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

October 1, 2012 updated by: University Hospital, Clermont-Ferrand

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

186

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Recruiting
        • CHU de Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

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

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
knowledge test on anticoagulant treatment
Time Frame: after 12 months
after 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

July 13, 2012

First Submitted That Met QC Criteria

October 1, 2012

First Posted (Estimate)

October 3, 2012

Study Record Updates

Last Update Posted (Estimate)

October 3, 2012

Last Update Submitted That Met QC Criteria

October 1, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0121

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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