Vaccination HesitancyNCT05689073
A Conversational AI System to Enhance Knowledge About Vaccines and Promote Vaccination
A study testing Conversational AI system and Printed educational Brochure in people with Vaccination Hesitancy, run by Sun Yat-sen University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccination Hesitancy
- What is being tested?
- Conversational AI system and Printed educational Brochure
- Type of treatment
- Vaccines, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals aged 18 or above
- Owning a smartphone/tablet capable of using the study app
- Willing to provide informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Vaccination Hesitancy
- Being tested
- Conversational AI system, Printed educational Brochure
- Medical subject headings
- Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conversational AI systemDevice
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).
Printed educational BrochureOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Conversational AI system | Experimental | Not described Receives: Device: Conversational AI system |
| Educational brochure | Active comparator | Not described Receives: Other: Printed educational Brochure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance of vaccines
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.
Measured: Day 14
Secondary outcomes (1)
Hesitancy of vaccination
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.
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start1 May 2023
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccination HesitancyStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yingfeng Zheng, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689073
- Sponsor's protocol ID
- 2021KYPJ182
- Status last verified
- Jan 2024
- First submitted
- 16 Jan 2023
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Conversational AI System to Enhance Knowledge About Vaccines and Promote Vaccination: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05689073
- Acronym / sponsor ID
- 2021KYPJ182
- Conditions
- Vaccination Hesitancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 18 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conversational AI system | Experimental | Device: Conversational AI system |
| Educational brochure | Active comparator | Other: Printed educational Brochure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals aged 18 or above
- Owning a smartphone/tablet capable of using the study app
- Willing to provide informed consent.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conversational AI systemThe 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). | Device | Conversational AI system |
| Printed educational BrochureA 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). | Other | Educational brochure |
Primary outcome
Acceptance of vaccines
Time frame: Day 14
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.
1 secondary outcome
Hesitancy of vaccination
Time frame: Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Individual participant dataSharing planned: No
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Development and Evaluation of a Digital Educational Intervention to Improve Vaccine Confidence and Communication Among Registered Nurses: Protocol for a Randomized Controlled Trial (VaxNurse-RCT).
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Communication Strategies to Increase HPV Vaccinations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conversational AI system and Printed educational Brochure in people with Vaccination Hesitancy, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptance of vaccines (time frame: Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.