Clinical trial NCT01513993: Remote Monitoring of Chronic Heart Failure in Veneto Region
Official title: RENEWING HEALTH - Large Scale Pilot in Veneto Region: Remote Monitoring of Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congestive Heart Failure
Keywords: CHF
Telemonitoring
Lead sponsor: Regione Veneto
Sponsor class: OTHER
Collaborators: name: European Commission
name: Azienda Unità Locale Socio Sanitaria n.9 Treviso
name: Azienda ULSS 7 Conegliano
name: Azienda ULSS 16 Padova
name: Azienda ULSS di Verona e Provincia
name: Azienda ULSS 12 Veneziana
name: Azienda Unità Socio Sanitaria di Dolo Mirano
name: Azienda Ospedaliera di Padova
name: Azienda Ospedaliera Universitaria Integrata Verona
First posted: 2012-01-20
Enrollment: 315
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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 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

Primary outcomes:
measure: Combined end point of all cause mortality and number of hospitalisations for heart failure
timeFrame: 12 months
Secondary outcomes:
measure: Cardiovascular and all-cause mortality
timeFrame: 12 months
measure: Health-Related Quality of Life
timeFrame: 12 months
measure: Number of hospitalisations (including rehospitalisations) for all causes and for heart failure
timeFrame: 12 months
measure: Total number of days in hospital
timeFrame: 12 months
measure: Number of specialist visits
timeFrame: 12 months
measure: Number of visits at emergency department for heart failure
timeFrame: 12 months
measure: Anxiety and depression status
timeFrame: 12 months
Other outcomes:
Locations:
city: Piove di Sacco
country: Italy
facility: Ospedale Immacolata Concezione - Cardiology Department
state: Padova
city: Conegliano
country: Italy
facility: Presidio ospedaliero di Conegliano - Department of Cardiology
state: Treviso
city: Mirano
country: Italy
facility: Ospedale di Mirano - Cardiology Department
state: Venezia
city: San Bonifacio
country: Italy
facility: Ospedale San Fracastoro - Cardiology Department
state: Verona
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova - Cardiology Department
city: Treviso
country: Italy
facility: Ospedale Ca'Foncello - Pulmonology Department
city: Venezia
country: Italy
facility: Ospedale SS Giovanni e Paolo - Cardiology Department
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata di Verona - Geriatric Medicine Department
Study officials:
affiliation: Azienda Unità Locale Socio Sanitaria n.9 Treviso
name: Zoran Olivari, DM
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.