Educ'Avk: Recommendations for the Antivitamin K's Gestion - Full Text View

Sponsored by:	University Hospital, Grenoble
Information provided by:	University Hospital, Grenoble
ClinicalTrials.gov Identifier:	NCT00227097

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 III

U.S. FDA Resources

Study Type:	Observational
Study Design:	Psychosocial, Longitudinal, Defined Population, Prospective Study
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.

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00227097

Locations

France, Grenoble Cédex 9
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:

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.

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.

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.

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.

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.

Study ID Numbers:	DCIC 02 03
Study First Received:	September 23, 2005
Last Updated:	July 6, 2006
ClinicalTrials.gov Identifier:	NCT00227097
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Grenoble:

therapeutic education
thrombi embolic disease

Study placed in the following topic categories:

Antivitamins K
Embolism
Thrombosis

Additional relevant MeSH terms:

Anticoagulants
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009