Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-01-12 @ 4:55 AM
Study NCT ID:
NCT02013505
Status:
TERMINATED
Last Update Posted:
2023-07-28
First Post:
2013-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Validated Educational Video Intervention Improves the Quality of Bowel Preparation for Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007410', 'term': 'Intestinal Diseases'}], 'ancestors': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 298}}, 'statusModule': {'whyStopped': 'Study expired; Investigator left facility.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-27', 'studyFirstSubmitDate': '2013-12-11', 'studyFirstSubmitQcDate': '2013-12-16', 'lastUpdatePostDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of bowel preparation', 'timeFrame': 'At the time of colonoscopy', 'description': 'Quality of bowel preparation at the time when the colonoscopy procedure is performed as reported by the physician performing the colonoscopy.'}], 'secondaryOutcomes': [{'measure': 'Adenoma detection rate', 'timeFrame': 'At time of colonoscopy', 'description': 'Number of patients undergoing screening colonoscopy for average risk in whom an adenoma was detected.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Colonoscopy'], 'conditions': ['Bowel Dysfunction']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesised that a video based patient education will help patients understand the process of colon cleansing prior to a colonoscopy procedure and hence will result in clean colons that will may help physician perform a better quality examination.', 'detailedDescription': 'After obtaining consent over phone, the investigators randomly assigned assigned participants to receive either the standard paper based instructions or receive an educational video in addition to the standard paper based instruction. Physicians performing the procedure were blinded to this assignment. The investigators obtained information relating to the cleanliness of the colon as noted during the colonoscopy examination. The investigators obtained this information from the colonoscopy reports. The investigators also obtained information regarding colon polyps,wanting to see if there is any difference in the number of patients in whom adenomatous polyps were detected.\n\nOutcome measures:\n\nPrimary Out come:\n\n1.Quality of bowel preparation\n\nSecondary outcome:\n\n1. Adenoma detection rate\n2. Rate of incomplete procedures due to poor bowel prep.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. At least 18 years of age\n2. Subjects who have the ability to give consent\n3. Subjects who are scheduled for colonoscopy as out patient\n4. Subjects consenting to participate in the study\n5. Subjects who are able to read and understand English\n\nExclusion Criteria:\n\n1. \\< 18 years age\n2. Subjects from whom consent cannot be obtained for any reason.\n3. Subjects who are scheduled for colonoscopy as in patient\n4. Subjects who are scheduled for colonoscopy within a time period or a situation where the educational material cannot be properly delivered to the study participant.\n5. Subjects who are advised to undergo bowel prep for more than one day.\n6. Subjects undergoing bowel prep with medications other than Colyte.\n7. Subjects who do not have access to equipment to watch the video (TV/CD player)\n8. Pregnant patients\n9. Prisoners\n10. Subjects who are not able to read or understand English.\n\n(j)Subjects who had bowel resection surgery'}, 'identificationModule': {'nctId': 'NCT02013505', 'briefTitle': 'A Validated Educational Video Intervention Improves the Quality of Bowel Preparation for Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'University of Missouri-Columbia'}, 'officialTitle': 'A Validated Educational Video Intervention Improves the Quality of Bowel Preparation for Colonoscopy.', 'orgStudyIdInfo': {'id': '1203774'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Instructions printed on a paper.', 'description': 'There will be no intervention.'}, {'type': 'EXPERIMENTAL', 'label': 'Paper and video instructions', 'description': '.Instructions printed on paper and a educational video.', 'interventionNames': ['Other: Educational video']}], 'interventions': [{'name': 'Educational video', 'type': 'OTHER', 'description': 'An educational video was developed based on the current paper instructions for bowel preparation. The video included a physician explaining the process, using more images and short clip videos of the example. The script of the video was approved by the patient education department of the University Hospital and language adjusted to 6th grade level.', 'armGroupLabels': ['Paper and video instructions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65212', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}], 'overallOfficials': [{'name': 'Dilip Bearelly, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Missouri-Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Missouri-Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}