Platform Therapeutic Education in Heart Failure and Coronary Disease (METISCARDIO)

May 4, 2015 updated by: Pr Ariel Cohen, Resicard

Telephonic Platform of Follow up, Therapeutical Education and Coordination in Secondary Prevention in Patients With Heart Failure and Coronary Disease

A first therapeutic education is given before patient's discharge at the hospital, then a dedicated nurse follows patients through the phone,regularly according to patients' needs, continues to give advise on risk factors, information on medication and alert symptoms and therapeutic education.

Study Overview

Detailed Description

Patients are assigned to an arm accordingly to their needs: class 1 with light therapeutic education, class 2 with moderate education, class 3 with heavy education. Assignement is based on the first education diagnosis during hospitalization time.

Quality of life and patient's knowledge are regularly evaluated through questionnaires

Study Type

Interventional

Enrollment (Actual)

555

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

      • Paris, France, 75012
        • Hopital Saint Antoine
      • Paris, France, 75005
        • Institut Coeur Effort Sante
      • Paris, France, 75008
        • Clinique Turin
      • Sarcelles, France, 95200
        • Centre Cardiologique Alfred Kastler

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • hospitalization for acute coronary syndrome (ST-segment elevation myocardial infarction ,no ST-segment elevation myocardial infarction ST , unstable angina)
  • hospitalization for heart failure
  • acute coronary syndrome < 3 months
  • heart failure < 3 months
  • coronary by-pass surgery < 3 months

Exclusion Criteria:

  • complicated acute coronary syndrome (ventricular arrhythmia, heart failure, mechanical complications, cardiogenic shock)
  • valvular cardiac pathology
  • obstructive cardiomyopathy
  • planned cardiac transplantation
  • severe neurological or psychiatric troubles
  • loss of autonomy
  • other (refusal, language, nursing house, way of life not compatible with follow up, refusal of telephonic contacts)

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: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: therapeutic education class 1
patients in class 1 will have a follow up call with therapeutic education every 3 months. this is the light follow up.
knowledge of disease, risk factors, diet, medication, alert symptoms
Other: therapeutic education class 2
patients in class 2 will have a follow up call with therapeutic education every month. this is the moderate follow up
knowledge of disease, risk factors, diet, medication, alert symptoms
Other: therapeutic education class 3
patients in class 3 will have a follow up call with therapeutic education twice a month. this is the heavy follow up.
knowledge of disease, risk factors, diet, medication, alert symptoms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of patient with a better of quality of life
Time Frame: 1 year
quality of life is evaluated with appropriate questionnaires
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of patients who improve their knowledge of disease
Time Frame: 1 year
Knowledge of disease includes risk factors, symptoms, medication, diet. It is evaluated with appropriate questionnaires.
1 year
number of hospitalizations during the follow up
Time Frame: 1 year
hospitalizations are recorded during the year of follow up, with cause and duration.
1 year

Collaborators and Investigators

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

Sponsor

Investigators

  • Principal Investigator: ariel a cohen, md, Resicard

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

May 1, 2010

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

May 23, 2013

First Submitted That Met QC Criteria

June 4, 2013

First Posted (Estimate)

June 5, 2013

Study Record Updates

Last Update Posted (Estimate)

May 5, 2015

Last Update Submitted That Met QC Criteria

May 4, 2015

Last Verified

May 1, 2015

More Information

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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