Impact of Artificial Intelligence-based Patient Reinforcement on Quality of Colonoscopy (ARCHES)

University of Ulm

Status: Unknown

Conditions: Bowel Preparation

Treatments: Other: Phone call; Other: Chatbot

Study type: Interventional

Funder types: Other

Identifiers

NCT05041283

ARCHES

Details and patient eligibility

About

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.

Full 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.

Enrollment: 258 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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258 participants in 3 patient groups

Standard Preparation

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Other: Phone call

Chatbot Supported Preparation

Experimental group

Description:

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.

Treatment:

Other: Chatbot