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

NCT06261008 | Not Yet Recruiting

• 1 other identifier: 2023.553
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 1

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 According to unpublished data, despite SC, only 34% of participants adhere to biennial repeat FIT in the CRC screening program.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.

Conditions

CRC, Colorectal Cancer

Keywords

colorectal cancer, screening, fecal immunochemical test

Outcome Measures

Primary Outcomes (1)

• adherence rate

  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.

  3 months

Secondary Outcomes (5)

• the number of days to repeat FIT

  6 months

• costs incurred in each study arm

  6 months

• uptake rate in positive FIT

  12 months

• detection rate in positive FIT

  12 months

• qualitative factors associated with repeat FIT adherence

  12 months

Study Arms (2)

Standard Care

NO INTERVENTION

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.

Telehealth Intervention group

EXPERIMENTAL

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.

Behavioral: TI group

Interventions

TI group BEHAVIORAL

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)

Telehealth Intervention group

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• already enrolled in the Program with negative FIT results in 2022
• either the participants themselves or their family members / caregivers have access to and agree to be contacted via WhatsApp
• ability to understand Chinese

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Centre of Digestive Health, Prince of Wales Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Felix Sia

CONTACT

26370428; felixsia@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: There will no masking
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: Patient will be randomized into either standard care or telehealth intervention group

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: February 15, 2024
• Study Start: June 1, 2024
• Primary Completion: March 26, 2025
• Study Completion (Estimated): June 26, 2026
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)