- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05689073
A Conversational AI System to Enhance Knowledge About Vaccines and Promote Vaccination
January 17, 2024 updated by: Yingfeng Zheng, Sun Yat-sen University
A Conversational AI System to Enhance Knowledge About Vaccines and Promote Vaccination: A Randomized Controlled Trial
This study is designed to contribute to the growing body of evidence on the efficacy of digital health interventions.
By rigorously evaluating the impact of the AI system on vaccine knowledge and acceptance, the study aims to inform future health communication strategies and policies.
It stands as a potential model for integrating AI into public health initiatives, showcasing how technology can be harnessed to improve health outcomes on a large scale.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
430
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 Locations
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Guangdong
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Guangzhou, Guangdong, China, 510000
- Zhongshan Ophthalmic Center
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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
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria
- Individuals aged 18 or above
- Owning a smartphone/tablet capable of using the study app
- Willing to provide informed consent.
Exclusion Criteria
- Individuals with ocular or hearing disorders that preclude the use of mobile phones or reading.
- Individuals with mental disorders that preclude the use of mobile phones or reading.
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: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Conversational AI system
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The conversational AI system based on LLM processes user queries with a sophisticated generation, decision, action, and safety framework to provide optimal feedback.
The system has several key features.
Firstly, it utilizes retrieval-augmented in-context learning to enhance responses generated by the LLM, sourcing information from trustworthy websites.
Secondly, it includes Guardrail module that addresses potential harmful content in the LLM-generated responses by clarifying and validating the content before delivery.
Furthermore, the AI system is equipped with Self-checking memory module that retains essential clinical characteristics across multi-turn dialogues, ensuring the continuity and consistency of its interactions with users.
The educational content about vaccination was derived from the official website of World Health Organization (https://www.who.int/news-room/questions-and-answers/item/vaccines-and-immunization-what-is-vaccination).
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Active Comparator: Educational brochure
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A printed brochure whose content about vaccination was derived from the official website of World Health Organization (https://www.who.int/news-room/questions-and-answers/item/vaccines-and-immunization-what-is-vaccination).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Acceptance of vaccines
Time Frame: Day 14
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Vaccine acceptance was evaluated based on responses to the question, 'Based on your actual situation, please choose the extent of your willingness to get vaccinated.'
The response options were: Absolutely refuse, Refuse but uncertain about the future, Have not considered it yet, Accept but still considering, and Completely willing.
Vaccine acceptance was considered if the participant selected 'Completely willing.
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Day 14
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hesitancy of vaccination
Time Frame: Day 14
|
The Vaccine Hesitancy Scale was developed based on the "3Cs" model (confidence, complacency, and convenience) by the SAGE Working Group on Vaccine Hesitancy, encompassing three aspects: confidence, complacency, and convenience.
It utilizes a Likert 5-point scale (Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree) for scoring.
For the complacency dimension, aspect, scoring is reversed with "Strongly Agree" to "Strongly Disagree" rated as 5 to 1 points, respectively.
In contrast, other items follow the standard scoring, where "Strongly Agree" to "Strongly Disagree" are scored from 1 to 5 points.
Confidence is measured by perceived vaccine safety and efficacy.
Complacency is assessed through perceived necessity of the vaccine and the severity of the preventable diseases.
Convenience is evaluated by the perceived ease of transportation and appointment scheduling.
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Day 14
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feelings of coercion
Time Frame: Day 14
|
To assess feelings of coercion related to vaccination, participants were asked a single question: 'When deciding whether to receive the vaccines, do you feel forced to either take or not take the vaccine?'
This question utilizes a 5-point Likert scale (very low, low, neutral, high, very high) with lower scores indicating lower feelings of perceived coercion.
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Day 14
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
May 1, 2023
Primary Completion (Actual)
August 31, 2023
Study Completion (Actual)
August 31, 2023
Study Registration Dates
First Submitted
January 16, 2023
First Submitted That Met QC Criteria
January 16, 2023
First Posted (Actual)
January 18, 2023
Study Record Updates
Last Update Posted (Estimated)
January 19, 2024
Last Update Submitted That Met QC Criteria
January 17, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021KYPJ182
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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