Remote Monitoring of Chronic Heart Failure in Veneto Region

Congestive Heart Failure Clinical Trial

Official title:

RENEWING HEALTH - Large Scale Pilot in Veneto Region: Remote Monitoring of Chronic Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01513993
• Other study ID #: G. A. 250487-Veneto WP8Cl7
• Status: Completed
• Phase: N/A
• First received: January 17, 2012
• Last updated: October 27, 2015
• Start date: October 2011
• Est. completion date: May 2014

Study information

• Verified date: January 2012
• Source: Regione Veneto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 315
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Italy	Presidio ospedaliero di Conegliano - Department of Cardiology	Conegliano	Treviso
Italy	Ospedale di Mirano - Cardiology Department	Mirano	Venezia
Italy	Azienda Ospedaliera di Padova - Cardiology Department	Padova
Italy	Ospedale Immacolata Concezione - Cardiology Department	Piove di Sacco	Padova
Italy	Ospedale San Fracastoro - Cardiology Department	San Bonifacio	Verona
Italy	Ospedale Ca'Foncello - Pulmonology Department	Treviso
Italy	Ospedale SS Giovanni e Paolo - Cardiology Department	Venezia
Italy	Azienda Ospedaliera Universitaria Integrata di Verona - Geriatric Medicine Department	Verona

Sponsors (10)

Lead Sponsor	Collaborator
Regione Veneto	Azienda Ospedaliera di Padova, Azienda Ospedaliera Universitaria Integrata Verona, Azienda ULSS 12 Veneziana, Azienda ULSS 16 Padova, Azienda ULSS 7 Conegliano, Azienda ULSS di Verona e Provincia, Azienda Unità Locale Socio Sanitaria n.9 Treviso, Azienda Unità Socio Sanitaria di Dolo Mirano, European Commission

Country where clinical trial is conducted

Italy, 

References & Publications (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. 2011 Feb 3;364(5):490. N Engl J Med. 2013 Nov 7;369(19):1869. — View 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. Epub 2007 Apr 10. Review. — View 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. Review. Update in: Cochrane Database Syst Rev. 2015;10:CD007228. — View 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. — View 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. Review. Erratum in: J Am Coll Cardiol. 2010 May 11;55(19):2185. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined end point of all cause mortality and number of hospitalisations for heart failure		12 months	No
Secondary	Cardiovascular and all-cause mortality		12 months	No
Secondary	Health-Related Quality of Life	Health-Related Quality of Life is assessed by the SF-36 questionnaire	12 months	No
Secondary	Number of hospitalisations (including rehospitalisations) for all causes and for heart failure		12 months	No
Secondary	Total number of days in hospital		12 months	No
Secondary	Number of specialist visits		12 months	No
Secondary	Number of visits at emergency department for heart failure		12 months	No
Secondary	Anxiety and depression status	Anxiety and depression status is assessed by Hospital Anxiety and Depression Scale (HADS)	12 months	No

External Links

•   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