Clinical trial NCT01075516: Health Economic Evaluation of Remote Follow up for Implantable Cardioverter Defibrillator (ICD) Patients
Official title: TARIFF Health Economics Evaluation Registry for Remote Follow up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complication of Cardiac Defibrillator
Keywords: Remote Monitoring
ICD patients
EQ-5D questionnaire
remote follow up
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2010-02-25
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients implanted with ICD according to current guidelines and with the possibility to use Merlin@home transmitters

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.

Detailed description: TARIFF is a prospective observational study aimed to measure direct, indirect costs and quality of life of all participants for the duration of the observational timeframe. Purpose of cost collecting is to include a complete set of medical services and productivity loses that could be directly affected by the different clinical Follow-Up (FU) pathway. The study consists of 2 phases: firstly standard follow up costs will be collected for 100 pts, then all costs associated to remote follow ups will be collected for other 100 patients.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Economic Impact of Remote Monitoring on Hospitals and Patients
timeFrame: 12 months follow-up
Secondary outcomes:
measure: Impact of Remote Monitoring on Procedural Costs for the Italian Health Economic System (SSN)
timeFrame: 1 year
measure: Impact of Remote Monitoring on Patients' Quality of Life
timeFrame: baseline, 12 months
Other outcomes:
Locations:
city: Monza
country: Italy
facility: Azienda Ospedaliera S.Gerardo
state: Monza (MB)
city: Peschiera del Garda
country: Italy
facility: Casa di Cura Pederzoli
state: VR
city: Firenze
country: Italy
facility: Ospedale Careggi
city: Milano
country: Italy
facility: Ospedale Luigi Sacco
city: Napoli
country: Italy
facility: Ospedale Monaldi
city: Roma
country: Italy
facility: Ospedale San Filippo Neri
Study officials:
affiliation: Ospedale San Filippo Neri, Roma, Italy
name: Massimo Santini, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.