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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01075516
First received: February 2, 2010
Last updated: January 30, 2014
Last verified: January 2014
History of Changes
  Purpose
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
Complication of Cardiac Defibrillator

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: TARIFF Health Economics Evaluation Registry for Remote Follow up

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Costs analysis of the 2 different way of patient follow up


Secondary Outcome Measures:
  • To evaluate the differential procedural costs for SSN (Italian Health Economic System) coming from the two follow up techniques. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Evaluation of patient quality of life during follow up with/without using Merlin@Home system
Enrollment: 200
Study Start Date: December 2009
Study Completion Date: April 2013
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
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

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.
  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Publications:

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01075516     History of Changes
Other Study ID Numbers: CR 09 021 IT RC 
Study First Received: February 2, 2010
Last Updated: January 30, 2014
Health Authority: Italy: Ministry of Health

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

ClinicalTrials.gov processed this record on September 23, 2016