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

Primary Purpose

Heart Failure, Acute Coronary Syndrome, Coronary Bypass Graft Stenosis of Native Artery Graft

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

therapeutic education

About this trial

This is an interventional prevention trial for Heart Failure focused on measuring education, risk factors, quality of life, coronary disease, telephone follow up, dedicated nurse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Institut Coeur Effort Sante
Clinique Turin
Hopital Saint Antoine
Centre Cardiologique Alfred Kastler

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Arm Label

therapeutic education class 1

therapeutic education class 2

therapeutic education class 3

Arm Description

patients in class 1 will have a follow up call with therapeutic education every 3 months. this is the light follow up.

patients in class 2 will have a follow up call with therapeutic education every month. this is the moderate follow up

patients in class 3 will have a follow up call with therapeutic education twice a month. this is the heavy follow up.

Outcomes

Primary Outcome Measures

number of patient with a better of quality of life

quality of life is evaluated with appropriate questionnaires

Secondary Outcome Measures

number of patients who improve their knowledge of disease

Knowledge of disease includes risk factors, symptoms, medication, diet. It is evaluated with appropriate questionnaires.

number of hospitalizations during the follow up

hospitalizations are recorded during the year of follow up, with cause and duration.

Full Information

NCT ID

NCT01869452

First Posted

May 23, 2013

Last Updated

May 4, 2015

Sponsor

Resicard

Collaborators

union nationale de formation et d'evaluation en medecine cardio-vasculaire

1. Study Identification

Unique Protocol Identification Number

NCT01869452

Brief Title

Platform Therapeutic Education in Heart Failure and Coronary Disease

Acronym

METISCARDIO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

May 2010 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Resicard

Collaborators

union nationale de formation et d'evaluation en medecine cardio-vasculaire

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure, Acute Coronary Syndrome, Coronary Bypass Graft Stenosis of Native Artery Graft

Keywords

education, risk factors, quality of life, coronary disease, telephone follow up, dedicated nurse

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

555 (Actual)

8. Arms, Groups, and Interventions

Arm Title

therapeutic education class 1

Arm Type

Other

Arm Description

patients in class 1 will have a follow up call with therapeutic education every 3 months. this is the light follow up.

Arm Title

therapeutic education class 2

Arm Type

Other

Arm Description

patients in class 2 will have a follow up call with therapeutic education every month. this is the moderate follow up

Arm Title

therapeutic education class 3

Arm Type

Other

Arm Description

patients in class 3 will have a follow up call with therapeutic education twice a month. this is the heavy follow up.

Intervention Type

Behavioral

Intervention Name(s)

therapeutic education

Intervention Description

knowledge of disease, risk factors, diet, medication, alert symptoms

Primary Outcome Measure Information:

Title

number of patient with a better of quality of life

Description

quality of life is evaluated with appropriate questionnaires

Time Frame

1 year

Secondary Outcome Measure Information:

Title

number of patients who improve their knowledge of disease

Description

Knowledge of disease includes risk factors, symptoms, medication, diet. It is evaluated with appropriate questionnaires.

Time Frame

1 year

Title

number of hospitalizations during the follow up

Description

hospitalizations are recorded during the year of follow up, with cause and duration.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ariel a cohen, md

Organizational Affiliation

Resicard

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institut Coeur Effort Sante

City

Paris

ZIP/Postal Code

75005

Country

France

Facility Name

Clinique Turin

City

Paris

ZIP/Postal Code

75008

Country

France

Facility Name

Hopital Saint Antoine

City

Paris

ZIP/Postal Code

75012

Country

France

Facility Name

Centre Cardiologique Alfred Kastler

City

Sarcelles

ZIP/Postal Code

95200

Country

France

12. IPD Sharing Statement

Learn more about this trial

Platform Therapeutic Education in Heart Failure and Coronary Disease

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