NCT02466724

Brief Summary

Colorectal cancer (CRC) is a common and life threatening condition that will affect one in thirteen individuals. Colonoscopy is the most commonly used procedure to identify colorectal malignancies or precancerous lesions at an earlier stage, which affords an opportunity for cure. However, low level of bowel cleanliness hinders polyp detection and therefore can limit colonoscopy effectiveness. Historically, the majority of the studies have focused on pharmacological factors to optimize bowel preparation quality. Recently, 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 web-based instructions vs. the historical phone/letter instructions given to patients planning to have a colonoscopy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2015

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 9, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

1.2 years

First QC Date

May 13, 2015

Last Update Submit

October 24, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patients with Excelent Colonoscopy preparation

    To determine the effectiveness of web-based instructions for patients preparing for colonoscopy by comparing the percentage of patients that achieve an excellent Boston Bowel Preparation score when following the web-based instructions compared to the control arm of patients receiving paper written instructions.

    Baseline

Secondary Outcomes (3)

  • Benefit and satisfaction to patients of this method of patient education.

    Baseline

  • Bowel preparation tolerability with this method of patient education.

    Baseline

  • Use of web-based educational platform

    Baseline

Study Arms (2)

Web Group

EXPERIMENTAL

Patients given web site (aiddly) instructions for colonoscopy

Device: Aiddly (Web Site)

Paper Group

NO INTERVENTION

Patients given paper instructions for colonoscopy

Interventions

A website designed to better educate patients on how to prepare for their colonoscopies

Web Group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 19 or greater
  • Patients scheduled for a colonoscopy using a doctors "normal prep" as outpatients
  • Willing to participate by filling out the survey
  • Must be able to read and understand English
  • Must have ability to use email, have a functioning email account, and are willing to be contacted by email.

You may not qualify if:

  • Unable to speak English
  • Unwilling to participate in reading online materials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 2K5, Canada

Location

Related Publications (16)

  • 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.

    PMID: 17652123BACKGROUND
  • 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.

    PMID: 17611916BACKGROUND
  • 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.

    PMID: 20082216BACKGROUND
  • 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.

    PMID: 12557158BACKGROUND
  • 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.

    PMID: 8247072BACKGROUND
  • 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.

    PMID: 7654107BACKGROUND
  • 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.

    PMID: 12838225BACKGROUND
  • 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.

    PMID: 15758907BACKGROUND
  • 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: 11419832BACKGROUND
  • 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.

    PMID: 12135020BACKGROUND
  • 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.

    PMID: 17269992BACKGROUND
  • 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.

    PMID: 16630226BACKGROUND
  • 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.

    PMID: 24949604BACKGROUND
  • 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.

    PMID: 16336556BACKGROUND
  • 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.

    PMID: 23381511BACKGROUND
  • 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.

    PMID: 23954647BACKGROUND

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Robert Enns, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 13, 2015

First Posted

June 9, 2015

Study Start

March 1, 2015

Primary Completion

May 1, 2016

Study Completion

June 1, 2017

Last Updated

October 26, 2017

Record last verified: 2017-10

Locations