Ignite Creation Date:
2025-12-26 @ 10:37 AM
Ignite Modification Date:
2026-02-02 @ 11:09 AM
Study NCT ID:
NCT03141528
Status:
COMPLETED
Last Update Posted:
2020-01-13
First Post:
2017-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Self-learning vs Instructor-led Learning in BLS
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tinaheidipedersen@yahoo.dk', 'phone': '+4522125797', 'title': 'Dr. Tina Pedersen', 'organization': 'Inselspital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2 Hours', 'description': 'No Adverse Event possible. The Study were only performed on Manikins.', 'eventGroups': [{'id': 'EG000', 'title': 'Instructor-led Learning', 'description': 'This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)\n\nInstructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)', 'otherNumAtRisk': 122, 'deathsNumAtRisk': 122, 'otherNumAffected': 0, 'seriousNumAtRisk': 122, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Self-learning', 'description': 'This group will Train alone without supervision and without communicating with the other participants.\n\nSelf-learning: Training without supervision', 'otherNumAtRisk': 118, 'deathsNumAtRisk': 188, 'otherNumAffected': 0, 'seriousNumAtRisk': 118, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Correct Compressions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Instructor-led Learning', 'description': 'This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)\n\nInstructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)'}, {'id': 'OG001', 'title': 'Self-learning', 'description': 'This group will Train alone without supervision and without communicating with the other participants.\n\nSelf-learning: Training without supervision'}], 'classes': [{'title': 'Teaching', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '83'}, {'value': '42', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '81'}]}]}, {'title': 'Follow - up', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '59'}, {'value': '47', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '78'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'after first BLS course and 3 months later', 'description': 'The percentage of correct compressions obtained from the printed report from the Laerdal Skill Reporter.', 'unitOfMeasure': 'percentage of correct compressions', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Assessment of the Participants BLS Competences After Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Instructor-led Learning', 'description': 'This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)\n\nInstructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)'}, {'id': 'OG001', 'title': 'Self-learning', 'description': 'This group will Train alone without supervision and without communicating with the other participants.\n\nSelf-learning: Training without supervision'}], 'classes': [{'title': 'Teaching', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000', 'lowerLimit': '61', 'upperLimit': '81'}, {'value': '68', 'groupId': 'OG001', 'lowerLimit': '56', 'upperLimit': '77'}]}]}, {'title': 'Follow-up', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000', 'lowerLimit': '56', 'upperLimit': '81'}, {'value': '65', 'groupId': 'OG001', 'lowerLimit': '54', 'upperLimit': '77'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'after first BLS course and 3 months later', 'description': "Assessment of the participant's BLS competence by the study team after test.\n\nRated on a Visual Analogue Scale from 0-100mm, where 0mm = completely incompetent, no idea what to do, and 100mm = totally competent, cannot be done better.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Self-assessment of the Participants BLS Competences Before Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Instructor-led Learning', 'description': 'This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)\n\nInstructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)'}, {'id': 'OG001', 'title': 'Self-learning', 'description': 'This group will Train alone without supervision and without communicating with the other participants.\n\nSelf-learning: Training without supervision'}], 'classes': [{'title': 'Teaching', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000', 'lowerLimit': '63', 'upperLimit': '77'}, {'value': '70', 'groupId': 'OG001', 'lowerLimit': '63', 'upperLimit': '80'}]}]}, {'title': 'Follow-up', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000', 'lowerLimit': '49', 'upperLimit': '70'}, {'value': '59', 'groupId': 'OG001', 'lowerLimit': '49', 'upperLimit': '68'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'before first BLS course and 3 months later', 'description': 'The participants assessment of their own BLS competences. Rated on a Visual Analogue Scale from 0-100mm, where 0mm = completely incompetent, no idea what to do, and 100mm = totally competent, cannot be done better.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Assessment of the Teaching Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Instructor-led Learning', 'description': 'This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)\n\nInstructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)'}, {'id': 'OG001', 'title': 'Self-learning', 'description': 'This group will Train alone without supervision and without communicating with the other participants.