Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2026-02-18 @ 9:17 PM
Study NCT ID:
NCT01567267
Status:
UNKNOWN
Last Update Posted:
2017-03-03
First Post:
2012-03-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Educational Intervention to Teach Principles of Evidence-based Medicine (EbM) in Biology Classes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2019-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-01', 'studyFirstSubmitDate': '2012-03-14', 'studyFirstSubmitQcDate': '2012-03-29', 'lastUpdatePostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in knowledge about EbM/GSP', 'timeFrame': 'Before (day1), during (day 2) and after (day 4) intervention', 'description': 'Difference in knowledge about EbM/GSP measured by alternating standardized, pre-validated, single-best/short-answer questionnaires consisting of 20 questions each'}], 'secondaryOutcomes': [{'measure': 'Difference in skills about critically appraising scientific literature', 'timeFrame': 'Before (day 1), during (day 2) and after (day 4) intervention', 'description': 'Difference in skills about critically appraising scientific literature measured by alternating randomized-controlled trials evaluated by a standardized checklist related to items of the CONSORT statement.'}, {'measure': 'Skills in teaching principles of EbM and GSP to high school students in intervention group', 'timeFrame': 'After educational intervention (day 5)', 'description': 'Skill in teaching principles of EbM and GSP are evaluated for preparation of lessons using a standardized preparation form and performance of lessons evaluated by transcription of video tapes from each participant in the intervention group using a consented evaluation catalogue'}, {'measure': 'Overall acceptance of educational intervention study participants', 'timeFrame': 'During (day 2) and after intervention (day 4)', 'description': 'Overall acceptance of educational intervention is evaluated by standardized questionnaires at day 2 and day 4 in the educational intervention group.'}, {'measure': 'Overall acceptance of study lessons for biology high-school students', 'timeFrame': 'After study lessons (day 5)', 'description': 'Overall acceptance of study lessons for biology high-school students is evaluated by a standardized questionnaire at day 5.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Evidence-based Medicine', 'Good Scientific Practice', 'Problem-based Learning', 'Critical health literacy', 'Educational intervention'], 'conditions': ['Health Knowledge, Attitudes, Practice']}, 'referencesModule': {'references': [{'pmid': '23415344', 'type': 'DERIVED', 'citation': 'Matic-Strametz M, Strametz R, Bohrt K, Ochsendorf F, Weberschock T. [Students in Training to Become Biology Teachers - a controlled phase II trial (NCT01567267)]. Z Evid Fortbild Qual Gesundhwes. 2013;107(1):53-61. doi: 10.1016/j.zefq.2012.11.017. Epub 2012 Dec 7. German.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to identify the effect of a short term educational intervention for upcoming biology teachers to teach principles of Evidence-based Medicine (EbM) and Good Scientific Practice (GSP) to high-school biology students.', 'detailedDescription': 'Shared decision making is increasingly demanded by patients in order to take part in health care decisions. However this demand for autonomy can only be used for shared decision making if the patient has basic skills in critical health literacy. To transfer health care literacy to young and healthy consumers educational intervention programs at high-school might be a feasible and effective way. This preliminary phase 2 study is designed to investigate the effect of an educational intervention to be integrated in a curriculum for upcoming teachers in biology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* students becoming biology teachers at participating university during enrollment period\n\nExclusion Criteria:\n\n* refusal to participate in study'}, 'identificationModule': {'nctId': 'NCT01567267', 'briefTitle': 'Evaluation of Educational Intervention to Teach Principles of Evidence-based Medicine (EbM) in Biology Classes', 'organization': {'class': 'OTHER', 'fullName': 'Goethe University'}, 'officialTitle': 'Phase II Study of a Short Term Educational Intervention for Upcoming Biology Teachers to Teach Principles of Evidence-based Medicine (EbM) in Biology Classes at High-school', 'orgStudyIdInfo': {'id': 'EbM@Bio-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental educational intervention', 'description': 'Experimental educational intervention', 'interventionNames': ['Behavioral: Experimental educational intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard educational intervention', 'description': 'Standard educational intervention', 'interventionNames': ['Behavioral: Standard educational intervention']}], 'interventions': [{'name': 'Experimental educational intervention', 'type': 'BEHAVIORAL', 'description': 'Educational intervention consisting of a 4-day-course in Evidence-based Medicine and Good Scientific Practice combined with the method of Problem-based Learning.', 'armGroupLabels': ['Experimental educational intervention']}, {'name': 'Standard educational intervention', 'type': 'BEHAVIORAL', 'description': 'Educational intervention on the didactics of biology (4-day-course) not containing elements of Evidence-based Medicine, Good Scientific Practice or Problem-based learning.', 'armGroupLabels': ['Standard educational intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '57068', 'city': 'Siegen', 'country': 'Germany', 'facility': 'University of Siegen, Section of biology and und their didactics', 'geoPoint': {'lat': 50.87481, 'lon': 8.02431}}], 'overallOfficials': [{'name': 'Reinhard Strametz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'EbM Working Group, Institute for General Practice, Faculty of Medicine, Goethe University, Frankfurt/Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Goethe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, EbM Working Group, Institute for General Practice, Faculty of Medicine', 'investigatorFullName': 'Reinhard Strametz', 'investigatorAffiliation': 'Goethe University'}}}}