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Educ'Avk: Recommendations for the Antivitamin K's Gestion

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ClinicalTrials.gov Identifier: NCT00227097
Recruitment Status : Terminated
First Posted : September 27, 2005
Last Update Posted : July 7, 2006
Sponsor:
Information provided by:
University Hospital, Grenoble

Brief Summary:
The objective of the project "Educ'Avk", is to document the efficacy of a strategy combining a specific follow up-notebook and education of attending patient with a pedagogic support, comparatively to an usual education on the impact of clinical events at three months (minor or major hemorrhagic events + recurrence of thrombi-embolic's disease).

Condition or disease Intervention/treatment
AVK Treatment Behavioral: Education Notebook for anticoagulant treatment

Detailed Description:

Standard strategies for the implementation of recommendations are exclusively focused on practitioners. But often they do not appear to be effective (insufficient time accorded per patient, lack of training…).

However some qualitative surveys have shown the benefit of a greater role on the part patient in the process of transmitting recommendations through the practitioner.

In this study, patient education is begun by the angiologist or a pharmacy student under the responsibility of the hospital investigator. Follow-up is realized by the patient’s general practitioner.

More patient involvement in the realization of the recommendations could increase the proportion of practitioners who follow the recommendations and decrease the iatrogenicity of antivitamin K (AVK).


Study Type : Observational
Enrollment : 300 participants
Observational Model: Defined Population
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Implication of Patient in the Making Ready of Recommendations for the Antivitamin K's Gestion in Case of Thrombosis Embolic Venous's Illness. Randomised Study for Clinical Validation.
Study Start Date : December 2002
Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots
U.S. FDA Resources





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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able to receive benefit sanitary educational act
  • Able to be followed up during three months
  • Acute episode of a venous's thrombi embolic illness (venous's thrombosis distal or proximal deep and/or lung embolism)
  • A.V.K. treatment for a period of at least three months
  • Return to residence (included return to retreat residence no medicalize)
  • Informed consent form signed

Exclusion Criteria:

  • Distal venous thrombosis limited muscular vein without lung embolism
  • Contra-indication of to an A.V.K. treatment
  • Difficult comprehension of the french language
  • Trouble of visual acuity
  • Trouble of superior function incompatible with an educational's act sanitary
  • Psycho-social instability incompatible with a regular follow-up of three months (without fixed residence, addictive lapsed)
  • Impossibility to return to residence (the return in retreat residence no medicalize is considered as a return to residence)
  • Psychiatric pathology not compensated
  • Life expectancy less than three months
  • Refusal of participation in the study
  • Participation in another clinical study
  • Anterior inclusion in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00227097


Locations
France
Cardiovascular Departement - University Hospital of Grenoble - BP 217
La tronche, Grenoble Cédex 9, France, 38700
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Jean-Luc BOSSON Institut National de la Santé Et de la Recherche Médicale, France

Publications:
ClinicalTrials.gov Identifier: NCT00227097     History of Changes
Other Study ID Numbers: DCIC 02 03
First Posted: September 27, 2005    Key Record Dates
Last Update Posted: July 7, 2006
Last Verified: July 2006

Keywords provided by University Hospital, Grenoble:
therapeutic education
thrombi embolic disease

Additional relevant MeSH terms:
Antivitamins K
Anticoagulants