Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-02-25 @ 4:13 AM
Study NCT ID:
NCT03039660
Status:
COMPLETED
Last Update Posted:
2023-01-17
First Post:
2017-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility and Efficacy Study of Student Wellness Online Course for Medical Students
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2019-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-12', 'studyFirstSubmitDate': '2017-01-27', 'studyFirstSubmitQcDate': '2017-01-30', 'lastUpdatePostDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Enrollment numbers per course', 'timeFrame': '2 weeks', 'description': '\\# of participants who enroll / # of participants invited to enroll'}, {'measure': 'Views per video', 'timeFrame': 'Throughout the course (6 weeks)'}, {'measure': 'Number of actively engaged students per course', 'timeFrame': 'Throughout the course (6 weeks)'}], 'secondaryOutcomes': [{'measure': 'Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Related Impairment', 'timeFrame': 'Through study completion (4 months)'}, {'measure': 'PROMIS Sleep Disturbance', 'timeFrame': 'Through study completion (4 months)'}, {'measure': 'PROMIS Depression', 'timeFrame': 'Through study completion (4 months)'}, {'measure': 'Stanford Medical Student Burnout Questionnaire', 'timeFrame': 'Through study completion (4 months)'}]}, 'conditionsModule': {'conditions': ['Student Wellness']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the feasibility and efficacy of online student wellness courses for improving medical student mental health and well-being.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Full-time medical student at a participating medical school\n* Will remain enrolled as full-time medical student throughout duration of study\n\nExclusion Criteria:\n\n* Not a full-time medical student at a participating medical school'}, 'identificationModule': {'nctId': 'NCT03039660', 'briefTitle': 'Feasibility and Efficacy Study of Student Wellness Online Course for Medical Students', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Evidence-Based Online Curriculum to Improve Sleep in Medical Students: A Multisite Trial to Assess Efficacy and Feasibility of RefreshMD', 'orgStudyIdInfo': {'id': 'RefreshMD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RefreshMD', 'description': 'An online course for sleep improvement in medical students', 'interventionNames': ['Behavioral: RefreshMD']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Bond Between Us', 'description': 'An online course covering communication skills and the physician-patient relationship', 'interventionNames': ['Behavioral: Bond Between Us']}], 'interventions': [{'name': 'RefreshMD', 'type': 'BEHAVIORAL', 'description': 'Online Sleep Improvement Course', 'armGroupLabels': ['RefreshMD']}, {'name': 'Bond Between Us', 'type': 'BEHAVIORAL', 'description': 'Online Educational Course', 'armGroupLabels': ['Bond Between Us']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '63130', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University in St Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '08854', 'city': 'Piscataway', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers Robert Wood Johnson', 'geoPoint': {'lat': 40.49927, 'lon': -74.39904}}], 'overallOfficials': [{'name': 'Sara G Cadman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University graduate, Penn Medicine Fellow'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Student', 'investigatorFullName': 'Sara Grace Connolly', 'investigatorAffiliation': 'Stanford University'}}}}