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Congestive Heart FailureRHCluster7GRNCT01503463

Remote Monitoring of Patients With CHF in Central Greece

A study testing Home telemonitoring of patients with CHF in people with Congestive Heart Failure, run by Regional Health Authority of Sterea & Thessaly at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Congestive Heart Failure
What is being tested?
Home telemonitoring of patients with CHF
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteGreece
Study dates
Mar 2011to Jan 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Greece1 site

  • Cardiology Department - Regional University Hospital of Larisa

    Larissa, Thessaly, 41110

Other trials in Greece

About this study

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

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.

Read the 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.

Being tested
Home telemonitoring of patients with CHF
Keywords
Congestive Heart Failure, Telemedicine
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Home telemonitoring of patients with CHFProcedure or surgery

    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.

Study groups in NCT01503463
Study groupRoleWhat they receive
Usual CareNo interventionPatients 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 CHFExperimentalNot described
Receives: Procedure: Home telemonitoring of patients with CHF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Combined end point of all cause mortality

    Measured: 12 months minimum

  2. Number of hospitalisations for heart failure

    Measured: 12 months minimum

Secondary outcomes (6)

  1. Cardiovascular and all-cause mortality

    Measured: 12 months minimum

  2. Health related quality of life as measured by the SF-36 v2

    Measured: 12 months minimum- at the entry point of the intervention and the end

  3. Patient's specific activity using Specific activity questionnaire (SAQ) and the Veterans specific activity questionnaire (VSAQ)

    Measured: 12 months minimum- at the entry point of the intervention and the end.

  4. Disease Specific Quality of Life using the Minnesota Living with Heart Failure questionnaire (MLHF)

    Measured: 12 months minimum- at the entry point of the intervention and the end.

  5. Economic Evaluation (Cost-Effective Analysis- Cost Utility Analysis)

    Measured: 12 months minimum

  6. Patients' Acceptance-Satisfaction measured by the WSD Questionnaire

    Measured: at 2nd and at 12th month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2012 (estimated)
  2. Study startMar 2011
  3. Primary completionDec 2013
  4. Study completionJan 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01503463
Sponsor's protocol ID
FR2016
Other IDs
EC Grant Agreement 250487
Acronym
RHCluster7GR
Status last verified
Mar 2015
First submitted
2 Jan 2012
Last updated
20 Mar 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 19687005

  • 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.

    PubMed 17426062

  • 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.

    PubMed 15893183

  • 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.

    PubMed 19850208

  • 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.

    PubMed 20687083

  • 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.

    PubMed 21733889

  • 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.

    PubMed 21080835

Questions about this trial

What is this clinical trial studying?

A study testing Home telemonitoring of patients with CHF in people with Congestive Heart Failure, run by Regional Health Authority of Sterea & Thessaly at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Combined end point of all cause mortality (time frame: 12 months minimum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01503463, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2015; AzTrials last refreshed its copy on 8 Nov 2026.

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