\n\nSelf-learning: Training without supervision'}], 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000', 'lowerLimit': '70', 'upperLimit': '90'}, {'value': '75', 'groupId': 'OG001', 'lowerLimit': '62', 'upperLimit': '84'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'after first BLS course', 'description': 'The participants assessment of the teaching method. Rated on a Visual Analogue Scale from 0-100mm, where 0mm = completely inefficient, and 100mm = totally efficient, nothing can be done better."', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Ventilation Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Instructor-led Learning', 'description': 'This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)\n\nInstructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)'}, {'id': 'OG001', 'title': 'Self-learning', 'description': 'This group will Train alone without supervision and without communicating with the other participants.\n\nSelf-learning: Training without supervision'}], 'classes': [{'title': 'Teaching', 'categories': [{'measurements': [{'value': '790', 'groupId': 'OG000', 'lowerLimit': '640', 'upperLimit': '1010'}, {'value': '810', 'groupId': 'OG001', 'lowerLimit': '620', 'upperLimit': '1150'}]}]}, {'title': 'Follow-up', 'categories': [{'measurements': [{'value': '615', 'groupId': 'OG000', 'lowerLimit': '530', 'upperLimit': '770'}, {'value': '660', 'groupId': 'OG001', 'lowerLimit': '570', 'upperLimit': '800'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'after first BLS course and 3 months later', 'description': 'Ventilation volume from the printed report from the Laerdal Skill Reporter (LSR)', 'unitOfMeasure': 'ml', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Ventilations Per Minute', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Instructor-led Learning', 'description': 'This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)\n\nInstructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)'}, {'id': 'OG001', 'title': 'Self-learning', 'description': 'This group will Train alone without supervision and without communicating with the other participants.\n\nSelf-learning: Training without supervision'}], 'classes': [{'title': 'Teaching', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '3'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '3'}]}]}, {'title': 'Follow-up', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'after first BLS course and 3 months later', 'description': 'Number of ventilations per minute from the printed report from the Laerdal Skill Reporter (LSR)', 'unitOfMeasure': '(ventilations/min)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Correct Ventilations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Instructor-led Learning', 'description': 'This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)\n\nInstructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)'}, {'id': 'OG001', 'title': 'Self-learning', 'description': 'This group will Train alone without supervision and without communicating with the other participants.\n\nSelf-learning: Training without supervision'}], 'classes': [{'title': 'Teaching', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '50'}, {'value': '22', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '50'}]}]}, {'title': 'Follow-up', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '71'}, {'value': '41', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '70'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'after first BLS course and 3 months later', 'description': 'Percentage of correct ventilations from the printed report from the Laerdal Skill Reporter (LSR)', 'unitOfMeasure': 'percentage of corrent ventilations', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Using Correct Ratio of Compressions:Ventilations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Instructor-led Learning', 'description': 'This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)\n\nInstructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)'}, {'id': 'OG001', 'title': 'Self-learning', 'description': 'This group will Train alone without supervision and without communicating with the other participants.\n\nSelf-learning: Training without supervision'}], 'classes': [{'title': 'Teaching', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'after first BLS course and 3 months later', 'description': 'the relationship between ventilations and compressions from the printed report from the Laerdal Skill Reporter (LSR). Ventilations - relationship 30 compressions and 2 ventilations.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Compression Depth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Instructor-led Learning', 'description': 'This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)\n\nInstructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)'}, {'id': 'OG001', 'title': 'Self-learning', 'description': 'This group will Train alone without supervision and without communicating with the other participants.