Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2025-12-28 @ 3:36 AM
Study NCT ID:
NCT07095595
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-28
First Post:
2025-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Education-based Patient Safety on Nursing Leaders' and Educators' Perceptions of Patient Safety Culture in Saudi Arabia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This a quasi-experimental with intervention or control groups.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 102}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-01-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-21', 'studyFirstSubmitDate': '2025-07-23', 'studyFirstSubmitQcDate': '2025-07-23', 'lastUpdatePostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Perceptions of Patient Safety Culture Among Nursing Leaders and Educators From Baseline to 3 Months Post-Intervention.', 'timeFrame': 'Baseline and 3 Months Post-Intervention', 'description': "This outcome measure will assess the change in nursing leaders' and educators' perceptions of patient safety culture before the educational intervention (baseline) and three months afterward. The assessment will be conducted using a validated patient safety culture survey instrument."}], 'secondaryOutcomes': [{'measure': 'Immediate Post-Intervention Feedback on Educational Program Effectiveness', 'timeFrame': 'Immediately Post-Intervention', 'description': "This outcome measure will assess participants' perceptions of the educational program's effectiveness immediately after completion. The questionnaire was developed and reviewed by WHO patient safety education team. Also, seven experts assessed the content validity using content validity index. The modifications were made in accordance with the suggestions provided by the jury."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Patient safety culture', 'safety culture', 'education', 'nursing'], 'conditions': ['Healthy Participants']}, 'descriptionModule': {'briefSummary': 'This interventional study is aimed to examine the effect of an education-based patient safety on the perceptions of patient safety culture among nursing leaders and educators in one of the medical cities in Saudi Arabia. Participants will complete a perception survey before and three months after the educational program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nNursing directors, deputy of nursing directors, head nurses, assistant head nurses, rotating shift nursing supervisors, nursing educators will be included in the current study.\n\nExclusion Criteria:\n\nBedside nurses were excluded from the study'}, 'identificationModule': {'nctId': 'NCT07095595', 'briefTitle': "The Effect of Education-based Patient Safety on Nursing Leaders' and Educators' Perceptions of Patient Safety Culture in Saudi Arabia", 'organization': {'class': 'OTHER', 'fullName': 'Universiti Putra Malaysia'}, 'officialTitle': "The Effect of Education-based Patient Safety on Nursing Leaders' and Educators' Perceptions of Patient Safety Culture in Saudi Arabia", 'orgStudyIdInfo': {'id': 'ALAHMADI-IRP-25-064'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional Group', 'description': 'Interventional Group will receive a 5 day patient safety educational program', 'interventionNames': ['Other: Patient Safety Educational Program based on WHO Curriculum']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Control group with no intervention'}], 'interventions': [{'name': 'Patient Safety Educational Program based on WHO Curriculum', 'type': 'OTHER', 'description': 'This study involves a structured 5-day educational program targeting nursing leaders and educators, with each day comprising 2 to 3 hours of instructional sessions. it will will include a combination of lectures, videos, group discussions, and case study analyses to enhance engagement and practical learning', 'armGroupLabels': ['Interventional Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42319', 'city': 'Madinah', 'state': 'Medina Region', 'country': 'Saudi Arabia', 'facility': 'Medina Health Cluster', 'geoPoint': {'lat': 24.46861, 'lon': 39.61417}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Individual participant data (IPD) will be shared, including participants' survey responses related to patient safety culture and program feedback. All personal identifiers (participants names, study city and name of institution) will not be shared.\n\nBased on IRP research team is not allowed to disclose personally identifiable data of the to any other party."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiti Putra Malaysia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD student - Department of Nursing - Faculty of Medicine and Health Sciences', 'investigatorFullName': 'Ashwaq Talal Alahmadi', 'investigatorAffiliation': 'Universiti Putra Malaysia'}}}}