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WhatsApp Reminder on Bowel Preparation Level

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ClinicalTrials.gov Identifier: NCT03209739
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : May 28, 2020
Sponsor:
Information provided by (Responsible Party):
Thomas Yuen Tung Lam, Chinese University of Hong Kong

Tracking Information
First Submitted Date  ICMJE July 4, 2017
First Posted Date  ICMJE July 6, 2017
Last Update Posted Date May 28, 2020
Actual Study Start Date  ICMJE June 2, 2017
Actual Primary Completion Date April 17, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 4, 2017)
Bowel preparation level [ Time Frame: Immediate after colonoscopy ]
Proportion of subjects having optimal bowel preparation level
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 4, 2017)
  • Polyp detection rate [ Time Frame: Immediate after colonoscopy ]
    Proportion of subjects having a polyp detected
  • adenoma detection rate [ Time Frame: a month after colonoscopy ]
    Proportion of subjects having a adenoma detected
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE WhatsApp Reminder on Bowel Preparation Level
Official Title  ICMJE Can a WhatsApp Reminder Improve the Quality of Screening Colonoscopy? A Randomized Controlled Study
Brief Summary

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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
Endoscopists will be masked if the patients have received WhatsApp reminder prior colonoscopy
Primary Purpose: Diagnostic
Condition  ICMJE
  • Bowel Preparation
  • WhatsApp Messenger
  • Colonoscopy
Intervention  ICMJE Other: 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
Study Arms  ICMJE
  • 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
    Intervention: Other: WhatsApp reminder
  • No Intervention: No reminder
    No additional reminder will be given
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 24, 2019)
666
Original Estimated Enrollment  ICMJE
 (submitted: July 4, 2017)
440
Actual Study Completion Date  ICMJE December 31, 2019
Actual Primary Completion Date April 17, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03209739
Other Study ID Numbers  ICMJE WhatsApp BPrep Study
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Thomas Yuen Tung Lam, Chinese University of Hong Kong
Study Sponsor  ICMJE Chinese University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas Yuen Tung Lam, MSc Chinese University of Hong Kong
PRS Account Chinese University of Hong Kong
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP