About this trial
Colorectal cancer (CRC) ranks third in both incidence and mortality among all malignant tumors in China. Studies have shown that early screening can significantly reduce its incidence and mortality. Colonoscopy is the gold standard for CRC screening; however, compliance with colonoscopy among high-risk groups in China is very low. Artificial intelligence (AI)-assisted tools can provide real-time, personalized health education, and nudge strategies can help translate intent into action. This trial aims to evaluate the effectiveness of AI-empowered nudge for improving colonoscopy uptake among high-risk individuals aged 45 to 74 in China. It's a two-arm, pragmatic cluster randomized controlled trial. The main question it aims to answer is whether the AI-enabled personalized health education and nudge strategies improve colonoscopy adherence.
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 care. In addition to usual care, participants in the other group will receive AI-empowered nudge, featuring an AI chatbot providing real-time personalized responses and a nudge environment with default screening option. 2. Have their colonoscopy status checked at the end of trial.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged 45-74 years;
Test positive on the Colorectal Cancer Risk Assessment Scale and the immunochemical fecal occult blood test;
In good general health, mentally competent;
Provide informed consent.
Disqualifiers
History of colorectal resection;
Previous diagnosis of cancer or currently undergoing any cancer-related treatment;
Underwent a colonoscopy or sigmoidoscopy within the past 5 years;
Contraindications to colonoscopy (e.g. severe cardiac, cerebral, lung diseases, or renal dysfunction).
Trial design
Parallel
Treatments tested in this trial
AI-empowered nudge (AINC) strategy
BehavioralA digital health education and behavioral nudge intervention. It utilizes an intelligent chatbot to provide real-time, personalized information about colonoscopy and implements a default screening mechanism to facilitate the translation from screening intention to behavior.
Usual Care
Other interventionUsual notification of screening results and opt-in appointment for colonoscopy.
Treatment groups
Trial outcomes
Primary outcomes
Uptake of colonoscopy
Defined as whether the participant completes the colonoscopy. Data will be collected through the Hospital Information System (HIS) using participants' identification.
Secondary outcomes
Time to completion of colonoscopy
The interval from intervention initiation to the colonoscopy procedure. Data will be collected from information systems of hospitals.
Other outcomes
User engagement level with intervention
Assessed by the issuing number of appointment card and chatbot usage metrics, including usage frequency, interaction duration, and the number of questions asked. Data will be obtained through backend system logs.
Usability of AI-empowered Nudge Intervention
The usability of the intervention will be evaluated using a series of questions on its feasibility, acceptability, and sustainability, as well as the facilitators and barriers of its implementation. Data will be collected via semi-structured interviews.
Intervention Cost
The costs associated with both study arms obtained through work logs, including expenses for doctor manpower, chatbot development, and usage. Unit of Measure: Chinese Yuan (CNY).
Locations
Sponsors and contacts
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Fudan University
Lead sponsor
Nantong Center for Disease Control and Prevention
Collaborator
This trial is not recruiting at the moment. You can still explore other options: