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Impact of Reinforced Education by Wechat and Short Message Service on the Quality of Bowel Preparation

Primary Purpose

Bowel Preparation Scale, Adenoma Detection Rate

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
short message service based re-education
Wechat based re-education
Sponsored by
Changhai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bowel Preparation Scale focused on measuring Polyp detection rate, Adenoma detection rate, Boston Bowel Preparation Scale

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Changhai Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

short message service

Wechat

Standard preparation instructions

Arm Description

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.

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.

The control arm will receive written instruction on preparing for a colonoscopy per standard of care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

polyp detection rate
The number of polyp prescribed by endoscopist
Patient compliance using a pre-procedure questionnaire
Patient compliance with preparation instructions self-reported in a pre-procedure questionnaire

Full Information

First Posted
July 12, 2016
Last Updated
June 17, 2017
Sponsor
Changhai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02832869
Brief Title
Impact of Reinforced Education by Wechat and Short Message Service on the Quality of Bowel Preparation
Official Title
Impact of Reinforced Education by Wechat and Short Message Service on the Quality of Bowel Preparation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bowel Preparation Scale, Adenoma Detection Rate
Keywords
Polyp detection rate, Adenoma detection rate, Boston Bowel Preparation Scale

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
short message service
Arm Type
Experimental
Arm Description
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.
Arm Title
Wechat
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard preparation instructions
Arm Type
No Intervention
Arm Description
The control arm will receive written instruction on preparing for a colonoscopy per standard of care
Intervention Type
Other
Intervention Name(s)
short message service based re-education
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Wechat based re-education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality of bowel preparation using Boston Bowel Preparation Scale
Description
The primary outcomes will be the endoscopist's assessment of the quality of preparation using Boston Bowel Preparation Scale
Time Frame
1 day
Secondary Outcome Measure Information:
Title
polyp detection rate
Description
The number of polyp prescribed by endoscopist
Time Frame
1 day
Title
Patient compliance using a pre-procedure questionnaire
Description
Patient compliance with preparation instructions self-reported in a pre-procedure questionnaire
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: aged 18-80 years can access to Wechat themselves or through close family members living in the same household Exclusion Criteria: inpatients pregnancy breast feeding history of colorectal surgery patients allergic to PEG-ELS based laxatives
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li zhao shen, Prof
Phone
+86-21-31161335
Email
zhaosli@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
bai yu, M.D
Phone
+86-21-31161335
Email
baiyu1998@hotmail.com
Facility Information:
Facility Name
Changhai Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26492848
Citation
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.
Results Reference
result
PubMed Identifier
26182387
Citation
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.
Results Reference
result

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Impact of Reinforced Education by Wechat and Short Message Service on the Quality of Bowel Preparation

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