Colon CancerNCT02804737
Impact of Patient Education Website on the Quality of Outpatient Bowel Preparation for Colonoscopy
An observational study of Colon Cancer, run by University of British Columbia at 1 site in Canada.
Trial summary
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. 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
- How many people
- 160 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2014to Jul 2015
- Phase
- Observational
- 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
Study population: Patients who have been scheduled for a colonoscopy as outpatients
Who may be able to join
- Patients scheduled for a colonoscopy as outpatients
Who cannot join
- Unable to speak English
- Unwilling to participate in reading online materials
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- 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 group | Role | What they receive |
|---|---|---|
| Web Group | Patients given web site (aiddly) instructions for colonoscopy Receives: Device: Aiddly (Web Site) | |
| Paper Group | Patients given paper instructions for colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of Web-based instructions
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.
Measured: Time 0
Secondary outcomes (1)
Benefit of web-based instructions
Determine through a survey the benefit to patients of this method of education.
Measured: Time 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startJul 2014
- Primary completionSep 2014
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Enns, University of British Columbia
- Investigators
- Robert Enns, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804737
- Sponsor's protocol ID
- H14-00468
- Status last verified
- Mar 2018
- First submitted
- 11 May 2015
- Last updated
- 13 Mar 2018
- 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 17652123Park 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 17611916Unger 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 20082216Winawer 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 12557158Winawer 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 8247072Muller 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 7654107Harewood 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 12838225Froehlich 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 15758907Ness 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 11419832Rex 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 12135020Belsey 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 17269992Tan 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 16630226Holt 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 24949604Hibbard 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 16336556Hibbard 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Patient Education Website on the Quality of Outpatient Bowel Preparation for Colonoscopy
- ClinicalTrials.gov ID
- NCT02804737
- Acronym / sponsor ID
- H14-00468
- Conditions
- Colon Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 17 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web Group | – | Device: Aiddly (Web Site)Patients given web site (aiddly) instructions for colonoscopy |
| Paper Group | – | –Patients given paper instructions for colonoscopy |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been scheduled for a colonoscopy as outpatients
Key inclusion criteria (1 listed)
- Patients scheduled for a colonoscopy as outpatients
Key exclusion criteria (2 listed)
- Unable to speak English
- Unwilling to participate in reading online materials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aiddly (Web Site)A website designed to better educate patients on how to prepare for their colonoscopies | Device | Web Group |
Primary outcome
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.
1 secondary outcome
Benefit of web-based instructions
Time frame: Time 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
- Background: PubMed 17652123Rex 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.
- Background: PubMed 17611916Park 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.
- Background: PubMed 20082216Unger 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.
- Background: PubMed 12557158Winawer 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.
- Background: PubMed 8247072Winawer 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.
- Background: PubMed 7654107Muller 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.
- Background: PubMed 12838225Harewood 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.
- Background: PubMed 15758907Froehlich 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.
- Background: PubMed 11419832Ness 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.
- Background: PubMed 12135020Rex 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.
- Background: PubMed 17269992Belsey 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.
- Background: PubMed 16630226Tan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Enns, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 1 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 13 Mar 2018. 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?
Effectiveness of Web-based instructions (time frame: Time 0). 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 NCT02804737, 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 13 Mar 2018.