Clinical trial NCT01503463: Remote Monitoring of Patients With CHF in Central Greece
Official title: Renewing Health RCT for the Evaluation of Remote Monitoring of Patients With Congestive Heart Failure (CHF) in Central Greece
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congestive Heart Failure
Keywords: Congestive Heart Failure
Telemedicine
Lead sponsor: Regional Health Authority of Sterea & Thessaly
Sponsor class: OTHER_GOV
Collaborators: name: Ministry for Health and Social Solidarity, Greece
name: Municipality of Trikala, Greece
name: Institute of Biomedical Research & Technology, Larissa, Greece
name: Institute of Communications and Computer Systems, Athens, Greece
name: Alexander Technological Educational Institute, Thessaloniki, Greece
name: University of Macedonia, Thessaloniki, Greece
name: University of Thessaly
First posted: 2012-01-04
Enrollment: 60
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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Combined end point of all cause mortality
timeFrame: 12 months minimum
measure: Number of hospitalisations for heart failure
timeFrame: 12 months minimum
Secondary outcomes:
measure: Cardiovascular and all-cause mortality
timeFrame: 12 months minimum
measure: Health related quality of life as measured by the SF-36 v2
timeFrame: 12 months minimum- at the entry point of the intervention and the end
measure: Patient's specific activity using Specific activity questionnaire (SAQ) and the Veterans specific activity questionnaire (VSAQ)
timeFrame: 12 months minimum- at the entry point of the intervention and the end.
measure: Disease Specific Quality of Life using the Minnesota Living with Heart Failure questionnaire (MLHF)
timeFrame: 12 months minimum- at the entry point of the intervention and the end.
measure: Economic Evaluation (Cost-Effective Analysis- Cost Utility Analysis)
timeFrame: 12 months minimum
measure: Patients' Acceptance-Satisfaction measured by the WSD Questionnaire
timeFrame: at 2nd and at 12th month
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: Cardiology Department - Regional University Hospital of Larisa
state: Thessaly
Study officials:
affiliation: Cardiology Department - Regional University Hospital of Larisa
name: Filippos Triposkiadis, MD, PhD
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: 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.
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.
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.