. Epub 2007 Apr 10.

  PMID: 17426062 BACKGROUND

• Lunati M, Gasparini M, Santini M, Landolina M, Perego GB, Pappone C, Marzegalli M, Argiolas C, Murthy A, Valsecchi S; InSync ICD Italian Registry Investigators. Follow-up of CRT-ICD: implications for the use of remote follow-up systems. Data from the InSync ICD Italian Registry. Pacing Clin Electrophysiol. 2008 Jan;31(1):38-46. doi: 10.1111/j.1540-8159.2007.00923.x.

  PMID: 18181908 BACKGROUND

• Ricci RP, D'Onofrio A, Padeletti L, Sagone A, Vicentini A, Vincenti A, Morichelli L, Cavallaro C, Ricciardi G, Lombardi L, Fusco A, Rovaris G, Silvestri P, Guidotto T, Pollastrelli A, Santini M. Rationale and design of the health economics evaluation registry for remote follow-up: TARIFF. Europace. 2012 Nov;14(11):1661-5. doi: 10.1093/europace/eus093. Epub 2012 Apr 27.

  PMID: 22544910 BACKGROUND

• Ricci RP, Vicentini A, D'Onofrio A, Sagone A, Vincenti A, Padeletti L, Morichelli L, Fusco A, Vecchione F, Lo Presti F, Denaro A, Pollastrelli A, Santini M. Impact of in-clinic follow-up visits in patients with implantable cardioverter defibrillators: demographic and socioeconomic analysis of the TARIFF study population. J Interv Card Electrophysiol. 2013 Nov;38(2):101-6. doi: 10.1007/s10840-013-9823-5. Epub 2013 Sep 21.

  PMID: 24057266 RESULT

• Ricci RP, Vicentini A, D'Onofrio A, Sagone A, Rovaris G, Padeletti L, Morichelli L, Fusco A, De Vivo S, Lombardi L, Denaro A, Pollastrelli A, Colangelo I, Santini M. Economic analysis of remote monitoring of cardiac implantable electronic devices: Results of the Health Economics Evaluation Registry for Remote Follow-up (TARIFF) study. Heart Rhythm. 2017 Jan;14(1):50-57. doi: 10.1016/j.hrthm.2016.09.008. Epub 2016 Sep 8.

  PMID: 27614025 RESULT

Results Point of Contact

• Title: Dr. Renato P. Ricci
• Organization: Department of Cardiology, San Filippo Neri Hospital - Rome

renatopietroricci@tin.it

Study Officials

• Massimo Santini, Prof.

  Ospedale San Filippo Neri, Roma, Italy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2010
• First Posted: February 25, 2010
• Study Start: December 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: April 1, 2013
• Last Updated: March 3, 2021
• Results First Posted: March 3, 2021

Record last verified: 2021-03

Locations

IT (6)