Ignite Creation Date:
2025-12-24 @ 1:27 PM
Ignite Modification Date:
2026-02-25 @ 11:47 PM
Study NCT ID:
NCT02059395
Status:
COMPLETED
Last Update Posted:
2018-01-30
First Post:
2014-02-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mastery Learning Versus Time-based Education: Skill Acquisition and Retention of Basic Life Support in Laypeople
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sboet@toh.on.ca', 'phone': '6137985555', 'title': 'Dr. Sylvain Boet', 'phoneExt': '14775', 'organization': 'The Ottawa Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Baseline to 4 months', 'eventGroups': [{'id': 'EG000', 'title': 'Time Based', 'description': 'Participants follow the traditional Canadian Heart and Stroke Foundation Heartsaver Course\n\nTime based learning: Participants follow the traditional Canadian Heart and Stroke Foundation Heartsaver Course according to the official course layout', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Mastery Based', 'description': 'Participants do follow the content of the Canadian Heart and Stroke Foundation Heartsaver Course content based on their own pace (timeframe)\n\nMastery based learning: Participants are allowed to follow the course content at their own speed', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Skill Retention Estimated From the Change of AHA Heartsaver Total Score From Immediate Post-test to Retention Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Time Based', 'description': 'Participants follow the traditional Canadian Heart and Stroke Foundation Heartsaver Course\n\nTime based learning: Participants follow the traditional Canadian Heart and Stroke Foundation Heartsaver Course according to the official course layout'}, {'id': 'OG001', 'title': 'Mastery Based', 'description': 'Participants do follow the content of the Canadian Heart and Stroke Foundation Heartsaver Course content based on their own pace (timeframe)\n\nMastery based learning: Participants are allowed to follow the course content at their own speed'}], 'classes': [{'title': 'Immediate post test total score', 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000', 'lowerLimit': '6.125', 'upperLimit': '8.375'}, {'value': '8.0', 'groupId': 'OG001', 'lowerLimit': '7.0', 'upperLimit': '9.0'}]}]}, {'title': 'Retention test total score', 'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000', 'lowerLimit': '5.625', 'upperLimit': '9.2'}, {'value': '7.0', 'groupId': 'OG001', 'lowerLimit': '6.0', 'upperLimit': '8.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 months', 'description': "The official AHA Heartsave adult CPR AED Skill Sheet checklist for single-rescuer BLS was used to capture participants' skills for single-rescuer BLS and defibrillation with an AED. The AHA Heartsaver checklist has 11 action items, participant receives 1 point when an action on the checklist is performed. Therefore, the total score range from 0-11, with higher values represent a better outcome. Immediate post-test and retention test skill performance were evaluated by 2 independent raters. Skill retention was estimated by calculating the change in score from immediate post-test to retention test.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Time Based', 'description': 'Participants follow the traditional Canadian Heart and Stroke Foundation Heartsaver Course\n\nTime based learning: Participants follow the traditional Canadian Heart and Stroke Foundation Heartsaver Course according to the official course layout'}, {'id': 'FG001', 'title': 'Mastery Based', 'description': 'Participants do follow the content of the Canadian Heart and Stroke Foundation Heartsaver Course content based on their own pace (timeframe)\n\nMastery based learning: Participants are allowed to follow the course content at their own speed'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Time Based', 'description': 'Participants follow the traditional Canadian Heart and Stroke Foundation Heartsaver Course\n\nTime based learning: Participants follow the traditional Canadian Heart and Stroke Foundation Heartsaver Course according to the official course layout'}, {'id': 'BG001', 'title': 'Mastery Based', 'description': 'Participants do follow the content of the Canadian Heart and Stroke Foundation Heartsaver Course content based on their own pace (timeframe)\n\nMastery based learning: Participants are allowed to follow the course content at their own speed'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '19.5', 'groupId': 'BG000', 'lowerLimit': '18.0', 'upperLimit': '21.0'}, {'value': '20.0', 'groupId': 'BG001', 'lowerLimit': '18.75', 'upperLimit': '21.0'}, {'value': '19.7', 'groupId': 'BG002', 'lowerLimit': '18.5', 'upperLimit': '21.0'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2015-09-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-05', 