Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-01-01 @ 6:59 AM
Study NCT ID:
NCT06003504
Status:
COMPLETED
Last Update Posted:
2024-08-26
First Post:
2023-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of First Aid Blended Learning Training on Learning Outcomes and Helping Behaviour of Adult Laypeople in Rwanda
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004630', 'term': 'Emergencies'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a randomised controlled trial in which the allocation is done at the level of the individual participant.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 540}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-03-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-23', 'studyFirstSubmitDate': '2023-08-15', 'studyFirstSubmitQcDate': '2023-08-15', 'lastUpdatePostDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Costs', 'timeFrame': 'Before, immediately after, and 6 months after the first aid trainings', 'description': 'Costs associated with a first aid training, relatively to the gain in knowledge.'}], 'primaryOutcomes': [{'measure': 'First aid knowledge', 'timeFrame': 'Before, immediately after, and 6 months after the first aid trainings', 'description': '20-item multiple choice questionnaire about first aid topics using a numerical scale. Possible scores range from 0 to 20, with higher scores meaning a better outcome.'}], 'secondaryOutcomes': [{'measure': 'First aid skills', 'timeFrame': 'Before, immediately after, and 6 months after the first aid trainings', 'description': '22-item observation checklist about first aid practical skills using a numerical scale. Possible scores range from 0 to 30, with higher scores meaning a better outcome.'}, {'measure': 'First aid self-efficacy', 'timeFrame': 'Before, immediately after, and 6 months after the first aid trainings', 'description': '10-item scenario-based questionnaire using a 5-point Likert scale assessing self-efficacy concerning first aid topics. Possible scores range from 0 to 40, with higher scores meaning a better outcome.'}, {'measure': 'First aid willingness to help', 'timeFrame': 'Before, immediately after, and 6 months after the first aid trainings', 'description': '6-item scenario-based questionnaire using a 5-point Likert scale assessing willingness to help concerning first aid topics. Possible scores range from 0 to 24, with higher scores meaning a better outcome.'}, {'measure': 'Helping behaviour in the past 6 months', 'timeFrame': 'Before and 6 months after the first aid trainings', 'description': 'Structured questionnaire to survey the helping behaviour and to gauge the potential barriers and facilitators.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['First aid', 'Blended learning', 'Laypeople'], 'conditions': ['Emergencies', 'Injuries', 'Illness Physical']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to assess the impact of a first aid training delivered through a blended learning approach on learning outcomes and helping behaviour in adult laypeople in Rwanda.\n\nParticipants will be randomly assigned to either:\n\n* a first aid training with blended learning approach;\n* a first aid training with conventional face-to-face approach;\n* no first aid training.\n\nAll participants will be asked before, immediately after, and 6 months after the first aid trainings to complete\n\n* a questionnaire on first aid-related knowledge, self-efficacy, and willingness to help;\n* a practical test on first aid-related skills.\n\nThe helping behaviour of the participants will be surveyed before and 6 months after the first aid trainings have been completed.\n\nResearchers will compare the effects in learning outcomes and helping behaviour after 6 months between:\n\n* the first aid training with blended learning approach and no first aid training;\n* the first aid training with blended learning approach and first aid training with conventional face-to-face approach.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (≥ 18 years) laypeople\n* Access to a smartphone or tablet, which is able to install and run a mobile application\n\nExclusion Criteria:\n\n* Having attended a first aid training in the past\n* Having an academic or professional background in the (para)medical field'}, 'identificationModule': {'nctId': 'NCT06003504', 'briefTitle': 'The Impact of First Aid Blended Learning Training on Learning Outcomes and Helping Behaviour of Adult Laypeople in Rwanda', 'organization': {'class': 'OTHER', 'fullName': 'Centre for Evidence-Based Practice, Belgium'}, 'officialTitle': 'The Impact of First Aid Training, Delivered Via a Face-to-face or Blended Learning Approach, on Learning Outcomes and Helping Behaviour of Adult Laypeople in Rwanda: a Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'FABL-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'First aid training with blended learning approach', 'description': 'Participants follow a first aid training delivered through a blended learning approach.', 'interventionNames': ['Other: First aid training with blended learning approach']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'First aid training with face-to-face approach', 'description': 'Participants follow a first aid training delivered through a conventional face-to-face approach.', 'interventionNames': ['Other: First aid training with face-to-face approach']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist control', 'description': 'Participants do not receive any training'}], 'interventions': [{'name': 'First aid training with blended learning approach', 'type': 'OTHER', 'otherNames': ['First Aid Blended Learning (FABL)'], 'description': 'The content of the first aid blended learning training is standardised and based on the 2021 edition of the Basic First Aid in Africa manual from the Belgian Red Cross, covering first aid general principles and instructions for:\n\n* emergencies (i.e. choking, unconsciousness with and without normal breathing, chest discomfort and stroke, poisoning, and severe external bleeding);\n* injuries (i.e. skin wounds, burns, and injuries to muscles, joints, limbs, head, neck, and back);\n* illnesses (i.e. fainting, fever, fits, and diarrhoea).\n\nThe training consists of 2 consecutive parts:\n\n1. First aid theory is learned independently in a mobile application followed by an online test to ob-tain an admission ticket for the subsequent in-class training;\n2. First aid skills are practiced during a 1-day in-class training facilitated by a certified first aid instructor of the Rwanda Red Cross.\n\nParticipants get at least 10 days to learn in the mobile application and obtain the admission ticket.', 'armGroupLabels': ['First aid training with blended learning approach']}, {'name': 'First aid training with face-to-face approach', 'type': 'OTHER', 'otherNames': ['Basic First Aid in Africa (BFA)'], 'description': 'The content of the first aid face-to-face training is standardised and based on the 2021 edition of the Basic First Aid in Africa manual from the Belgian Red Cross, covering first aid general principles and instructions for:\n\n* emergencies (i.e. choking, unconsciousness with and without normal breathing, chest discomfort and stroke, poisoning, and severe external bleeding);\n* injuries (i.e. skin wounds, burns, and injuries to muscles, joints, limbs, head, neck, and back);\n* illnesses (i.e. fainting, fever, fits, and diarrhoea).\n\nThe training consists of a 3-days in-class training with lectures and practical exercises on first aid the-ory and skills, facilitated by a certified first aid instructor of the Rwanda Red Cross.', 'armGroupLabels': ['First aid training with face-to-face approach']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kigali', 'country': 'Rwanda', 'facility': 'Rwanda Red Cross', 'geoPoint': {'lat': -1.94995, 'lon': 30.05885}}], 'overallOfficials': [{'name': 'Emmy De Buck, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Evidence-Based Practice, Belgium'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre for Evidence-Based Practice, Belgium', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rwanda Red Cross', 'class': 'UNKNOWN'}, {'name': 'Belgian Red Cross', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}