Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2025-12-30 @ 5:36 PM
Study NCT ID:
NCT00954161
Status:
COMPLETED
Last Update Posted:
2011-05-03
First Post:
2009-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bystander Helping Behaviour for Myocardial Infarction Following First Aid Training
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006266', 'term': 'Health Education'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D000099060', 'term': 'Adherence Interventions'}, {'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-02', 'studyFirstSubmitDate': '2009-08-06', 'studyFirstSubmitQcDate': '2009-08-06', 'lastUpdatePostDateStruct': {'date': '2011-05-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delay time for seeking help during deception experiment', 'timeFrame': 'within 4 weeks after the control or intervention training', 'description': 'Time to seeking help was measured between the simulated patient grabbing the heart and the study participant opening the door to get help.'}], 'secondaryOutcomes': [{'measure': 'Rate of helping during deception experiment', 'timeFrame': 'within 4 weeks after control or intervention training', 'description': 'This refers to the number of participants that assessed the victim, or asked for help, or provided direct help to the victim during the test.'}, {'measure': 'First aid self efficacy belief', 'timeFrame': 'within 15 minutes after experimental or control intervention', 'description': 'scores on 6 questions related to helping behaviour barriers with the following structure: " I will do x (action) even if y (barrier)"'}, {'measure': 'Impact of event', 'timeFrame': 'Within 15 minutes after deception experiment', 'description': 'This indicates how shocking the study participants found the simulated emergency situation'}, {'measure': 'State of mood', 'timeFrame': 'Within 15 minutes after deception experiment', 'description': 'Indication of how study participants feel after being told about the deception.'}, {'measure': 'Credibility of deception', 'timeFrame': 'Within 15 minutes after deception', 'description': 'Indication of how credible study participants found the simulated emergency situation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['First aid', 'Helping behaviour', 'Health education', 'Myocardial infarction', 'Emergencies'], 'conditions': ['Acute Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '19157654', 'type': 'BACKGROUND', 'citation': 'Van de Velde S, Heselmans A, Roex A, Vandekerckhove P, Ramaekers D, Aertgeerts B. Effectiveness of nonresuscitative first aid training in laypersons: a systematic review. Ann Emerg Med. 2009 Sep;54(3):447-57, 457.e1-5. doi: 10.1016/j.annemergmed.2008.11.005. Epub 2009 Jan 21.'}, {'pmid': '22562070', 'type': 'DERIVED', 'citation': 'Van de Velde S, Roex A, Vangronsveld K, Niezink L, Van Praet K, Heselmans A, Donceel P, Vandekerckhove P, Ramaekers D, Aertgeerts B. Can training improve laypersons helping behaviour in first aid? A randomised controlled deception trial. Emerg Med J. 2013 Apr;30(4):292-7. doi: 10.1136/emermed-2012-201128. Epub 2012 May 5.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to measure the effect of an innovative training programme on the help seeking behaviour and helping rates of bystanders in medical emergencies.', 'detailedDescription': 'A systematic review on the effects of first aid training concluded that training must also include ways to overcome obstacles to bystander intervention. This could lead to better help and higher helping rates in medical emergencies.\n\nThe objective of this paper is to measure the effect of an innovative training programme on the help seeking behaviour and helping rates of bystanders in medical emergencies. We chose to test the helping behaviour for acute myocardial infarction because it is an important cause of mortality and invalidity. While the victim is urgently in need of help, delay in seeking professional help is an important problem.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Course participants that are 18 years or older\n\nExclusion Criteria:\n\n* Course participants that are younger than 18 years\n* Health care students\n* Health care professionals'}, 'identificationModule': {'nctId': 'NCT00954161', 'briefTitle': 'Bystander Helping Behaviour for Myocardial Infarction Following First Aid Training', 'organization': {'class': 'OTHER', 'fullName': 'KU Leuven'}, 'officialTitle': 'Bystander Helping Behaviour for Acute Myocardial Infarction Following a First Aid Training Programme That Draws Attention to the Barriers to Providing Help - Protocol for a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'S51742'}, 'secondaryIdInfos': [{'id': 'S51742, ML5859, B32220096701', 'type': 'OTHER', 'domain': 'Commissie Medische Ethiek UZ Gasthuisberg'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'first aid and helping behaviour', 'description': 'The helping behaviour training is given after 24 hours first aid training and aims to sensitise participants towards a helping reaction and teach participants how to deal with barriers to helping', 'interventionNames': ['Other: Helping behaviour curriculum']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'first aid only', 'description': 'This group receives training in first aid only without training in helping behaviour.', 'interventionNames': ['Other: First aid only curriculum']}], 'interventions': [{'name': 'Helping behaviour curriculum', 'type': 'OTHER', 'description': 'The objective of the helping behaviour curriculum is to sensitise participants to develop a helping reaction, and to teach participants how to deal with barriers to helping. The helping behaviour curriculum is being taught in 2hours.', 'armGroupLabels': ['first aid and helping behaviour']}, {'name': 'First aid only curriculum', 'type': 'OTHER', 'description': 'Two hours training on first aid for alcohol and drug incidents', 'armGroupLabels': ['first aid only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2800', 'city': 'Mechelen', 'country': 'Belgium', 'facility': 'Belgian Red Cross-Flanders', 'geoPoint': {'lat': 51.02574, 'lon': 4.47762}}], 'overallOfficials': [{'name': 'Bert Aertgeerts', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Academic Centre for General Practice, Catholic University Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KU Leuven', 'class': 'OTHER'}, 'collaborators': [{'name': 'Belgian Red Cross', 'class': 'OTHER'}, {'name': 'University Ghent', 'class': 'OTHER'}, {'name': 'Laerdal Medical', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Bert Aertgeerts', 'oldOrganization': 'Academic Centre for General Practice'}}}}