'studyFirstSubmitDate': '2014-02-07', 'resultsFirstSubmitDate': '2017-02-01', 'studyFirstSubmitQcDate': '2014-02-10', 'lastUpdatePostDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-05', 'studyFirstPostDateStruct': {'date': '2014-02-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skill Retention Estimated From the Change of AHA Heartsaver Total Score From Immediate Post-test to Retention Test', 'timeFrame': 'Baseline and 4 months', 'description': "The official AHA Heartsave adult CPR AED Skill Sheet checklist for single-rescuer BLS was used to capture participants' skills for single-rescuer BLS and defibrillation with an AED. The AHA Heartsaver checklist has 11 action items, participant receives 1 point when an action on the checklist is performed. Therefore, the total score range from 0-11, with higher values represent a better outcome. Immediate post-test and retention test skill performance were evaluated by 2 independent raters. Skill retention was estimated by calculating the change in score from immediate post-test to retention test."}]}, 'conditionsModule': {'conditions': ['Basic Life Support', 'Cardiac Arrest']}, 'descriptionModule': {'briefSummary': "Background:\n\nIn cardiac arrest survival rates dramatically increase when bystanders are present and initiate Basic Life Support (BLS). However, even though serious efforts have been made, skill retention after a traditional time-based BLS course for laypeople remains suboptimal. In contrast, a mastery learning-based educational approach was shown to be efficacious and might be promising even for laypersons. Therefore the investigators aim to evaluate the impact of a mastery learning-based BLS course on skills retention of BLS in laypeople.\n\nMethods:\n\nForty laypeople without previous BLS experiences will be randomized into the traditional time-based BLS course group (Control - TB group) or mastery learning-based group (Intervention - ML group).\n\nBoth groups will receive BLS training consisting of 6 successive stations including diagnosis of cardiac arrest, chest compression, ventilation, one-rescuer BLS, two-rescuer BLS and AED use. In the ML group, subjects will deliberately practice and receive feedback at each station until a pre-set target level is reached. Subjects will be allowed to proceed to the next station only when they achieve the required target level of performance. In contrast, participants of the TB group will be taught the same 6 stations in two hours, according to standard American Heart Association BLS criteria. All subjects will have an assessment of knowledge and skills immediately after teaching (immediate post-test) and at four months (retention post-test).\n\nImplications:\n\nPrevious research has shown that mastery learning-based education improves learners' procedural skill performance. The investigators study will determine the impact of a mastery learning-based BLS course on skill retention in laypeople."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* University students in Ottawa\n\nExclusion Criteria:\n\n* Students of the Faculty of Medicine\n* Previous Basic Life Support Training Certificate'}, 'identificationModule': {'nctId': 'NCT02059395', 'briefTitle': 'Mastery Learning Versus Time-based Education: Skill Acquisition and Retention of Basic Life Support in Laypeople', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Hospital Research Institute'}, 'orgStudyIdInfo': {'id': 'Mastery of BLS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Time based', 'description': 'Participants follow the traditional Canadian Heart and Stroke Foundation Heartsaver Course', 'interventionNames': ['Other: Time based learning']}, {'type': 'EXPERIMENTAL', 'label': 'Mastery based', 'description': 'Participants do follow the content of the Canadian Heart and Stroke Foundation Heartsaver Course content based on their own pace (timeframe)', 'interventionNames': ['Other: Mastery based learning']}], 'interventions': [{'name': 'Mastery based learning', 'type': 'OTHER', 'description': 'Participants are allowed to follow the course content at their own speed', 'armGroupLabels': ['Mastery based']}, {'name': 'Time based learning', 'type': 'OTHER', 'description': 'Participants follow the traditional Canadian Heart and Stroke Foundation Heartsaver Course according to the official course layout', 'armGroupLabels': ['Time based']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K1Y 4E9', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The University of Ottawa Skills and Simulation Centre', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'Sylvain Boet, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ottawa Hospital Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Hospital Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}