Enhancing Health Literacy Through AI-Powered Chatbot: a Randomized Controlled Trial

November 20, 2024 updated by: The University of Hong Kong

Enhancing Health Literacy Through Artificial Intelligence-Powered Chatbot: a Randomized Controlled Trial on Addressing Human Papillomavirus Vaccination Misinformation Among Caregivers in Japan

The goal of this study is to learn if an innovative digital artificial intelligence (AI)-based communication tool works to enhance health literacy among Japanese caregivers regarding Human Papillomavirus (HPV) vaccination.

Participants will:

  • Answer a pre-intervention survey, get information regarding HPV vaccination from an AI-based chatbot or leaflet, and answer a post-intervention survey.
  • Continue interacting with the chatbot or leaflet for two weeks.
  • Answer a follow-up survey.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will evaluate the efficacy and feasibility of an AI-driven chatbot in enhancing caregivers' health literacy about HPV vaccination and examines its impact on informed decision-making concerning their daughters' vaccination through a randomized controlled trial (RCT). To achieve this, the study will undertake the following interconnected activities:

  1. Randomized Controlled Trial Participants will be randomly assigned to either the control or intervention group. Those in the control group will spend 5-10 minutes reading a publicly accessible HPV vaccination leaflet prepared by the MHLW, serving as the standard of care. Conversely, participants in the intervention group will be invited to interact with the chatbot for 5-10 minutes, posing inquiries (n>10) about HPV vaccination policies and related topics in Japan. Pre- and post-intervention assessments, as detailed below, will be administered to evaluate the chatbot's effectiveness and feasibility to counter HPV vaccine misinformation and support caregivers' vaccination decision-making processes.
  2. Pre- and post-intervention assessments Following informed consent and enrollment, participants will complete a pre-intervention survey to establish baseline data. Post-intervention survey will be introduced at two touchpoints: the first is directly after spending time with either a leaflet (control) or a chatbot (intervention), and the second is two weeks after the first touchpoint.

The surveys are designed to assess the chatbot's effectiveness in enhancing caregivers' digital health literacy about HPV vaccination and facilitating informed vaccine decision-making.

Study Type

Interventional

Enrollment (Estimated)

844

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

Study Contact Backup

Study Locations

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • A nationally representative sample of female caregivers with daughters aged 12-18 who have not received any HPV vaccine.
  • Those who have access to a smartphone or computer with internet connectivity to interact with experiment materials (chatbot or online leaflet).
  • Those who provide informed consent and agree to participate in the study.

Exclusion Criteria:

  • Those who need help reading through the participant information sheet, providing consent online, accessing experiment materials (chatbot or online leaflet), or answering surveys will be excluded. This may include people who do not have access to an online environment or people with severe cognitive impairments who cannot interact with the experiment materials. Also, those who have participated or are participating in similar studies regarding vaccination or experiments that utilize chatbots will be excluded.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AI-based chatbot
A chatbot that was developed using information related to HPV vaccines from authoritative sources such as the Japanese Ministry of Health, Labour, and Welfare, World Health Organization, Centers for Disease Control and Prevention, and other reputable public health organizations and validated survey questions from published research.
Behavioral: AI-based chatbot
A tailored Japanese HPV vaccination chatbot.
Active Comparator: Leaflet
A leaflet which is a publicly accessible HPV vaccination document prepared by the Ministry of Health, Labour, and Welfare.
Behavioral: Leaflet
A publicly accessible HPV vaccination leaflet prepared by the Ministry of Health, Labour, and Welfare.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
health literacy
Time Frame: 2 weeks
Health literacy related to HPV vaccination will be measured by changes in caregivers' scores on questions concerning facts about HPV vaccines and associated health information. This metric will be evaluated by determining the proportion of respondents who correctly answer these questions, reflecting their understanding and knowledge.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
decision-making
Time Frame: 2 weeks
Decision-making regarding HPV vaccination will be evaluated based on changes in the uptake status of HPV vaccines among caregivers' daughters. This will be measured by the proportion of respondents who answer 'Yes' to the question, 'Have you decided to vaccinate your daughter against HPV?' Response options will include 'Yes' and 'No.'
2 weeks

Collaborators and Investigators

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

Sponsor

The University of Hong Kong

Collaborators

London School of Hygiene and Tropical Medicine
Nagasaki University

Investigators

  • Principal Investigator: Leesa Lin, PhD, London School of Hygiene and Tropical Medicine

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)

November 25, 2024

Primary Completion (Estimated)

December 15, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

November 20, 2024

First Submitted That Met QC Criteria

November 20, 2024

First Posted (Estimated)

November 25, 2024

Study Record Updates

Last Update Posted (Estimated)

November 25, 2024

Last Update Submitted That Met QC Criteria

November 20, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UW231392

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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