Remote Monitoring of Chronic Heart Failure in Veneto Region
NCT ID: NCT01513993
Last Updated: 2015-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
315 participants
INTERVENTIONAL
2011-10-31
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Control group
Treatment as usual
No interventions assigned to this group
Telemonitoring for patients with Congestive Heart Failure
Telemonitoring for patients with Congestive Heart Failure
Patients are equipped with a telemonitoring kit composed by a portable wrist-clinic device and digital weight scale for clinical parameters measuring and a gateway device for data transmission.
The patient can monitor a complete set of clinical parameters, such as pulse-oxymetry, heart rate, blood pressure, ECG and body weight, with a frequency set by the clinician in the personalised treatment plan. Data are transmitted to a regional eHealth centre where a group of operators keeps these information under control and alerts the reference clinician in case of worsening of symptoms.
Interventions
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Telemonitoring for patients with Congestive Heart Failure
Patients are equipped with a telemonitoring kit composed by a portable wrist-clinic device and digital weight scale for clinical parameters measuring and a gateway device for data transmission.
The patient can monitor a complete set of clinical parameters, such as pulse-oxymetry, heart rate, blood pressure, ECG and body weight, with a frequency set by the clinician in the personalised treatment plan. Data are transmitted to a regional eHealth centre where a group of operators keeps these information under control and alerts the reference clinician in case of worsening of symptoms.
Eligibility Criteria
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Inclusion Criteria
* Discharge from hospital after acute heart failure in the previous 3 months and EF \< 40% or EF \> 40% plus BNP \> 400 (or plus NT-proBNP\>1500) during hospitalization
Exclusion Criteria
* Impossibility or inability to use the equipment and help at home not available.
* Myocardial infarction or percutaneous coronary intervention in the last 3 months or scheduled.
* Coronary artery bypass, valve substitution or correction in the last 6 months.
* Being on waiting list for heart transplantation.
* Being enrolled in other trial
65 Years
ALL
No
Sponsors
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European Commission
OTHER
Azienda Unità Locale Socio Sanitaria n.9 Treviso
OTHER
Azienda ULSS 7 Conegliano
OTHER
Azienda ULSS 16 Padova
OTHER
Azienda ULSS di Verona e Provincia
OTHER
Azienda ULSS 12 Veneziana
OTHER
Azienda Unità Socio Sanitaria di Dolo Mirano
OTHER
Azienda Ospedaliera di Padova
OTHER
Azienda Ospedaliera Universitaria Integrata Verona
OTHER
Regione Veneto
OTHER
Responsible Party
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Principal Investigators
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Zoran Olivari, DM
Role: PRINCIPAL_INVESTIGATOR
Azienda Unità Locale Socio Sanitaria n.9 Treviso
Locations
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Azienda Ospedaliera di Padova - Cardiology Department
Padua, Padova, Italy
Ospedale Immacolata Concezione - Cardiology Department
Piove di Sacco, Padova, Italy
Presidio ospedaliero di Conegliano - Department of Cardiology
Conegliano, Treviso, Italy
Ospedale Ca'Foncello - Pulmonology Department
Treviso, Treviso, Italy
Ospedale di Mirano - Cardiology Department
Mirano, Venezia, Italy
Ospedale SS Giovanni e Paolo - Cardiology Department
Venezia, Venezia, Italy
Ospedale San Fracastoro - Cardiology Department
San Bonifacio, Verona, Italy
Azienda Ospedaliera Universitaria Integrata di Verona - Geriatric Medicine Department
Verona, Verona, Italy
Countries
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References
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Scherr D, Kastner P, Kollmann A, Hallas A, Auer J, Krappinger H, Schuchlenz H, Stark G, Grander W, Jakl G, Schreier G, Fruhwald FM; MOBITEL Investigators. Effect of home-based telemonitoring using mobile phone technology on the outcome of heart failure patients after an episode of acute decompensation: randomized controlled trial. J Med Internet Res. 2009 Aug 17;11(3):e34. doi: 10.2196/jmir.1252.
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.
Inglis SC, Clark RA, McAlister FA, Stewart S, Cleland JG. Which components of heart failure programmes are effective? A systematic review and meta-analysis of the outcomes of structured telephone support or telemonitoring as the primary component of chronic heart failure management in 8323 patients: Abridged Cochrane Review. Eur J Heart Fail. 2011 Sep;13(9):1028-40. doi: 10.1093/eurjhf/hfr039. Epub 2011 Jul 6.
Chaudhry SI, Mattera JA, Curtis JP, Spertus JA, Herrin J, Lin Z, Phillips CO, Hodshon BV, Cooper LS, Krumholz HM. Telemonitoring in patients with heart failure. N Engl J Med. 2010 Dec 9;363(24):2301-9. doi: 10.1056/NEJMoa1010029. Epub 2010 Nov 16.
Klersy C, De Silvestri A, Gabutti G, Regoli F, Auricchio A. A meta-analysis of remote monitoring of heart failure patients. J Am Coll Cardiol. 2009 Oct 27;54(18):1683-94. doi: 10.1016/j.jacc.2009.08.017.
Inglis SC, Clark RA, McAlister FA, Ball J, Lewinter C, Cullington D, Stewart S, Cleland JG. Structured telephone support or telemonitoring programmes for patients with chronic heart failure. Cochrane Database Syst Rev. 2010 Aug 4;(8):CD007228. doi: 10.1002/14651858.CD007228.pub2.
Related Links
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The Renewing Health project is partially funded under the ICT Policy Support Programme (ICT PSP) as part of the Competitiveness and Innovation Framework Programme by the European Community
Other Identifiers
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G. A. 250487-Veneto WP8Cl7
Identifier Type: -
Identifier Source: org_study_id
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