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
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Condition or disease |
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Complication of Cardiac Defibrillator |
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 |
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Standard Follow Up
ICD patients followed through periodic in-hospital visits
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Remote Follow Up
ICD patients followed with remote transmitters (Merlin@Home) that periodically communicate correct system functioning
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- 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.
- 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
- 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 |
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)

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
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 |
Principal Investigator: | Massimo Santini, Prof. | Ospedale San Filippo Neri, Roma, Italy |
Other Publications:
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 |
Remote Monitoring ICD patients EQ-5D questionnaire remote follow up |