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

NCT05041283 | Unknown

• 1 other identifier: ARCHES
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 3

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.

Conditions

Bowel Preparation

Keywords

Bowel Preparation; Artificial Intelligence; Polyp Detection

Outcome Measures

Primary Outcomes (1)

• Quality of bowel preparation

  evaluated with the Boston Bowel Preparation Scale (0-9, 1=worst preparation, 9= best preparation)

  During colonoscopy

Secondary Outcomes (7)

• Patients satisfaction with bowel preparation

  Immediately after the intervention

• Comprehensiveness of bowel preparation

  During colonoscopy

• Sedation dose

  During colonoscopy

• Coecal intubation

  During colonoscopy

• Polyp and adenoma detection rate

  During colonoscopy

Study Arms (3)

Standard Preparation

NO INTERVENTION

Control arm; patients receive a standard support for bowel preparation consisting of a explanatory dialogue with a gastroenterologist and a brochure with a structurated description of bowel preparation and colonoscopy conduct

Phone-call Supported Preparation

ACTIVE COMPARATOR

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.

Other: Phone call

Chatbot Supported Preparation

EXPERIMENTAL

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.

Other: Chatbot

Interventions

Chatbot OTHER

A artificial-intelligence based chatbot is provided 3 days before colonoscopy to answer questions concerning bowel preparation and colonoscopy conduct.

Chatbot Supported Preparation

Phone call OTHER

A phone call is performed every day starting at 3 days before colonoscopy to support bowel preparation.

Phone-call Supported Preparation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• informed consent
• smartphone with access to WhatsApp
• indication for ambulatory colonoscopy
• ASA I or II

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ulm: lead

Study Sites (3)

Specialist Practice Profes. Dikopoulos/Ludwig

Ulm, Baden-Würrtemberg, 89081, Germany

RECRUITING

University of Ulm, Interdisciplinary Endoscopy

Ulm, Baden-Würrtemberg, 89081, Germany

RECRUITING

Specialist Practice

Berlin, 13581, Germany

RECRUITING

Study Officials

• Thomas Seufferlein, Prof.

  University Hospital Ulm

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin Walter, MD

CONTACT

+49731/5000; benjamin.walter@uniklinik-ulm.de

Niklas Sturm, MD

CONTACT

+49731/5000; niklas.sturm@uniklinik-ulm.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: September 13, 2021
• Study Start: May 21, 2021
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: September 27, 2021

Record last verified: 2021-09

Locations

DE (3)