Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-26 @ 1:55 AM
Study NCT ID:
NCT04656405
Status:
UNKNOWN
Last Update Posted:
2021-05-18
First Post:
2020-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Online Real-time CPR Training
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058687', 'term': 'Out-of-Hospital Cardiac Arrest'}], 'ancestors': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-15', 'studyFirstSubmitDate': '2020-11-30', 'studyFirstSubmitQcDate': '2020-11-30', 'lastUpdatePostDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Chest compression depth', 'timeFrame': 'Assessed during 6 minute CPR simulation test', 'description': 'Depth of chest compressions measured in millimeters'}], 'secondaryOutcomes': [{'measure': 'Chest compression rate', 'timeFrame': 'Assessed during 6 minute CPR simulation test', 'description': 'Rate of chest compression per minute'}, {'measure': 'Hand position', 'timeFrame': 'Assessed during 6 minute CPR simulation test', 'description': 'Correct hand position measured by QCPR mannequin'}, {'measure': 'No flow time', 'timeFrame': 'Assessed during 6 minute CPR simulation test', 'description': 'Time with no chest compression after start of chest compression'}, {'measure': 'Time to chest compression', 'timeFrame': 'Assessed during 6 minute CPR simulation test', 'description': 'Time from start of simulation to start of chest compression'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiopulmonary Resuscitation', 'Education', 'Out-Of-Hospital Cardiac Arrest'], 'conditions': ['Cardiopulmonary Resuscitation', 'Education']}, 'referencesModule': {'references': [{'pmid': '29369963', 'type': 'BACKGROUND', 'citation': 'Kim TH, Lee YJ, Lee EJ, Ro YS, Lee K, Lee H, Jang DB, Song KJ, Shin SD, Myklebust H, Birkenes TS. Comparison of Cardiopulmonary Resuscitation Quality Between Standard Versus Telephone-Basic Life Support Training Program in Middle-Aged and Elderly Housewives: A Randomized Simulation Study. Simul Healthc. 2018 Feb;13(1):27-32. doi: 10.1097/SIH.0000000000000286.'}, {'pmid': '32604135', 'type': 'BACKGROUND', 'citation': 'Park GJ, Kong SYJ, Song KJ, Shin SD, Kim TH, Ro YS, Myklebust H, Birkenes TS. The Effectiveness of a New Dispatcher-Assisted Basic Life Support Training Program on Quality in Cardiopulmonary Resuscitation Performance During Training and Willingness to Perform Bystander Cardiopulmonary Resuscitation: A Cluster Randomized Controlled Study. Simul Healthc. 2020 Oct;15(5):318-325. doi: 10.1097/SIH.0000000000000435.'}, {'pmid': '29930020', 'type': 'BACKGROUND', 'citation': 'Cheng A, Nadkarni VM, Mancini MB, Hunt EA, Sinz EH, Merchant RM, Donoghue A, Duff JP, Eppich W, Auerbach M, Bigham BL, Blewer AL, Chan PS, Bhanji F; American Heart Association Education Science Investigators; and on behalf of the American Heart Association Education Science and Programs Committee, Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation; Council on Cardiovascular and Stroke Nursing; and Council on Quality of Care and Outcomes Research. Resuscitation Education Science: Educational Strategies to Improve Outcomes From Cardiac Arrest: A Scientific Statement From the American Heart Association. Circulation. 2018 Aug 7;138(6):e82-e122. doi: 10.1161/CIR.0000000000000583.'}, {'pmid': '28115027', 'type': 'BACKGROUND', 'citation': "Baldi E, Cornara S, Contri E, Epis F, Fina D, Zelaschi B, Dossena C, Fichtner F, Tonani M, Di Maggio M, Zambaiti E, Somaschini A. Real-time visual feedback during training improves laypersons' CPR quality: a randomized controlled manikin study. CJEM. 2017 Nov;19(6):480-487. doi: 10.1017/cem.2016.410. Epub 2017 Jan 24."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness of a new online real-time quality measurement and feedback video-based CPR training program. The study participants will be allocated to three different CPR training programs: online real-time quality measurement and feedback video-based CPR training program, online real-time feedback video-based CPR training without quality measurement program, and conventional CPR training program. After CPR training, each participant will perform a 6 minute CPR simulation test. The investigators will compare the quality of chest compression between the three study groups. The investigators hypothesize that the new online real-time quality measurement and feedback video-based CPR training program is non-inferior to the preexisting conventional CPR training program and is superior to online real-time feedback video-based CPR training without quality measurement.', 'detailedDescription': 'Bystander CPR is important for the survival of out-of-hospital cardiac arrest patients. CPR training for the general public is important to improve the rate and quality of bystander CPR. Preexisting CPR education was conducted under face-to-face contact with instructors and multiple trainees gathering at a training center, but after the coronavirus disease 2019 pandemic, face-to-face training became difficult. To overcome this limitation the investigators have developed a new online real-time quality measurement and feedback video-based CPR training program that uses online video conferencing, Little Anne QCPR mannequin (Laerdal, Stavanger, Norway) and SkillGuide (Laerdal, Stavanger, Norway) device.\n\nThe purpose of this study is to evaluate the effectiveness of a new online real-time quality measurement and feedback video-based CPR training program. To evaluate the effectiveness of the new CPR training program the investigators propose to conduct a randomized clinical trial with three arms: online real-time quality measurement and feedback video-based CPR training program, online real-time feedback video-based CPR training without quality measurement program, and conventional CPR training program. 60 non healthcare provider, healthy adult volunteers will be randomized to each study arm. After CPR training, each participant will perform a 6 minute CPR simulation test. The investigators will measure the depth and rate of chest compression, hand positioning during chest compression, no-flow time and start to chest compression time.