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

• ClinicalTrials.gov Identifier: NCT01075516
• Recruitment Status: Completed
• First Posted: February 25, 2010
• Last Update Posted: February 3, 2014
• Sponsor: Abbott Medical Devices
• Information provided by (Responsible Party): Abbott Medical Devices

Tracking Information

• First Submitted Date: February 2, 2010
• First Posted Date: February 25, 2010
• Last Update Posted Date: February 3, 2014
• Study Start Date: December 2009
• Actual Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 24, 2010)

To determine cost minimization analysis from hospital's point of view and to determine cost utility analysis from patient's and third payer's point of view using Merlin@home and Merlin.net versus standard follow up in the Italian real life setting. [ Time Frame: 12 months follow up ]

Costs analysis of the 2 different way of patient follow up

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 24, 2010)

• To evaluate the differential procedural costs for SSN (Italian Health Economic System) coming from the two follow up techniques. [ Time Frame: 12 months ]
  Comparison of costs for the Italian Health Economic System derived from the use of Merlin@Home system versus standard in clinic follow up
• To evaluate patients' quality of life through EQ-5D questionnaire performing standard and remote care follow up. [ Time Frame: 12 months ]
  Evaluation of patient quality of life during follow up with/without using Merlin@Home system

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Health Economic Evaluation of Remote Follow up for Implantable Cardioverter Defibrillator (ICD) Patients
• Official Title: TARIFF Health Economics Evaluation Registry for Remote Follow up
• 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 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.
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: Patients implanted with ICD according to current guidelines and with the possibility to use Merlin@home transmitters
• Condition: Complication of Cardiac Defibrillator
• Intervention: Not Provided

Study Groups/Cohorts

• 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

Publications *

• 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. Review.
• 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.
• 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.
• 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.
• 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.
• 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. Review.
• 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. Epub 2007 Apr 10. Review.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 24, 2010): 200
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: April 2013
• Actual Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)

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 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 GSM/UMTS connection)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT01075516
• Other Study ID Numbers: CR 09 021 IT RC
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Abbott Medical Devices
• Study Sponsor: Abbott Medical Devices
• Collaborators: Not Provided

Investigators

• Principal Investigator: Massimo Santini, Prof.; Ospedale San Filippo Neri, Roma, Italy

• PRS Account: Abbott Medical Devices
• Verification Date: January 2014