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

NCT ID: NCT05041283

Last Updated: 2021-09-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 258 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-21
• Study Completion Date: 2022-02-01

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.

Conditions

Bowel Preparation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard Preparation

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Phone-call Supported Preparation

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.

Group Type: ACTIVE_COMPARATOR

Phone call

Intervention Type: OTHER

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

Chatbot Supported Preparation

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.

Group Type: EXPERIMENTAL

Chatbot

Intervention Type: OTHER

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

Interventions

Chatbot

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

Intervention Type: OTHER

Phone call

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Ulm

OTHER

Sponsor Role: lead

Responsible Party

Thomas Seufferlein

Prof. Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas Seufferlein, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Ulm

Locations

Specialist Practice Profes. Dikopoulos/Ludwig

Ulm, Baden-Würrtemberg, Germany

Site Status: RECRUITING

University of Ulm, Interdisciplinary Endoscopy

Ulm, Baden-Würrtemberg, Germany

Site Status: RECRUITING

Specialist Practice

Berlin, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Benjamin Walter, MD

Role: CONTACT

benjamin.walter@uniklinik-ulm.de

+49731/5000

Niklas Sturm, MD

Role: CONTACT

niklas.sturm@uniklinik-ulm.de

+49731/5000

Facility Contacts

Nektarios Dikopoulos, Prof.

Role: primary

info@praxis-endoskopie.de

+497348 9671747

Leopold Ludwig, Prof.

Role: backup

info@praxis-endoskopie.de

+497348 9671747

benjamin Walter, MD

Role: primary

benjamin.walter@uniklinik-ulm.de

+497315000

Jens Aschenbeck, MD

Role: primary

info@aschenbeck-berlin.de

+4930 - 331 44 44

Other Identifiers

ARCHES

Identifier Type: -

Identifier Source: org_study_id