\n\nThe primary outcome of the study is mean chest compression depth. Chest compression rate, hand position, total no flow time, and time to chest compression will also be measured. The investigators hypothesize that the new online real-time quality measurement and feedback video-based CPR training program is non-inferior to the preexisting conventional CPR training program and is superior to online real-time feedback video-based CPR training without quality measurement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Volunteers aged 18 years or older\n\nExclusion Criteria:\n\n* Healthcare providers\n* Participants with chronic lung diseases\n* Participants with cardiovascular diseases\n* Participants with visual disabilities\n* Participants with hearing disabilities\n* Participants with musculoskeletal disabilities'}, 'identificationModule': {'nctId': 'NCT04656405', 'briefTitle': 'Efficacy of Online Real-time CPR Training', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Evaluation of Efficacy of Online Real-time Quality Measurement and Feedback Video-based CPR Training Program', 'orgStudyIdInfo': {'id': '30-2020-232'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Online real-time CPR training program', 'description': 'Online real-time quality measurement and feedback video-based CPR training will be provided to participants', 'interventionNames': ['Other: Online real-time quality measurement and feedback video-based CPR training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Online real-time CPR training without quality measurement program', 'description': 'Online real-time feedback video-based CPR training without quality measurement will be provided to participants', 'interventionNames': ['Other: Online real-time feedback video-based CPR training without quality measurement']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Conventional CPR training program', 'description': 'Conventional CPR training will be provided to participants', 'interventionNames': ['Other: Conventional CPR training']}], 'interventions': [{'name': 'Online real-time quality measurement and feedback video-based CPR training', 'type': 'OTHER', 'description': 'Participants in the online real-time quality measurement and feedback video-based CPR training program group will access an online training center with laptop computers provided by the researcher. All education and communication is conducted online. The study instructors shows the study participants an edited version of the CPR training video used in the conventional CPR training program. A Little Anne QCPR mannequin (Laerdal, Stavanger, Norway) and SkillGuide (Laerdal, Stavanger, Norway) are provided so that the participants can use while watching the video and during the following hands-on practice session.\n\nAfter watching the video, hands-on practice will be conducted by the instructor on-line. The instructor will watch each individual participants CPR performance via video conferencing and collect real-time performance data using the QCPR mannequin device. Using this information, the instructor will provide real-time online feedback to participants.', 'armGroupLabels': ['Online real-time CPR training program']}, {'name': 'Online real-time feedback video-based CPR training without quality measurement', 'type': 'OTHER', 'description': 'Participants in the online real-time feedback video-based CPR training without quality measurement program group will access an online training center with laptop computers provided by the researcher. All education and communication is conducted online. When study participants access the online training center, study instructors shows the study participants an edited version of the CPR training video used in the conventional CPR training program. A Little Anne QCPR mannequin (Laerdal, Stavanger, Norway) is provided so that the participants can use while watching the video and during the following hands-on practice session.\n\nAfter watching the video, hands-on practice will be conducted by the instructor on-line. The instructor will watch each individual participants CPR performance via video conferencing. The instructor will provide real-time online feedback to participants.', 'armGroupLabels': ['Online real-time CPR training without quality measurement program']}, {'name': 'Conventional CPR training', 'type': 'OTHER', 'description': 'Participants in the conventional CPR training program group will be provided CPR education with the "Home Education and Resuscitation Outcome Study (HEROS)" program that is currently provided in Seoul, Korea. The HEROS program is a 1-hour training course, consisting of a 30-minute video-based self-instruction training with a mannequin. The program also includes a bystander CPR simulation with a simulated dispatcher using the participants own cell phone. Little Anne QCPR mannequin (Laerdal, Stavanger, Norway) and SkillGuide (Laerdal, Stavanger, Norway) device are provided to measure and give feedback on the participants CPR performance.', 'armGroupLabels': ['Conventional CPR training program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07061', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'STEPHEN GW LEE, MD', 'role': 'CONTACT', 'email': 'LEESTEPHENGYUNGWON@GMAIL.COM', 'phone': '82)-10-5124-8415'}], 'facility': 'Seoul Metropolitan Government-Seoul National University Borame Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'STEPHEN GW LEE, MD', 'role': 'CONTACT', 'email': 'LEESTEPHENGYUNGWON@GMAIL.COM', 'phone': '82)-10-5124-8415'}], 'overallOfficials': [{'name': 'TAE HAN KIM, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'SMG-SNU Boramae Medical Center'}, {'name': 'STEPHEN GW LEE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Tae Han Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}