Remote Monitoring of Patients With CHF in Central Greece

NCT01503463 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-03-20

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Ministry for Health and Social Solidarity, Greece

    collaborator OTHER
  • Municipality of Trikala, Greece

    collaborator OTHER
  • Institute of Biomedical Research & Technology, Larissa, Greece

    collaborator OTHER
  • Institute of Communications and Computer Systems, Athens, Greece

    collaborator OTHER
  • Alexander Technological Educational Institute, Thessaloniki, Greece

    collaborator OTHER
  • University of Macedonia, Thessaloniki, Greece

    collaborator OTHER
  • University of Thessaly

    collaborator OTHER
  • Regional Health Authority of Sterea & Thessaly

    lead OTHER_GOV

Principal Investigators

  • Filippos Triposkiadis, MD, PhD · Cardiology Department - Regional University Hospital of Larisa

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2013-12-31
Completion
2014-01-31

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01503463 on ClinicalTrials.gov