\n\nSelf-learning: Training without supervision'}], 'classes': [{'title': 'Teaching', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000', 'lowerLimit': '44', 'upperLimit': '57'}, {'value': '52', 'groupId': 'OG001', 'lowerLimit': '45', 'upperLimit': '57'}]}]}, {'title': 'Follow-up', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000', 'lowerLimit': '42', 'upperLimit': '56'}, {'value': '53', 'groupId': 'OG001', 'lowerLimit': '46', 'upperLimit': '58'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'after first BLS course and 3 months later', 'description': 'Compression depth from the printed report from the Laerdal Skill Reporter (LSR)', 'unitOfMeasure': 'mm', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Compressions Per Minute', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Instructor-led Learning', 'description': 'This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)\n\nInstructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)'}, {'id': 'OG001', 'title': 'Self-learning', 'description': 'This group will Train alone without supervision and without communicating with the other participants.\n\nSelf-learning: Training without supervision'}], 'classes': [{'title': 'Teaching', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000', 'lowerLimit': '46', 'upperLimit': '58'}, {'value': '51', 'groupId': 'OG001', 'lowerLimit': '44', 'upperLimit': '57'}]}]}, {'title': 'Follow-up', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000', 'lowerLimit': '53', 'upperLimit': '64'}, {'value': '59', 'groupId': 'OG001', 'lowerLimit': '51', 'upperLimit': '63'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'after first BLS course and 3 months later', 'description': 'Number of compressions per minute from the Laerdal Skill Reporter (LSR)', 'unitOfMeasure': 'compressions per minute', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Compression Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Instructor-led Learning', 'description': 'This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)\n\nInstructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)'}, {'id': 'OG001', 'title': 'Self-learning', 'description': 'This group will Train alone without supervision and without communicating with the other participants.\n\nSelf-learning: Training without supervision'}], 'classes': [{'title': 'Teaching', 'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000', 'lowerLimit': '105', 'upperLimit': '118'}, {'value': '111', 'groupId': 'OG001', 'lowerLimit': '103', 'upperLimit': '116'}]}]}, {'title': 'Follow - up', 'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000', 'lowerLimit': '104', 'upperLimit': '121'}, {'value': '114', 'groupId': 'OG001', 'lowerLimit': '103', 'upperLimit': '122'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'after first BLS course and 3 months later', 'description': 'Compression frequency from the Laerdal Skill Reporter (LSR). Compressions per minute ventilation break included.', 'unitOfMeasure': 'compressions per minute', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Compressions Too Shallow', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Instructor-led Learning', 'description': 'This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)\n\nInstructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)'}, {'id': 'OG001', 'title': 'Self-learning', 'description': 'This group will Train alone without supervision and without communicating with the other participants.\n\nSelf-learning: Training without supervision'}], 'classes': [{'title': 'Teaching', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '82'}, {'value': '24', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '76'}]}]}, {'title': 'Follow-up', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '87'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '66'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'after first BLS course and 3 months later', 'description': 'Total percentage of Compressions too shallow from the Laerdal Skill Reporter (LSR)', 'unitOfMeasure': 'percentage of Compressions too shallow', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'False Hand Placement During Compressions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Instructor-led Learning', 'description': 'This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)\n\nInstructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)'}, {'id': 'OG001', 'title': 'Self-learning', 'description': 'This group will Train alone without supervision and without communicating with the other participants.\n\nSelf-learning: Training without supervision'}], 'classes': [{'title': 'Teaching', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '20'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '34'}]}]}, {'title': 'Follow-up', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '0.', 'upperLimit': '41'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '96'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'after first BLS course and 3 months later', 'description': 'False hand placement during compressions.', 'unitOfMeasure': 'percentage of False hand placement durin', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incomplete Decompression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Instructor-led Learning', 'description': 'This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)\n\nInstructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)'}, {'id': 'OG001', 'title': 'Self-learning', 'description': 'This group will Train alone without supervision and without communicating with the other participants.