- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01869452
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
Status
Completed
Conditions
Intervention / Treatment
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
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Paris, France, 75008
- Clinique Turin
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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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PlaTform
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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