Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT07292532
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Learning Cardiopulmonary Resuscitation in the School Setting: RCP-KNOW Project.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 550}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2025-12-05', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Anthropometry: weight', 'timeFrame': 'Immediately post-intervention', 'description': 'Corporal weight measured in Kilograms'}, {'measure': 'Anthropometry: height', 'timeFrame': 'Immediately post-intervention', 'description': 'Height measured in centimeters'}, {'measure': 'Anthropometry: BMI', 'timeFrame': 'Immediately post-intervention', 'description': 'BMI calculated by the follow form: weight (kg)/height\\*2 (m)'}, {'measure': 'Anthropometry: corporal composition', 'timeFrame': 'Immediately post-intervention', 'description': 'Percentage of fat mass and percentage of lean mass. Measured by bioimpedance scale Tanita MC-780MA N'}, {'measure': 'Cardiorespiratory fitness', 'timeFrame': 'Immediately post-intervention', 'description': 'Cardiorespiratory fitness measured through Course Navette Test'}, {'measure': 'Muscular strength', 'timeFrame': 'Immediately post-intervention', 'description': 'Muscular strength measured through dynamometry and horizontal jump with feet together'}, {'measure': 'socioeconomic variables', 'timeFrame': 'immediately post-intervention', 'description': 'socioeconomic variables such as: the academic level and economic level of the father and mother'}], 'primaryOutcomes': [{'measure': 'Theoretical CPR Knowledge', 'timeFrame': 'On the same day as the intervention, before (pre-intervention) and immediately after this (post-intervention) and follow-up (8 months later)', 'description': 'Theoretical CPR Knowledge measured by a questionnaire.'}, {'measure': 'CPR Practice Skills', 'timeFrame': 'On the same day as the intervention immediately after this (post-intervention) and follow-up (8 months later)', 'description': 'CPR Practice Skills measured with a checklist'}, {'measure': 'Quality of CRP', 'timeFrame': 'On the same day as the intervention, immediately after this (post-intervention) and follow-up (8 months later)', 'description': 'Quality of CPR measured by Little-Anne Mannequin.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Participants', 'Knowledge Acquisition', 'Cardiopulmonary Resuscitation (CPR)', 'Children', 'School']}, 'descriptionModule': {'briefSummary': 'Title: Out-of-hospital cardiorespiratory arrest and learning cardiopulmonary resuscitation in the school setting: evidence synthesis. CPR-KNOW PROYECT.\n\nBackground: The high incidence, associated morbidity and mortality, and the great individual, social and economic impact of out-of-hospital cardiorespiratory arrest (OHCA) make it a priority for all health systems worldwide. To increase the rates of potential first responders who act appropriately, applying basic life support (BLS) measures in the OHCA, the European Resuscitation Council includes among its latest recommendations the training of all school children through the "Kids Save Lives" initiative.\n\nObjectives: to determine, through a randomized clinical trial, the effectiveness of two training strategies for increasing theoretical and practical knowledge of BLS in schoolchildren and adolescents.\n\nMethodology: To evaluate the effectiveness of two (Cardiopulmonary Resuscitation) CPR teaching interventions in improving the following outcome variables: theoretical knowledge and practical skills, CPR quality; as well as its relationship with the anthropometric, sociodemographic and physical condition variables of the schoolers.\n\n* Intervention group 1 (IG1): a 2-hour theoretical-practical session on the BLS sequence taught by a Nursing professional performing the practice with a mannequin. Instructor/school ratio: 1/25 for the theoretical session and a school/mannequin ratio: 2-3/1.