\n\nSelf-learning: Training without supervision'}], 'classes': [{'title': 'Teaching', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0.3'}]}]}, {'title': 'Follow - up', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'after first BLS course and 3 months later', 'description': 'Incomplete decompression from the Laerdal Skill Reporter (LSR)', 'unitOfMeasure': 'percentage of Incomplete decompression', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time From Start of Test Till Call for Help', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Instructor-led Learning', 'description': 'This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)\n\nInstructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)'}, {'id': 'OG001', 'title': 'Self-learning', 'description': 'This group will Train alone without supervision and without communicating with the other participants.\n\nSelf-learning: Training without supervision'}], 'classes': [{'title': 'Teaching', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '16'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '18'}]}]}, {'title': 'Follow-up', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '16'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '15'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'after first BLS course and 3 months later', 'description': 'Time measured from the beginning of the test until the participant calls for help.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time From Start of Test Till First Compression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Instructor-led Learning', 'description': 'This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)\n\nInstructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)'}, {'id': 'OG001', 'title': 'Self-learning', 'description': 'This group will Train alone without supervision and without communicating with the other participants.\n\nSelf-learning: Training without supervision'}], 'classes': [{'title': 'Teaching', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000', 'lowerLimit': '27', 'upperLimit': '46'}, {'value': '35', 'groupId': 'OG001', 'lowerLimit': '26', 'upperLimit': '46'}]}]}, {'title': 'Follow-up', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000', 'lowerLimit': '23', 'upperLimit': '35'}, {'value': '25', 'groupId': 'OG001', 'lowerLimit': '21', 'upperLimit': '32'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'after first BLS course and 3 months later', 'description': 'Time measured from the beginning of the test until the participant makes the first compression.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time From Start of Test Till First Ventilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Instructor-led Learning', 'description': 'This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)\n\nInstructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)'}, {'id': 'OG001', 'title': 'Self-learning', 'description': 'This group will Train alone without supervision and without communicating with the other participants.\n\nSelf-learning: Training without supervision'}], 'classes': [{'title': 'Teaching', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000', 'lowerLimit': '56', 'upperLimit': '112'}, {'value': '64', 'groupId': 'OG001', 'lowerLimit': '55', 'upperLimit': '92'}]}]}, {'title': 'Follow-up', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000', 'lowerLimit': '56', 'upperLimit': '106'}, {'value': '63', 'groupId': 'OG001', 'lowerLimit': '45', 'upperLimit': '97'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'after first BLS course and 3 months later', 'description': 'Time measured from the beginning of the test until the participant makes the first ventilation.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time From Start of Test Till First Shock', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Instructor-led Learning', 'description': 'This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)\n\nInstructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)'}, {'id': 'OG001', 'title': 'Self-learning', 'description': 'This group will Train alone without supervision and without communicating with the other participants.\n\nSelf-learning: Training without supervision'}], 'classes': [{'title': 'Teaching', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '82', 'upperLimit': '120'}, {'value': '118', 'groupId': 'OG001', 'lowerLimit': '95', 'upperLimit': '145'}]}]}, {'title': 'Follow-up', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000', 'lowerLimit': '73', 'upperLimit': '102'}, {'value': '88', 'groupId': 'OG001', 'lowerLimit': '75', 'upperLimit': '107'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'after first BLS course and 3 months later', 'description': 'Time measured from the beginning of the test until the participant gives the first shock.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Instructor-led Learning', 'description': 'This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)\n\nInstructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)'}, {'id': 'FG001', 'title': 'Self-learning', 'description': 'This group will Train alone without supervision and without communicating with the other participants.