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

Abbott

Status: Completed

Conditions: Complication of Cardiac Defibrillator

Study type: Observational

Funder types: Industry

Identifiers

NCT01075516

CR 09 021 IT RC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 209 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

209 participants in 2 patient groups

Standard Follow Up

Description:

ICD patients followed through periodic in-hospital visits

Remote Follow Up

Description:

ICD patients followed with remote transmitters (Merlin@Home) that periodically communicate correct system functioning