Interactive Telehealth Intervention to Increase Longitudinal Adherence to Repeat Faecal Immunochemical Test Screening

Not Applicable

Not yet recruiting

• Conditions: CRC, Colorectal Cancer
• Interventions: Behavioral: TI group

• Registration Number: NCT06261008
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

In Hong Kong, Colorectal cancer ranks second in both cancer incidence and mortality. The government-subsidized population-based CRC screening program (the Program) was launched for asymptomatic individuals aged 50-75 years to undergo biennial FIT screenings. A subsidized follow-up colonoscopy is offered to participants with positive FIT results. Participants are advised to repeat the FIT screening 2 years after receiving a negative result. An automated noninteractive short message service (SMS) text reminder, used by the Program as standard care (SC), is delivered to participants who are due for repeat FIT. According to unpublished data, despite SC, only 34% of participants adhere to biennial repeat FIT in the CRC screening program. Nonadherence to repeat FIT screening is caused by forgetfulness and is associated with an individual's psychological health behaviour.

Detailed Description

Eligible subject will be randomised to either the TI group or SC group. All subjects will receive an automated SMS text reminder delivered by the Program as the standard care.

Subjects randomized to the TI group will receive the SC as well as an interactive TI with interactive health education messages via a WhatsApp-based chatbot on the repeat FIT due date. All subjects will be followed up on WhatsApp at 3 months after their repeat FIT due date and asked about their repeat FIT status.

Subjects will be invited to participate in four focus group discussions to elucidate how the study intervention influences repeat FIT adherence behaviours, explore the complexity of regular FIT screening, and reveal, based on the participants' accounts, the barriers to and facilitators of their adherence to the repeat FIT screening. The discussion will be audiotaped.

Study Timeline

• Study First Submitted: 2023-12-04
• Study First Submitted QC: 2024-02-07
• Study First Posted: 2024-02-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-16
• Last Update Posted: 2024-05-17
• Study Start: 2024-06-01
• Primary Completion: 2025-03-26
• Study Completion: 2026-06-26

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 370

Inclusion Criteria

• 50-75 years old
• already enrolled in the Program with negative FIT results in 2022
• eligible for the Program inclusion and due for repeat FIT screening in 2024
• either the participants themselves or their family members / caregivers have access to and agree to be contacted via WhatsApp
• ability to understand Chinese

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Exclusion Criteria

• who have incomplete conversations with the chatbot, lack of access to WhatsApp, or are unable to provide informed consent will be excluded

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telehealth Intervention group	TI group	Subjects randomized to the Telehealth Intervention (TI) group will receive the SC as well as an interactive TI with interactive health education messages via a WhatsApp-based chatbot on the repeat FIT due date. All subjects will be followed up on WhatsApp at 3 months after their repeat FIT due date and asked about their repeat FIT status.

Primary Outcome Measures

Name	Time	Method
adherence rate	3 months	The primary outcome will be the repeat FIT screening adherence rate defined as returning completed FIT kits within 3 months after the repeat FIT due date in 2024.

Secondary Outcome Measures

Name	Time	Method
detection rate in positive FIT	12 months	For those who have positive FIT, we will also assess the detection rate of advanced neoplasm as defined as at least one colorectal cancer or advanced adenoma (size ≥10 mm, tubulovillous or villous component, or high-grade dysplasia).
costs incurred in each study arm	6 months	including the cost of chatbot development, video production and the standard care of SMS reminder
the number of days to repeat FIT	6 months	the number of days to participate in (FIT kits collection date to intervention date) and complete the repeat FIT screening after the intervention (completed FIT kits return date to intervention date)
uptake rate in positive FIT	12 months	For those who have positive FIT, we will also assess their uptake rate of colonoscopy following positive FIT
qualitative factors associated with repeat FIT adherence	12 months	Subjects will be invited to join the focus group for assessing qualitative factors associated with repeat FIT adherence in the biennial population-based CRC screening program

Trial Locations

Locations (1)

Centre of Digestive Health, Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong