Instant Messaging Program (Wechat) Improve the Quality of Bowel Preparation

Bowel Preparation Clinical Trial

Official title:

Communication Through Instant Messaging Program for the Improvement of Bowel Preparation: a Two Centers Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02140827
• Other study ID #: 20140508-5
• Secondary ID: 20140508-5
• Status: Completed
• Phase: N/A
• First received: May 14, 2014
• Last updated: December 20, 2014
• Start date: May 2014
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Fourth Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 770
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• age 18-80

• PEG as purgatives;

• using we-chat software by patients or their relatives

• outpatients

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Screening

Related Conditions & MeSH terms

• Bowel Preparation

Intervention

Other:
• IMP interactive education
The detail and FAQ (Frequently Asked Questions) of bowel preparation instructions is delivered by Wechat.

Locations

Country	Name	City	State
China	Department of gastroenterology, Chancheng Central Hospital of Foshan	Foshan	Guangdong
China	Department of gastroenterology, Shaanxi Second People's Hospital	Xi'an	Shaanxi
China	Xijing Hospital of Digestive Diseases	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Polyp detection rate	The proportion of participants with at least one polyp in each group	up to 5 months	No
Secondary	Compliance rate to instruction	The proportion of participants compliance to the instructions of diet and bowel preparation in each group	up to 5 months	No
Secondary	Willingness undergo a repeated bowel preparation	The number of participants have a willingness to undergo a repeated bowel preparation if needed	up to 5 months	No