Health Economic Evaluation of Remote Follow up for Implantable Cardioverter Defibrillator (ICD) Patients (TARIFF)
2. marts 2021 opdateret af: Abbott Medical Devices
TARIFF Health Economics Evaluation Registry for Remote Follow up
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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
209
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Firenze, Italien
- Ospedale Careggi
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Milano, Italien
- Ospedale Luigi Sacco
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Napoli, Italien
- Ospedale Monaldi
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Roma, Italien, 00135
- Ospedale San Filippo Neri
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Monza (MB)
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Monza, Monza (MB), Italien, 20052
- Azienda Ospedaliera S.Gerardo
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VR
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Peschiera del Garda, VR, Italien
- Casa di cura Pederzoli
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
14 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Patients implanted with ICD according to current guidelines and with the possibility to use Merlin@home transmitters
Beskrivelse
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)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Economic Impact of Remote Monitoring on Hospitals and Patients
Tidsramme: 12 months follow-up
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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.
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12 months follow-up
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Impact of Remote Monitoring on Procedural Costs for the Italian Health Economic System (SSN)
Tidsramme: 1 year
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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
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1 year
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Impact of Remote Monitoring on Patients' Quality of Life
Tidsramme: baseline, 12 months
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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). |
baseline, 12 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Massimo Santini, Prof., Ospedale San Filippo Neri, Roma, Italy
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Clark RA, Inglis SC, McAlister FA, Cleland JG, Stewart S. Telemonitoring or structured telephone support programmes for patients with chronic heart failure: systematic review and meta-analysis. BMJ. 2007 May 5;334(7600):942. doi: 10.1136/bmj.39156.536968.55. Epub 2007 Apr 10.
- Wilkoff BL, Auricchio A, Brugada J, Cowie M, Ellenbogen KA, Gillis AM, Hayes DL, Howlett JG, Kautzner J, Love CJ, Morgan JM, Priori SG, Reynolds DW, Schoenfeld MH, Vardas PE; Heart Rhythm Society; European Heart Rhythm Association; American College of Cardiology; American Heart Association; European Society of Cardiology; Heart Failure Association of ESC; Heart Failure Society of America. HRS/EHRA expert consensus on the monitoring of cardiovascular implantable electronic devices (CIEDs): description of techniques, indications, personnel, frequency and ethical considerations. Heart Rhythm. 2008 Jun;5(6):907-25. doi: 10.1016/j.hrthm.2008.04.013. No abstract available.
- Morichelli L, Ricci RP. Remote monitoring of implantable devices: the European experience. Heart Rhythm. 2009 Jul;6(7):1077-80. doi: 10.1016/j.hrthm.2009.02.030. Epub 2009 Feb 24. No abstract available.
- Ricci RP, Morichelli L, Santini M. Remote control of implanted devices through Home Monitoring technology improves detection and clinical management of atrial fibrillation. Europace. 2009 Jan;11(1):54-61. doi: 10.1093/europace/eun303. Epub 2008 Nov 16.
- Marzegalli M, Lunati M, Landolina M, Perego GB, Ricci RP, Guenzati G, Schirru M, Belvito C, Brambilla R, Masella C, Di Stasi F, Valsecchi S, Santini M. Remote monitoring of CRT-ICD: the multicenter Italian CareLink evaluation--ease of use, acceptance, and organizational implications. Pacing Clin Electrophysiol. 2008 Oct;31(10):1259-64. doi: 10.1111/j.1540-8159.2008.01175.x.
- Ricci RP, Morichelli L, Santini M. Home monitoring remote control of pacemaker and implantable cardioverter defibrillator patients in clinical practice: impact on medical management and health-care resource utilization. Europace. 2008 Feb;10(2):164-70. doi: 10.1093/europace/eum289. Epub 2008 Jan 16.
- Seto E. Cost comparison between telemonitoring and usual care of heart failure: a systematic review. Telemed J E Health. 2008 Sep;14(7):679-86. doi: 10.1089/tmj.2007.0114.
- Lunati M, Gasparini M, Santini M, Landolina M, Perego GB, Pappone C, Marzegalli M, Argiolas C, Murthy A, Valsecchi S; InSync ICD Italian Registry Investigators. Follow-up of CRT-ICD: implications for the use of remote follow-up systems. Data from the InSync ICD Italian Registry. Pacing Clin Electrophysiol. 2008 Jan;31(1):38-46. doi: 10.1111/j.1540-8159.2007.00923.x.
- Ricci RP, D'Onofrio A, Padeletti L, Sagone A, Vicentini A, Vincenti A, Morichelli L, Cavallaro C, Ricciardi G, Lombardi L, Fusco A, Rovaris G, Silvestri P, Guidotto T, Pollastrelli A, Santini M. Rationale and design of the health economics evaluation registry for remote follow-up: TARIFF. Europace. 2012 Nov;14(11):1661-5. doi: 10.1093/europace/eus093. Epub 2012 Apr 27.
- Ricci RP, Vicentini A, D'Onofrio A, Sagone A, Vincenti A, Padeletti L, Morichelli L, Fusco A, Vecchione F, Lo Presti F, Denaro A, Pollastrelli A, Santini M. Impact of in-clinic follow-up visits in patients with implantable cardioverter defibrillators: demographic and socioeconomic analysis of the TARIFF study population. J Interv Card Electrophysiol. 2013 Nov;38(2):101-6. doi: 10.1007/s10840-013-9823-5. Epub 2013 Sep 21.
- Ricci RP, Vicentini A, D'Onofrio A, Sagone A, Rovaris G, Padeletti L, Morichelli L, Fusco A, De Vivo S, Lombardi L, Denaro A, Pollastrelli A, Colangelo I, Santini M. Economic analysis of remote monitoring of cardiac implantable electronic devices: Results of the Health Economics Evaluation Registry for Remote Follow-up (TARIFF) study. Heart Rhythm. 2017 Jan;14(1):50-57. doi: 10.1016/j.hrthm.2016.09.008. Epub 2016 Sep 8.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. december 2009
Primær færdiggørelse (Faktiske)
1. marts 2012
Studieafslutning (Faktiske)
1. april 2013
Datoer for studieregistrering
Først indsendt
2. februar 2010
Først indsendt, der opfyldte QC-kriterier
24. februar 2010
Først opslået (Skøn)
25. februar 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. marts 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. marts 2021
Sidst verificeret
1. marts 2021
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- CR 09 021 IT RC
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Komplikation af hjertedefibrillator
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Abbott Medical DevicesAfsluttetPatienten opfylder ACC/AHA/ESC-retningslinjerne for implanterbar cardioverter-defibrillator (ICD) eller cardiac resynchronization therapy (CRT-D)-enhedDet Forenede Kongerige, Tyskland
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Ye ShengIkke rekrutterer endnuOut-of-Hospital Cardiac Arrest (Simuleret)Kina