- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03209739
WhatsApp Reminder on Bowel Preparation Level
Can a WhatsApp Reminder Improve the Quality of Screening Colonoscopy? A Randomized Controlled Study
It is estimated that there are about 1.4 million patients with colorectal cancer (CRC) worldwide, with a rising trend in CRC incidence in many Asian Pacific countries. In Hong Kong, colorectal cancer ranks first in cancer incidence and second in cancer mortality based on data from 2014.
CRC is one of the most preventable cancers because its development in general follows an adenoma-carcinoma sequence. Adenomas are considered precursor lesions for CRC. Recent guidelines from USA, Europe and Asia Pacific region recommend CRC screening for average-risk asymptomatic individuals starting at age 50. Modalities such as guaiac-based fecal occult blood tests (gFOBT), fecal immunochemical tests (FIT), flexible sigmoidoscopy (FS), and colonoscopy are among the acceptable options for CRC screening.
While early detection and removal of colorectal adenoma by screening colonoscopy with polypectomy reduce CRC incidence and mortality, interval cancers (cancers that develop after a colonoscopy and before the next scheduled colonoscopy) may still occur and were reported to account for up to 10.5% of CRC. a CRC has been associated with proximal colon location, small lesion, flat lesion, missed lesion, inadequate examination, incomplete resection of lesion, tumor biology, and low adenoma detection rate (ADR). High ADR (eg, ≥ 20%) has been associated with a reduced risk of interval CRC.
Bowel preparation includes diet restriction and proper use of laxative before the colonoscopy, and this is one of the important factors to ensure a high quality colonoscopy. Suboptimal bowel preparation may lead to decreased ADR, cecal intubation rate, and surveillance interval and increased procedural time. Efforts to improve bowel cleansing quality through traditional communication routines, including face-to-face verbal education, written booklet or visual aids or telephone-based re-instruction have proven to be useful. A recent study using WeChat, a widely used social media mobile app in China, has also shown to be effectively improving bowel preparation level of a mixed population who received diagnostic (77%), screening (15.8%) and surveillance (7.2%) colonoscopy. However, the impact of social media mobile app on the bowel preparation level of screening colonoscopy is not yet known. Hence, this study will investigate the effectiveness of the most popular social media app worldwide, WhatsApp in bowel preparation level of screening colonoscopy.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
It is estimated that there are about 1.4 million patients with colorectal cancer (CRC) worldwide, with a rising trend in CRC incidence in many Asian Pacific countries. In Hong Kong, colorectal cancer ranks first in cancer incidence and second in cancer mortality based on data from 2014.
CRC is one of the most preventable cancers because its development in general follows an adenoma-carcinoma sequence. Adenomas are considered precursor lesions for CRC. Recent guidelines from USA, Europe and Asia Pacific region recommend CRC screening for average-risk asymptomatic individuals starting at age 50. Modalities such as guaiac-based fecal occult blood tests (gFOBT), fecal immunochemical tests (FIT), flexible sigmoidoscopy (FS), and colonoscopy are among the acceptable options for CRC screening.
While early detection and removal of colorectal adenoma by screening colonoscopy with polypectomy reduce CRC incidence and mortality, interval cancers (cancers that develop after a colonoscopy and before the next scheduled colonoscopy) may still occur and were reported to account for up to 10.5% of CRC. a CRC has been associated with proximal colon location, small lesion, flat lesion, missed lesion, inadequate examination, incomplete resection of lesion, tumor biology, and low adenoma detection rate (ADR). High ADR (eg, ≥ 20%) has been associated with a reduced risk of interval CRC.
Bowel preparation includes diet restriction and proper use of laxative before the colonoscopy, and this is one of the important factors to ensure a high quality colonoscopy. Suboptimal bowel preparation may lead to decreased ADR, cecal intubation rate, and surveillance interval and increased procedural time. Efforts to improve bowel cleansing quality through traditional communication routines, including face-to-face verbal education, written booklet or visual aids or telephone-based re-instruction have proven to be useful. A recent study using WeChat, a widely used social media mobile app in China, has also shown to be effectively improving bowel preparation level of a mixed population who received diagnostic (77%), screening (15.8%) and surveillance (7.2%) colonoscopy. However, the impact of social media mobile app on the bowel preparation level of screening colonoscopy is not yet known. Hence, this study will investigate the effectiveness of the most popular social media app worldwide, WhatsApp in bowel preparation level of screening colonoscopy.
Subjects already recruited by other studies in Institute of Digestive Disease and arranged for an out-patient screening colonoscopy will be identified and recruited.
Demographic data including age, sex, smoking and alcohol habits, comorbidities, education level, family income, time of using WhatsApp of the eligible subjects will be collected. Subjects will then be randomized to either standard group or WhatsApp group. As a usual practice, all subjects will receive a verbal explanation of bowel preparation by a healthcare professional on the day of appointment making. A detailed written bowel preparation instruction will be also given to subjects.
For subjects randomized to the WhatsApp reminder group, they will receive an additional WhatsApp reminder with same content of the written instruction and a video of explanation of bowel preparation by a nurse 4 days prior colonoscopy. Subjects are encouraged to ask any question regarding the bowel preparation via WhatsApp. All these enquiries will be replied by the principal investigator during office hours.
The colonoscopy results, including, the bowel preparation level and the number and nature of lesion found (if any) will be collected afterwards. Two investigators reviewed all the colonoscopy videos independently to grade the quality of bowel preparation by Boston Bowel Preparation Scale.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hong Kong, Hong Kong
- Prince of Wales Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects arranged for an out-patient screening colonoscopy in Prince of Wales Hospital and Alice Ho Miu Ling Hospital.
Exclusion Criteria:
- Lack of access to WhatsApp Messenger
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: WhatsApp reminder
An additional WhatsApp reminder with same content of the written instruction and a video of explanation of bowel preparation by a nurse 4 days prior colonoscopy
|
An additional WhatsApp reminder with same content of the written instruction and a video of explanation of bowel preparation by a nurse 4 days prior colonoscopy
|
|
No Intervention: No reminder
No additional reminder will be given
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bowel preparation level
Time Frame: Immediate after colonoscopy
|
Proportion of subjects having optimal bowel preparation level
|
Immediate after colonoscopy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Polyp detection rate
Time Frame: Immediate after colonoscopy
|
Proportion of subjects having a polyp detected
|
Immediate after colonoscopy
|
|
adenoma detection rate
Time Frame: a month after colonoscopy
|
Proportion of subjects having a adenoma detected
|
a month after colonoscopy
|
|
Mean number of adenoma detected per patient
Time Frame: 1 year after study started, i.e. when all subjects undergo colonoscopy
|
Mean number of adenoma detected per patient
|
1 year after study started, i.e. when all subjects undergo colonoscopy
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thomas Yuen Tung Lam, MSc, Chinese University of Hong Kong
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- WhatsApp BPrep Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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