AI-assisted Integrated Care to Promote Colonoscopy Uptake

December 2, 2025 updated by: Zhiyuan Hou, Fudan University

Artificial Intelligence-assisted Integrated Care to Promote Colonoscopy Uptake in China: a Cluster Randomized Controlled Trial

Colorectal cancer (CRC) ranks the second most common cancer and the fourth leading cause of cancer-related deaths in China. Early screening of CRC has been proven to reduce the incidence and mortality, with colonoscopy as the gold standard for CRC screening. This trial aims to evaluate the effectiveness of artificial intelligence-assistant integrated care for improving uptake rate of colonoscopy among high-risk individuals aged 40 to 64 in China. It's a two-arm, parallel cluster randomized controlled trial. The main question it aims to answer is whether the AI-assisted integrated care influence participants' screening-related knowledge, health beliefs, behavioral intention, and uptake of colonoscopy.

Participants will:

  1. Be recruited and allocated into one of two groups according to the assigned clusters. Participants in one group will be invited to receive usual specialty care. In addition to usual specialty care, participants in the other group will receive AI-assisted integrated care provided by specialist and general practitioners collaboratively.
  2. Complete a questionnaire survey on their knowledge, health beliefs, behavioral intention on CRC screening.
  3. Have their colonoscopy status checked at the middle and end of trial.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

We will conduct a two-arm, cluster randomized controlled trial to evaluate the effectiveness of an AI-assisted integrated care (AICC) model in improving colonoscopy uptake rate among high-risk individuals aged 40-64. This will be followed by a pragmatic implementation science study to assess user engagement of AICC and identify the facilitators and barriers to its real-world implementation.

Sample size calculation, based on detecting an increase in colonoscopy uptake from 15% to 30% with 80% power (α=0.05, two-sided), an ICC of 0.05, and 10 participants per cluster, indicates a need for 18 clusters per arm. Allowing for 10% attrition, the final sample size is determined to be 20 clusters per arm. Thus, a total sample size is 400 participants from 40 clusters.

Participant recruitment will be conducted across 40 villages/communities in three representative counties/cities in China. An independent biostatistician will randomly allocate these villages/communities within each county/city to the study arms in a 1:1 ratio. The study procedure involves first identifying high-risk individuals for CRC through an initial risk assessment questionnaire and a fecal immunochemical test (FIT). Those who meet the criteria will then receive the intervention corresponding to their village's assigned study group.

Participants in the intervention group will receive AICC. This includes a colonoscopy recommendation from a county specialist for both participants and their families, followed by an introduction to and guided registration for a CRC education chatbot with an initial 5-minute tutorial. Subsequently, general practitioners will conduct three monthly face-by-face follow-ups, each comprising a brief reminder of colonoscopy and a guided usage of CRC education chatbot. The control group will receive only a colonoscopy recommendation from a county specialist, with access to the chatbot granted only after the end of the 6-month study period. Post-intervention, all participants will complete a questionnaire assessing CRC screening knowledge, health beliefs, and behavioral intention. Colonoscopy uptake will be collected via the hospital information system at the 3- and 6-month follow-up.

The primary analysis will follow the intention-to-treat (ITT) principle. The primary outcome is the uptake and timing of colonoscopy at 3 and 6 months after intervention. Secondary outcomes encompassed several domains: CRC screening knowledge, beliefs, and intention; chatbot usability and user engagement; and intervention costs. Between-group comparisons for continuous and categorical variables will utilize t-tests and chi-square tests. To account for potential confounders, the generalized estimating equation (GEE) will be employed to derive robust effect estimates. The timing of colonoscopy uptake will be analyzed using Kaplan-Meier survival curves and log-rank tests, and the intervention effects on the time-to-event will be quantified with a Cox proportional hazards model. Subgroup analyses will be conducted to elucidate the effect heterogeneity across populations stratified by baseline characteristics.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • 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

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Individuals who test positive on either the Colorectal Cancer Risk Assessment Scale or the fecal immunochemical test (FIT);
  • Aged 40 ~ 64 years;
  • Proficient in smartphone use and able to engage with the intervention;
  • Provided informed consent .

Exclusion Criteria:

  • History of colorectal cancer;
  • Contraindications to colonoscopy,(e.g. severe cardiac, cerebral, lung diseases, or renal dysfunction).

