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

NCT ID: NCT00227097

Last Updated: 2006-07-07

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

TERMINATED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-12-31

Study Completion Date

2004-12-31

Brief Summary

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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

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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).

Conditions

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AVK Treatment

Keywords

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therapeutic education thrombi embolic disease

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Interventions

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Education Notebook for anticoagulant treatment

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Principal Investigators

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Jean-Luc BOSSON

Role: PRINCIPAL_INVESTIGATOR

Institut National de la Santé Et de la Recherche Médicale, France

Locations

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Cardiovascular Departement - University Hospital of Grenoble - BP 217

La Tronche, Grenoble Cédex 9, France

Site Status

Countries

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France

References

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Gratacap-Cavallier B, Bosson JL, Morand P, Dutertre N, Chanzy B, Jouk PS, Vandekerckhove C, Cart-Lamy P, Seigneurin JM. Cytomegalovirus seroprevalence in French pregnant women: parity and place of birth as major predictive factors. Eur J Epidemiol. 1998 Feb;14(2):147-52. doi: 10.1023/a:1007450729633.

Reference Type BACKGROUND
PMID: 9556173 (View on PubMed)

Bertrand D, Francois P, Bosson JL, Fauconnier J, Weil G. Quality assessment of discharge letters in a French university hospital. Int J Health Care Qual Assur Inc Leadersh Health Serv. 1998;11(2-3):90-5. doi: 10.1108/09526869810213019.

Reference Type BACKGROUND
PMID: 10185321 (View on PubMed)

Mezin P, Payen JF, Bosson JL, Brambilla E, Stieglitz P. Histological support for the difference between malignant hyperthermia susceptible (MHS), equivocal (MHE) and negative (MHN) muscle biopsies. Br J Anaesth. 1997 Sep;79(3):327-31. doi: 10.1093/bja/79.3.327.

Reference Type BACKGROUND
PMID: 9389850 (View on PubMed)

Payen JF, Bosson JL, Bourdon L, Jacquot C, Le Bas JF, Stieglitz P, Benabid AL. Improved noninvasive diagnostic testing for malignant hyperthermia susceptibility from a combination of metabolites determined in vivo with 31P-magnetic resonance spectroscopy. Anesthesiology. 1993 May;78(5):848-55. doi: 10.1097/00000542-199305000-00007.

Reference Type BACKGROUND
PMID: 8489056 (View on PubMed)

Vermont J, Bosson JL, Francois P, Robert C, Rueff A, Demongeot J. Strategies for graphical threshold determination. Comput Methods Programs Biomed. 1991 Jun;35(2):141-50. doi: 10.1016/0169-2607(91)90072-2.

Reference Type BACKGROUND
PMID: 1914452 (View on PubMed)

Other Identifiers

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DCIC 02 03

Identifier Type: -

Identifier Source: org_study_id