Evaluation of the Contribution of a Pre-consultation Questionnaire on the Therapeutic Education (EDUCONSULT)

May 4, 2018 updated by: University Hospital, Montpellier

Evaluation of the Contribution of a Pre-consultation Questionnaire on the Therapeutic Education of Patients on Anticoagulants During a Routine Inspection by the Cardiologist.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The main objective is to study the impact of a pre-consultation questionnaire on the knowledge gained by the patient on anticoagulant treatment at the exit of cardiology consultation.

The assumption is that this questionnaire would help educate patients about their shortcomings and educate cardiologists lack of knowledge of his patient.

The secondary objectives are :

  • Target specific areas in which patients have the greatest lack of information
  • Assess the impact of educational level on information
  • Assess the impact of age on information
  • Evaluate the satisfaction of the information delivered
  • Assess patient anxiety vis-à-vis their treatment
  • Evaluate the failure rate of the questionnaire to know the number of patients refusing to participate in the study

Study Type

Observational

Enrollment (Actual)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Leclercq

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients scheduled for cardiac consultation treated with oral anticoagulation

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Complete a survey prior to the consultation and a questionnaire after
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of correct answers
Time Frame: 3 months
score (number of correct answers) to the survey
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score information
Time Frame: 3 months
Score information for the different areas of the survey
3 months
Score on the provision of additional information
Time Frame: 3 months
Score on the provision of additional information in the consultation.
3 months
anxiety score
Time Frame: 3 months
anxiety score by a self-evaluation of the patient.
3 months
Score information based on subgroups
Time Frame: 3 months

Score information based on subgroups:

  • level of education
  • Age
  • Sex
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Study Director: Florence Leclercq, MD PHD, University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

September 15, 2016

First Submitted That Met QC Criteria

September 15, 2016

First Posted (Estimate)

September 20, 2016

Study Record Updates

Last Update Posted (Actual)

May 7, 2018

Last Update Submitted That Met QC Criteria

May 4, 2018

Last Verified

September 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • RECHMPL16_0275

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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