\n\nSelf-learning: Training without supervision'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '118'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '77'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '41'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '240', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Instructor-led Learning', 'description': 'This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)\n\nInstructor-led learning: Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)'}, {'id': 'BG001', 'title': 'Self-learning', 'description': 'This group will Train alone without supervision and without communicating with the other participants.\n\nSelf-learning: Training without supervision'}, {'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': '122', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '240', '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': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '22'}, {'value': '21', 'groupId': 'BG001', 'lowerLimit': '20', 'upperLimit': '22'}, {'value': '21', 'groupId': 'BG002', 'lowerLimit': '20', 'upperLimit': '22'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '99', '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': '122', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '240', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Switzerland', 'categories': [{'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '240', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-01-08', 'size': 806638, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-03-27T02:17', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-07', 'studyFirstSubmitDate': '2017-02-09', 'resultsFirstSubmitDate': '2018-11-19', 'studyFirstSubmitQcDate': '2017-05-02', 'lastUpdatePostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-07', 'studyFirstPostDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Correct Compressions', 'timeFrame': 'after first BLS course and 3 months later', 'description': 'The percentage of correct compressions obtained from the printed report from the Laerdal Skill Reporter.'}], 'secondaryOutcomes': [{'measure': 'Assessment of the Participants BLS Competences After Test', 'timeFrame': 'after first BLS course and 3 months later', 'description': "Assessment of the participant's BLS competence by the study team after test.\n\nRated on a Visual Analogue Scale from 0-100mm, where 0mm = completely incompetent, no idea what to do, and 100mm = totally competent, cannot be done better."}, {'measure': 'Self-assessment of the Participants BLS Competences Before Test', 'timeFrame': 'before first BLS course and 3 months later', 'description': 'The participants assessment of their own BLS competences. Rated on a Visual Analogue Scale from 0-100mm, where 0mm = completely incompetent, no idea what to do, and 100mm = totally competent, cannot be done better.'}, {'measure': 'Assessment of the Teaching Method', 'timeFrame': 'after first BLS course', 'description': 'The participants assessment of the teaching method. Rated on a Visual Analogue Scale from 0-100mm, where 0mm = completely inefficient, and 100mm = totally efficient, nothing can be done better."'}, {'measure': 'Average Ventilation Volume', 'timeFrame': 'after first BLS course and 3 months later', 'description': 'Ventilation volume from the printed report from the Laerdal Skill Reporter (LSR)'}, {'measure': 'Number of Ventilations Per Minute', 'timeFrame': 'after first BLS course and 3 months later', 'description': 'Number of ventilations per minute from the printed report from the Laerdal Skill Reporter (LSR)'}, {'measure': 'Percentage of Correct Ventilations', 'timeFrame': 'after first BLS course and 3 months later', 'description': 'Percentage of correct ventilations from the printed report from the Laerdal Skill Reporter (LSR)'}, {'measure': 'Number of Participants Using Correct Ratio of Compressions:Ventilations', 'timeFrame': 'after first BLS course and 3 months later', 'description': 'the relationship between ventilations and compressions from the printed report from the Laerdal Skill Reporter (LSR). Ventilations - relationship 30 compressions and 2 ventilations.'}, {'measure': 'Compression Depth', 'timeFrame': 'after first BLS course and 3 months later', 'description': 'Compression depth from the printed report from the Laerdal Skill Reporter (LSR)'}, {'measure': 'Number of Compressions Per Minute', 'timeFrame': 'after first BLS course and 3 months later', 'description': 'Number of compressions per minute from the Laerdal Skill Reporter (LSR)'}, {'measure': 'Compression Frequency', 'timeFrame': 'after first BLS course and 3 months later', 'description': 'Compression frequency from the Laerdal Skill Reporter (LSR). Compressions per minute ventilation break included.'}, {'measure': 'Compressions Too Shallow', 'timeFrame': 'after first BLS course and 3 months later', 'description': 'Total percentage of Compressions too shallow from the Laerdal Skill Reporter (LSR)'}, {'measure': 'False Hand Placement During Compressions', 'timeFrame': 'after first BLS course and 3 months later', 'description': 'False hand placement during compressions.'}, {'measure': 'Incomplete Decompression', 'timeFrame': 'after first BLS course and 3 months later', 'description': 'Incomplete decompression from the Laerdal Skill Reporter (LSR)'}, {'measure': 'Time From Start of Test Till Call for Help', 'timeFrame': 'after first BLS course and 3 months later', 'description': 'Time measured from the beginning of the test until the participant calls for help.'