Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2025-12-28 @ 11:34 AM
Study NCT ID:
NCT06835192
Status:
COMPLETED
Last Update Posted:
2025-02-19
First Post:
2024-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Combining Incontinence-associated Dermatitis Prevention and Management Course and Directive Wheel Chart
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D001519', 'term': 'Behavior'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'educational intervention'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'pretest-posttest design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-16', 'studyFirstSubmitDate': '2024-12-18', 'studyFirstSubmitQcDate': '2025-02-16', 'lastUpdatePostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incontinence associated dermatitis knowledge, attitude and practice questionnaire (KAP-IAD-Q)', 'timeFrame': 'Four weeks prior to the course, after the teaching courses, four weeks after the course', 'description': 'The total score ranges from 22 to 110 with higher scores indicating better the knowledge, attitude, and practical behaviors concerning IAD.'}, {'measure': 'The attitude towards the prevention of incontinence-associated dermatitis instrument (APrIAD)', 'timeFrame': 'Four weeks prior to the course, after the teaching courses, four weeks after the course', 'description': 'The questionnaire consists of 14 questions, each scored on a 4-point Likert scale., with a total score ranging from 0 to 42.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Attitude', 'Course', 'Directive wheel chart', 'Incontinence-associated dermatitis', 'Knowledge', 'Practice'], 'conditions': ['Dermatitis', 'Knowledge, Attitudes, Practice']}, 'descriptionModule': {'briefSummary': 'Background: Knowledge, attitudes, and behaviors regarding the prevention and care of incontinence-associated dermatitis (IAD) need to be enhanced through educational training. There is a lack of innovative courses and convenient tools to assist nursing staff in learning and teaching in clinical settings.\n\nPurpose: This study aims to investigate the learning outcomes of nursing staff in adult wards regarding the prevention and care of IAD, comparing the effectiveness of a course combined with an Directive Wheel Chart versus a course alone. Additionally, the study examines the effectiveness of nursing staff applying the course and Directive Wheel Chart in peer teaching.', 'detailedDescription': 'Design: This study was a two-phase randomized controlled trial conducted at a regional teaching hospital in Taiwan.\n\nMaterials and Methods: The study involved eight wards, comprising a total of 106 nurses, who were initially randomly assigned to either an experimental group (EG) or a control group (CG). Subsequently, the nurses within each ward were randomly allocated to two phases. The researcher delivered a 50-minute lecture to both groups, providing the IAD directive wheel chart only to the nurses in the EG. After a two-weeks period, one or two nurses from each ward in the first phase utilized the same course and directive wheel chart to peer-teach the nurses in the second phase within the same wards. The Chinese version of the Knowledge, Attitudes and Practices of Incontinence-associated Dermatitis Questionnaire (KAP-IAD-Q-C) and the Chinese version of the attitude towards the prevention of incontinence-associated dermatitis instrument (APrIAD-C) were employed to evaluate effectiveness. The Generalized Estimating Equation (GEE) was utilized to analyze the effectiveness of the educational intervention for each phase.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n(1)Nurses in the eight adult wards.\n\nExclusion criteria:\n\n1. New nurses had not completed the three-month probation period;\n2. Nurses are holding administrative management positions\n3. Nurse practitioners;\n4. Nurses who expected to be employed within six months due to job transitions.'}, 'identificationModule': {'nctId': 'NCT06835192', 'briefTitle': 'Impact of Combining Incontinence-associated Dermatitis Prevention and Management Course and Directive Wheel Chart', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}, 'officialTitle': 'Impact of Combining Course on Incontinence-associated Dermatitis Prevention and Management with Directive Wheel Chart for Nurses in Adult Wards', 'orgStudyIdInfo': {'id': 'KMUHIRB-E(I)-20240128'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Combining Incontinence-associated Dermatitis Prevention and Management Course and Directive Wheel Chart', 'interventionNames': ['Other: Experimental group', 'Other: Control Group']}, {'type': 'OTHER', 'label': 'Control Group', 'description': 'The first author conducted a 25-minute knowledge lecture for the nurses in the CG on the same topics covered in the EG. This lecture included an explanation of IAD, its causes, the latest global classification of IAD, as well as methods for skin prevention and IAD care. Following the lecture, the same three clinical examples presented in the EG were discussed for an additional 20 minutes, during which the nurses were divided into groups for case discussions. Finally, a 5-minute quiz competition was held, featuring the same five actual clinical photographs used in the EG.', 'interventionNames': ['Other: Experimental group', 'Other: Control Group']}], 'interventions': [{'name': 'Experimental group', 'type': 'OTHER', 'otherNames': ['Combining Incontinence-associated Dermatitis Prevention and Management Course and Directive Wheel Chart'], 'description': 'Initially, the first author presented a 25-minute lecture with a PowerPoint presentation to the nurses of the EG. Following this, each nurse received an IAD directive wheel chart. In the subsequent 25 minutes, the first author presented three clinical cases examples and relevant information, encouraging the nurses to utilize the IAD directive wheel chart in groups. To conclude the session, a 5-minute quiz was conducted, featuring five actual clinical photographs. After the course, the nurses were instructed to take the IAD directive wheel chart back to their clinics for review and use in health education and teaching.', 'armGroupLabels': ['Control Group', 'Experimental group']}, {'name': 'Control Group', 'type': 'OTHER', 'otherNames': ['Incontinence-associated Dermatitis Prevention and Management Course'], 'description': 'The first author conducted a 25-minute knowledge lecture for the nurses in the CG on the same topics covered in the EG. This lecture included an explanation of IAD, its causes, the latest global classification of IAD, as well as methods for skin prevention and IAD care. Following the lecture, the same three clinical examples presented in the EG were discussed for an additional 20 minutes, during which the nurses were divided into groups for case discussions. Finally, a 5-minute quiz competition was held, featuring the same five actual clinical photographs used in the EG.', 'armGroupLabels': ['Control Group', 'Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '801', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaohsiung Municipal Ta-Tung Hospital, Kaohsiung Medical University', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'overallOfficials': [{'name': 'Yu-Ting Su, BSN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaohsiung Municipal Ta-Tung Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}