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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
Results First Posted : March 3, 2021
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date February 2, 2010
First Posted Date February 25, 2010
Results First Submitted Date June 9, 2020
Results First Posted Date March 3, 2021
Last Update Posted Date March 3, 2021
Study Start Date December 2009
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 2, 2021)
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.
Original Primary Outcome Measures
 (submitted: February 24, 2010)
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
Change History
Current Secondary Outcome Measures
 (submitted: March 2, 2021)
  • 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
  • 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).
Original Secondary Outcome Measures
 (submitted: February 24, 2010)
  • 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
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 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
Study Design Observational Model: Cohort
Time Perspective: Prospective
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
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 2, 2021)
209
Original Estimated Enrollment
 (submitted: February 24, 2010)
200
Actual Study Completion Date April 2013
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility 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 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)
Sex/Gender
Sexes Eligible for Study: All
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
Principal Investigator: Massimo Santini, Prof. Ospedale San Filippo Neri, Roma, Italy
PRS Account Abbott Medical Devices
Verification Date March 2021