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

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ClinicalTrials.gov Identifier: NCT01699282
Recruitment Status : Unknown
Verified October 2012 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Recruiting
First Posted : October 3, 2012
Last Update Posted : October 3, 2012
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

July 13, 2012
October 3, 2012
October 3, 2012
July 2010
December 2012   (Final data collection date for primary outcome measure)
knowledge test on anticoagulant treatment [ Time Frame: after 12 months ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Benefits of a Comprehensive Patient Education on Oral Anticoagulant Compared to Conventional Hospital Education
Benefits of a Comprehensive Patient Education on Oral Anticoagulant Compared to Conventional Hospital Education.

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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Cardiac Surgery
  • Behavioral: VKA (antivitamin K) education
    Evaluate benefits of a comprehensive patient education on oral anticoagulant compared to conventional hospital education
  • Behavioral: conventional hospital education
    Group thorough VKA education V.S. control group (conventional hospital education)
  • Experimental: Group thorough VKA (antivitamin K)education
    Intervention: Behavioral: VKA (antivitamin K) education
  • Active Comparator: control group
    Intervention: Behavioral: conventional hospital education
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
186
Same as current
December 2012
December 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01699282
CHU-0121
Not Provided
Not Provided
Not Provided
University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
Not Provided
Principal Investigator: Kasra Azarnoush University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP