Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-24 @ 4:04 PM
Study NCT ID:
NCT06857266
Status:
COMPLETED
Last Update Posted:
2025-03-04
First Post:
2024-11-27
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Remote Video-Delivered Suturing Education with Smartphones
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-26', 'studyFirstSubmitDate': '2024-11-27', 'studyFirstSubmitQcDate': '2025-02-26', 'lastUpdatePostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in University of Bergen suturing skills Assessment Tool score', 'timeFrame': 'At 48 hours after feedback given to student'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgical Skill Training']}, 'descriptionModule': {'briefSummary': 'Medical students were randomized to receive live video- or recorded video-delivered feedback on suturing skills. A non-randomized control group received in-person feedback. Pre- and post-feedback recordings of suturing were evaluated to see if the students receiving video-delivered feedback improved just as much as students receiving in-person feedback.', 'detailedDescription': 'Medical students were randomized to receive live video- or recorded video-delivered feedback on suturing skills. A non-randomized control group received in-person feedback. Pre- and post-feedback recordings of suturing were evaluated by blinded assessors to determine improvement using the University of Bergen suturing skills assessment tool (UBAT) and Objective Structured Assessment of Technical Skills (OSATS). Study arms were compared to the control arm in a non-inferiority analysis. Participants and feedback providers completed questionnaires regarding feasibility and utility of their feedback modality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* First and second year students at McMaster University's Degroote School of Medicine\n\nExclusion Criteria:\n\n* None"}, 'identificationModule': {'nctId': 'NCT06857266', 'acronym': 'REVISE', 'briefTitle': 'Remote Video-Delivered Suturing Education with Smartphones', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'Remote Video-Delivered Suturing Education with Smartphones: a Non-Inferiority Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '11324'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'In-person teaching', 'interventionNames': ['Other: In-Person Feedback']}, {'type': 'EXPERIMENTAL', 'label': 'Live Video Feedback', 'interventionNames': ['Other: Live Video-delivered Feedback']}, {'type': 'EXPERIMENTAL', 'label': 'Recorded Video Feedback', 'interventionNames': ['Other: Recorded Video-delivered feedback']}], 'interventions': [{'name': 'Live Video-delivered Feedback', 'type': 'OTHER', 'description': 'Feedback is delivered to students through a live video call.', 'armGroupLabels': ['Live Video Feedback']}, {'name': 'In-Person Feedback', 'type': 'OTHER', 'description': 'In-Person Feedback', 'armGroupLabels': ['In-person teaching']}, {'name': 'Recorded Video-delivered feedback', 'type': 'OTHER', 'description': "Feedback is delivered via a personalized recorded video made by the instructor specific to the student's performance.", 'armGroupLabels': ['Recorded Video Feedback']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8S 4L8', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'McMaster University', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}