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临床试验/NCT06702423
NCT06702423已完成不适用

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

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 804 人开始时间: 2024年11月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
804
试验地点
1
主要终点
health literacy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

AI-based chatbot

Experimental

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.

干预措施: AI-based chatbot (Behavioral)

Leaflet

Active Comparator

A leaflet which is a publicly accessible HPV vaccination document prepared by the Ministry of Health, Labour, and Welfare.

干预措施: Leaflet (Behavioral)

结局指标

主要结局

health literacy

时间窗: 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. The score consists of 7 factual questions, with total scores ranging from 0 to 7 based on the number of correct responses. Higher scores indicate greater literacy. This metric will be evaluated by determining the proportion of respondents who correctly answer these questions, reflecting their understanding and knowledge.

次要结局

  • decision-making(2 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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