NCT03323320

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 5, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 27, 2017

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

February 27, 2018

Status Verified

February 1, 2018

Enrollment Period

4 months

First QC Date

October 24, 2017

Last Update Submit

February 26, 2018

Conditions

Anticoagulant

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients under AOD treatment in GHPSJ (hospitalization and consultation)

You may qualify if:

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

You may not qualify if:

  • dementia
  • cognitive trouble
  • refusing participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

Study Officials

  • Romain CADOR, MD

    GHPSJ

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2017

First Posted

October 27, 2017

Study Start

December 5, 2016

Primary Completion

March 31, 2017

Study Completion

November 1, 2017

Last Updated

February 27, 2018

Record last verified: 2018-02

Locations

FR(1)