Bowel PreparationPhase 3NCT01911052
The Impact of Telephone and Short Message System Based Education on Bowel Preparation for Colonoscopy
A Phase 3 study testing Telephone based re-education and Short message system based re-education in people with Bowel Preparation, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
Trial summary
Inadequate bowel preparation results in decreased rates of cecal intubation, increased rates of missing important lesions, increased patient discomfort, higher risk of complications, prolonged procedure time and increased health-care cost. Read more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Bowel Preparation
- What is being tested?
- Telephone based re-education and Short message system based re-education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2013to Feb 2014
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All health screened populations
- age >18
- scheduled for an elective screening colonoscopy
Who cannot join
- inpatients
- pregnancy
- breast feeding
- prior history of surgical large bowel resection
- patients allergic to PEG-ELS based laxatives
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Telephone and Short Message System Based Education on Bowel Preparation for Colonoscopy in Health Screened Population
Inadequate bowel preparation results in decreased rates of cecal intubation, increased rates of missing important lesions, increased patient discomfort, higher risk of complications, prolonged procedure time and increased health-care cost. Recent study reported that Telephone-based re-education (TRE) on the day before colonoscopy significantly improved the quality of bowel preparation and polyp detection rate. However, there is no study to compare the effect of telephone with short message system (SMS) based re-education on the quality of bowel preparation in health screened population. Our goal is to improve the quality of bowel preparation with telephone or SMS based re-education for outpatients undergoing screening colonoscopies. The investigators hypothesise that efforts to improve education and maximise patient compliance during the preparatory period will enhance the efficacy of bowel preparation.
- Conditions
- Bowel Preparation
- Being tested
- Telephone based re-education, Short message system based re-education
- Keywords
- Bowel preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone based re-educationOther
The investigational, or experimental arm, will receive standard written instructions on preparing for a colonoscopy plus intervention such as telephone based re-education by one investigator on the day before colonoscopy.
Short message system based re-educationOther
The investigational, or experimental arm, will receive standard written instructions on preparing for a colonoscopy plus intervention such as short message system based re-education by one investigator on the day before colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The investigational, or experimental arm, will receive standard written instructions on preparing for a colonoscopy plus intervention such as telephone based re-education by one investigator on the day before colonoscopy. Receives: Other: Telephone based re-education |
| Standard preparation instructions | No intervention | The control arm will receive written instruction on preparing for a colonoscopy per standard of care at Keimyung University Dongsan Medical Center |
| Interventional | Experimental | The investigational, or experimental arm, will receive standard written instructions on preparing for a colonoscopy plus intervention such as short message system based re-education by one investigator on the day before colonoscopy. Receives: Other: Short message system based re-education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of bowel preparation
The primary outcomes will be the endoscopist's assessment of the quality of preparation using Boston and Ottawa bowel preparation scare
Measured: day 1
Secondary outcomes (1)
polyp detection rate
The number of polyp prescribed by endoscopist.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bowel PreparationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim Eun Soo, Keimyung University Dongsan Medical Center
- Investigators
- Eun Soo Kim, Professor, Principal investigator, Keimyung University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01911052
- Sponsor's protocol ID
- 2013-05-050-002
- Status last verified
- Jul 2014
- First submitted
- 22 Jul 2013
- Last updated
- 17 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23503044Lee YJ, Kim ES, Choi JH, Lee KI, Park KS, Cho KB, Jang BK, Chung WJ, Hwang JS. Impact of reinforced education by telephone and short message service on the quality of bowel preparation: a randomized controlled study. Endoscopy. 2015 Nov;47(11):1018-27. doi: 10.1055/s-0034-1392406. Epub 2015 Jul 16.
PubMed 26182387
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Telephone and Short Message System Based Education on Bowel Preparation for Colonoscopy in Health Screened Population
- ClinicalTrials.gov ID
- NCT01911052
- Acronym / sponsor ID
- 2013-05-050-002
- Conditions
- Bowel Preparation
- Keywords
- Bowel preparation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 30 Jul 2013 (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.
Inadequate bowel preparation results in decreased rates of cecal intubation, increased rates of missing important lesions, increased patient discomfort, higher risk of complications, prolonged procedure time and increased health-care cost. Recent study reported that Telephone-based re-education (TRE) on the day before colonoscopy significantly improved the quality of bowel preparation and polyp detection rate. However, there is no study to compare the effect of telephone with short message system (SMS) based re-education on the quality of bowel preparation in health screened population. Our goal is to improve the quality of bowel preparation with telephone or SMS based re-education for outpatients undergoing screening colonoscopies. The investigators hypothesise that efforts to improve education and maximise patient compliance during the preparatory period will enhance the efficacy of bowel preparation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Telephone based re-educationThe investigational, or experimental arm, will receive standard written instructions on preparing for a colonoscopy plus intervention such as telephone based re-education by one investigator on the day before colonoscopy. |
| Standard preparation instructions | No intervention | –The control arm will receive written instruction on preparing for a colonoscopy per standard of care at Keimyung University Dongsan Medical Center |
| Interventional | Experimental | Other: Short message system based re-educationThe investigational, or experimental arm, will receive standard written instructions on preparing for a colonoscopy plus intervention such as short message system based re-education by one investigator on the day before colonoscopy. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All health screened populations
- age >18
- scheduled for an elective screening colonoscopy
Key exclusion criteria (5 listed)
- inpatients
- pregnancy
- breast feeding
- prior history of surgical large bowel resection
- patients allergic to PEG-ELS based laxatives
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 |
|---|---|---|
| Telephone based re-educationThe investigational, or experimental arm, will receive standard written instructions on preparing for a colonoscopy plus intervention such as telephone based re-education by one investigator on the day before colonoscopy. | Other | Intervention |
| Short message system based re-educationThe investigational, or experimental arm, will receive standard written instructions on preparing for a colonoscopy plus intervention such as short message system based re-education by one investigator on the day before colonoscopy. | Other | Interventional |
Primary outcome
Quality of bowel preparation
Time frame: day 1
The primary outcomes will be the endoscopist's assessment of the quality of preparation using Boston and Ottawa bowel preparation scare
1 secondary outcome
polyp detection rate
Time frame: day 1
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 17 Jul 2014.
- Background: PubMed 23503044Liu 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.
- Derived from this study: PubMed 26182387Lee YJ, Kim ES, Choi JH, Lee KI, Park KS, Cho KB, Jang BK, Chung WJ, Hwang JS. Impact of reinforced education by telephone and short message service on the quality of bowel preparation: a randomized controlled study. Endoscopy. 2015 Nov;47(11):1018-27. doi: 10.1055/s-0034-1392406. Epub 2015 Jul 16.
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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.
Eun Soo Kim, Professor principal investigator
Keimyung University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Telephone based re-education and Short message system based re-education in people with Bowel Preparation, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
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 3 inclusion and 5 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 17 Jul 2014. 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 South Korea. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Quality of bowel preparation (time frame: day 1). 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 NCT01911052, which also lists 2 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 17 Jul 2014.