Artificial Intelligence (AI) Technology May Help Patients to Understand Bowel Preparation Better Before They go for Colonoscopy.This Study Attempts to Leverage AI Chatbot in Counselling Patients to Improve Bowel Cleanliness, Reduce Anxiety as Well as Increase Procedural Satisfaction

March 24, 2025 updated by: Nabil Mohammad Azmi, National University of Malaysia

Prospective Single Blinded Randomized Control Trial on the Effectiveness of Using Large Language Model Artificial Intelligence Chatbot to Improve Boston Bowel Preparation Score (BBPS) for Colonoscopy Preparation

Traditional pre-colonoscopy counselling requires significant time from healthcare workers to explain procedures, limiting efficiency and patient turnover. Inadequate bowel preparation exacerbates this issue, leading to repeat procedures and increased costs. However, no study has yet evaluated the effectiveness of AI in improving the Boston Bowel Preparation Scale (BBPS) for colonoscopy preparation. By addressing this gap, AI chatbots could provide personalized guidance, reduce healthcare worker burden, improve preparation quality, and enhance patient experience.This research attempts to evaluate the effectiveness of using Artificial intelligence (AI) chat bot to improve bowel preparation, anxiety level and patient's satisfaction among colonoscopy patients in Hospital Tuanku Muhriz (HCTM), compared to conventional instructions

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Nabil Mohammad Azmi, Doctor in General Surgery
  • Phone Number: +60122177050
  • Email: nabil@ukm.edu.my

Study Locations

  • Malaysia
    • Kuala Lumpur
      • Cheras, Kuala Lumpur, Malaysia, 56000
        • Faculty of Medicine, The National University of Malaysia
        • Contact:
          • Nabil Mohammad Azmi, Doctor of General Surgery
          • Phone Number: +60122177050
          • Email: nabil@ukm.edu.my

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • All scheduled colonoscopy with indication
  • Adequate digital literacy
  • Adequate language literacy with Malay and English language

Exclusion Criteria:

  • Patients with memory impairment due to previous stroke, dementia or Alzheimer's disease
  • Diagnosed with clinical anxiety

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Artificial Intelligence (AI) Chatbot
Patient's who will be interacting with AI chatbot for bowel preparation counselling
Procedure: AI chatbot study arm
Intervention arm will have to undergo bowel preparation using standard polyethylene glycol solution (Fortrans)
Procedure: Traditional counselling study arm
Intervention arm will have to undergo bowel preparation using standard polyethylene glycol solution (Fortrans)
Other: Conventional counselling by healthcare workers
Patients receiving conventional way of counselling for bowel preparation before colonoscopy
Procedure: AI chatbot study arm
Intervention arm will have to undergo bowel preparation using standard polyethylene glycol solution (Fortrans)
Procedure: Traditional counselling study arm
Intervention arm will have to undergo bowel preparation using standard polyethylene glycol solution (Fortrans)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To determine the effectiveness of artificial intelligence (AI) chat bot in improving bowel preparation among colonoscopy patients in Hospital Tuanku Mukhriz (HCTM), compared to conventional instructions
Time Frame: 1 year
Patients in interventional arm will be receiving counselling via interaction with AI chatbot.Each interaction session were limited to 15 minutes maximum. The quality of bowel preparation will be graded by the masked endoscopists using Boston Bowel Preparation Score (BBPS). Each of the three colon segments (right, transverse and left) will be assigned scores (0 - 3) . 0 - unprepared colon while 3 indicates the best possible preparation.A total score will range from 0 to 9, where higher scores indicate better bowel preparation.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To determine the effectiveness of AI chat bot in relieving anxiety among colonoscopy patients in HCTM, compared to conventional instructions.
Time Frame: 1 year
Anxiety level for both arms will be measured before and after colonoscopy using the validated Depression Anxiety and Stress Scale 21 (Anxiety Scale). Is a self-reporting scale that measure the the anxiety.DASS interpretation ;Normal 0-7, Mild 8-9, Moderate 10-14, Severe 15-19 and Extremely severe 20+
1 year
To determine the effectiveness of AI chat bot in improving satisfaction among colonoscopy patients in HCTM, compared to conventional instructions.
Time Frame: 1 year
Patients from both arms will be interviewed after colonoscopy using the validated Patient Satisfaction Questionnaire (PSQ).PSQ are a set of questionnaires that help researchers to understand patient experiences and identify areas of improvement.Patients will be evaluated on multiple domains- general satisfaction, technical quality, interpersonal aspect, clarity of communication,access to care and confidence in healthcare provider. Each domain will be given scores according to the Likert scale ranging from 1 to 5. 1 means very dissatisfied while 5 means very satisfied.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National University of Malaysia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nabil Mohammad Azmi, Doctor of General Surgery, Faculty of Medicine, The National University of Malaysia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 2, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 2, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JEP-2025-035

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Protocol , Informed Consent Form, Clinical Study Report upon considerable request

IPD Sharing Time Frame

APRIL 2025 - FEBRUARY 2026

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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