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

Phase 3

• Conditions: Cardiac Surgery
• Interventions: Behavioral: VKA (antivitamin K) education; Behavioral: conventional hospital education

• Registration Number: NCT01699282
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2012-07-13
• Status Verified: 2012-10
• Study First Submitted QC: 2012-10-01
• Last Update Submitted: 2012-10-01
• Study First Posted: 2012-10-03
• Last Update Posted: 2012-10-03
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 186

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group thorough VKA (antivitamin K)education	VKA (antivitamin K) education	-
control group	conventional hospital education	-

Primary Outcome Measures

Name	Time	Method
knowledge test on anticoagulant treatment	after 12 months

Trial Locations

Locations (1)

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France