- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02804737
Impact of Patient Education Website on the Quality of Outpatient Bowel Preparation for Colonoscopy
March 12, 2018 updated by: Robert Enns, University of British Columbia
The purpose of this study is to evaluate the effectiveness of the GI clinic's currently used web-based instructions at St. Paul's Hospital.
Study Overview
Detailed Description
Colorectal cancer (CRC) is a relatively common and life threatening condition that affect one in thirteen individuals in their lifetime.
Colonoscopy is the most used procedure to allow gastroenterologist to identify colorectal malignancies or precancerous lesions at an earlier stage, which affords a greater chance for cure.
However, low bowel cleanliness hinders polyp detection rates and therefore colonoscopy effectiveness.
In the past, the majority of the studies have focused on pharmacological factors to optimize bowel preparation quality.
Recently, the non-pharmacological factors have been found to have significant increases in bowel preparation quality.
The purpose of this study is to evaluate the effectiveness of the GI clinic's currently used web-based instructions at St. Paul's Hospital.
Study Type
Observational
Enrollment (Actual)
160
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6Z 2K5
- St. Paul's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients who have been scheduled for a colonoscopy as outpatients
Description
Inclusion Criteria:
- Patients scheduled for a colonoscopy as outpatients
Exclusion Criteria:
- Unable to speak English
- Unwilling to participate in reading online materials
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Web Group
Patients given web site (aiddly) instructions for colonoscopy
|
A website designed to better educate patients on how to prepare for their colonoscopies
|
|
Paper Group
Patients given paper instructions for colonoscopy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effectiveness of Web-based instructions
Time Frame: Time 0
|
Determine the effectiveness of Web-based instructions patients in preparing for colonoscopy by comparing the percentage of patients that achieved an excellent Boston Bowel Preparation Score when following the web-based instructions compared to historical control of paper written instructions.
|
Time 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Benefit of web-based instructions
Time Frame: Time 0
|
Determine through a survey the benefit to patients of this method of education.
|
Time 0
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert Enns, MD, University of British Columbia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hibbard JH, Mahoney ER, Stockard J, Tusler M. Development and testing of a short form of the patient activation measure. Health Serv Res. 2005 Dec;40(6 Pt 1):1918-30. doi: 10.1111/j.1475-6773.2005.00438.x.
- Froehlich F, Wietlisbach V, Gonvers JJ, Burnand B, Vader JP. Impact of colonic cleansing on quality and diagnostic yield of colonoscopy: the European Panel of Appropriateness of Gastrointestinal Endoscopy European multicenter study. Gastrointest Endosc. 2005 Mar;61(3):378-84. doi: 10.1016/s0016-5107(04)02776-2.
- 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.
- Winawer SJ, Zauber AG, Ho MN, O'Brien MJ, Gottlieb LS, Sternberg SS, Waye JD, Schapiro M, Bond JH, Panish JF, et al. Prevention of colorectal cancer by colonoscopic polypectomy. The National Polyp Study Workgroup. N Engl J Med. 1993 Dec 30;329(27):1977-81. doi: 10.1056/NEJM199312303292701.
- Rex DK, Imperiale TF, Latinovich DR, Bratcher LL. Impact of bowel preparation on efficiency and cost of colonoscopy. Am J Gastroenterol. 2002 Jul;97(7):1696-700. doi: 10.1111/j.1572-0241.2002.05827.x.
- Harewood GC, Sharma VK, de Garmo P. Impact of colonoscopy preparation quality on detection of suspected colonic neoplasia. Gastrointest Endosc. 2003 Jul;58(1):76-9. doi: 10.1067/mge.2003.294.
- Hibbard JH, Greene J. What the evidence shows about patient activation: better health outcomes and care experiences; fewer data on costs. Health Aff (Millwood). 2013 Feb;32(2):207-14. doi: 10.1377/hlthaff.2012.1061.
- Holt EW, Yimam KK, Ma H, Shaw RE, Sundberg RA, Verhille MS. Patient tolerability of bowel preparation is associated with polyp detection rate during colonoscopy. J Gastrointestin Liver Dis. 2014 Jun;23(2):135-40. doi: 10.15403/jgld.2014.1121.232.ewh1.
- Rex DK. Dosing considerations in the use of sodium phosphate bowel preparations for colonoscopy. Ann Pharmacother. 2007 Sep;41(9):1466-75. doi: 10.1345/aph.1K206. Epub 2007 Jul 24.
- Park JS, Sohn CI, Hwang SJ, Choi HS, Park JH, Kim HJ, Park DI, Cho YK, Jeon WK, Kim BI. Quality and effect of single dose versus split dose of polyethylene glycol bowel preparation for early-morning colonoscopy. Endoscopy. 2007 Jul;39(7):616-9. doi: 10.1055/s-2007-966434.
- Unger RZ, Amstutz SP, Seo DH, Huffman M, Rex DK. Willingness to undergo split-dose bowel preparation for colonoscopy and compliance with split-dose instructions. Dig Dis Sci. 2010 Jul;55(7):2030-4. doi: 10.1007/s10620-009-1092-x. Epub 2010 Jan 16.
