Benefits of a Comprehensive Patient Education on Oral Ant... | NCT01699282

Studies
Benefits of a Comprehensive Patient Education on Oral Anticoagulant Compared to Conventional Hospital Education

NCT01699282

Sponsor

University Hospital, Clermont-Ferrand

Status

Unknown status

Last Update Posted

Oct 3, 2012Estimated

Enrollment

186Estimated

Phase

Phase 3

Conditions

Cardiac Surgery

Interventions

VKA (antivitamin K) education
conventional hospital education

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

Oct 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Dec 2012Estimated

Completion Date

Dec 2012Estimated

First Submitted Date

Jul 13, 2012

First Submission Date that Met QC Criteria

Oct 1, 2012

First Posted Date

Oct 3, 2012Estimated

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

Oct 1, 2012

Last Update Posted Date

Oct 3, 2012Estimated

Description Module

Brief Summary

To meet the wishes of the Ministry of Health, the division of Cardiology University Hospital of Clermont Ferrand, combining the cardiology and cardiac surgery department, has developed since January 2009, a therapeutic education to use oral anticoagulants, in collaboration with the functional rehabilitation center Durtol. All patients under VKA, are formed by nurses. The purpose of this local study, in cardiac surgery department, is to evaluate the therapeutic impact of two methods of comprehensive education, one conventional and performed by nurses service, less elaborate, relying solely on the book Information from The National Security Agency of Medicines and Health Products, the other based on more detailed documents created by a multidisciplinary group. Various studies show that the effect of therapeutic education is observed only during the first six months and then disappears.

This study is the first French study evaluating the impact of a comprehensive education to oral anticoagulation according to the latest recommendations of the National Security Agency of Medicines and Health Products and the French National Health Authority.

Detailed Description

Design Module

Study Type

Interventional

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

186Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group thorough VKA (antivitamin K)education	Experimental		Behavioral: VKA (antivitamin K) education
control group	Active Comparator		Behavioral: conventional hospital education

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VKA (antivitamin K) education	Behavioral	Evaluate benefits of a comprehensive patient education on oral anticoagulant compared to conventional hospital education	Group thorough VKA (antivitamin K)education

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
knowledge test on anticoagulant treatment		after 12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults, male or female, over 18 years
After cardiac surgery
Requiring an oral anticoagulant in the long term (> 12 months)
Accepting the principle of extended follow-up
Voluntary Consent, written and signed by patients

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

Name	Role	Phone	Extension	Email
Patrick LACARIN	Contact	04 73 75 11 95		placarin@chu-clermontferrand.fr

Overall Officials

Name	Affiliation	Role
Kasra Azarnoush	University Hospital, Clermont-Ferrand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Clermont-Ferrand	Recruiting	Clermont-Ferrand		63003	France

Intervention Browse Module

MeSH Terms

ID	Term
D004522	Educational Status

Ancestor Terms

ID	Term
D012959	Socioeconomic Factors
D011154	Population Characteristics

Browse Leaves

Not provided

Browse Branches

Not provided