Remote Monitoring of Patients With CHF in Central Greece (RHCluster7GR)

March 19, 2015 updated by: Filippos Triposkiadis, Regional Health Authority of Sterea & Thessaly

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Thessaly
      • Larissa, Thessaly, Greece, 41110
        • Cardiology Department - Regional University Hospital of Larisa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
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.
Experimental: Home telemonitoring of patients with CHF
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Combined end point of all cause mortality
Time Frame: 12 months minimum
12 months minimum
Number of hospitalisations for heart failure
Time Frame: 12 months minimum
12 months minimum

Secondary Outcome Measures

Outcome Measure
Time Frame
Cardiovascular and all-cause mortality
Time Frame: 12 months minimum
12 months minimum
Health related quality of life as measured by the SF-36 v2
Time Frame: 12 months minimum- at the entry point of the intervention and the end
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)
Time Frame: 12 months minimum- at the entry point of the intervention and the end.
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)
Time Frame: 12 months minimum- at the entry point of the intervention and the end.
12 months minimum- at the entry point of the intervention and the end.
Economic Evaluation (Cost-Effective Analysis- Cost Utility Analysis)
Time Frame: 12 months minimum
12 months minimum
Patients' Acceptance-Satisfaction measured by the WSD Questionnaire
Time Frame: at 2nd and at 12th month
at 2nd and at 12th month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regional Health Authority of Sterea & Thessaly

Collaborators

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

Investigators

  • Principal Investigator: Filippos Triposkiadis, MD, PhD, Cardiology Department - Regional University Hospital of Larisa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

January 2, 2012

First Submitted That Met QC Criteria

January 3, 2012

First Posted (Estimate)

January 4, 2012

Study Record Updates

Last Update Posted (Estimate)

March 20, 2015

Last Update Submitted That Met QC Criteria

March 19, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FR2016
  • EC Grant Agreement 250487 (Other Grant/Funding Number: European Commission CIP/PSP-ICT Grant Agreement 250487)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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