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

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

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
Complication of Cardiac Defibrillator

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 Design
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: TARIFF Health Economics Evaluation Registry for Remote Follow up
Study Start Date : December 2009
Actual Primary Completion Date : March 2012
Actual Study Completion Date : April 2013
Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients implanted with ICD according to current guidelines and with the possibility to use Merlin@home transmitters
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)
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01075516


Locations
Italy
Azienda Ospedaliera S.Gerardo
Monza, Monza (MB), Italy, 20052
Casa di Cura Pederzoli
Peschiera del Garda, VR, Italy
Ospedale Careggi
Firenze, Italy
Ospedale Luigi Sacco
Milano, Italy
Ospedale Monaldi
Napoli, Italy
Ospedale San Filippo Neri
Roma, Italy, 00135
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Massimo Santini, Prof. Ospedale San Filippo Neri, Roma, Italy
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Other Publications:

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01075516     History of Changes
Other Study ID Numbers: CR 09 021 IT RC
First Posted: February 25, 2010    Key Record Dates
Last Update Posted: February 3, 2014
Last Verified: January 2014

Keywords provided by St. Jude Medical:
Remote Monitoring
ICD patients
EQ-5D questionnaire
remote follow up