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Health Economic Evaluation of Remote Follow up for Implantable Cardioverter Defibrillator (ICD) Patients (TARIFF)
This study has been completed.
Sponsor:
St. Jude Medical
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01075516
First received: February 2, 2010
Last updated: January 30, 2014
Last verified: January 2014
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Purpose
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.
| Condition |
|---|
| Complication of Cardiac Defibrillator |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | TARIFF Health Economics Evaluation Registry for Remote Follow up |
Further study details as provided by St. Jude Medical:
Primary Outcome Measures:
- To determine cost minimization analysis from hospital's point of view and to determine cost utility analysis from patient's and third payer's point of view using Merlin@home and Merlin.net versus standard follow up in the Italian real life setting. [ Time Frame: 12 months follow up ]Costs analysis of the 2 different way of patient follow up
Secondary Outcome Measures:
- To evaluate the differential procedural costs for SSN (Italian Health Economic System) coming from the two follow up techniques. [ Time Frame: 12 months ]Comparison of costs for the Italian Health Economic System derived from the use of Merlin@Home system versus standard in clinic follow up
- To evaluate patients' quality of life through EQ-5D questionnaire performing standard and remote care follow up. [ Time Frame: 12 months ]Evaluation of patient quality of life during follow up with/without using Merlin@Home system
| Enrollment: | 200 |
| Study Start Date: | December 2009 |
| Study Completion Date: | April 2013 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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
|
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 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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients implanted with ICD according to current guidelines and with the possibility to use Merlin@home transmitters
Criteria
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 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 GSM/UMTS connection)
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01075516
Please refer to this study by its ClinicalTrials.gov identifier: NCT01075516
Locations
| 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 | |
Sponsors and Collaborators
St. Jude Medical
Investigators
| Principal Investigator: | Massimo Santini, Prof. | Ospedale San Filippo Neri, Roma, Italy |
More Information
Publications:
| Responsible Party: | St. Jude Medical |
| ClinicalTrials.gov Identifier: | NCT01075516 History of Changes |
| Other Study ID Numbers: |
CR 09 021 IT RC |
| Study First Received: | February 2, 2010 |
| Last Updated: | January 30, 2014 |
Keywords provided by St. Jude Medical:
|
Remote Monitoring ICD patients EQ-5D questionnaire remote follow up |
ClinicalTrials.gov processed this record on August 17, 2017