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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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TARIFF Health Economics Evaluation Registry for Remote Follow up

Conditions
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Complication of Cardiac Defibrillator

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard Follow Up<br>ICD patients followed through periodic in-hospital visits | |
| Remote Follow Up<br>ICD patients followed with remote transmitters (Merlin@Home) that periodically communicate correct system functioning | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Economic Impact of Remote Monitoring on Hospitals and Patients | 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. | 12 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of Remote Monitoring on Procedural Costs for the Italian Health Economic System (SSN) | 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 | 1 year | 
| Impact of Remote Monitoring on Patients' Quality of Life | 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). | baseline, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Remote Monitoring, ICD patients, EQ-5D questionnaire, remote follow up