Under Oral Anticoagulation PatientsEDUCONSULTNCT02907151
Evaluation of the Contribution of a Pre-consultation Questionnaire on the Therapeutic Education
An observational study of Under Oral Anticoagulation Patients, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Under Oral Anticoagulation Patients
- What is being tested?
- Survey
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2016to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients scheduled for cardiac consultation treated with oral anticoagulation
Who may be able to join
- Patient monitoring Cardiology Consultation at University Hospital of Montpellier, whatever the reason
- Patients on oral anticoagulant therapy (warfarin or AOD) for over a month.
Who cannot join
- Severe cognitive disorders, making it impossible to understand the patient on therapeutic education.
- Disorders of the important vision.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Under Oral Anticoagulation Patients
- Being tested
- Survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Complete a survey prior to the consultation and a questionnaire after
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of correct answers
score (number of correct answers) to the survey
Measured: 3 months
Secondary outcomes (4)
Score information
Score information for the different areas of the survey
Measured: 3 months
Score on the provision of additional information
Score on the provision of additional information in the consultation.
Measured: 3 months
anxiety score
anxiety score by a self-evaluation of the patient.
Measured: 3 months
Score information based on subgroups
Score information based on subgroups:
- level of education
- Age
- Sex
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionJan 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Under Oral Anticoagulation PatientsStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence Leclercq, MD PHD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02907151
- Sponsor's protocol ID
- RECHMPL16_0275
- Acronym
- EDUCONSULT
- Status last verified
- Sep 2016
- First submitted
- 15 Sep 2016
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Contribution of a Pre-consultation Questionnaire on the Therapeutic Education of Patients on Anticoagulants During a Routine Inspection by the Cardiologist.
- ClinicalTrials.gov ID
- NCT02907151
- Acronym / sponsor ID
- EDUCONSULT / RECHMPL16_0275
- Conditions
- Under Oral Anticoagulation Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 20 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pre-consultation survey group | – | Other: SurveyThe group completing a pre consultation survey filled the same questionnaire in post consultation but the doctor will see the result in the consultation. |
| 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients scheduled for cardiac consultation treated with oral anticoagulation
Key inclusion criteria (2 listed)
- Patient monitoring Cardiology Consultation at University Hospital of Montpellier, whatever the reason
- Patients on oral anticoagulant therapy (warfarin or AOD) for over a month.
Key exclusion criteria (2 listed)
- Severe cognitive disorders, making it impossible to understand the patient on therapeutic education.
- Disorders of the important vision.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveyComplete a survey prior to the consultation and a questionnaire after | Other | pre-consultation survey group |
Primary outcome
number of correct answers
Time frame: 3 months
score (number of correct answers) to the survey
4 secondary outcomes
Score information
Time frame: 3 months
Score on the provision of additional information
Time frame: 3 months
anxiety score
Time frame: 3 months
Score information based on subgroups
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florence Leclercq, MD PHD study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Under Oral Anticoagulation Patients, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of correct answers (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2018; AzTrials last refreshed its copy on 8 Nov 2026.