Remote Monitoring of Patients With CHF in Central Greece

NCT01503463 | Completed DMC

• 2 other identifiers: FR2016EC Grant Agreement 250487
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Congestive Heart Failure

Keywords

Congestive Heart Failure; Telemedicine

Outcome Measures

Primary Outcomes (2)

• Combined end point of all cause mortality

  12 months minimum

• Number of hospitalisations for heart failure

  12 months minimum

Secondary Outcomes (6)

• Cardiovascular and all-cause mortality

  12 months minimum

• 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

• 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.

• 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.

• Economic Evaluation (Cost-Effective Analysis- Cost Utility Analysis)

  12 months minimum

Study Arms (2)

Usual Care

NO INTERVENTION

Patients in the control group receive usual care delivered by their primary care physicians and cardiologists. Usual care consists of regular visits to the specialist or primary care clinics every time a medication change is required, or a medical examination is needed.

Home telemonitoring of patients with CHF

EXPERIMENTAL

Procedure: Home telemonitoring of patients with CHF

Interventions

Home telemonitoring of patients with CHF PROCEDURE

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.

Home telemonitoring of patients with CHF

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Cardiology Department - Regional University Hospital of Larisa

Larissa, Thessaly, 41110, Greece

Location

Related Publications (7)

• 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.

  PMID: 19687005 BACKGROUND

• 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.

  PMID: 17426062 BACKGROUND

• 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. doi: 10.1016/j.jacc.2005.01.050. Epub 2005 Apr 22.

  PMID: 15893183 BACKGROUND

• 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.

  PMID: 19850208 BACKGROUND

• 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.

  PMID: 20687083 BACKGROUND

• 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.

  PMID: 21733889 BACKGROUND

• 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.

  PMID: 21080835 BACKGROUND

Related 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"

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Filippos Triposkiadis, MD, PhD

  Cardiology Department - Regional University Hospital of Larisa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffesor, Director of the Cardiology Department, University Hospital of Larissa

Study Record Dates

• First Submitted: January 2, 2012
• First Posted: January 4, 2012
• Study Start: March 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: March 20, 2015

Record last verified: 2015-03

Locations

GR (1)