Interactive Telehealth Intervention to Increase Longitudinal Adherence to Repeat Faecal Immunochemical Test Screening
NCT ID: NCT06261008
Last Updated: 2024-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
370 participants
INTERVENTIONAL
2024-06-01
2026-06-26
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Standard Care
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.
No interventions assigned to this group
Telehealth Intervention 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.
TI group
CRC screening is arranged by referring the participants to the government-subsidized population-based CRC screening program. Our center is a PCP clinic offering FIT screenings under the Program. Colonoscopy is arranged if the FIT result is positive. Participants are instructed to repeat FIT at any PCP clinic 2 years after receiving a negative result. Based on the 34% local FIT screening adherence rate under SC and the assumption of improved FIT adherence to 49% after interactive TI, a minimum sample size of 332 subjects (166 per group) is required to achieve a statistical significance of p\<0.05 and power of 80%. Assuming that 10% of the subjects will drop out, be lost to follow-up, or have incomplete chatbot conversations, the required sample size is rounded up to 370 (185 per group)
Interventions
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TI group
CRC screening is arranged by referring the participants to the government-subsidized population-based CRC screening program. Our center is a PCP clinic offering FIT screenings under the Program. Colonoscopy is arranged if the FIT result is positive. Participants are instructed to repeat FIT at any PCP clinic 2 years after receiving a negative result. Based on the 34% local FIT screening adherence rate under SC and the assumption of improved FIT adherence to 49% after interactive TI, a minimum sample size of 332 subjects (166 per group) is required to achieve a statistical significance of p\<0.05 and power of 80%. Assuming that 10% of the subjects will drop out, be lost to follow-up, or have incomplete chatbot conversations, the required sample size is rounded up to 370 (185 per group)
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
50 Years
75 Years
ALL
Yes
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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Thomas Yuen Tung Lam
Assistant professor
Locations
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Centre of Digestive Health, Prince of Wales Hospital
Hong Kong, , Hong Kong
Countries
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Central Contacts
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Other Identifiers
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2023.553
Identifier Type: -
Identifier Source: org_study_id
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