NCT02907151

Brief Summary

To assess the value of a dedicated knowledge questionnaire, filled by the patient prior consultation. Indeed, it could allow to target specific shortcomings of patients first, and help the cardiologist to prioritize the other therapeutic education, targeting specifically the information provided.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 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

September 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

May 7, 2018

Status Verified

September 1, 2016

Enrollment Period

4 months

First QC Date

September 15, 2016

Last Update Submit

May 4, 2018

Conditions

Under Oral Anticoagulation Patients

Outcome Measures

Primary Outcomes (1)

  • number of correct answers

    score (number of correct answers) to the survey

    3 months

Secondary Outcomes (4)

  • Score information

    3 months

  • Score on the provision of additional information

    3 months

  • anxiety score

    3 months

  • Score information based on subgroups

    3 months

Study Arms (2)

pre-consultation survey group

The group completing a pre consultation survey filled the same questionnaire in post consultation but the doctor will see the result in the consultation.

Other: Survey

Group absence of pre-consultation survey

This group will be a control group to see if there is a difference between completing a pre-consultation survey before or not.

Interventions

SurveyOTHER

Complete a survey prior to the consultation and a questionnaire after

pre-consultation survey group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients scheduled for cardiac consultation treated with oral anticoagulation

You may qualify if:

  • Patient monitoring Cardiology Consultation at University Hospital of Montpellier, whatever the reason
  • Patients on oral anticoagulant therapy (warfarin or AOD) for over a month.

You may not qualify if:

  • Severe cognitive disorders, making it impossible to understand the patient on therapeutic education.
  • Disorders of the important vision.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leclercq

Montpellier, 34295, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Florence Leclercq, MD PHD

    University Hospital, Montpellier

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

September 15, 2016

First Posted

September 20, 2016

Study Start

September 1, 2016

Primary Completion

January 1, 2017

Study Completion

March 1, 2017

Last Updated

May 7, 2018

Record last verified: 2016-09

Locations

FR(1)