Evaluation of Patient's Knowledge of Their NACO Treatment | NCT03323320

Studies
Evaluation of Patient's Knowledge of Their NACO Treatment

NCT03323320

Sponsor

Fondation Hôpital Saint-Joseph

Status

Completed

Last Update Posted

Feb 27, 2018Actual

Enrollment

51Actual

Phase

Not provided

Conditions

Anticoagulant

Interventions

Not provided

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

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 5, 2016Actual

Primary Completion Date

Mar 31, 2017Actual

Completion Date

Nov 1, 2017Actual

First Submitted Date

Oct 24, 2017

First Submission Date that Met QC Criteria

Oct 25, 2017

First Posted Date

Oct 27, 2017Actual

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

Feb 26, 2018

Last Update Posted Date

Feb 27, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

More than one million of patient receive anti vitamine K treatment which is the main cause of hospitalization. About 50 000 patient receive direct oral anticoagulant .

The aim is to evaluate the patient's level of knowledge about their anticoagulant treatment and specially about the side effect

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

51Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
questionnaire score >80%	it's a questionnaire about anticoagulant treatment ; each question has a score ans for the study investigators calculate the total	Day 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patient with AOD treatment
capable to answer to questionnaire
with or without antivitamin K

Exclusion Criteria:

dementia
cognitive trouble
refusing participation

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

patients under AOD treatment in GHPSJ (hospitalization and consultation)

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Romain CADOR, MD	GHPSJ	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Groupe Hospitalier Paris Saint Joseph		Paris	Île-de-France Region	75014	France