Bowel PreparationNCT02140827
Instant Messaging Program (Wechat) Improve the Quality of Bowel Preparation
A study testing IMP interactive education in people with Bowel Preparation, run by Air Force Military Medical University, China at 3 sites in China.
Trial summary
Colonoscopy is the gold standard in the diagnosis of colorectal disease. The success of colonoscopy depends on high-quality bowel preparation by patients. Inadequate bowel cleansing reduces the cecal intubation rate, and the polyp detection rate (PDR). It also increases costs, mostly due to repeated procedures. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bowel Preparation
- What is being tested?
- IMP interactive education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 770 participants
- Where
- 3 sitesChina
- Study dates
- May 2014to Dec 2014
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-80
- PEG as purgatives;
- using we-chat software by patients or their relatives
- outpatients
Who cannot join
- history of colorectal surgery
- known severe colonic stricture or obstructing tumor
- known or suspected bowel obstruction or perforation
- pregnant or lactating women
- patients who cannot give informed consent
Trial locations and contacts
3 sites in 1 country.
China3 sites
Department of gastroenterology, Chancheng Central Hospital of Foshan
Foshan, Guangdong, 528000
Department of gastroenterology, Shaanxi Second People's Hospital
Xi'an, Shaanxi, 710032
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, 710032
About this study
Official title: Communication Through Instant Messaging Program for the Improvement of Bowel Preparation: a Two Centers Study
Colonoscopy is the gold standard in the diagnosis of colorectal disease. The success of colonoscopy depends on high-quality bowel preparation by patients. Inadequate bowel cleansing reduces the cecal intubation rate, and the polyp detection rate (PDR). It also increases costs, mostly due to repeated procedures. The quality of bowel cleansing has remained suboptimal even though numerous different products and regimens have been tested and compared in no fewer than six meta-analyses. Therefore, a completely different approach to improve bowel cleansing is welcome.
Here the investigators assume that instant messaging program (Wechat) delivery the detail and FAQ (Frequently Asked Questions) of bowel preparation instructions would improve the quality of the bowel preparation. The Wechat program has some advantages, 1. Wechat supports over 400 million users, nearly half of the mobile subscribers population in China; 2. Wechat provided a real time communications including voice messages, pictures and text exchange timely; 3.Compare with telephone, Wechat is economical of both time and money; 4. Compare with bowel preparation instructional software and litera or cartoon educational booklet, Wechat is more interactive and responsive.
- Conditions
- Bowel Preparation
- Being tested
- IMP interactive education
- Keywords
- bowel preparation, instant messaging program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMP interactive educationOther
Also called Wechat education
The detail and FAQ (Frequently Asked Questions) of bowel preparation instructions is delivered by Wechat.
| Study group | Role | What they receive |
|---|---|---|
| IMP education | Experimental | patients in this group are educated about bowel preparation by instant messaging program and meanwhile a booklet was also sent to them. Receives: Other: IMP interactive education |
| normal education | No intervention | patients in this group are educated about bowel preparation on the day of reservation by nurse for about 15 minutes and meanwhile a booklet was also sent to them. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate bowel preparation quality at the time of colonoscopy defined by Ottawa score<6
Ottawa score：A)cleanliness of each part of the colon: 0=excellent 1=good 2=fair 3=poor 4=inadequate B)fluid in whole colon: small=0 moderate=1 large=2
The bowel preparation was considered inadequate if (1) inadequate visualization on colonoscopy defined by Ottawa score≥6; (2) the colonoscopy was cancelled because of poor bowel preparation; (3) incompleted colonoscopy because of inadequate bowel preparation (the Ottawa score was rated as 14 when patients with failed colonoscopy because of inadequate bowel preparation).
Measured: up to 5 months
Secondary outcomes (3)
Polyp detection rate
The proportion of participants with at least one polyp in each group
Measured: up to 5 months
Compliance rate to instruction
The proportion of participants compliance to the instructions of diet and bowel preparation in each group
Measured: up to 5 months
Willingness undergo a repeated bowel preparation
The number of participants have a willingness to undergo a repeated bowel preparation if needed
Measured: up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 770 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanglin Pan, Air Force Military Medical University, China
- Investigators
- Yanglin Pan, M.D., Principal investigator, Air Force Military Medical University, ChinaLimei Wang, M.D., Principal investigator, Department of gastroenterology, Shaanxi Second People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02140827
- Sponsor's protocol ID
- 20140508-5
- Other IDs
- 20140508-5
- Status last verified
- Dec 2014
- First submitted
- 14 May 2014
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 26492848
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communication Through Instant Messaging Program for the Improvement of Bowel Preparation: a Two Centers Study
- ClinicalTrials.gov ID
- NCT02140827
- Acronym / sponsor ID
- 20140508-5
- Conditions
- Bowel Preparation
- Keywords
- bowel preparation, instant messaging program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 770 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 16 May 2014 (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.
