Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-02-08 @ 3:19 AM
Study NCT ID:
NCT02478918
Status:
COMPLETED
Last Update Posted:
2017-02-16
First Post:
2015-06-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Automated Telephone Reminder for Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011127', 'term': 'Polyps'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 234}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-14', 'studyFirstSubmitDate': '2015-06-18', 'studyFirstSubmitQcDate': '2015-06-22', 'lastUpdatePostDateStruct': {'date': '2017-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ottawa preparation scale score', 'timeFrame': 'Immediately after procedure', 'description': 'measures the cleanliness of each part of the colon and the overall fluid volume as assessed by the endoscopist'}], 'secondaryOutcomes': [{'measure': 'Number of glasses of fluid consumed pre-colonoscopy', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Polyps']}, 'referencesModule': {'references': [{'pmid': '11419830', 'type': 'BACKGROUND', 'citation': 'Abuksis G, Mor M, Segal N, Shemesh I, Morad I, Plaut S, Weiss E, Sulkes J, Fraser G, Niv Y. A patient education program is cost-effective for preventing failure of endoscopic procedures in a gastroenterology department. Am J Gastroenterol. 2001 Jun;96(6):1786-90. doi: 10.1111/j.1572-0241.2001.03872.x.'}, {'pmid': '21168840', 'type': 'BACKGROUND', 'citation': 'Calderwood AH, Lai EJ, Fix OK, Jacobson BC. An endoscopist-blinded, randomized, controlled trial of a simple visual aid to improve bowel preparation for screening colonoscopy. Gastrointest Endosc. 2011 Feb;73(2):307-14. doi: 10.1016/j.gie.2010.10.013. Epub 2010 Dec 18.'}, {'pmid': '23503044', 'type': 'BACKGROUND', 'citation': 'Liu X, Luo H, Zhang L, Leung FW, Liu Z, Wang X, Huang R, Hui N, Wu K, Fan D, Pan Y, Guo X. Telephone-based re-education on the day before colonoscopy improves the quality of bowel preparation and the polyp detection rate: a prospective, colonoscopist-blinded, randomised, controlled study. Gut. 2014 Jan;63(1):125-30. doi: 10.1136/gutjnl-2012-304292. Epub 2013 Mar 16.'}, {'pmid': '20051190', 'type': 'BACKGROUND', 'citation': 'Modi C, Depasquale JR, Digiacomo WS, Malinowski JE, Engelhardt K, Shaikh SN, Kothari ST, Kottam R, Shakov R, Maksoud C, Baddoura WJ, Spira RS. Impact of patient education on quality of bowel preparation in outpatient colonoscopies. Qual Prim Care. 2009;17(6):397-404.'}, {'pmid': '11419832', 'type': 'BACKGROUND', 'citation': 'Ness RM, Manam R, Hoen H, Chalasani N. Predictors of inadequate bowel preparation for colonoscopy. Am J Gastroenterol. 2001 Jun;96(6):1797-802. doi: 10.1111/j.1572-0241.2001.03874.x.'}, {'pmid': '15044882', 'type': 'BACKGROUND', 'citation': 'Rostom A, Jolicoeur E. Validation of a new scale for the assessment of bowel preparation quality. Gastrointest Endosc. 2004 Apr;59(4):482-6. doi: 10.1016/s0016-5107(03)02875-x.'}, {'pmid': '19940781', 'type': 'BACKGROUND', 'citation': 'Shaikh AA, Hussain SM, Rahn S, Desilets DJ. Effect of an educational pamphlet on colon cancer screening: a randomized, prospective trial. Eur J Gastroenterol Hepatol. 2010 Apr;22(4):444-9. doi: 10.1097/MEG.0b013e328333fca6.'}, {'pmid': '24454341', 'type': 'BACKGROUND', 'citation': 'Shieh TY, Chen MJ, Chang CW, Hung CY, Hu KC, Kuo YC, Shih SC, Wang HY. Effect of physician-delivered patient education on the quality of bowel preparation for screening colonoscopy. Gastroenterol Res Pract. 2013;2013:570180. doi: 10.1155/2013/570180. Epub 2013 Dec 17.'}, {'pmid': '21483463', 'type': 'BACKGROUND', 'citation': 'Spiegel BM, Talley J, Shekelle P, Agarwal N, Snyder B, Bolus R, Kurzbard N, Chan M, Ho A, Kaneshiro M, Cordasco K, Cohen H. Development and validation of a novel patient educational booklet to enhance colonoscopy preparation. Am J Gastroenterol. 2011 May;106(5):875-83. doi: 10.1038/ajg.2011.75. Epub 2011 Apr 12.'}, {'pmid': '22840295', 'type': 'BACKGROUND', 'citation': 'Tae JW, Lee JC, Hong SJ, Han JP, Lee YH, Chung JH, Yoon HG, Ko BM, Cho JY, Lee JS, Lee MS. Impact of patient education with cartoon visual aids on the quality of bowel preparation for colonoscopy. Gastrointest Endosc. 2012 Oct;76(4):804-11. doi: 10.1016/j.gie.2012.05.026. Epub 2012 Jul 27.'}]}, 'descriptionModule': {'briefSummary': 'This is a quality improvement study to determine the impact of an automated telephone reminder on the quality of bowel preparation in patients undergoing outpatient colonoscopy.', 'detailedDescription': 'Randomized trial of automated reminders with bowel prep instructions and encouraging clear fluid ingestion. The phone calls will occur 48-96 hours prior to the scheduled colonoscopy.\n\nAll patients undergoing outpatient colonoscopy and prescribed sodium picosulfate plus magnesium citrate will be eligible for enrollment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients\n* Scheduled for outpatient colonoscopy at a later date\n* Prescribed evening-before or split-dose low volume preparation regimens\n\nExclusion Criteria:\n\n* Refusal to receive automated telephone reminder\n* No access to telephone\n* Urgent/emergent indication for colonoscopy\n* Prescribed a bowel prep other than Pico-Salax/Purgodan\n* Receiving upper and lower combined procedure'}, 'identificationModule': {'nctId': 'NCT02478918', 'briefTitle': 'Automated Telephone Reminder for Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': "Queen's University"}, 'officialTitle': 'Automated Telephone Reminder Prior to Outpatient Colonoscopy and the Effect on Bowel Preparation Quality', 'orgStudyIdInfo': {'id': '6013364'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Receiving reminder phone call', 'description': 'Will receive phone call to remind colonoscopy date and bowel prep', 'interventionNames': ['Other: Phone call']}, {'type': 'NO_INTERVENTION', 'label': 'Not receiving reminder phone call', 'description': 'Will not receive phone call to remind colonoscopy date and bowel prep'}], 'interventions': [{'name': 'Phone call', 'type': 'OTHER', 'description': 'Automated phone call reminder', 'armGroupLabels': ['Receiving reminder phone call']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K7L5G2', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hotel Dieu Hospital', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}], 'overallOfficials': [{'name': 'Lawrence Hookey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Queen's University"}, {'name': 'Matthew Church', 'role': 'STUDY_DIRECTOR', 'affiliation': "Queen's University"}, {'name': 'Natalie Rubinger', 'role': 'STUDY_DIRECTOR', 'affiliation': "Queen's University"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Queen's University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Division of Gastroenterology', 'investigatorFullName': 'Dr. Lawrence Hookey', 'investigatorAffiliation': "Queen's University"}}}}