Health Economic Evaluation of Remote Follow up for Implantable Cardioverter Defibrillator (ICD) Patients (TARIFF)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01075516|
Recruitment Status : Completed
First Posted : February 25, 2010
Results First Posted : March 3, 2021
Last Update Posted : March 3, 2021
|Condition or disease|
|Complication of Cardiac Defibrillator|
|Study Type :||Observational|
|Actual Enrollment :||209 participants|
|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|
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
- 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).
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
|Azienda Ospedaliera S.Gerardo|
|Monza, Monza (MB), Italy, 20052|
|Casa di Cura Pederzoli|
|Peschiera del Garda, VR, Italy|
|Ospedale Luigi Sacco|
|Ospedale San Filippo Neri|
|Roma, Italy, 00135|
|Principal Investigator:||Massimo Santini, Prof.||Ospedale San Filippo Neri, Roma, Italy|