Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-01-10 @ 8:46 PM
Study NCT ID:
NCT02907151
Status:
COMPLETED
Last Update Posted:
2018-05-07
First Post:
2016-09-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Contribution of a Pre-consultation Questionnaire on the Therapeutic Education
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-04', 'studyFirstSubmitDate': '2016-09-15', 'studyFirstSubmitQcDate': '2016-09-15', 'lastUpdatePostDateStruct': {'date': '2018-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of correct answers', 'timeFrame': '3 months', 'description': 'score (number of correct answers) to the survey'}], 'secondaryOutcomes': [{'measure': 'Score information', 'timeFrame': '3 months', 'description': 'Score information for the different areas of the survey'}, {'measure': 'Score on the provision of additional information', 'timeFrame': '3 months', 'description': 'Score on the provision of additional information in the consultation.'}, {'measure': 'anxiety score', 'timeFrame': '3 months', 'description': 'anxiety score by a self-evaluation of the patient.'}, {'measure': 'Score information based on subgroups', 'timeFrame': '3 months', 'description': 'Score information based on subgroups:\n\n* level of education\n* Age\n* Sex'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Under Oral Anticoagulation Patients']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe assumption is that this questionnaire would help educate patients about their shortcomings and educate cardiologists lack of knowledge of his patient.\n\nThe secondary objectives are :\n\n* Target specific areas in which patients have the greatest lack of information\n* Assess the impact of educational level on information\n* Assess the impact of age on information\n* Evaluate the satisfaction of the information delivered\n* Assess patient anxiety vis-à-vis their treatment\n* Evaluate the failure rate of the questionnaire to know the number of patients refusing to participate in the study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients scheduled for cardiac consultation treated with oral anticoagulation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient monitoring Cardiology Consultation at University Hospital of Montpellier, whatever the reason\n* Patients on oral anticoagulant therapy (warfarin or AOD) for over a month.\n\nExclusion Criteria:\n\n* Severe cognitive disorders, making it impossible to understand the patient on therapeutic education.\n* Disorders of the important vision.'}, 'identificationModule': {'nctId': 'NCT02907151', 'acronym': 'EDUCONSULT', 'briefTitle': 'Evaluation of the Contribution of a Pre-consultation Questionnaire on the Therapeutic Education', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Evaluation of the Contribution of a Pre-consultation Questionnaire on the Therapeutic Education of Patients on Anticoagulants During a Routine Inspection by the Cardiologist.', 'orgStudyIdInfo': {'id': 'RECHMPL16_0275'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'pre-consultation survey group', 'description': 'The group completing a pre consultation survey filled the same questionnaire in post consultation but the doctor will see the result in the consultation.', 'interventionNames': ['Other: Survey']}, {'label': 'Group absence of pre-consultation survey', 'description': 'This group will be a control group to see if there is a difference between completing a pre-consultation survey before or not.'}], 'interventions': [{'name': 'Survey', 'type': 'OTHER', 'description': 'Complete a survey prior to the consultation and a questionnaire after', 'armGroupLabels': ['pre-consultation survey group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Leclercq', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Florence Leclercq, MD PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}