- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01911052
The Impact of Telephone and Short Message System Based Education on Bowel Preparation for Colonoscopy
July 16, 2014 updated by: Kim Eun Soo, Keimyung University Dongsan Medical Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
390
Phase
- Phase 3
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
-
-
-
Daegu, Korea, Republic of, 700-712
- Eun Soo Kim
-
-
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 to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All health screened populations
- age >18
- scheduled for an elective screening colonoscopy
Exclusion Criteria:
- inpatients
- pregnancy
- breast feeding
- prior history of surgical large bowel resection
- patients allergic to PEG-ELS based laxatives
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
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.
|
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.
|
|
No Intervention: Standard preparation instructions
The control arm will receive written instruction on preparing for a colonoscopy per standard of care at Keimyung University Dongsan Medical Center
|
|
|
Experimental: Interventional
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
polyp detection rate
Time Frame: day 1
|
The number of polyp prescribed by endoscopist.
|
day 1
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient compliance
Time Frame: baseline
|
Patient compliance with preparation instructions self-reported in a pre-procedure questionnaire
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Eun Soo Kim, Professor, Keimyung University School of Medicine
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
- 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.
- Lee 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.
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, 2013
Primary Completion (Actual)
February 1, 2014
Study Completion (Actual)
February 1, 2014
Study Registration Dates
First Submitted
July 22, 2013
First Submitted That Met QC Criteria
July 26, 2013
First Posted (Estimate)
July 30, 2013
Study Record Updates
Last Update Posted (Estimate)
July 17, 2014
Last Update Submitted That Met QC Criteria
July 16, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2013-05-050-002
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 Bowel Preparation
-
Universitaire Ziekenhuizen KU LeuvenNorgine BVActive, not recruitingHealthy | Bowel Preparation | Bowel Preparation for Colonoscopy | Bowel Cleansing for ColonoscopyBelgium
-
University of British ColumbiaCompletedEfficacy of Bowel Preparation | Ease of Bowel Preparation and Patient TolerabilityCanada
-
Alexandra Hospital, Athens, GreeceRecruitingBowel Preparation | Preparation for ColonoscopyGreece
-
Inje UniversityUnknownBOWEL PREPARATION (BOWEL CLEANSING)Korea, Republic of
-
Joseph SpataroHappy Colon FoodsCompletedAssessment of Safety, Quality, and Acceptance of a Bowel Preparation Using a Food Kit With LaxativesBowel Preparation for Colonoscopy | Colon Cancer Screening | Bowel Preparation, Efficacy, Tolerability, SafetyUnited States
-
Hitit UniversityNot yet recruitingBowel PreparationTurkey
-
Ferring PharmaceuticalsRecruitingBowel PreparationUnited States
-
Fu Jen Catholic University HospitalCompleted
-
Jinling Hospital, ChinaCompleted
-
Tongji HospitalCompleted
Clinical Trials on Telephone based re-education
-
First Affiliated Hospital Xi'an Jiaotong UniversityCompleted
-
Shandong UniversityCompleted
-
Changhai HospitalUnknownAdenoma Detection Rate | Bowel Preparation ScaleChina
-
Shandong UniversityUnknownHelicobacter Pylori Eradication RateChina
-
VA Office of Research and DevelopmentCompleted
-
University of Kansas Medical CenterEunice Kennedy Shriver National Institute of Child Health and Human Development...Completed
-
Saglik Bilimleri UniversitesiActive, not recruitingHIV Infections | Sexual BehaviorTurkey (Türkiye)
-
Taipei Medical UniversityNational Science and Technology CouncilNot yet recruiting
-
University of WashingtonU.S. Department of EducationCompletedBrain InjuriesUnited States
-
Universidad de GranadaUnknownChronic Obstructive Pulmonary DiseaseSpain