Benefits of a Comprehensive Patient Education on Oral Anticoagulant Compared to Conventional Hospital Education
EDUCA
1 other identifier
interventional
186
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 13, 2012
CompletedFirst Posted
Study publicly available on registry
October 3, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedOctober 3, 2012
October 1, 2012
2.4 years
July 13, 2012
October 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
knowledge test on anticoagulant treatment
after 12 months
Study Arms (2)
Group thorough VKA (antivitamin K)education
EXPERIMENTALcontrol group
ACTIVE COMPARATORInterventions
Evaluate benefits of a comprehensive patient education on oral anticoagulant compared to conventional hospital education
Group thorough VKA education V.S. control group (conventional hospital education)
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Clermont-Ferrand
Clermont-Ferrand, 63003, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kasra Azarnoush
University Hospital, Clermont-Ferrand
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2012
First Posted
October 3, 2012
Study Start
July 1, 2010
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
October 3, 2012
Record last verified: 2012-10