}, {'measure': 'Time From Start of Test Till First Compression', 'timeFrame': 'after first BLS course and 3 months later', 'description': 'Time measured from the beginning of the test until the participant makes the first compression.'}, {'measure': 'Time From Start of Test Till First Ventilation', 'timeFrame': 'after first BLS course and 3 months later', 'description': 'Time measured from the beginning of the test until the participant makes the first ventilation.'}, {'measure': 'Time From Start of Test Till First Shock', 'timeFrame': 'after first BLS course and 3 months later', 'description': 'Time measured from the beginning of the test until the participant gives the first shock.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Self-learning', 'Instructor-led learning', 'Long-term retention'], 'conditions': ['Basic Life Support']}, 'descriptionModule': {'briefSummary': 'This study investigates whether there is a difference in the BLS skills in first year medical students directly after training and three months later, when randomly assigned to self-learning versus instructor-led training courses.', 'detailedDescription': 'This is a randomized controlled trial investigating whether self-learning versus instructor-led learning results in the same BLS skills in first year medical students directly after training and three months later.\n\nWhen participants attend the "Erweiterte Erste Hilfe für Studierende der Humanmedizin" they will receive a short introduction about the study. The investigators will invite all first year students to participate in the study. As the study is voluntarily, participants need to sign a written informed consent. After that, the investigators will randomize the students to either group A or Group B. Group A will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching) and group B will train without supervision. The participants in group B will not be allowed to communicate with each other during the training and they will be prevented from watching each other. The training will take about 30 minutes for each group. Directly after the training each group will be tested and the printed report form from the Laerdal Skill Reporter will be obtained for each participant. In the test the students will perform CPR in a simulated scenario as a first responder. The scenario is: "A male person has collapsed at the railway station." The participant should start CPR as learned in the training. During the CPR a departmental research fellow will observe the study participants and record BLS/AED actions on a scoring sheet.\n\nThe investigators will record three cycles of two minutes CPR (with five times 30:2 compression : ventilation intervals, as recommended by the current international resuscitation guidelines). During the three cycles an AED will be delivered and the study participant has to apply the AED and deliver a shock - after three cycles the study terminates.\n\nAfter the BLS/AED competence testing, both groups will continue the rest of their first aid course together and the first part of the study ends. Three months later, the investigators will repeat the same scenario over the same time interval and record the same parameters. At the end of the second testing, a short feedback will be provided on the BLS/AED competence and further practice will be provided to the students to improve their CPR competence. From this point forward no further data will be collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First year medical students at the University of Bern participating in the course "Erweiterte Erste Hilfe für Studierende der Humanmedizin" with written informed consent.\n\nExclusion Criteria:\n\n* Students with professional BLS-experience, unable to perform BLS, or missing informed consent will be excluded.'}, 'identificationModule': {'nctId': 'NCT03141528', 'briefTitle': 'Self-learning vs Instructor-led Learning in BLS', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'Self-learning Versus Instructor-led Learning in Basic Life Support Training - A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Req-2016-00071'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Instructor-led learning', 'description': 'This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)', 'interventionNames': ['Other: Instructor-led learning']}, {'type': 'EXPERIMENTAL', 'label': 'Self-learning', 'description': 'This group will Train alone without supervision and without communicating with the other participants.', 'interventionNames': ['Other: Self-learning']}], 'interventions': [{'name': 'Self-learning', 'type': 'OTHER', 'description': 'Training without supervision', 'armGroupLabels': ['Self-learning']}, {'name': 'Instructor-led learning', 'type': 'OTHER', 'description': 'Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)', 'armGroupLabels': ['Instructor-led learning']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'University Hospital Inselspital', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Robert Greif, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Bern Inselspital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Bern', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}