\n* Intervention group 2 (IG2): a session with short video (approximately 5-10 min) and other teaching resources (puzzle), without practice on a mannequin. Video/school ratio: 1/25 and a school/teaching resource (puzzle) ratio: 1/1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Schools that have at least one complete year of 1st, 2nd, 3rd, 4th, 5th and 6th year of Primary Education, in which the School Council has given its approval for their participation.\n* Schoolchildren who wish to participate must:\n* Belong to the courses from 1st to 6th grade of Primary Education\n* Understand the written and spoken Spanish language\n* Not have any physical, mental or cognitive pathology that prevents them from participating in the project.\n* Their father/mother or guardian must have signed the informed consent to be able to participate in the project.'}, 'identificationModule': {'nctId': 'NCT07292532', 'acronym': 'RCP-KNOW', 'briefTitle': 'Learning Cardiopulmonary Resuscitation in the School Setting: RCP-KNOW Project.', 'organization': {'class': 'OTHER', 'fullName': 'University of Castilla-La Mancha'}, 'officialTitle': 'Out-of-hospital Cardiorespiratory Arrest and Learning Cardiopulmonary Resuscitation in the School Setting: Evidence Synthesis', 'orgStudyIdInfo': {'id': 'SBPLY/23/180225/000060'}, 'secondaryIdInfos': [{'id': 'SBPLY/23/180225/000060', 'type': 'OTHER_GRANT', 'domain': 'Junta de Comunidades de Castilla-La Mancha and FEDER Funds'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional CPR teaching', 'description': 'A 2-hour session of conventional theoretical-practical training with a mannequin, about the BLS sequence to follow in a CPR-OHCA, adapted to the age of schoolchildren, and taught by nursing professionals. Theoretical-practical training on the operation of the semi-automatic defibrillator.', 'interventionNames': ['Other: Cardiopulmonary Resuscitation Teaching Intervention in Children']}, {'type': 'EXPERIMENTAL', 'label': 'Video and teaching material', 'description': 'A short video (5min) in which the basic sequence of BLS to follow in a CPR-OHCA is explained, accompanied by a puzzle adapted to the age of the children in which the BLS sequence is reflected, but without practice on a mannequin. Theoretical training included in the video about the operation of the semi-automatic defibrillator.', 'interventionNames': ['Other: Cardiopulmonary Resuscitation Teaching Intervention in Children']}], 'interventions': [{'name': 'Cardiopulmonary Resuscitation Teaching Intervention in Children', 'type': 'OTHER', 'description': 'Comparation of two type of Cardiopulmonary Resuscitation Teaching Intervention in Children: traditional teaching vs video with puzzle.', 'armGroupLabels': ['Traditional CPR teaching', 'Video and teaching material']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16002', 'city': 'Cuenca', 'state': 'Cuenca', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Diana P Pozuelo Carrascosa, Dr', 'role': 'CONTACT', 'email': 'dianap.pozuelo@uclm.es', 'phone': '+34655412253'}, {'role': 'CONTACT', 'email': 'dianap.pozuelo@uclm.es'}], 'facility': 'CEIP Ciudad Encantada', 'geoPoint': {'lat': 40.06667, 'lon': -2.13333}}, {'zip': '16004', 'city': 'Cuenca', 'state': 'Cuenca', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Diana P Pozuelo Carrascosa, Dr', 'role': 'CONTACT', 'email': 'dianap.pozuelo@uclm.es', 'phone': '+34655412253'}, {'role': 'CONTACT', 'email': 'dianap.pozuelo@uclm.es'}], 'facility': 'CEIP Isaac Albeniz', 'geoPoint': {'lat': 40.06667, 'lon': -2.13333}}], 'centralContacts': [{'name': 'Diana P Pozuelo-Carrascosa, Dr.', 'role': 'CONTACT', 'email': 'dianap.pozuelo@uclm.es', 'phone': '926053755'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Castilla-La Mancha', 'class': 'OTHER'}, 'collaborators': [{'name': 'ConsejerÃa de Educación, Cultura y Deportes de Castilla-La Mancha', 'class': 'UNKNOWN'}, {'name': 'European Regional Development Fund', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Profesora Titular de Universidad', 'investigatorFullName': 'Diana Patricia Pozuelo Carrascosa', 'investigatorAffiliation': 'University of Castilla-La Mancha'}}}}