Impact of Artificial Intelligence-based Patient Reinforcement on Quality of Colonoscopy

Bowel Preparation Clinical Trial

— ARCHES  

Official title:

Impact of Artificial Intelligence-based Patient Reinforcement on Quality of Colonoscopy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05041283
• Other study ID #: ARCHES
• Status: Recruiting
• Phase: N/A
• Start date: May 21, 2021
• Est. completion date: February 1, 2022

Study information

• Verified date: September 2021
• Source: University of Ulm
• Contact: Benjamin Walter, MD
• Phone: +49731/5000
• Email: benjamin.walter[@]uniklinik-ulm.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In order to improve bowel preparation for colonoscopy and consequently enhance detection rate of malignant and premalignant findings, a prospective, randomized and controlled three-arm study was developed. Patients who undergo ambulatory colonoscopy are randomly assigned into a control group with standard preparation, a phone call supported preparation group or a group supported by an artificial intelligence based chatbot. Primary endpoint is defined as quality of bowel preparation (Boston Bowel Preparation Score), secondary endpoints are patients satisfaction, comprehensiveness of bowel preparation, sedation dose, rate of coecal intubation and the rate of adenoma and polyp detection, anxiety referred to colonoscopy and patients satisfaction with preparation support.

Description:

Adequate bowel preparation is crucial for detection of adenoma and polyps of the colon, which can transform into malignant and premalignant lesions. In particular ambulatory performed colonoscopy is often insufficient due to inadequate preparation by patients at home. To focus this issue, a artificial intelligence based chatbot was developed to help patients who undergo bowel preparation by answering questions concerning bowel preparation. To compare the effect of this program, a three-arm randomized, controled multicentric clinical trial was developed. All patients who undergo ambulatory colonoscopy and meet the inclusion criteria (18 y.o., informed consent, WhatsApp access) were randomized in a standard preparation group (medical briefing and preparation brochure), a group receiving phone calls with instructions for bowel preparation and a third group with access to the chat bot answering questions concerning bowel preparation and examination conduct. As the primary end point, the quality of bowel preparation measured as Boston Bowel Preparation Scale was defined. As secondary endpoints patients satisfaction, comprehensiveness of bowel preparation, sedation dose, rate of coecal intubation, the rate of adenoma and polyp detection, anxiety referred to colonoscopy and patients satisfaction with preparation support were measured.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 258
• Est. completion date: February 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• informed consent

• smartphone with access to WhatsApp

• indication for ambulatory colonoscopy

• ASA I or II

Exclusion Criteria:

• no informed consent given or possible

• no access to a smartphone with WhatsApp

• <18 years old

• Pregnancy/Lactation

• Allergy to Moviprep©

• ASA (American Society of Anesthesiologists) state >II

• extended abdominal surgery in past history

• no indication for ambulatory colonoscopy

Related Conditions & MeSH terms

• Bowel Preparation

Intervention

Other:
• Chatbot
A artificial-intelligence based chatbot is provided 3 days before colonoscopy to answer questions concerning bowel preparation and colonoscopy conduct.
• Phone call
A phone call is performed every day starting at 3 days before colonoscopy to support bowel preparation.

Locations

Country	Name	City	State
Germany	Specialist Practice	Berlin
Germany	Specialist Practice Profes. Dikopoulos/Ludwig	Ulm	Baden-Würrtemberg
Germany	University of Ulm, Interdisciplinary Endoscopy	Ulm	Baden-Würrtemberg

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of bowel preparation	evaluated with the Boston Bowel Preparation Scale (0-9, 1=worst preparation, 9= best preparation)	During colonoscopy
Secondary	Patients satisfaction with bowel preparation	Via questionnaire; 8 items, ordinal scale with 4 grades (completely satisfied/mainly satisfied/mainly dissatisfied/completely dissatisfied)	Immediately after the intervention
Secondary	Comprehensiveness of bowel preparation	Rate of successfully completed colonoscopy without premature termination due to remaining feces(from anus to terminal ileum)	During colonoscopy
Secondary	Sedation dose	Total amount of administered sedation per examination	During colonoscopy
Secondary	Coecal intubation	Successful coecal intubation during colonoscopy	During colonoscopy
Secondary	Polyp and adenoma detection rate	Rate of detected polyps and adenomas	During colonoscopy
Secondary	Patients satisfaction with preparation support	Via questionnaire; 8 items, ordinal scale with 4 grades (completely satisfied/mainly satisfied/mainly dissatisfied/completely dissatisfied)	Within 3 days after the intervention
Secondary	Anxiety referred to colonoscopy	German ABI-MS questionnaire (questionnaire on overcoming fear considering medical therapy;	Within 3 days before the intervention and 3 days after the intervention; 8 items with binary answer yes/no)