Health Economic Evaluation of Remote Follow up for Implantable Cardioverter Defibrillator (ICD) Patients (TARIFF)
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| ClinicalTrials.gov Identifier: NCT01075516 |
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Recruitment Status :
Completed
First Posted : February 25, 2010
Last Update Posted : February 3, 2014
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Sponsor:
Abbott Medical Devices
Information provided by (Responsible Party):
Abbott Medical Devices
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Brief Summary:
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 or disease |
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| Complication of Cardiac Defibrillator |
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.
| Study Type : | Observational |
| Actual Enrollment : | 200 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| 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 |
| Group/Cohort |
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Standard Follow Up
ICD patients followed through periodic in-hospital visits
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Remote Follow Up
ICD patients followed with remote transmitters (Merlin@Home) that periodically communicate correct system functioning
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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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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)
Information from the National Library of Medicine
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
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
Abbott Medical Devices
Investigators
| Principal Investigator: | Massimo Santini, Prof. | Ospedale San Filippo Neri, Roma, Italy |
Publications of Results:
Other Publications:
Other Publications:
| Responsible Party: | Abbott Medical Devices |
| ClinicalTrials.gov Identifier: | NCT01075516 |
| Other Study ID Numbers: |
CR 09 021 IT RC |
| First Posted: | February 25, 2010 Key Record Dates |
| Last Update Posted: | February 3, 2014 |
| Last Verified: | January 2014 |
Keywords provided by Abbott Medical Devices:
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Remote Monitoring ICD patients EQ-5D questionnaire remote follow up |