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

NCT ID: NCT01699282

Last Updated: 2012-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-12-31

Brief Summary

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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

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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.

Conditions

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Cardiac Surgery

Keywords

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oral anticoagulant in the long term (> 12 months)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Group thorough VKA (antivitamin K)education

Group Type EXPERIMENTAL

VKA (antivitamin K) education

Intervention Type BEHAVIORAL

Evaluate benefits of a comprehensive patient education on oral anticoagulant compared to conventional hospital education

control group

Group Type ACTIVE_COMPARATOR

conventional hospital education

Intervention Type BEHAVIORAL

Group thorough VKA education V.S. control group (conventional hospital education)

Interventions

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VKA (antivitamin K) education

Evaluate benefits of a comprehensive patient education on oral anticoagulant compared to conventional hospital education

Intervention Type BEHAVIORAL

conventional hospital education

Group thorough VKA education V.S. control group (conventional hospital education)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kasra Azarnoush

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Patrick LACARIN

Role: CONTACT

Phone: 04 73 75 11 95

Email: [email protected]

Facility Contacts

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Patrick LACARIN

Role: primary

Other Identifiers

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CHU-0121

Identifier Type: -

Identifier Source: org_study_id