Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-01-01 @ 11:40 AM
Study NCT ID:
NCT06981650
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-21
First Post:
2025-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Video Education to Improve First Time Colonoscopy Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014743', 'term': 'Videotape Recording'}, {'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D013637', 'term': 'Tape Recording'}, {'id': 'D001296', 'term': 'Audiovisual Aids'}, {'id': 'D018961', 'term': 'Educational Technology'}, {'id': 'D013672', 'term': 'Technology'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D013690', 'term': 'Television'}, {'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 362}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-12', 'studyFirstSubmitDate': '2025-04-24', 'studyFirstSubmitQcDate': '2025-05-12', 'lastUpdatePostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Boston Bowel Preparation Scale (continuous)', 'timeFrame': 'Perioperative/Periprocedural', 'description': 'Quality of bowel preparation measured by the Boston Bowel Preparation Scale. Scores range from 0 through 3. Higher scores indicate a better outcome..'}], 'secondaryOutcomes': [{'measure': 'Boston Bowel Preparation Scale (categorical)', 'timeFrame': 'Perioperative/Periprocedural', 'description': 'Boston Bowel Preparation Scale adequacy of preparation score ≥ 2 in all regions.\n\nQuality measured by the Boston Bowel Preparation Scale. Scores range from 0 through 3. Higher scores indicate a better outcome..'}, {'measure': 'Polyp detection rate proportion', 'timeFrame': 'Perioperative/Periprocedural', 'description': 'Proportion of individuals undergoing a colonoscopy in whom at least one polyp is detected. Values range from 0 through 1. Higher values indicate a better outcome.'}, {'measure': 'Adenoma detection rate proportion', 'timeFrame': 'Perioperative/Periprocedural', 'description': 'Proportion of individuals undergoing a colonoscopy in whom at least one adenomatous polyp is found. Values range from 0 through 1. Higher values indicate a better outcome.'}, {'measure': 'Cecal intubation rate proportion', 'timeFrame': 'Perioperative/Periprocedural', 'description': 'Proportion of colonoscopies in which the endoscope successfully reaches the caecum. Values range from 0 through 1. Higher values indicate a better outcome.'}, {'measure': 'Withdrawal time', 'timeFrame': 'Perioperative/Periprocedural', 'description': 'Duration in minutes taken to withdraw the colonoscope from the caecum to the rectum. Values range from 1 through 60. Higher values indicate a worse outcome.'}, {'measure': 'Adherence to bowel preparation instructions', 'timeFrame': 'Perioperative/Periprocedural', 'description': 'Following what was told to do by bowel preparation instructions. Total of 7 original questions scored as no for 0 or yes for 1 with a total score ranging from 0 through 7. Higher values indicate a better outcome.'}, {'measure': 'Amsterdam Preoperative Anxiety and Information Scale', 'timeFrame': 'baseline', 'description': 'Self-assessed at baseline using the Amsterdam Preoperative Anxiety and Information Scale (APAIS). Scores range from 6 through 30. Higher scores greater anxiety.'}, {'measure': 'Overall experience with the bowel preparation process', 'timeFrame': 'Perioperative/Periprocedural', 'description': 'Self-report about experience with the bowel preparation process. One original question with 5 choices of very unpleasant, unpleasant , neutral , pleasant , very pleasant . There is no score. The best answer would be "very pleasant."'}, {'measure': 'Desire to undergo future colonoscopies if indicated', 'timeFrame': 'Perioperative/Periprocedural', 'description': 'Self-report about having another colonoscopy. One original question with 5 choices of strongly disagree, disagree, neutral, agree , strongly agree. The best answer would be "strongly agree."'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['colonoscopy'], 'conditions': ['Colonoscopy Education']}, 'referencesModule': {'references': [{'pmid': '29847488', 'type': 'BACKGROUND', 'citation': 'Mahmood S, Farooqui SM, Madhoun MF. Predictors of inadequate bowel preparation for colonoscopy: a systematic review and meta-analysis. Eur J Gastroenterol Hepatol. 2018 Aug;30(8):819-826. doi: 10.1097/MEG.0000000000001175.'}]}, 'descriptionModule': {'briefSummary': 'The investigators compare video education plus standard education versus standard education for bowel preparation before a colonoscopy. The primary outcome will be the quality of bowel preparation.', 'detailedDescription': 'The investigators compare video education plus standard education versus standard education for bowel preparation before a colonoscopy and include a number of languages including English, Spanish, Russian, Haitian Creole, and Urdu. The educational content also includes psychological content based upon the Theory of Planned Behavior. The primary outcome will be the quality of bowel preparation, as measured by the Boston Bowel Preparation Scale (BBPS) score,'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: all outpatients aged 18 to 75 years scheduled for their first screening colonoscopy\n\n\\-\n\nExclusion Criteria: ● Contraindications for colonoscopy\n\n* History of bowel surgery, particularly colorectal surgery\n* Severe comorbid conditions (e.g., impaired hepatic, renal or bone marrow function, congestive heart failure, recent coronary artery disease)\n* Chronic constipation (typically \\<3 bowel movements per week with hard stools, a feeling of incomplete evacuation, or abdominal discomfort) requiring the use of laxatives\n* Pregnancy or lactation\n* Prisoners\n* Diagnosis of inflammatory bowel disease\n* Inability to use video presentation devices (e.g., blindness)\n* Active cancers.'}, 'identificationModule': {'nctId': 'NCT06981650', 'briefTitle': 'Video Education to Improve First Time Colonoscopy Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'New York City Health and Hospitals Corporation'}, 'officialTitle': 'Video Education to Improve First Time Colonoscopy Outcomes: A Prospective Randomized Control Trial.', 'orgStudyIdInfo': {'id': 'MED2024-555'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'education', 'description': 'standard education', 'interventionNames': ['Behavioral: education']}, {'type': 'EXPERIMENTAL', 'label': 'education plus video education', 'description': 'standard education plus an additional approach', 'interventionNames': ['Behavioral: video', 'Behavioral: education']}], 'interventions': [{'name': 'video', 'type': 'BEHAVIORAL', 'description': 'use of a video', 'armGroupLabels': ['education plus video education']}, {'name': 'education', 'type': 'BEHAVIORAL', 'description': 'standard talk and paper handout', 'armGroupLabels': ['education', 'education plus video education']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'John Trillo, MD', 'role': 'CONTACT', 'email': 'John.Trillo@nychhc.org', 'phone': '718-616-4400'}, {'name': 'Joel Konlack, MD', 'role': 'CONTACT', 'email': 'konlackj@nychhc.org', 'phone': '718-616-4400'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'After study using data is published.', 'ipdSharing': 'YES', 'description': 'Deidentfied data based upon a reasonable request', 'accessCriteria': 'Academic researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York City Health and Hospitals Corporation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Gastroenetrology, South Brooklyn Health', 'investigatorFullName': 'John Trillo', 'investigatorAffiliation': 'New York City Health and Hospitals Corporation'}}}}