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

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

NCT00227097

Sponsor

University Hospital, Grenoble

Status

Terminated

Last Update Posted

Jul 7, 2006Estimated

Enrollment

300

Phase

Not provided

Conditions

AVK Treatment

Interventions

Education Notebook for anticoagulant treatment

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2006

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2002

Primary Completion Date

Not provided

Completion Date

Dec 2004

First Submitted Date

Sep 23, 2005

First Submission Date that Met QC Criteria

Sep 23, 2005

First Posted Date

Sep 27, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2006

Last Update Posted Date

Jul 7, 2006Estimated

Description Module

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300

Name	Type	Description	Arm Group Labels	Other Names
Education Notebook for anticoagulant treatment	Behavioral

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean-Luc BOSSON	Institut National de la Santé Et de la Recherche Médicale, France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cardiovascular Departement - University Hospital of Grenoble - BP 217		La Tronche	Grenoble Cédex 9	38700	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
9556173	Background	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.
10185321	Background