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TerminatedNCT00227097Updated Jul 7, 2006

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

An observational study in AVK Treatment, sponsored by University Hospital, Grenoble. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2006-07-07.

Sponsored by University Hospital, Grenoble · Observational

Study type
Observational
Model
Defined population
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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).

02

Conditions studied

  • AVK Treatment

Keywords

  • therapeutic education
  • thrombi embolic disease
03

In context

Lead sponsor

University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Observational model
Defined population
Time perspective
Prospective
Enrollment
300 participants

Interventions

  • BehavioralEducation Notebook for anticoagulant treatment
06

Study locations

1 site
  • Cardiovascular Departement - University Hospital of Grenoble - BP 217
    La tronche, Grenoble Cédex 9 38700, France
07

References and documents

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. doi: 10.1023/a:1007450729633. PubMed 9556173 ↗
  • 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. PubMed 10185321 ↗
  • 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. PubMed 9389850 ↗
  • 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. PubMed 8489056 ↗
  • 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. PubMed 1914452 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00227097
Lead sponsor
University Hospital, Grenoble
First posted
Sep 27, 2005
Start date
Dec 2002
Completion
Dec 2004
Last update
Jul 7, 2006

Study contacts

Jean-Luc BOSSON
principal investigator · Institut National de la Santé Et de la Recherche Médicale, France
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2006. You cannot join it, but the record below documents what was studied.

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