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

This study has been terminated.
Sponsor:
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00227097
First received: September 23, 2005
Last updated: July 6, 2006
Last verified: July 2006
  Purpose

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 Intervention Phase
AVK Treatment
Behavioral: Education Notebook for anticoagulant treatment
Phase 3

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
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.

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Estimated Enrollment: 300
Study Start Date: December 2002
Estimated Study Completion Date: December 2004
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00227097     History of Changes
Other Study ID Numbers: DCIC 02 03
Study First Received: September 23, 2005
Last Updated: July 6, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Antivitamins K
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014