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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Benefits of a Comprehensive Patient Education on Oral Anticoagulant Compared to Conventional Hospital Education.

Conditions
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Cardiac Surgery

Intervention / Treatment
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* Behavioral: VKA (antivitamin K) education
* Behavioral: conventional hospital education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults, male or female, over 18 years After cardiac surgery Requiring an oral anticoagulant in the long term (> 12 months) Accepting the principle of extended follow-up Voluntary Consent, written and signed by patients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group thorough VKA (antivitamin K)education<br> | Behavioral: VKA (antivitamin K) education<br>* Evaluate benefits of a comprehensive patient education on oral anticoagulant compared to conventional hospital education<br>|
| Active Comparator: control group<br> | Behavioral: conventional hospital education<br>* Group thorough VKA education V.S. control group (conventional hospital education)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| knowledge test on anticoagulant treatment |  | after 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral anticoagulant, in the long term (> 12 months)