Ignite Creation Date:
2025-12-24 @ 7:33 PM
Ignite Modification Date:
2025-12-25 @ 5:15 PM
Study NCT ID:
NCT07155603
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-04
First Post:
2025-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Visual Aids for Colonoscopy Preparation: A Prospective Study on Patient Understanding and Bowel Cleanliness in Colonoscopy Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-01', 'studyFirstSubmitDate': '2025-03-10', 'studyFirstSubmitQcDate': '2025-09-01', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bowel Preperation', 'timeFrame': '24 months', 'description': "The objective of assessing the primary endpoint the patient's bowel cleanliness, will be measured during the routine colonoscopy, using the Boston Bowel Preperation Scale.\n\nThe Boston Bowel Preparation Scale (BBPS) is a validated tool used to assess the cleanliness of the colon during a colonoscopy,\n\nEach of the three segments of the colon (right, transverse, and left) is assigned a score ranging from 0 to 3, with the following criteria:\n\nTotal Score 0: The entire colon is unprepared, and no mucosa is visible. Total Score 1-3: Poor preparation, significant portions of the mucosa are not visible.\n\nTotal Score 4-6: Fair preparation, with some portions of the mucosa visible but others obscured.\n\nTotal Score 7-9: Good to excellent preparation, with most or all mucosa well visualized.\n\nInterpretation Scores of 0-3: Generally considered inadequate for proper assessment and diagnosis, likely requiring repeat preparation and examination.\n\nScores of 4-6: Indicative of suboptimal preparation"}], 'secondaryOutcomes': [{'measure': 'Patient Health Literacy & Communication Satisfaction', 'timeFrame': '24 months', 'description': "The secondary outcome seeks to assess the patient's health literacy and general communication satisfaction. This will be done by assessing their answers to the Health Literacy Questionnaire."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['The Effect of Audio-visual Aids on Bowel Cleanliness', 'Audiovisual Aids']}, 'descriptionModule': {'briefSummary': 'Effective communication in healthcare is critical for improving patient outcomes, particularly in enhancing health literacy and enabling informed decision-making. Traditional informed consent for colonoscopy often fails to clearly explain the procedure, risks, and preparation requirements, leading to inadequate bowel preparation, longer procedures, and missed lesions. Standard educational materials like videos and written instructions are often impersonal, lack cultural inclusivity, and fail to engage patients effectively. Emerging tools, such as the multilingual, visually enhanced Meine Behandlung video series from Visikon®, aim to improve patient comprehension and adherence. This study seeks to compare the effectiveness of these animated videos against traditional consent methods in enhancing patient understanding and adherence, particularly for complex procedures like colonoscopy, which is crucial for diagnosing and preventing colorectal cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Scheduled for a routine outpatient colonoscopy procedure\n* Capable of understanding communication in German and willing to participate in the study\n\nExclusion Criteria:\n\n* Patients with cognitive impairments\n* Those unwilling to participate'}, 'identificationModule': {'nctId': 'NCT07155603', 'acronym': 'VACP', 'briefTitle': 'Visual Aids for Colonoscopy Preparation: A Prospective Study on Patient Understanding and Bowel Cleanliness in Colonoscopy Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cantonal Hosptal, Baselland'}, 'officialTitle': 'Visual Aids for Colonoscopy Preparation: A Prospective Study on Patient Understanding and Bowel Cleanliness in Colonoscopy Patients', 'orgStudyIdInfo': {'id': '2024-01572'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional Consent (Control Group)', 'description': 'The traditional informed consent process involves the provision of written documents and verbal explanation to the patient regarding the colonoscopy procedure, risks, and preparation requirements', 'interventionNames': ['Behavioral: Animated Video Group 1']}, {'type': 'EXPERIMENTAL', 'label': 'Animated Video 1', 'description': 'Patients of this group will be asked to watch the Visikon animated videos, in addition to receiving standard informed consent', 'interventionNames': ['Behavioral: Animated Video Group 1']}], 'interventions': [{'name': 'Animated Video Group 1', 'type': 'BEHAVIORAL', 'description': 'The animated video intervention provides a clear and engaging multimedia explanation of the colonoscopy procedure in multiple languages. It includes visual aids to help explain the process, preparation instructions, risks, and expected outcomes, aiming to improve patient comprehension and adherence.', 'armGroupLabels': ['Animated Video 1', 'Traditional Consent (Control Group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4410', 'city': 'Liestal', 'country': 'Switzerland', 'contacts': [{'name': 'Zahra Pasha', 'role': 'CONTACT', 'email': 'zahra.pasha@ksbl.ch', 'phone': '0041 61 400 40 40'}, {'name': 'Zahra Pasha, B.A, M.A., TESOL, iPGCE, MCIL', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jörg D Leuppi, M.D, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cantonal Hospital of Baselland', 'geoPoint': {'lat': 47.48455, 'lon': 7.73446}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prof. Dr. Jörg Leuppi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med. Jörg Daniel Leuppi', 'investigatorFullName': 'Prof. Dr. Jörg Leuppi', 'investigatorAffiliation': 'Cantonal Hosptal, Baselland'}}}}