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

March 2, 2021 updated by: Abbott Medical Devices

TARIFF Health Economics Evaluation Registry for Remote Follow up

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

209

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Firenze, Italy
        • Ospedale Careggi
      • Milano, Italy
        • Ospedale Luigi Sacco
      • Napoli, Italy
        • Ospedale Monaldi
      • Roma, Italy, 00135
        • Ospedale San Filippo Neri
    • Monza (MB)
      • Monza, Monza (MB), Italy, 20052
        • Azienda Ospedaliera S.Gerardo
    • VR
      • Peschiera del Garda, VR, Italy
        • Casa di Cura Pederzoli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients implanted with ICD according to current guidelines and with the possibility to use Merlin@home transmitters

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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
1 year
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).
baseline, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Massimo Santini, Prof., Ospedale San Filippo Neri, Roma, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

February 2, 2010

First Submitted That Met QC Criteria

February 24, 2010

First Posted (Estimate)

February 25, 2010

Study Record Updates

Last Update Posted (Actual)

March 3, 2021

Last Update Submitted That Met QC Criteria

March 2, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CR 09 021 IT RC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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