Colonoscopy is the gold standard in the diagnosis of colorectal disease. The success of colonoscopy depends on high-quality bowel preparation by patients. Inadequate bowel cleansing reduces the cecal intubation rate, and the polyp detection rate (PDR). It also increases costs, mostly due to repeated procedures. The quality of bowel cleansing has remained suboptimal even though numerous different products and regimens have been tested and compared in no fewer than six meta-analyses. Therefore, a completely different approach to improve bowel cleansing is welcome.
Here the investigators assume that instant messaging program (Wechat) delivery the detail and FAQ (Frequently Asked Questions) of bowel preparation instructions would improve the quality of the bowel preparation. The Wechat program has some advantages, 1. Wechat supports over 400 million users, nearly half of the mobile subscribers population in China; 2. Wechat provided a real time communications including voice messages, pictures and text exchange timely; 3.Compare with telephone, Wechat is economical of both time and money; 4. Compare with bowel preparation instructional software and litera or cartoon educational booklet, Wechat is more interactive and responsive.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMP education | Experimental | Other: IMP interactive educationpatients in this group are educated about bowel preparation by instant messaging program and meanwhile a booklet was also sent to them. |
| normal education | No intervention | –patients in this group are educated about bowel preparation on the day of reservation by nurse for about 15 minutes and meanwhile a booklet was also sent to them. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18-80
- PEG as purgatives;
- using we-chat software by patients or their relatives
- outpatients
Key exclusion criteria (5 listed)
- history of colorectal surgery
- known severe colonic stricture or obstructing tumor
- known or suspected bowel obstruction or perforation
- pregnant or lactating women
- patients who cannot give informed consent
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 |
|---|---|---|
| IMP interactive educationAlso: Wechat educationThe detail and FAQ (Frequently Asked Questions) of bowel preparation instructions is delivered by Wechat. | Other | IMP education |
Primary outcome
Adequate bowel preparation quality at the time of colonoscopy defined by Ottawa score<6
Time frame: up to 5 months
Ottawa score：A)cleanliness of each part of the colon: 0=excellent 1=good 2=fair 3=poor 4=inadequate B)fluid in whole colon: small=0 moderate=1 large=2 The bowel preparation was considered inadequate if (1) inadequate visualization on colonoscopy defined by Ottawa score≥6; (2) the colonoscopy was cancelled because of poor bowel preparation; (3) incompleted colonoscopy because of inadequate bowel preparation (the Ottawa score was rated as 14 when patients with failed colonoscopy because of inadequate bowel preparation).
3 secondary outcomes
Polyp detection rate
Time frame: up to 5 months
Compliance rate to instruction
Time frame: up to 5 months
Willingness undergo a repeated bowel preparation
Time frame: up to 5 months
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 23 Dec 2014.
- Derived from this study: PubMed 26492848Kang 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.
Related trials for Bowel Preparation
Recruiting
Visual Aids for Colonoscopy Preparation: A Prospective Study on Patient Understanding and Bowel Cleanliness in Colonoscopy Patients
The Effect of Audio-visual Aids on Bowel Cleanliness, Audiovisual Aids
Not yet recruiting
Dose-Escalated Short-Course Proton Therapy for Locally Advanced Rectal Cancer
Locally Advanced Rectal Cancer, Rectal Adenocarcinoma
Not yet recruiting
Social Software-Based Intelligent Management System for Bowel Preparation
Colorectal Polyp, Colorectal Adenoma
Not yet recruiting
Mechanical Bowel Preparation Prior To Sphincter-Sparing Surgery For Complex Anal Fistulae
Anal Fistula, Rectal Fistula
RecruitingPhase 4
Bisacodyl Oral for Lowering Dysfunction (of Tenckhoff Catheter)
Renal Failure Chronic Requiring Dialysis, Peritoneal Dialysis
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.
Yanglin Pan, M.D. principal investigator
Air Force Military Medical University, China
Limei Wang, M.D. principal investigator
Department of gastroenterology, Shaanxi Second People's Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMP interactive education in people with Bowel Preparation, run by Air Force Military Medical University, China at 3 sites in China.
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 4 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 23 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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?
Adequate bowel preparation quality at the time of colonoscopy defined by Ottawa score<6 (time frame: up to 5 months). 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 NCT02140827, which also lists 1 linked publication.
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 23 Dec 2014.