Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-03-18 @ 9:25 AM
Study NCT ID:
NCT07186569
Status:
COMPLETED
Last Update Posted:
2025-09-22
First Post:
2025-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Digital Interactive and Face-to-Face Peer Support on Medical Students' Clinical Skill Performance, Reflection Skills, and Retention of Clinical Skills
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-09-16', 'size': 79803, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-09-16T09:19', 'hasProtocol': True}, {'date': '2025-09-16', 'size': 52233, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-09-16T09:27', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'OSCE assessors were blinded to group assignment. Students were instructed not to disclose allocation, and assessment materials contained no arm-specific cues.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Individually randomized, parallel-group, three-arm educational trial. Participants are allocated in a 1:1:1 ratio to: (A) Digital Interactive Peer Support, (B) Face-to-Face Peer Support, or (C) Standard Training (control). Interventions are delivered during the clinical skills course; there is no masking. Outcomes are assessed immediately post-intervention, with a follow-up assessment to evaluate retention at a predefined interval.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2025-09-16', 'studyFirstSubmitQcDate': '2025-09-16', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Structured Clinical Examination (OSCE) Total Score', 'timeFrame': 'Immediately post-intervention', 'description': 'Assessed using an OSCE comprising standardized stations scored with validated checklists. Total score range \\[min-max\\] points; higher scores indicate better clinical skill performance. No results or conclusions are included here.'}], 'secondaryOutcomes': [{'measure': 'Reflection Skills Scale Total Score', 'timeFrame': 'Immediately post-intervention', 'description': 'Assessed using a validated reflection skills instrument \\[write the full, unabbreviated scale name\\]. Scores range \\[min-max\\] points; higher scores indicate stronger reflection skills. No results or conclusions are included here.'}, {'measure': 'Retention of Clinical Skills (OSCE Total Score)', 'timeFrame': '8 weeks post-intervention', 'description': 'Follow-up OSCE total score at the specified time point using the same scoring rubric as the immediate OSCE. Higher scores indicate better performance. No results or conclusions are included here.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Peer support', 'Digital learning', 'Face-to-face learning', 'OSCE', 'Reflection', 'Skill retention', 'Medical students', 'Clinical skills', 'Randomized Controlled trial'], 'conditions': ['Clinical Skills Education', 'Peer Support Interventions', 'Medical Students', 'Objective Structured Clinical Examination', 'Clinical Competence', 'Education, Medical, Undergraduate', 'Students, Medical', 'Social Support']}, 'descriptionModule': {'briefSummary': 'This randomized educational trial compares two peer-support approaches for teaching clinical skills to medical students. Participants are randomly assigned to one of three groups: (1) Digital interactive peer support delivered through an online platform with structured tasks and feedback; (2) Face-to-face peer support delivered in small group sessions with guided practice; or (3) Standard training according to the usual curriculum. All participants complete an objective structured clinical examination (OSCE) immediately after training, and complete a validated questionnaire to assess reflection skills. A follow-up OSCE is administered to evaluate retention of clinical skills. There is no drug or device involved and risks are minimal.', 'detailedDescription': 'Design: Interventional, randomized, parallel-assignment trial with three arms (digital interactive peer support, face-to-face peer support, standard training). Allocation is approximately equal across arms; masking is not used.\n\nSetting and participants: Medical students who meet eligibility criteria at a university clinical skills program. Participants provide informed consent prior to enrollment.\n\nInterventions:\n\n* Digital interactive peer support - structured peer learning via an online platform (e.g., modules, quizzes, discussion, and peer feedback).\n* Face-to-face peer support - structured in-person peer sessions with guided practice, observation, and formative feedback.\n* Standard training - the usual curriculum without additional structured peer-support.\n\nAssessments and timing: A baseline checklist may be collected as part of routine instruction. Primary endpoint is the OSCE total score obtained immediately post-intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Enrolled medical students \\[1st year\\]\n* Age ≥18 years and able to provide informed consent\n* Sufficient proficiency in the language of instruction\n* Access to the digital platform (for the digital arm)\n* Availability for post-intervention and follow-up assessments\n\nExclusion Criteria:\n\n* Prior formal certification or extensive training in the targeted clinical skills\n* Inability to attend scheduled peer-support sessions (digital or face-to-face)\n* Conditions that would prevent participation in OSCE/assessment procedures'}, 'identificationModule': {'nctId': 'NCT07186569', 'briefTitle': "Effect of Digital Interactive and Face-to-Face Peer Support on Medical Students' Clinical Skill Performance, Reflection Skills, and Retention of Clinical Skills", 'organization': {'class': 'OTHER', 'fullName': 'Çanakkale Onsekiz Mart University'}, 'officialTitle': "The Effect of Digital Interactive and Face-to-Face Peer Support on Medical Students' Clinical Skill Performance, Reflection Skills, and Retention of Clinical Skills", 'orgStudyIdInfo': {'id': '2023-YÖNP-0719'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Digital Interactive Peer Support', 'description': 'Structured peer support via an online platform (modules, quizzes, discussion, and peer feedback).', 'interventionNames': ['Behavioral: Digital Interactive Peer Support']}, {'type': 'EXPERIMENTAL', 'label': 'Face-to-Face Peer Support', 'description': 'Structured in-person peer sessions with guided practice, observation, and formative feedback (fece-to-face)', 'interventionNames': ['Behavioral: Face-to-Face Peer Support']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Training (Usual Curriculum)', 'description': 'Usual curriculum-based clinical skills training without additional structured peer support.', 'interventionNames': ['Behavioral: Standard Training (Control)']}], 'interventions': [{'name': 'Digital Interactive Peer Support', 'type': 'BEHAVIORAL', 'description': 'Individually randomized participants receive digital interactive peer support.', 'armGroupLabels': ['Digital Interactive Peer Support']}, {'name': 'Face-to-Face Peer Support', 'type': 'BEHAVIORAL', 'description': 'Individually randomized participants receive face-to-face peer support.', 'armGroupLabels': ['Face-to-Face Peer Support']}, {'name': 'Standard Training (Control)', 'type': 'BEHAVIORAL', 'description': 'Standard Training (Usual Curriculum)-Participants receive usual curriculum-based training without structured peer support.', 'armGroupLabels': ['Standard Training (Usual Curriculum)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17020', 'city': 'Çanakkale', 'state': 'Center', 'country': 'Turkey (Türkiye)', 'facility': 'Faculty of Medicine', 'geoPoint': {'lat': 40.15552, 'lon': 26.41271}}], 'overallOfficials': [{'name': 'Remzi Yavas Kincal, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Çanakkale Onsekiz Mart University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan to share individual participant data. This study involves educational records and student assessment data; consent did not include external data sharing. Aggregate (de-identified) results will be available in publications.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Çanakkale Onsekiz Mart University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mustafa Onur Yurdal', 'investigatorAffiliation': 'Çanakkale Onsekiz Mart University'}}}}