Bowel Preparation ScalePhase 4NCT02832869
Impact of Reinforced Education by Wechat and Short Message Service on the Quality of Bowel Preparation
A Phase 4 study testing short message service based re-education and Wechat based re-education in people with Bowel Preparation Scale and Adenoma Detection Rate, run by Changhai Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Bowel Preparation Scale, Adenoma Detection Rate
- What is being tested?
- short message service based re-education and Wechat based re-education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Dec 2017
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 18-80 years
- can access to Wechat themselves or through close family members living in the same household
Who cannot join
- inpatients
- pregnancy
- breast feeding
- history of colorectal surgery
- patients allergic to PEG-ELS based laxatives
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Bowel Preparation Scale, Adenoma Detection Rate
- Being tested
- short message service based re-education, Wechat based re-education
- Keywords
- Polyp detection rate, Adenoma detection rate, Boston Bowel Preparation Scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
short message service based re-educationOther
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.
Wechat based re-educationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| short message service | Experimental | 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. Receives: Other: short message service based re-education |
| Experimental | 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. Receives: Other: Wechat based re-education | |
| Standard preparation instructions | No intervention | The control arm will receive written instruction on preparing for a colonoscopy per standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of bowel preparation using Boston Bowel Preparation Scale
The primary outcomes will be the endoscopist's assessment of the quality of preparation using Boston Bowel Preparation Scale
Measured: 1 day
Secondary outcomes (2)
polyp detection rate
The number of polyp prescribed by endoscopist
Measured: 1 day
Patient compliance using a pre-procedure questionnaire
Patient compliance with preparation instructions self-reported in a pre-procedure questionnaire
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionJul 2017 (estimated)
- Study completionDec 2017 (estimated)
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 Preparation ScaleStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832869
- Sponsor's protocol ID
- Wechat-01
- Status last verified
- Jun 2017
- First submitted
- 12 Jul 2016
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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 26492848Lee 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 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Reinforced Education by Wechat and Short Message Service on the Quality of Bowel Preparation
- ClinicalTrials.gov ID
- NCT02832869
- Acronym / sponsor ID
- Wechat-01
- Conditions
- Bowel Preparation Scale, Adenoma Detection Rate
- Keywords
- Polyp detection rate, Adenoma detection rate, Boston Bowel Preparation Scale
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 14 Jul 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| short message service | Experimental | Other: short message service based re-educationThe 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 | Other: Wechat based re-educationThe 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. | |
| Standard preparation instructions | No intervention | –The control arm will receive written instruction on preparing for a colonoscopy per standard of care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged 18-80 years
- can access to Wechat themselves or through close family members living in the same household
Key exclusion criteria (5 listed)
- inpatients
- pregnancy
- breast feeding
- history of colorectal surgery
- 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 |
|---|---|---|
| short message service based re-educationThe 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. | Other | short message service |
| Wechat based re-educationThe 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. | Other |
Primary outcome
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
2 secondary outcomes
polyp detection rate
Time frame: 1 day
Patient compliance using a pre-procedure questionnaire
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Results publication: 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.
- Results publication: 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.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing short message service based re-education and Wechat based re-education in people with Bowel Preparation Scale and Adenoma Detection Rate, run by Changhai Hospital at 1 site 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 2 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: status not confirmed, as of the sponsor's last update on 20 Jun 2017. 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li zhao shen, Prof (+86-21-31161335, zhaosli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of bowel preparation using Boston Bowel Preparation Scale (time frame: 1 day). 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 NCT02832869, 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 20 Jun 2017.