Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2026-02-20 @ 1:13 AM
Study NCT ID:
NCT06693804
Status:
COMPLETED
Last Update Posted:
2025-07-17
First Post:
2024-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ophthalmoscope and Otoscope Training in Family Medicine Residency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019721', 'term': 'Ophthalmoscopes'}], 'ancestors': [{'id': 'D019719', 'term': 'Diagnostic Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-15', 'studyFirstSubmitDate': '2024-11-10', 'studyFirstSubmitQcDate': '2024-11-15', 'lastUpdatePostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resident Confidence Survey (Pre)', 'timeFrame': '0 months', 'description': "Survey will measure Resident's confidence. Survey will consist of 10 questions based on a Likert scale where a value of 1=not at all confident and 5=very confident. A score of 10 would indicate no confidence and a score of 50 would indicate complete confidence."}, {'measure': 'Resident Knowledge Survey (Post)', 'timeFrame': '3 months', 'description': "Survey will measure Resident's knowledge. Survey will consist of 12 questions based on a Likert scale where a value of 1=not at all confident and 5=very confident. A score of 12 would indicate absence of knowledge and a score of 60 would indicate complete knowledge."}, {'measure': 'Visual Identification of Images (Pre)', 'timeFrame': '0 months', 'description': 'Residents will be shown 34 images of the eye and ear which they will need to correctly identify. Correct identification of 0 images = lowest score. Correct identification of 34 images = highest score.'}, {'measure': 'Visual Identification of Images (Post)', 'timeFrame': '3 months', 'description': 'Residents will be shown 34 images of the eye and ear which they will need to correctly identify. Correct identification of 0 images = lowest score. Correct identification of 34 images = highest score.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['otoscope', 'ophthalmoscope', 'visual arts', 'resident', 'device', 'instrument', 'eye exam', 'ear exam', 'family medicine', 'education'], 'conditions': ['Resident Education', 'Digital Technology']}, 'descriptionModule': {'briefSummary': "The purpose of the study is to evaluate the effectiveness of Welch Allyn PanOptic Plus Ophthalmoscope with smartphone adaptor, and assess residents' opinions on acceptability and usability of the device and curriculum vs the conventional non-digital device used in current clinical practice."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Resident in Penn States Family and Community Medicine Department\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT06693804', 'briefTitle': 'Ophthalmoscope and Otoscope Training in Family Medicine Residency', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Quality Improvement Initiative: Using Digital Ophthalmoscope and Otoscope Visual Arts Observation Training to Improve Family Medicine Residency Training', 'orgStudyIdInfo': {'id': 'STUDY00020873'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Welch Allyn PanOptic iExaminer Digital Imaging Kit', 'description': 'Novel digital instrument to visualize eyes and ears in clinical practice', 'interventionNames': ['Other: Digital Otoscope and Ophthalmoscope']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional non-digital instrument used in current clinical training and standard practice', 'description': 'Standard practice', 'interventionNames': ['Other: Conventional otoscope and ophthalmoscope']}], 'interventions': [{'name': 'Digital Otoscope and Ophthalmoscope', 'type': 'OTHER', 'description': 'The otoscope and ophthalmoscope will be used by residents to examine the eyes and ears under illumination and magnification during physical examinations.', 'armGroupLabels': ['Welch Allyn PanOptic iExaminer Digital Imaging Kit']}, {'name': 'Conventional otoscope and ophthalmoscope', 'type': 'OTHER', 'description': 'The otoscope and ophthalmoscope will be used by residents to examine the eyes and ears under illumination during physical examinations.', 'armGroupLabels': ['Conventional non-digital instrument used in current clinical training and standard practice']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17112', 'city': 'Harrisburg', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Milton S. Hershey Medical Center', 'geoPoint': {'lat': 40.2737, 'lon': -76.88442}}, {'zip': '19605', 'city': 'Reading', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Health St. Joseph Medical Center', 'geoPoint': {'lat': 40.33565, 'lon': -75.92687}}], 'overallOfficials': [{'name': 'Joseph Wiedemer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Pennsylvania State University, College of Medicine, Family and Community Medicine Department'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Associate Professor, Program Director of Penn State Health Family and Community Medicine Residency at Mount Nittany Medical Center', 'investigatorFullName': 'Joseph Wiedemer', 'investigatorAffiliation': 'Penn State Health Milton S Hershey Medical Center'}}}}