Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT02464618
Status:
COMPLETED
Last Update Posted:
2018-09-17
First Post:
2015-06-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Using Patients' Social Contact to Improve Out-Patient Endoscopy Among Blacks
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 812}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-03-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-13', 'studyFirstSubmitDate': '2015-06-02', 'studyFirstSubmitQcDate': '2015-06-03', 'lastUpdatePostDateStruct': {'date': '2018-09-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "Social contact's activity", 'timeFrame': 'During the duration of the project, an average of 6 months', 'description': 'Characteristics of participants and Lubbens social network scale correlation with other outcomes and activities of the social contact'}], 'primaryOutcomes': [{'measure': 'Compliance with appointment and colonoscopy', 'timeFrame': '6 months', 'description': 'For primary care subjects: Making appointment with Gastrointestinal endoscopist within 3 months and completing colonoscopy within 6 months of enrolment'}, {'measure': 'Compliance with scheduled upper endoscopy and colonoscopy', 'timeFrame': 'Scheduled procedure time, an average of 8 weeks', 'description': 'For specialty subjects: Completing scheduled upper endoscopy or colonoscopy'}], 'secondaryOutcomes': [{'measure': 'Bowel preparation quality', 'timeFrame': 'At scheduled colonoscopy, an average of 8 weeks', 'description': 'Adequacy of bowel preparation with ratings of good to excellent on Aronchick scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Colonoscopy', 'Upper endoscopy', 'Adherence', 'Disparities'], 'conditions': ['Compliance', 'Colon Cancer']}, 'referencesModule': {'references': [{'pmid': '25180285', 'type': 'BACKGROUND', 'citation': 'Laiyemo AO, Williams CD, Burnside C, Moghadam S, Sanasi-Bhola KD, Kwagyan J, Brim H, Ashktorab H, Scott VF, Smoot DT. Factors associated with attendance to scheduled outpatient endoscopy. Postgrad Med J. 2014 Oct;90(1068):571-5. doi: 10.1136/postgradmedj-2012-131650. Epub 2014 Sep 1.'}, {'pmid': '24574761', 'type': 'BACKGROUND', 'citation': 'Tammana VS, Laiyemo AO. Colorectal cancer disparities: issues, controversies and solutions. World J Gastroenterol. 2014 Jan 28;20(4):869-76. doi: 10.3748/wjg.v20.i4.869.'}, {'pmid': '22571991', 'type': 'BACKGROUND', 'citation': 'Badurdeen DS, Umar NA, Begum R, Sanderson AK 2nd, Jack M, Mekasha G, Kwagyan J, Smoot DT, Laiyemo AO. Timing of procedure and compliance with outpatient endoscopy among an underserved population in an inner-city tertiary institution. Ann Epidemiol. 2012 Jul;22(7):531-5. doi: 10.1016/j.annepidem.2012.04.013. Epub 2012 May 8.'}, {'pmid': '22183821', 'type': 'BACKGROUND', 'citation': 'Laiyemo AO. In search of a perfect solution to ensure that "no colon is left behind". Dig Dis Sci. 2012 Feb;57(2):263-5. doi: 10.1007/s10620-011-2010-6. Epub 2011 Dec 20. No abstract available.'}, {'pmid': '31478919', 'type': 'DERIVED', 'citation': "Laiyemo AO, Kwagyan J, Williams CD, Rogers J, Kibreab A, Jack MA, Lee EE, Brim H, Ashktorab H, Howell CD, Smoot DT, Platz EA. Using Patients' Social Network to Improve Compliance to Outpatient Screening Colonoscopy Appointments Among Blacks: A Randomized Clinical Trial. Am J Gastroenterol. 2019 Oct;114(10):1671-1677. doi: 10.14309/ajg.0000000000000387."}]}, 'descriptionModule': {'briefSummary': 'Non-attendance to out-patient endoscopic procedures is high among underserved blacks. The overall goal of this proposal is to evaluate the effect of directly involving a social contact (chosen by the patient) on completion and quality of out-patient endoscopy recommended for the patient by his/her primary care physician, or after scheduling by the gastrointestinal endoscopist.\n\nImproved adherence and better quality of procedures are postulated with involvement of social contacts.', 'detailedDescription': 'The overarching goal of this proposal is to determine whether directly involving a social contact, chosen by the patient, will improve the completion and quality of scheduled out-patient endoscopy among blacks.\n\nThese are three sub-projects:\n\nProject 1: Involves recruiting 400 patients referred for colonoscopy by their primary care physicians\n\nProject 2: Involves recruiting 400 patients scheduled for colonoscopy by their endoscopist\n\nProject 3: Involves recruiting 200 patients scheduled for upper endoscopy by their endoscopists'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients referred for out-patient colonoscopy by primary care physicians\n* Patients scheduled for out-patient screening colonoscopy\n* Patients scheduled for out-patient upper endoscopy\n\nExclusion Criteria:\n\n* Patients who were referred for colorectal cancer (CRC) screening as in-patients\n* Patients with personal history of familial adenomatous polyposis syndrome (FAP)\n* Patients with family history of Hereditary non-polyposis colorectal cancer syndrome (HNPCC)\n* Patients with inflammatory bowel disease\n* Patients with Crohn's disease\n* Patients with ulcerative colitis\n* Patients with personal history of CRC\n* Patients who have had colonic resection"}, 'identificationModule': {'nctId': 'NCT02464618', 'briefTitle': "Using Patients' Social Contact to Improve Out-Patient Endoscopy Among Blacks", 'organization': {'class': 'OTHER', 'fullName': 'Howard University'}, 'officialTitle': 'Improving Attendance to Outpatient Endoscopy Among Blacks', 'orgStudyIdInfo': {'id': 'IRB-14-MED-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'The social contact of patients in this arm will not be contacted'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Social contact intervention', 'description': 'The social contact of patients in this arm will be contacted and asked to facilitate the endoscopy care plan of the patient', 'interventionNames': ['Behavioral: Social contact intervention']}], 'interventions': [{'name': 'Social contact intervention', 'type': 'BEHAVIORAL', 'description': 'The social contact of the patients in this arm will be engaged to improve adherence to out-patient endoscopy', 'armGroupLabels': ['Social contact intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20060', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Howard University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'overallOfficials': [{'name': 'Adeyinka O Laiyemo, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Howard University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Howard University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}