Remote Monitoring of Chronic Heart Failure in Veneto Region
Information source: Regione Veneto
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Congestive Heart Failure
Intervention: Telemonitoring for patients with Congestive Heart Failure (Procedure)
Phase: N/A
Status: Recruiting
Sponsored by: Regione Veneto Official(s) and/or principal investigator(s): Zoran Olivari, DM, Principal Investigator, Affiliation: Azienda Unità Locale Socio Sanitaria n.9 Treviso
Overall contact: Zoran Olivari, MD, Phone: 0422322767, Email: segcardiotv@ulss.tv.it
Summary
The purpose of this study is to evaluate whether telemonitoring of patients with chronic
heart failure produces a reduction in the combined end point of all cause mortality and
number of hospitalisations, and whether it improves health related quality of life. In
addition, the trials evaluate the economic and organisational impact of the telemonitoring
service and examine its acceptability by patients and health professionals.
Clinical Details
Official title: RENEWING HEALTH - Large Scale Pilot in Veneto Region: Remote Monitoring of Chronic Heart Failure
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
Primary outcome: Combined end point of all cause mortality and number of hospitalisations for heart failure
Secondary outcome: Cardiovascular and all-cause mortalityHealth-Related Quality of Life Number of hospitalisations (including rehospitalisations) for all causes and for heart failure Total number of days in hospital Number of specialist visits Number of visits at emergency department for heart failure Anxiety and depression status
Detailed description:
The study is designed to evaluate the impact of telemonitoring on the management of CHF
compared with outpatient usual care. From a clinical point of view, the trial will allow to
investigate how telemonitoring contributes to reduct the combined end point of all cause
mortality and re-hospitalizations, as well as the other kinds of access to hospital
facilities (bed-days, specialistic and ER visits). The trial will examine whether the CHF
patients improve their health-related quality of life and reduct the anxiety about health
conditions, thanks to the telemonitoring. A cost-effectiveness and cost-utility analysis
will be carried out in order to determine if and how telemonitoring helps to limit the
healthcare expenditure. The evaluation will deal also with organizational changes and task
shift due to telemonitoring introduction and patients and professional perception towards
the service.
Eligibility
Minimum age: 65 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age ≥ 65 years.
- 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:
- Comorbidities prevalent on CHF with life expectation < 12 months.
- 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
Locations and Contacts
Zoran Olivari, MD, Phone: 0422322767, Email: segcardiotv@ulss.tv.it
Azienda Ospedaliera di Padova - Cardiology Department, Padova 35128, Italy; Recruiting Sabino Iliceto, MD, Principal Investigator
Ospedale Ca'Foncello - Pulmonology Department, Treviso 31100, Italy; Recruiting Zoran Olivari, MD, Principal Investigator
Ospedale SS Giovanni e Paolo - Cardiology Department, Venezia 30122, Italy; Recruiting Michelangelo Penzo, MD, Principal Investigator
Azienda Ospedaliera Universitaria Integrata di Verona - Geriatric Medicine Department, Verona 37124, Italy; Recruiting Vincenzo Di Francesco, MD, Principal Investigator
Ospedale Immacolata Concezione - Cardiology Department, Piove di Sacco, Padova 35028, Italy; Recruiting Domenico Marchese, MD, Principal Investigator
Presidio ospedaliero di Conegliano - Department of Cardiology, Conegliano, Treviso 31015, Italy; Recruiting Carlo Marcon, MD, Principal Investigator
Ospedale di Mirano - Cardiology Department, Mirano, Venezia 30035, Italy; Recruiting Emanuele Bertaglia, MD, Principal Investigator
Ospedale San Fracastoro - Cardiology Department, San Bonifacio, Verona 37047, Italy; Recruiting Maurizio Anselmi, MD, Principal Investigator Claudio Bellamoli, MD, Principal Investigator
Additional Information
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
Related publications: 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. Epub 2007 Apr 10. Review. 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. Erratum in: N Engl J Med. 2013 Nov 7;369(19):1869. N Engl J Med. 2011 Feb 3;364(5):490. 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. Review. Erratum in: J Am Coll Cardiol. 2010 May 11;55(19):2185. 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. Review.
Starting date: October 2011
Last updated: January 21, 2014
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