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WhatsApp Reminder on Bowel Preparation Level

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.


Condition or disease Intervention/treatment Phase
Bowel Preparation WhatsApp Messenger Colonoscopy Other: WhatsApp reminder Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 666 participants
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
Official Title: Can a WhatsApp Reminder Improve the Quality of Screening Colonoscopy? A Randomized Controlled Study
Actual Study Start Date : June 2, 2017
Actual Primary Completion Date : April 17, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

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
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

No Intervention: No reminder
No additional reminder will be given



Primary Outcome Measures :
  1. Bowel preparation level [ Time Frame: Immediate after colonoscopy ]
    Proportion of subjects having optimal bowel preparation level


Secondary Outcome Measures :
  1. Polyp detection rate [ Time Frame: Immediate after colonoscopy ]
    Proportion of subjects having a polyp detected

  2. adenoma detection rate [ Time Frame: a month after colonoscopy ]
    Proportion of subjects having a adenoma detected

  3. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209739


Locations
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Hong Kong
Alice Ho Miu Ling Nethersole Hospital
Hong Kong, Hong Kong
Prince of Wales Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Thomas Yuen Tung Lam, MSc Chinese University of Hong Kong
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Responsible Party: Thomas Yuen Tung Lam, Nursing Officer, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03209739    
Other Study ID Numbers: WhatsApp BPrep Study
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No