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AzTrials

Colon CancerNCT02466724

Study on the Impact of Education Website on the Quality of Outpatient Bowel Preparation for Colonoscopy

A study testing Aiddly (Web Site) in people with Colon Cancer, run by University of British Columbia at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Colon Cancer
What is being tested?
Aiddly (Web Site)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
900 participants
Where
1 siteCanada
Study dates
Mar 2015to Jun 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • St. Paul's Hospital

    Vancouver, British Columbia, V6Z 2K5

Other trials in Canada

About this study

Official title: Randomized Prospective Study on the Impact of the Patient Education Website on the Quality of Outpatient Bowel Preparation for Colonoscopy

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.

Read the detailed description

This study is a prospective randomized trial. Four hundred and fifty consecutive eligible patients will be randomized to ideally have two hundred and twenty five patients in each arm. Those who will have traditional paper based instructions and those who will be using an online system. Both groups will receive their instructions by the research assistant prior to leaving the office after being consented. The paper based instructions will be given as a handout and those in the online group will receive their bowel preparation instructions via an email sent by a scheduling assistant

Conditions
Colon Cancer
Being tested
Aiddly (Web Site)
Medical subject headings
Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aiddly (Web Site)Device

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

Study groups in NCT02466724
Study groupRoleWhat they receive
Web GroupExperimentalPatients given web site (aiddly) instructions for colonoscopy
Receives: Device: Aiddly (Web Site)
Paper GroupNo interventionPatients given paper instructions for colonoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline

Secondary outcomes (3)

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

    To determine through follow-up survey the benefit and satisfaction to patients of this method of patient education.

    Measured: Baseline

  2. Bowel preparation tolerability with this method of patient education.

    To determine through follow-up survey differences in bowel preparation tolerability with this method of patient education.

    Measured: Baseline

  3. Use of web-based educational platform

    To determine the number of patients who cannot use or participate in the web-based educational platform and through survey results determine limiting factors of access and use.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionMay 2016
  4. Study completionJun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
900 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02466724
Sponsor's protocol ID
H14-02390
Status last verified
Oct 2017
First submitted
13 May 2015
Last updated
26 Oct 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 17652123

  • 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.

    PubMed 17611916

  • 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.

    PubMed 20082216

  • 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.

    PubMed 12557158

  • 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.

    PubMed 8247072

  • 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.

    PubMed 7654107

  • 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.

    PubMed 12838225

  • 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.

    PubMed 15758907

  • 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.

    PubMed 11419832

  • 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.

    PubMed 12135020

  • 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.

    PubMed 17269992

  • 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.

    PubMed 16630226

  • 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.

    PubMed 24949604

  • 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.

    PubMed 16336556

  • 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.

    PubMed 23381511

Questions about this trial

What is this clinical trial studying?

A study testing Aiddly (Web Site) in people with Colon Cancer, run by University of British Columbia at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patients with Excelent Colonoscopy preparation (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02466724, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2017.

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