NCT02832869

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 14, 2016

Completed
18 days until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

June 20, 2017

Status Verified

June 1, 2017

Enrollment Period

11 months

First QC Date

July 12, 2016

Last Update Submit

June 17, 2017

Conditions

Bowel Preparation ScaleAdenoma Detection Rate

Keywords

Polyp detection rateAdenoma detection rateBoston Bowel Preparation Scale

Outcome Measures

Primary Outcomes (1)

  • 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

    1 day

Secondary Outcomes (2)

  • polyp detection rate

    1 day

  • Patient compliance using a pre-procedure questionnaire

    1 day

Study Arms (3)

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.

Other: short message service based re-education

Wechat

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.

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

Interventions

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.

short message service
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.

Wechat

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 18-80 years
  • can access to Wechat themselves or through close family members living in the same household

You may not qualify if:

  • inpatients
  • pregnancy
  • breast feeding
  • history of colorectal surgery
  • patients allergic to PEG-ELS based laxatives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Related Publications (2)

  • 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.

    PMID: 26492848RESULT

  • Lee 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.

    PMID: 26182387RESULT

Central Study Contacts

Li zhao shen, Prof

CONTACT

+86-21-31161335zhaosli@gmail.com

bai yu, M.D

CONTACT

+86-21-31161335baiyu1998@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Head of Department of Gastroenterology, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

July 12, 2016

First Posted

July 14, 2016

Study Start

August 1, 2016

Primary Completion

July 1, 2017

Study Completion

December 1, 2017

Last Updated

June 20, 2017

Record last verified: 2017-06

Locations

CN(1)