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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
Results First Posted : March 3, 2021
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

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 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.

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Study Type : Observational
Actual Enrollment : 209 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

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



Primary Outcome Measures :
  1. Economic Impact of Remote Monitoring on Hospitals and Patients [ Time Frame: 12 months follow-up ]
    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.


Secondary Outcome Measures :
  1. Impact of Remote Monitoring on Procedural Costs for the Italian Health Economic System (SSN) [ Time Frame: 1 year ]
    Comparison of Cardiovascular Hospitalizations costs for the Italian Health Economic System derived from the use of Merlin@Home system versus standard in clinic follow-up

  2. Impact of Remote Monitoring on Patients' Quality of Life [ Time Frame: baseline, 12 months ]

    Evaluation of patient quality of life through Quality of Life (EQ-5D) questionnaire during follow up with/without using Merlin@Home system.

    Utility (patients' preferences) and Quality-adjusted life-year (QALY) scales were used. QALYs were based on utility, the EuroQoL EQ-5D-3L questionnaire was administered to each patient at baseline and at 12 months in order to calculate utility values (both ranges from 0 to 1). High score means better outcomes.

    One quality-adjusted life-year (QALY) is equal to 1 year of life in perfect health. QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment or intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale).




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 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)

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
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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
Abbott Medical Devices
Investigators
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Principal Investigator: Massimo Santini, Prof. Ospedale San Filippo Neri, Roma, Italy
Publications of Results:
Other Publications:

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT01075516    
Other Study ID Numbers: CR 09 021 IT RC
First Posted: February 25, 2010    Key Record Dates
Results First Posted: March 3, 2021
Last Update Posted: March 3, 2021
Last Verified: March 2021
Keywords provided by Abbott Medical Devices:
Remote Monitoring
ICD patients
EQ-5D questionnaire
remote follow up