- Winawer S, Fletcher R, Rex D, Bond J, Burt R, Ferrucci J, Ganiats T, Levin T, Woolf S, Johnson D, Kirk L, Litin S, Simmang C; Gastrointestinal Consortium Panel. Colorectal cancer screening and surveillance: clinical guidelines and rationale-Update based on new evidence. Gastroenterology. 2003 Feb;124(2):544-60. doi: 10.1053/gast.2003.50044.
- Muller AD, Sonnenberg A. Protection by endoscopy against death from colorectal cancer. A case-control study among veterans. Arch Intern Med. 1995 Sep 11;155(16):1741-8. doi: 10.1001/archinte.1995.00430160065007.
- Belsey J, Epstein O, Heresbach D. Systematic review: oral bowel preparation for colonoscopy. Aliment Pharmacol Ther. 2007 Feb 15;25(4):373-84. doi: 10.1111/j.1365-2036.2006.03212.x.
- Tan JJ, Tjandra JJ. Which is the optimal bowel preparation for colonoscopy - a meta-analysis. Colorectal Dis. 2006 May;8(4):247-58. doi: 10.1111/j.1463-1318.2006.00970.x.
- Serper M, Gawron AJ, Smith SG, Pandit AA, Dahlke AR, Bojarski EA, Keswani RN, Wolf MS. Patient factors that affect quality of colonoscopy preparation. Clin Gastroenterol Hepatol. 2014 Mar;12(3):451-7. doi: 10.1016/j.cgh.2013.07.036. Epub 2013 Aug 15.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
May 11, 2015
First Submitted That Met QC Criteria
June 14, 2016
First Posted (Estimate)
June 17, 2016
Study Record Updates
Last Update Posted (Actual)
March 13, 2018
Last Update Submitted That Met QC Criteria
March 12, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H14-00468
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Colon Cancer
-
Chaoxi ZhouRecruitingProximal Transverse Colon Cancer | Ascending Colon CancerChina
-
National Cancer Institute (NCI)NSABP Foundation IncCompletedColon Adenocarcinoma | Stage IIIA Colon Cancer AJCC v7 | Stage IIIB Colon Cancer AJCC v7 | Stage IIIC Colon Cancer AJCC v7 | Stage IIA Colon Cancer AJCC v7 | Stage IIB Colon Cancer AJCC v7 | Stage IIC Colon Cancer AJCC v7United States
-
Case Comprehensive Cancer CenterCompletedStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Stage IVA Colon Cancer | Stage IVA Rectal Cancer and other conditionsUnited States
-
Gruppo Oncologico del Nord-OvestSeagen Inc.; Servier; Foundation MedicineSuspendedStage II Colon Cancer | Stage III Colon Cancer | HER2-positive Colon Cancer | RAS Wild-type Colon CancerItaly
-
Chang Gung Memorial HospitalCompletedColon Cancer | Cancer Recurrence | Colon Adenocarcinoma | Colon Cancer Stage II | Colon Cancer Stage I | Survival Analysis | Colon Cancer Stage IIITaiwan
-
Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)CompletedFatigue | Depressive Symptoms | Stage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Psychosocial Effects of Cancer and Its Treatment | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Stage I Colon Cancer | Stage... and other conditionsUnited States
-
Hospital da Senhora da OliveiraCompletedColon Cancer | Colon Adenoma | Colon Polyp | Colon Rectal CancerPortugal
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Active, not recruitingStage III Colon Cancer AJCC v8 | Colon Adenocarcinoma | Microsatellite Stable Colon Carcinoma | Stage IIB Colon Cancer AJCC v8 | Stage IIC Colon Cancer AJCC v8United States
-
National Cancer Institute (NCI)CompletedStage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Stage IVA Colon Cancer | Stage IVA Rectal Cancer | Stage IVB Colon Cancer | Stage IVB Rectal CancerUnited States
Clinical Trials on Aiddly (Web Site)
-
University of British ColumbiaCompleted
-
University of California, San FranciscoNational Cancer Institute (NCI)CompletedNicotine Dependence | Cigarette SmokingUnited States
-
Agency for Healthcare Research and Quality (AHRQ)UnknownWell Child Preventive CareUnited States
-
Coordinación de Investigación en Salud, MexicoActive, not recruiting
-
University of California, San DiegoCompletedObesity | Diabetes | OverweightUnited States
-
The Reading Hospital and Medical CenterReading Hospital Foundation; Complete Statistical Services (Consult-Stat)RecruitingDiabetes Mellitus, Type 2 | Lifestyle Modification | Diabetes EducationUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingMalignant NeoplasmUnited States
-
University of MichiganAgency for Healthcare Research and Quality (AHRQ)Completed
-
SVS Institute of Dental SciencesCompleted
-
AkesoNot yet recruitingHealthy Male Adults ParticipantsChina