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

Not Applicable

• Conditions: Bowel Preparation
• Interventions: Other: Phone call; Other: Chatbot

• Registration Number: NCT05041283
• Lead Sponsor: University of Ulm

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-05-21
• Status Verified: 2021-09
• Study First Submitted: 2021-09-06
• Study First Submitted QC: 2021-09-09
• Study First Posted: 2021-09-13
• Last Update Submitted: 2021-09-21
• Last Update Posted: 2021-09-27
• Primary Completion: 2022-02-01
• Study Completion: 2022-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 258

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phone-call Supported Preparation	Phone call	In addition to standard preparation, patients receive a phone call every day starting at 3 days before colonoscopy in which a investigator explains key points of bowel preparation and patients can ask questions concerning bowel preparation and colonoscopy conduct.
Chatbot Supported Preparation	Chatbot	In addition to standard preparation, patients receive an access to a chatbot which can be contacted via Whats App starting at 3 days before colonoscopy. The chatbot is programed to answer questions concerning bowel preparation and colonoscopy conduct.

Primary Outcome Measures

Name	Time	Method
Quality of bowel preparation	During colonoscopy	evaluated with the Boston Bowel Preparation Scale (0-9, 1=worst preparation, 9= best preparation)

Secondary Outcome Measures

Name	Time	Method
Patients satisfaction with bowel preparation	Immediately after the intervention	Via questionnaire; 8 items, ordinal scale with 4 grades (completely satisfied/mainly satisfied/mainly dissatisfied/completely dissatisfied)
Coecal intubation	During colonoscopy	Successful coecal intubation during colonoscopy
Patients satisfaction with preparation support	Within 3 days after the intervention	Via questionnaire; 8 items, ordinal scale with 4 grades (completely satisfied/mainly satisfied/mainly dissatisfied/completely dissatisfied)
Comprehensiveness of bowel preparation	During colonoscopy	Rate of successfully completed colonoscopy without premature termination due to remaining feces(from anus to terminal ileum)
Polyp and adenoma detection rate	During colonoscopy	Rate of detected polyps and adenomas
Anxiety referred to colonoscopy	Within 3 days before the intervention and 3 days after the intervention; 8 items with binary answer yes/no)	German ABI-MS questionnaire (questionnaire on overcoming fear considering medical therapy;
Sedation dose	During colonoscopy	Total amount of administered sedation per examination

Trial Locations

Locations (3)

Specialist Practice Profes. Dikopoulos/Ludwig; 🇩🇪 Ulm, Baden-Würrtemberg, Germany

University of Ulm, Interdisciplinary Endoscopy; 🇩🇪 Ulm, Baden-Würrtemberg, Germany

Specialist Practice; 🇩🇪 Berlin, Germany