Health Economic Evaluation of Remote Follow up for Implantable Cardioverter Defibrillator (ICD) Patients (TARIFF)
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ClinicalTrials.gov Identifier: NCT01075516 |
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
Tracking Information | ||||
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First Submitted Date | February 2, 2010 | |||
First Posted Date | February 25, 2010 | |||
Last Update Posted Date | February 3, 2014 | |||
Study Start Date | December 2009 | |||
Actual Primary Completion Date | March 2012 (Final data collection date for primary outcome measure) | |||
Current 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
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Original Primary Outcome Measures | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Health Economic Evaluation of Remote Follow up for Implantable Cardioverter Defibrillator (ICD) Patients | |||
Official Title | TARIFF Health Economics Evaluation Registry for Remote Follow up | |||
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. | |||
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. | |||
Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Probability Sample | |||
Study Population | Patients implanted with ICD according to current guidelines and with the possibility to use Merlin@home transmitters | |||
Condition | Complication of Cardiac Defibrillator | |||
Intervention | Not Provided | |||
Study Groups/Cohorts |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
200 | |||
Original Estimated Enrollment | Same as current | |||
Actual Study Completion Date | April 2013 | |||
Actual Primary Completion Date | March 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Italy | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01075516 | |||
Other Study ID Numbers | CR 09 021 IT RC | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Abbott Medical Devices | |||
Study Sponsor | Abbott Medical Devices | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Abbott Medical Devices | |||
Verification Date | January 2014 |