Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-01-06 @ 5:08 AM
Study NCT ID:
NCT06417294
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a 3D-Printed Port-A Catheter Model Training Course
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017060', 'term': 'Patient Satisfaction'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-07', 'studyFirstSubmitDate': '2024-05-12', 'studyFirstSubmitQcDate': '2024-05-12', 'lastUpdatePostDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient education effectiveness questionnaire', 'timeFrame': 'immediately after the intervention', 'description': 'higher scores mean a better outcome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['3D printed model', 'port-a catheter', 'discharge education'], 'conditions': ['Patient Satisfaction', 'Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to develop a highly realistic 3D-printed Port-A catheter upper body model to improve the knowledge and self-care skills of patients and primary caregivers regarding Port-A catheter placement through patient education.', 'detailedDescription': 'Background： Cancer patients often require long-term administration of chemotherapy drugs, nutritional supplementation, and blood transfusions. During these treatments, an implantable central venous access (port-a catheter) is often utilized to avoid the inconvenience of repeated needle insertions for treatment and to minimize the risk of medication leakage. Port-A catheters are considered a safer clinical measure. However, poor care and maintenance of the catheter can lead to complications such as infection, catheter damage, and leakage, which can even result in death. The study aims to assess the impact of patient discharge education on their knowledge and satisfaction regarding catheter care.\n\nMethods： This study focuses on patient education and evaluating its effectiveness. It employs a prospective randomized controlled trial with a cross-sectional design and parallel groups. The participants are divided into the 3D model group (experimental group) and the conventional education group (control group). A total of 120 subjects from the hematology-oncology ward are included in the study. The participants are randomly assigned to either the experimental group (60 participants) or the control group (60 participants) based on the month of admission, following a cluster randomization approach.\n\nEffect： The investigator anticipate that the use of a 3D-printed upper body Port-A catheter model will yield better results in patient discharge education.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted to the hematology and oncology ward of Fu Jen Catholic University Hospital\n* Have Chinese communication skills\n\nExclusion Criteria:\n\n* Refused to participate in the study.'}, 'identificationModule': {'nctId': 'NCT06417294', 'briefTitle': 'Effects of a 3D-Printed Port-A Catheter Model Training Course', 'organization': {'class': 'OTHER', 'fullName': 'Fu Jen Catholic University'}, 'officialTitle': 'Effects of a 3D-Printed Port-A Catheter Model Training Course for Patient Discharge Instruction', 'orgStudyIdInfo': {'id': 'FJUH112278'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3D model group', 'description': 'Received a explanation combined with 3D printed model', 'interventionNames': ['Other: 3D health education model']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'traditional education group', 'description': 'Received a regular education', 'interventionNames': ['Other: traditional education']}], 'interventions': [{'name': '3D health education model', 'type': 'OTHER', 'description': 'explanation combined with 3D printed health education model', 'armGroupLabels': ['3D model group']}, {'name': 'traditional education', 'type': 'OTHER', 'description': 'Regular education', 'armGroupLabels': ['traditional education group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24352', 'city': 'New Taipei City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Ke-Yun Chao, PhD', 'role': 'CONTACT', 'email': 'ck_qq@hotmail.com', 'phone': '+886-905-301-879'}, {'name': 'Ke-Yun Chao, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fu Jen Catholic University Hospital, Fu Jen Catholic University', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}], 'centralContacts': [{'name': 'Ke-Yun Chao, PhD', 'role': 'CONTACT', 'email': 'C00152@mail.fjuh.fju.edu.tw', 'phone': '+886905301879'}], 'overallOfficials': [{'name': 'Ke-Yun Chao, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fu Jen Catholic University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fu Jen Catholic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Group leader of Respiratory Therapists', 'investigatorFullName': 'Ke-Yun, Chao', 'investigatorAffiliation': 'Fu Jen Catholic University'}}}}