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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02907151
Other study ID # RECHMPL16_0275
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2016
Est. completion date March 2017

Study information

Verified date September 2016
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date March 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • Under Oral Anticoagulation Patients

Intervention

Other:
Survey
Complete a survey prior to the consultation and a questionnaire after

Locations

Country Name City State
France Leclercq Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary number of correct answers score (number of correct answers) to the survey 3 months
Secondary Score information Score information for the different areas of the survey 3 months
Secondary Score on the provision of additional information Score on the provision of additional information in the consultation. 3 months
Secondary anxiety score anxiety score by a self-evaluation of the patient. 3 months
Secondary Score information based on subgroups Score information based on subgroups:
level of education
Age
Sex
3 months