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

Terminated

• Conditions: AVK Treatment

• Registration Number: NCT00227097
• Lead Sponsor: 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).

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 Timeline

• Study Start: 2002-12
• Study Completion: 2004-12
• Study First Submitted: 2005-09-23
• Study First Submitted QC: 2005-09-23
• Study First Posted: 2005-09-27
• Status Verified: 2006-07
• Last Update Submitted: 2006-07-06
• Last Update Posted: 2006-07-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Cardiovascular Departement - University Hospital of Grenoble - BP 217; 🇫🇷 La tronche, Grenoble Cédex 9, France