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EDUCABenefits of a Comprehensive Patient Education on Oral Anticoagulant Compared to Conventional Hospital Education.

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What is being tested

VKA (antivitamin K) education

+ conventional hospital education

Behavioral
Who is being recruted

Over 18 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Phase 3
Interventional
Study Start: July 2010
See protocol details

Summary

Principal SponsorUniversity Hospital, Clermont-Ferrand
Study ContactPatrick LACARINMore contacts
Last updated: October 3, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2010

Actual date on which the first participant was enrolled.

To meet the wishes of the Ministry of Health, the division of Cardiology University Hospital of Clermont Ferrand, combining the cardiology and cardiac surgery department, has developed since January 2009, a therapeutic education to use oral anticoagulants, in collaboration with the functional rehabilitation center Durtol. All patients under VKA, are formed by nurses. The purpose of this local study, in cardiac surgery department, is to evaluate the therapeutic impact of two methods of comprehensive education, one conventional and performed by nurses service, less elaborate, relying solely on the book Information from The National Security Agency of Medicines and Health Products, the other based on more detailed documents created by a multidisciplinary group. Various studies show that the effect of therapeutic education is observed only during the first six months and then disappears. This study is the first French study evaluating the impact of a comprehensive education to oral anticoagulation according to the latest recommendations of the National Security Agency of Medicines and Health Products and the French National Health Authority.

Principal SponsorUniversity Hospital, Clermont-Ferrand
Study ContactPatrick LACARINMore contacts
Last updated: October 3, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

186 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate
Accepting the principle of extended follow-up

Adults, male or female, over 18 years

After cardiac surgery

Requiring an oral anticoagulant in the long term ( > 12 months)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Active Comparator

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

CHU de Clermont-Ferrand

Clermont-Ferrand, FranceOpen CHU de Clermont-Ferrand in Google Maps
SuspendedOne Study Center