Platform Therapeutic Education in Heart Failure and Coronary Disease

Heart Failure Clinical Trial

— METISCARDIO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01869452
• Other study ID #: Platform
• Status: Completed
• Phase: N/A
• First received: May 23, 2013
• Last updated: May 4, 2015
• Start date: May 2010
• Est. completion date: June 2014

Study information

• Verified date: May 2015
• Source: Resicard
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 555
• Est. completion date: June 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Coronary Bypass Graft Stenosis of Native Artery Graft
• Coronary Disease
• Heart Failure

Intervention

Behavioral:
• therapeutic education
knowledge of disease, risk factors, diet, medication, alert symptoms

Locations

Country	Name	City	State
France	Clinique Turin	Paris
France	Hopital Saint Antoine	Paris
France	Institut Coeur Effort Sante	Paris
France	Centre Cardiologique Alfred Kastler	Sarcelles

Sponsors (2)

Lead Sponsor	Collaborator
Resicard	union nationale de formation et d'evaluation en medecine cardio-vasculaire

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patient with a better of quality of life	quality of life is evaluated with appropriate questionnaires	1 year	No
Secondary	number of patients who improve their knowledge of disease	Knowledge of disease includes risk factors, symptoms, medication, diet. It is evaluated with appropriate questionnaires.	1 year	No
Secondary	number of hospitalizations during the follow up	hospitalizations are recorded during the year of follow up, with cause and duration.	1 year	No