Clinical trial NCT00227097: Educ'Avk: Recommendations for the Antivitamin K's Gestion
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 type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: AVK Treatment
Keywords: therapeutic education
thrombi embolic disease
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2005-09-27
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

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).

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: La tronche
country: France
facility: Cardiovascular Departement - University Hospital of Grenoble - BP 217
state: Grenoble Cédex 9
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Jean-Luc BOSSON
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.