NCT01869452

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
555

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
Completed

Started May 2010

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2013

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2013

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

May 5, 2015

Status Verified

May 1, 2015

Enrollment Period

3.1 years

First QC Date

May 23, 2013

Last Update Submit

May 4, 2015

Conditions

Keywords

educationrisk factorsquality of lifecoronary diseasetelephone follow updedicated nurse

Outcome Measures

Primary Outcomes (1)

  • number of patient with a better of quality of life

    quality of life is evaluated with appropriate questionnaires

    1 year

Secondary Outcomes (2)

  • number of patients who improve their knowledge of disease

    1 year

  • number of hospitalizations during the follow up

    1 year

Study Arms (3)

therapeutic education class 1

OTHER

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

Behavioral: therapeutic education

therapeutic education class 2

OTHER

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

Behavioral: therapeutic education

therapeutic education class 3

OTHER

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

Behavioral: therapeutic education

Interventions

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

therapeutic education class 1therapeutic education class 2therapeutic education class 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Institut Coeur Effort Sante

Paris, 75005, France

Location

Clinique Turin

Paris, 75008, France

Location

Hopital Saint Antoine

Paris, 75012, France

Location

Centre Cardiologique Alfred Kastler

Sarcelles, 95200, France

Location

MeSH Terms

Conditions

Heart FailureAcute Coronary SyndromeCoronary Disease

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesMyocardial IschemiaVascular Diseases

Study Officials

  • ariel a cohen, md

    Resicard

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
head of the departement of cardiology,Saint Antoine hospital , Paris

Study Record Dates

First Submitted

May 23, 2013

First Posted

June 5, 2013

Study Start

May 1, 2010

Primary Completion

June 1, 2013

Study Completion

June 1, 2014

Last Updated

May 5, 2015

Record last verified: 2015-05

Locations