Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2026-03-03 @ 2:30 AM
Study NCT ID:
NCT03312218
Status:
COMPLETED
Last Update Posted:
2021-02-12
First Post:
2017-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Study Guide Cluster Randomized Control Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'roland.grad@mcgill.ca', 'phone': '514-947-3718', 'title': 'Dr. Roland Grad', 'organization': 'McGill University'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were not monitored/assessed.', 'description': 'Adverse Events were not monitored/assessed. The meaning of "0" Total Number of Participants at Risk is stated because adverse events were not monitored.', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': 'Intervention site residents will receive alerts through an app to adaptively reinforce the learning of clinical content based on cases and test questions (spaced education).\n\nSpaced educational intervention: A spaced educational intervention will be provided to participants', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Residents in the control group will receive the same app providing identical clinical cases and test questions-on-demand, but with alerts inactivated (no spaced education).', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Scores on the Certification Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}, {'value': '241', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention site residents will receive alerts through an app to adaptively reinforce the learning of clinical content based on cases and test questions (spaced education).\n\nSpaced educational intervention: A spaced educational intervention will be provided to participants'}, {'id': 'OG001', 'title': 'Control', 'description': 'Residents in the control group will receive the same app providing identical clinical cases and test questions-on-demand, but with alerts inactivated (no spaced education).'}], 'classes': [{'categories': [{'measurements': [{'value': '73.9', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '73.1', 'spread': '5.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'This is the score on the written component of the examination of the College of Family Physicians of Canada. This refers to the grade/score given to participants on the Short Answer Management Problems (SAMP) section of the exam ranging from 0 to 100. Higher values represent a better outcome. The score minimum observed was 53.9 and max is 84.4 for this study.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': 'Intervention site residents will receive alerts through an app to adaptively reinforce the learning of clinical content based on cases and test questions (spaced education).\n\nSpaced educational intervention: A spaced educational intervention will be provided to participants'}, {'id': 'FG001', 'title': 'Control', 'description': 'Residents in the control group will receive the same app providing identical clinical cases and test questions-on-demand, but with alerts inactivated (no spaced education).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '335'}, {'groupId': 'FG001', 'numSubjects': '299'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '281'}, {'groupId': 'FG001', 'numSubjects': '241'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '58'}]}], 'dropWithdraws': [{'type': 'Never signed in to access the app', 'reasons': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '58'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'BG000'}, {'value': '299', 'groupId': 'BG001'}, {'value': '634', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': 'Intervention site residents will receive alerts through an app to adaptively reinforce the learning of clinical content based on cases and test questions (spaced education).\n\nSpaced educational intervention: A spaced educational intervention will be provided to participants'}, {'id': 'BG001', 'title': 'Control', 'description': 'Residents in the control group will receive the same app providing identical clinical cases and test questions-on-demand, but with alerts inactivated (no spaced education).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '335', 'groupId': 'BG000'}, {'value': '299', 'groupId': 'BG001'}, {'value': '634', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Disclosed gender (included 6 undisclosed in male intervention count)', 'categories': [{'title': 'Female', 'measurements': [{'value': '229', 'groupId': 'BG000'}, {'value': '210', 'groupId': 'BG001'}, {'value': '439', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '195', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '335', 'groupId': 'BG000'}, {'value': '299', 'groupId': 'BG001'}, {'value': '634', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '335', 'groupId': 'BG000'}, {'value': '299', 'groupId': 'BG001'}, {'value': '634', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Smart phone', 'classes': [{'categories': [{'measurements': [{'value': '234', 'groupId': 'BG000'}, {'value': '213', 'groupId': 'BG001'}, {'value': '447', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'International Medical Graduate', 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Graduate degree', 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-01', 'size': 