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AICC intervention group
Participants in the intervention group will receive AICC. This includes a colonoscopy recommendation from a county specialist for both participants and their families, followed by an introduction to and guided registration for a CRC education chatbot with an initial 5-minute tutorial. Subsequently, general practitioners will conduct three monthly face-by-face follow-ups, each comprising a brief reminder of colonoscopy and a guided usage of CRC education chatbot.
Behavioral: AI-assisted integrated care

A colorectal cancer screening chatbot delivered via WeChat or a web browser, designed to provide information and health education about the colonoscopy, including essential knowledge, screening rationale, methods, procedural details, and local screening policies,. The chatbot is powered by large language models and is trained on an expert-validated knowledge base derived from authoritative sources such as the China colorectal cancer screening guidelines to ensure accuracy. The knowledge base is validated by colorectal cancer specialists. The chatbot engages users in interactive, conversational dialogue to answer questions and address concerns regarding colorectal cancer and colonoscopy.

In addition to a colonoscopy recommendation from a county specialist at on-site, general practitioners will also join to provide recommendation and brief reminder of colonoscopy within the follow-up period.
No Intervention: Control group
Participants in this group will receive usual specialty care, only a colonoscopy recommendation from a county specialists. For ethical considerations, participants in this arm will be offered access to the chatbot after the end of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uptake of colonoscopy
Time Frame: Three and six months after recruitment
Whether participants receive colonoscopy for colorectal cancer screening.Data will be collected from information system of hospitals.
Three and six months after recruitment
Time to completion of colonoscopy
Time Frame: Six months after recruitment
The interval from intervention initiation to the colonoscopy procedure. Data will be collected from information systems of hospitals.
Six months after recruitment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CRC screening literacy
Time Frame: One month after recruitment
CRC screening literacy will be assessed using a "Colorectal Cancer Screening Literacy Questionnaire" developed by the research team to ensure alignment with the study aims and intervention. The questionnaire comprises of 7 items , covering the basic knowledge of CRC, screening methods, benefits, and common misconceptions. Each item is answered with "yes", "no", and "not sure", with one point for a correct answer and no points for "not sure" and incorrect answers. The total score ranges from 0 to 7, and the higher the score, the higher the literacy level of the participants about CRC screening.
One month after recruitment
CRC screening belief
Time Frame: One month after recruitment
Participants' perceptions of CRC risk and their beliefs regarding benefits and barriers of colonoscopy will be assessed using a 5-point Likert scale (from "completely disagree" to "completely agree"). A higher score indicates a stronger belief.
One month after recruitment
Colonoscopy behavioral intention
Time Frame: One month after recruitment
Participants' intention to receive colonoscopy will be measured using a 5-point Likert scale (from "completely disagree" to "completely agree"). Those who agree or completely agree are defined as having colonoscopy intention.
One month after recruitment
User engagement level with chatbot
Time Frame: Six months after recruitment
Chatbot engagement level is measured by a binary variable whether users highly engage with chatbot in terms of usage frequency, usage duration, the number of asked questions, and the presence of free-text questions. High-engagement is defined as those using chatbot frequently and longer, and asking more questions and free-text questions; others are low-engagement.
Six months after recruitment
Usability of AI-assisted integrated care intervention
Time Frame: Six months after recruitment
The usability of the AICC intervention will be evaluated using a series of questions on its acceptability, feasibility, and sustainability. It covers two sections with 9 entries: Evaluation of Clinician-Delivered Health Education (4 entries) and Evaluation of the Chatbot (5 entries). The Likert 5-point scale is used, with scores ranging from 1 to 5 on a scale of "completely disagree" to "completely agree". The total usability score ranges from 9 to 45 points, with higher scores indicating greater perceived usability of the AICC intervention.
Six months after recruitment
Incremental cost-effectiveness ratio (ICER)
Time Frame: Six months after recruitment
The incremental cost-effectiveness ratio (ICER) of the AICC intervention versus usual specialty care will be assessed from the perspective of the health care system. The ICER is defined as the cost per additional quality-adjusted life year (QALY) gained. Cost data will include screening program costs (from project records), direct medical costs, direct non-medical costs, and indirect costs (sourced from the study in Shandong Province). QALYs will be calculated by applying health utility weights, derived from existing literature, according to patients based on their diagnostic states. The specific ICER value will be reported as the primary economic outcome. Unit of Measure: United States dollar (Dollar).
Six months after recruitment

Collaborators and Investigators

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

Sponsor

Fudan University

Collaborators

Shandong University
Sun Yat-sen University
Shandong Cancer Hospital and Institute

Investigators

  • Principal Investigator: Zhiyuan Hou, PhD, Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 8, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 21, 2025

First Submitted That Met QC Criteria

December 2, 2025

First Posted (Estimated)

December 3, 2025

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fudan-CRC chatbot

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to participant privacy concerns and institutional data protection policies.

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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