Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:37 PM
Study NCT ID:
NCT07409233
Status:
COMPLETED
Last Update Posted:
2026-02-13
First Post:
2026-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SOPHIE: Standardized Online Patient for Healthcare Interaction Education
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcome assessors rating simulated patient encounters were blinded to participant group assignment.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were randomly assigned to either an AI based simulation training program or a control educational condition and completed simulated patient encounters for assessment.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-08', 'studyFirstSubmitDate': '2026-02-08', 'studyFirstSubmitQcDate': '2026-02-08', 'lastUpdatePostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Communication Performance Improvement Score in Simulated Patient Encounters', 'timeFrame': 'Immediately following completion of the assigned educational condition', 'description': 'Communication performance was assessed during simulated patient encounters using standardized rating instruments completed by trained standardized patients or expert reviewers. The mean communication performance score improvement was calculated for each participant and used to describe communication skills following the assigned educational condition.'}], 'secondaryOutcomes': [{'measure': 'Immediately following completion of the assigned educational condition', 'timeFrame': 'Immediately following simulated patient encounter', 'description': 'A structured communication skills rating tool was used to evaluate specific communication behaviors demonstrated during simulated patient encounters. The total communication skill rating score was calculated for each participant.'}, {'measure': 'Mean Empathy Rating Score in Simulated Encounters', 'timeFrame': 'Immediately following simulated patient encounter', 'description': 'Empathy was assessed during simulated patient encounters using standardized empathy rating scales completed by trained evaluators. The mean empathy rating score was calculated for each participant.'}, {'measure': 'Mean Participant Self Reported Confidence Score', 'timeFrame': 'Immediately following completion of the educational intervention', 'description': 'Participant confidence in communication skills was assessed using a self reported questionnaire administered after completion of the educational intervention. Mean confidence scores were calculated across questionnaire items.'}, {'measure': 'Mean Usability Score of the Educational Intervention', 'timeFrame': 'Immediately following completion of the educational intervention', 'description': 'Usability of the assigned educational intervention was assessed using a standardized usability questionnaire. Mean usability scores were calculated to describe participant experience with the intervention.'}, {'measure': 'Total Participant Satisfaction Score', 'timeFrame': 'Immediately following completion of the educational intervention', 'description': 'Participant satisfaction with the educational experience was assessed using a structured questionnaire. The total satisfaction score was calculated for each participant.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Medical education', 'Artificial intelligence'], 'conditions': ['Clinician Communication Skills Training']}, 'descriptionModule': {'briefSummary': 'This study evaluated an online simulation based educational program designed to improve clinician communication skills. Participants were clinicians and clinical trainees who completed simulated patient interactions and communication assessments as part of an educational evaluation. Participants were randomly assigned to receive either an AI based simulation training program or standard educational materials. Communication performance was assessed using standardized rating methods in simulated scenarios. The study did not involve patients or health related clinical interventions.', 'detailedDescription': 'This study was a randomized educational evaluation of an AI based online simulation training program designed to support the development of clinician communication skills. Participants included clinicians and clinical trainees who routinely engage in patient communication as part of their professional roles.\n\nParticipants were randomly assigned to either the SOPHIE simulation training program or a control educational condition consisting of standard instructional materials. All participants completed simulated patient encounters that were evaluated by trained standardized patients and expert raters using structured communication assessment tools.\n\nThe primary outcomes of interest focused on communication skill performance in simulated scenarios as well as participant feedback on the educational experience. The study did not involve real patients clinical care or health related interventions and was conducted as an educational research project.\n\nThe study was approved by the institutional review board prior to participant enrollment. It was registered retrospectively in ClinicalTrials.gov at the request of a journal during manuscript preparation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants are clinicians or clinical trainees involved in patient communication as part of their professional or educational role\n* Age 18 years or older\n* Ability to participate in online educational activities and simulated patient encounters\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Prior participation in this study\n* Inability to complete the required online activities or simulated encounters\n* Any condition that in the opinion of the investigator would interfere with participation or data quality'}, 'identificationModule': {'nctId': 'NCT07409233', 'acronym': 'SOPHIE', 'briefTitle': 'SOPHIE: Standardized Online Patient for Healthcare Interaction Education', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'SOPHIE: Standardized Online Patient for Healthcare Interaction Education', 'orgStudyIdInfo': {'id': 'STUDY00006689'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SOPHIE Simulation Training', 'description': 'Participants assigned to this arm completed an AI based online simulation training program designed to support the development of clinician communication skills. The training involved interactive virtual patient scenarios focused on communication practice in simulated clinical encounters.', 'interventionNames': ['Behavioral: SOPHIE Simulation Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Educational Materials', 'description': 'Participants assigned to this arm completed standard educational materials related to clinician communication skills. These materials included instructional content such as videos and readings and did not involve interactive simulation training.', 'interventionNames': ['Behavioral: Control Educational Materials']}], 'interventions': [{'name': 'SOPHIE Simulation Training', 'type': 'BEHAVIORAL', 'description': 'An online simulation based educational training program that uses interactive virtual patient scenarios to support the development of clinician communication skills in simulated clinical encounters.', 'armGroupLabels': ['SOPHIE Simulation Training']}, {'name': 'Control Educational Materials', 'type': 'BEHAVIORAL', 'description': 'Standard educational content related to clinician communication skills delivered through instructional materials such as videos and readings without interactive simulation.', 'armGroupLabels': ['Control Educational Materials']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14620', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'Ehsan Hoque, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}]}, 'ipdSharingStatementModule': {'infoTypes': ['ANALYTIC_CODE'], 'timeFrame': '03/01/2025 - Indefinitely', 'ipdSharing': 'YES', 'description': 'Communication skill ratings of individual participants, as measured by expert standardized patients, will be made fully public. All data will be fully anonymized.', 'accessCriteria': 'The data is publicly available on an online repository.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'collaborators': [{'name': 'James P. Wilmot Cancer Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Computer Science', 'investigatorFullName': 'Ehsan Hoque', 'investigatorAffiliation': 'University of Rochester'}}}}