Remote Monitoring of Patients With CHF in Central Greece

Congestive Heart Failure Clinical Trial

— RHCluster7GR  

Official title:

Renewing Health RCT for the Evaluation of Remote Monitoring of Patients With Congestive Heart Failure (CHF) in Central Greece

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01503463
• Other study ID #: FR2016
• Secondary ID: EC Grant Agreeme
• Status: Completed
• Phase: N/A
• First received: January 2, 2012
• Last updated: March 19, 2015
• Start date: March 2011
• Est. completion date: January 2014

Study information

• Verified date: March 2015
• Source: Regional Health Authority of Sterea & Thessaly
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• 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 purpose of this study is to the evaluate the use of a mobile and PSTN phone-based telehealth platform will be able to produce a reduction in the combined end point of all cause mortality, will have positive or negative impact in their generic and disease specific quality of life , or their specific activity compared with usual care. Following this; it is also hypothesized that this will also lead to a change in overall risk for CHF complications. In addition the patients' satisfaction using the telemedicine service will be studied. A Cost-Effective Analysis and Cost Utility Analysis will evaluate the tele-health service compared with the usual care from the health and social perspective.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• 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 FE < 40% or FE > 40% plus BNP > 400 (or plus NT-proBNP>1500) during hospitalization

Exclusion Criteria:

• Comorbidities prevalent on CHF with life expectation < 12 months.

• Inability to use the equipment and help at home not available.

• Myocardial infarction or percutaneous coronary intervention in the last 3 months.

• Coronary artery bypass, valve substitution or correction in the last 6 months or scheduled.

• 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:
• Home telemonitoring of patients with CHF
Patients in the intervention group receive a personal 1-lead or 12-lead ECG recorder, a blood pressure monitor, a digital weight scale and appropriate education regarding the use of these devices. ThA trained nurse visits the patients weekly during the first month, and monthly thereafter, to confirm the appropriate use of the devices and services, to monitor symptoms, adherence to pharmacological and non-pharmacological treatment, and to complete the case record forms when necessary. If there is deterioration in the monitored vital signs, or if symptoms are reported, the allocated cardiologist is informed via the telehealth platform and has to decide whether the patient has to visit the hospital as in- or outpatient and whether the therapy has to be modified.

Locations

Country	Name	City	State
Greece	Cardiology Department - Regional University Hospital of Larisa	Larissa	Thessaly

Sponsors (8)

Lead Sponsor	Collaborator
Regional Health Authority of Sterea & Thessaly	Alexander Technological Educational Institute, Thessaloniki, Greece, Institute of Biomedical Research & Technology, Larissa, Greece, Institute of Communications and Computer Systems, Athens, Greece, Ministry for Health and Social Solidarity, Greece, Municipality of Trikala, Greece, University of Macedonia, Thessaloniki, Greece, University of Thessaly

Country where clinical trial is conducted

Greece, 

References & Publications (7)

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

Cleland JG, Louis AA, Rigby AS, Janssens U, Balk AH; TEN-HMS Investigators. Noninvasive home telemonitoring for patients with heart failure at high risk of recurrent admission and death: the Trans-European Network-Home-Care Management System (TEN-HMS) study. J Am Coll Cardiol. 2005 May 17;45(10):1654-64. Epub 2005 Apr 22. — 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		12 months minimum	No
Primary	Number of hospitalisations for heart failure		12 months minimum	No
Secondary	Cardiovascular and all-cause mortality		12 months minimum	No
Secondary	Health related quality of life as measured by the SF-36 v2		12 months minimum- at the entry point of the intervention and the end	No
Secondary	Patient's specific activity using Specific activity questionnaire (SAQ) and the Veterans specific activity questionnaire (VSAQ)		12 months minimum- at the entry point of the intervention and the end.	No
Secondary	Disease Specific Quality of Life using the Minnesota Living with Heart Failure questionnaire (MLHF)		12 months minimum- at the entry point of the intervention and the end.	No
Secondary	Economic Evaluation (Cost-Effective Analysis- Cost Utility Analysis)		12 months minimum	No
Secondary	Patients' Acceptance-Satisfaction measured by the WSD Questionnaire		at 2nd and at 12th month	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"