218035, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-01-25T11:44', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 634}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-25', 'studyFirstSubmitDate': '2017-10-06', 'resultsFirstSubmitDate': '2021-01-05', 'studyFirstSubmitQcDate': '2017-10-11', 'lastUpdatePostDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-25', 'studyFirstPostDateStruct': {'date': '2017-10-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Scores on the Certification Examination', 'timeFrame': '2 years', 'description': 'This is the score on the written component of the examination of the College of Family Physicians of Canada. This refers to the grade/score given to participants on the Short Answer Management Problems (SAMP) section of the exam ranging from 0 to 100. Higher values represent a better outcome. The score minimum observed was 53.9 and max is 84.4 for this study.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Behavior']}, 'descriptionModule': {'briefSummary': 'Spaced education is a promising theory-driven strategy to improve clinical competence. Our aim is to improve the clinical competence of Family Physicians, an outcome associated with the quality of care delivered to Canadians.', 'detailedDescription': 'Research Question: Among family medicine residents, does enhanced feedback through an app providing alerts and test questions (spaced education), compared to the same app without alerts and enhanced feedback (no spaced education), improve competence as measured by the certification examination? In building this proposal for a definitive trial, the investigators have support from coast to coast. In addition to key clinician educators, the team includes knowledge users from the organization responsible for the certification examination in Family Medicine, methodologists and experienced researchers who study how mobile apps can promote engagement with clinical information. The team has the right blend of expertise in medical education and cluster randomized trials.\n\nApproach and Methods: The investigators will follow an organizational participatory research approach, and propose a cluster randomized controlled trial. Setting: All incoming family medicine residents in Canada will be eligible to participate. Intervention site residents will receive alerts through an app to adaptively reinforce the learning of clinical content based on cases and test questions (spaced education). Residents in the control group will receive the same app providing identical clinical cases and test questions-on-demand, but with alerts inactivated (no spaced education). The primary outcome will be scores on the certification examination. This routinely collected data will be provided to the team by the College of Family Physicians of Canada.\n\nExpected Results and Conclusion: Spaced education will improve examination scores. This will inform educational practice by providing evidence to optimize the training of residents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* incoming family medicine residents in Canada (July 2017)\n\nExclusion Criteria:\n\n* not a family medicine resident\n* did not start residency on July 1, 2017'}, 'identificationModule': {'nctId': 'NCT03312218', 'briefTitle': 'The Study Guide Cluster Randomized Control Trial', 'organization': {'class': 'OTHER', 'fullName': 'Jewish General Hospital'}, 'officialTitle': 'Can an App Improve the Examination Scores of Family Medicine Residents? A Cluster Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'The Study Guide Trial 2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Intervention site residents will receive alerts through an app to adaptively reinforce the learning of clinical content based on cases and test questions (spaced education).', 'interventionNames': ['Behavioral: Spaced educational intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Residents in the control group will receive the same app providing identical clinical cases and test questions-on-demand, but with alerts inactivated (no spaced education).'}], 'interventions': [{'name': 'Spaced educational intervention', 'type': 'BEHAVIORAL', 'description': 'A spaced educational intervention will be provided to participants', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jewish General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Western University, Canada', 'class': 'OTHER'}, {'name': 'College of Family Physicians of Canada', 'class': 'OTHER'}, {'name': 'Memorial University of Newfoundland', 'class': 'OTHER'}, {'name': 'Université de Montréal', 'class': 'OTHER'}, {'name': 'University of Ottawa', 'class': 'OTHER'}, {'name': "Queen's University, Kingston, Ontario", 'class': 'OTHER'}, {'name': 'University of Toronto', 'class': 'OTHER'}, {'name': 'McMaster University', 'class': 'OTHER'}, {'name': 'University of British Columbia', 'class': 'OTHER'}, {'name': 'University of Alberta', 'class': 'OTHER'}, {'name': 'Université de Sherbrooke', 'class': 'OTHER'}, {'name': 'University of Calgary', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, McGill University Dept. of Family Medicine, Director of the Clinician Scholar Program', 'investigatorFullName': 'Roland Grad', 'investigatorAffiliation': 'Jewish General Hospital'}}}}