Educ'Avk: Recommendations for the Antivitamin K's Gestion NCT00227097

Clinical Trial Details — Status: Terminated

Administrative data
NCT number	NCT00227097
Other study ID #	DCIC 02 03
Secondary ID
Status	Terminated
Phase	Phase 3
First received	September 23, 2005
Last updated	July 6, 2006
Start date	December 2002
Est. completion date	December 2004

Study information
Verified date	July 2006
Source	University Hospital, Grenoble
Contact	n/a
Is FDA regulated	No
Health authority	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type	Observational

Clinical Trial 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).

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).

Recruitment information / eligibility
Status	Terminated
Enrollment	300
Est. completion date	December 2004
Est. primary completion date
Accepts healthy volunteers	No
Gender	Both
Age group	18 Years and older
Eligibility	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

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

AVK Treatment

Intervention

Behavioral:
• Education Notebook for anticoagulant treatment

Locations
Country	Name	City	State
France	Cardiovascular Departement - University Hospital of Grenoble - BP 217	La tronche	Grenoble Cédex 9

Sponsors *(1)*
Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France,

References & Publications (5)

Bertrand D, François 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. — View 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. — View 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. — View 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. — View Citation

Vermont J, Bosson JL, François P, Robert C, Rueff A, Demongeot J. Strategies for graphical threshold determination. Comput Methods Programs Biomed. 1991 Jun;35(2):141-50. — View Citation

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

Clinical Trial Details — Status: Terminated

Administrative data

Study information