<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01699282</url>
  </required_header>
  <id_info>
    <org_study_id>CHU-0121</org_study_id>
    <nct_id>NCT01699282</nct_id>
  </id_info>
  <brief_title>Benefits of a Comprehensive Patient Education on Oral Anticoagulant Compared to Conventional Hospital Education</brief_title>
  <acronym>EDUCA</acronym>
  <official_title>Benefits of a Comprehensive Patient Education on Oral Anticoagulant Compared to Conventional Hospital Education.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</source>
  <brief_summary>
    <textblock>
      To meet the wishes of the Ministry of Health, the division of Cardiology University Hospital&#xD;
      of Clermont Ferrand, combining the cardiology and cardiac surgery department, has developed&#xD;
      since January 2009, a therapeutic education to use oral anticoagulants, in collaboration with&#xD;
      the functional rehabilitation center Durtol. All patients under VKA, are formed by nurses.&#xD;
      The purpose of this local study, in cardiac surgery department, is to evaluate the&#xD;
      therapeutic impact of two methods of comprehensive education, one conventional and performed&#xD;
      by nurses service, less elaborate, relying solely on the book Information from The National&#xD;
      Security Agency of Medicines and Health Products, the other based on more detailed documents&#xD;
      created by a multidisciplinary group. Various studies show that the effect of therapeutic&#xD;
      education is observed only during the first six months and then disappears.&#xD;
&#xD;
      This study is the first French study evaluating the impact of a comprehensive education to&#xD;
      oral anticoagulation according to the latest recommendations of the National Security Agency&#xD;
      of Medicines and Health Products and the French National Health Authority.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To meet the wishes of the Ministry of Health, the division of Cardiology University Hospital&#xD;
      of Clermont Ferrand, combining the cardiology and cardiac surgery department, has developed&#xD;
      since January 2009, a therapeutic education to use oral anticoagulants, in collaboration with&#xD;
      the functional rehabilitation center Durtol. All patients under VKA, are formed by nurses.&#xD;
      The purpose of this local study, in cardiac surgery department, is to evaluate the&#xD;
      therapeutic impact of two methods of comprehensive education, one conventional and performed&#xD;
      by nurses service, less elaborate, relying solely on the book Information from The National&#xD;
      Security Agency of Medicines and Health Products, the other based on more detailed documents&#xD;
      created by a multidisciplinary group. Various studies show that the effect of therapeutic&#xD;
      education is observed only during the first six months and then disappears.&#xD;
&#xD;
      This study is the first French study evaluating the impact of a comprehensive education to&#xD;
      oral anticoagulation according to the latest recommendations of the National Security Agency&#xD;
      of Medicines and Health Products and the French National Health Authority.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2010</start_date>
  <completion_date type="Anticipated">December 2012</completion_date>
  <primary_completion_date type="Anticipated">December 2012</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>knowledge test on anticoagulant treatment</measure>
    <time_frame>after 12 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">186</enrollment>
  <condition>Cardiac Surgery</condition>
  <arm_group>
    <arm_group_label>Group thorough VKA (antivitamin K)education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>VKA (antivitamin K) education</intervention_name>
    <description>Evaluate benefits of a comprehensive patient education on oral anticoagulant compared to conventional hospital education</description>
    <arm_group_label>Group thorough VKA (antivitamin K)education</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>conventional hospital education</intervention_name>
    <description>Group thorough VKA education V.S. control group (conventional hospital education)</description>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults, male or female, over 18 years&#xD;
&#xD;
          -  After cardiac surgery&#xD;
&#xD;
          -  Requiring an oral anticoagulant in the long term (&gt; 12 months)&#xD;
&#xD;
          -  Accepting the principle of extended follow-up&#xD;
&#xD;
          -  Voluntary Consent, written and signed by patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kasra Azarnoush</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Clermont-Ferrand</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Patrick LACARIN</last_name>
    <phone>04 73 75 11 95</phone>
    <email>placarin@chu-clermontferrand.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU de Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patrick LACARIN</last_name>
      <phone>04 73 75 11 95</phone>
      <email>placarin@chu-clermontferrand.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>July 13, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>October 1, 2012</last_update_submitted>
  <last_update_submitted_qc>October 1, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 3, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>oral anticoagulant</keyword>
  <keyword>in the long term (&gt; 12 months)</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antivitamins K</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01699282
org study id: CHU-0121
nct id: NCT01699282
lead sponsor: 
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.
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: knowledge test on anticoagulant treatment
time frame: after 12 months
arm group label: Group thorough VKA (antivitamin K)education
arm group type: Experimental
arm group label: control group
arm group type: Active Comparator
intervention type: Behavioral
intervention name: VKA (antivitamin K) education
description: Evaluate benefits of a comprehensive patient education on oral anticoagulant compared to conventional hospital education
arm group label: Group thorough VKA (antivitamin K)education
intervention type: Behavioral
intervention name: conventional hospital education
description: Group thorough VKA education V.S. control group (conventional hospital education)
arm group label: control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kasra Azarnoush
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
last name: Patrick LACARIN
phone: 04 73 75 11 95
email: placarin@chu-clermontferrand.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Antivitamins K