Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-27 @ 1:44 PM
Study NCT ID:
NCT04864756
Status:
UNKNOWN
Last Update Posted:
2021-04-29
First Post:
2021-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Simulation Based Learning and Academic Performance in Medical School
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No masking applicable'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Before and after comparison'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-25', 'studyFirstSubmitDate': '2021-04-17', 'studyFirstSubmitQcDate': '2021-04-25', 'lastUpdatePostDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Academic performance', 'timeFrame': '36 months after introduction of simulation based techniques', 'description': 'Change in CGPA scores Before and after introduction of simulation based techniques'}], 'secondaryOutcomes': [{'measure': 'Retention of academic faculty', 'timeFrame': '2 years after initiation of simulation based learning', 'description': 'Percentage of faculty retained in the training program'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Academic Performance']}, 'descriptionModule': {'briefSummary': 'The investigators will use a multi-methods approach, including both qualitative and quantitative methods. In the quantitative methodology, the investigators will use a before and after approach to compare medical student grades/scores before and after the integration of Simulation based learning (SBL) in the curriculum. The hypothesis is that SBL will generally increase knowledge and skills and hence improve the scores from the theory (MCQ) and clinical (OSCE) examinations conducted outside simulated settings in the clinical departments.', 'detailedDescription': 'Simulation faculty development will be measured by retention and engagement in simulation sessions. The investigators will use survival analysis methods and plot Kaplan Meier curves to calculate probability of retention and determine the factors that are associated with retention as derived from participant in-depth interviews and departmental meetings. A faculty member will be considered disengaged if they do not participate in simulation session for at least 6 months post training, despite reminders and opportunities for participation. Reasons for potential disengagement will be explored qualitatively.\n\nIn the qualitative approach, the investigators will conduct in-depth key informant interviews (45 minutes to 1 hour) with administrators at the institution, namely Academic Registrar, Deans of Medical School, heads of Departments and Simulation facilitators (the post-graduate student trainers). The investigators will conduct focus group discussions (1 hour) with postgraduate simulation facilitators, the medical and nursing students before, during and after their enrollment in SBL. The interviews and focus group discussions will be audio-recorded and transcribed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medical (Medicine and Nursing) students\n* Enrolled in the Faculty of medicine at Mbarara University of Science and Technology\n* Currently attending clinical years\n\nExclusion Criteria:\n\n* Non clinical student years in the Faculty of Medicine\n* not enrolled in Medicine or Nursing programs at Mbarara University of Science and Technology'}, 'identificationModule': {'nctId': 'NCT04864756', 'briefTitle': 'Simulation Based Learning and Academic Performance in Medical School', 'organization': {'class': 'OTHER', 'fullName': 'Mbarara University of Science and Technology'}, 'officialTitle': 'Medical Simulation Teaching and Academic Performance Among Medical Students at a Medical School in Rural Uganda', 'orgStudyIdInfo': {'id': '2020/MUST/SIM-II'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Before/After', 'description': 'Grade performance before and after introduction of simulation based learning', 'interventionNames': ['Other: Simulation based learning']}], 'interventions': [{'name': 'Simulation based learning', 'type': 'OTHER', 'description': 'Learning for medical students using simulation based techniques including scenario execution as a complement to conventional teaching methodologies', 'armGroupLabels': ['Before/After']}]}, 'contactsLocationsModule': {'locations': [{'zip': '256', 'city': 'Mbarara', 'status': 'RECRUITING', 'country': 'Uganda', 'contacts': [{'name': 'Data Santorino, MD', 'role': 'CONTACT', 'email': 'sdata@must.ac.ug', 'phone': '0774500571'}], 'facility': 'Mbarara University of Science and Technology', 'geoPoint': {'lat': -0.60467, 'lon': 30.64851}}], 'centralContacts': [{'name': 'Data Santorino, MD', 'role': 'CONTACT', 'email': 'sdata@must.ac.ug', 'phone': '0774500571'}, {'name': 'Francis Bajunirwe, MD, PhD', 'role': 'CONTACT', 'email': 'fbaj@must.ac.ug', 'phone': '0772 576 396'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'ipdSharing': 'YES', 'description': "Data will share with permission from the research ethics committee and Mbarara University Academic Registrar's authorization"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mbarara University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Calgary', 'class': 'OTHER'}, {'name': "Alberta Children's Hospital Research Institute", 'class': 'OTHER'}, {'name': 'The ELMA Foundation', 'class': 'OTHER'}, {'name': 'Laerdal Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}