NCT02140827

Brief Summary

Colonoscopy is the gold standard in the diagnosis of colorectal disease. The success of colonoscopy depends on high-quality bowel preparation by patients. Inadequate bowel cleansing reduces the cecal intubation rate, and the polyp detection rate (PDR). It also increases costs, mostly due to repeated procedures. The quality of bowel cleansing has remained suboptimal even though numerous different products and regimens have been tested and compared in no fewer than six meta-analyses. Therefore, a completely different approach to improve bowel cleansing is welcome. Here the investigators assume that instant messaging program (Wechat) delivery the detail and FAQ (Frequently Asked Questions) of bowel preparation instructions would improve the quality of the bowel preparation. The Wechat program has some advantages, 1. Wechat supports over 400 million users, nearly half of the mobile subscribers population in China; 2. Wechat provided a real time communications including voice messages, pictures and text exchange timely; 3.Compare with telephone, Wechat is economical of both time and money; 4. Compare with bowel preparation instructional software and litera or cartoon educational booklet, Wechat is more interactive and responsive.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
770

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

Study Start

First participant enrolled

May 1, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 23, 2014

Status Verified

December 1, 2014

Enrollment Period

7 months

First QC Date

May 14, 2014

Last Update Submit

December 20, 2014

Conditions

Keywords

bowel preparationinstant messaging program

Outcome Measures

Primary Outcomes (1)

  • Adequate bowel preparation quality at the time of colonoscopy defined by Ottawa score<6

    Ottawa score:A)cleanliness of each part of the colon: 0=excellent 1=good 2=fair 3=poor 4=inadequate B)fluid in whole colon: small=0 moderate=1 large=2 The bowel preparation was considered inadequate if (1) inadequate visualization on colonoscopy defined by Ottawa score≥6; (2) the colonoscopy was cancelled because of poor bowel preparation; (3) incompleted colonoscopy because of inadequate bowel preparation (the Ottawa score was rated as 14 when patients with failed colonoscopy because of inadequate bowel preparation).

    up to 5 months

Secondary Outcomes (3)

  • Polyp detection rate

    up to 5 months

  • Compliance rate to instruction

    up to 5 months

  • Willingness undergo a repeated bowel preparation

    up to 5 months

Study Arms (2)

IMP education

EXPERIMENTAL

patients in this group are educated about bowel preparation by instant messaging program and meanwhile a booklet was also sent to them.

Other: IMP interactive education

normal education

NO INTERVENTION

patients in this group are educated about bowel preparation on the day of reservation by nurse for about 15 minutes and meanwhile a booklet was also sent to them.

Interventions

The detail and FAQ (Frequently Asked Questions) of bowel preparation instructions is delivered by Wechat.

Also known as: Wechat education
IMP education

Eligibility Criteria

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

You may qualify if:

  • age 18-80
  • PEG as purgatives;
  • using we-chat software by patients or their relatives
  • outpatients

You may not qualify if:

  • history of colorectal surgery
  • known severe colonic stricture or obstructing tumor
  • known or suspected bowel obstruction or perforation
  • pregnant or lactating women
  • patients who cannot give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of gastroenterology, Chancheng Central Hospital of Foshan

Foshan, Guangdong, 528000, China

Location

Department of gastroenterology, Shaanxi Second People's Hospital

Xi'an, Shaanxi, 710032, China

Location

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710032, China

Location

Related Publications (1)

  • 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.

Study Officials

  • Yanglin Pan, M.D.

    Air Force Military Medical University, China

    PRINCIPAL INVESTIGATOR
  • Limei Wang, M.D.

    Department of gastroenterology, Shaanxi Second People's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated professor

Study Record Dates

First Submitted

May 14, 2014

First Posted

May 16, 2014

Study Start

May 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

December 23, 2014

Record last verified: 2014-12

Locations