- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02832869
Impact of Reinforced Education by Wechat and Short Message Service on the Quality of Bowel Preparation
June 17, 2017 updated by: Zhaoshen Li, Changhai Hospital
High quality bowel preparation is essential for successful colonoscopy.
This study aimed to assess the impact of reinforced education by Wechat or short message service (SMS) on the quality of bowel preparation.
This prospective, endoscopist-blinded, randomized, controlled study was conducted.
Reinforced education groups received additional education via reminders by Wechat or SMS 2 days before colonoscopy.
The primary outcome was the quality of the bowel preparation according to the Boston Bowel Preparation Scale (BBPS).
The secondary outcomes included polyp detection rate (PDR), adenoma detection rate (ADR), tolerance, and subjective feelings of patients.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
450
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Li zhao shen, Prof
- Phone Number: +86-21-31161335
- Email: zhaosli@gmail.com
Study Contact Backup
- Name: bai yu, M.D
- Phone Number: +86-21-31161335
- Email: baiyu1998@hotmail.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200433
- Changhai Hospital
-
-
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
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- aged 18-80 years
- can access to Wechat themselves or through close family members living in the same household
Exclusion Criteria:
- inpatients
- pregnancy
- breast feeding
- history of colorectal surgery
- 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: short message service
The patients 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 patients 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.
|
Experimental: Wechat
The patients will receive standard written instructions on preparing for a colonoscopy plus intervention such as Wechat based re-education by one investigator on the day before colonoscopy.
|
The patients will receive standard written instructions on preparing for a colonoscopy plus intervention such as Wechat 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of bowel preparation using Boston Bowel Preparation Scale
Time Frame: 1 day
|
The primary outcomes will be the endoscopist's assessment of the quality of preparation using Boston Bowel Preparation Scale
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
polyp detection rate
Time Frame: 1 day
|
The number of polyp prescribed by endoscopist
|
1 day
|
Patient compliance using a pre-procedure questionnaire
Time Frame: 1 day
|
Patient compliance with preparation instructions self-reported in a pre-procedure questionnaire
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- Kang X, Zhao L, Leung F, Luo H, Wang L, Wu J, Guo X, Wang X, Zhang L, Hui N, Tao Q, Jia H, Liu Z, Chen Z, Liu J, Wu K, Fan D, Pan Y, Guo X. Delivery of Instructions via Mobile Social Media App Increases Quality of Bowel Preparation. Clin Gastroenterol Hepatol. 2016 Mar;14(3):429-435.e3. doi: 10.1016/j.cgh.2015.09.038. Epub 2015 Oct 20.
- 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
August 1, 2016
Primary Completion (Anticipated)
July 1, 2017
Study Completion (Anticipated)
December 1, 2017
Study Registration Dates
First Submitted
July 12, 2016
First Submitted That Met QC Criteria
July 13, 2016
First Posted (Estimate)
July 14, 2016
Study Record Updates
Last Update Posted (Actual)
June 20, 2017
Last Update Submitted That Met QC Criteria
June 17, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Wechat-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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.
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