NCT05689073

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
430

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 18, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

January 19, 2024

Status Verified

January 1, 2024

Enrollment Period

4 months

First QC Date

January 16, 2023

Last Update Submit

January 17, 2024

Conditions

Vaccination Hesitancy

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day 14

Secondary Outcomes (1)

  • Hesitancy of vaccination

    Day 14

Other Outcomes (1)

  • Feelings of coercion

    Day 14

Study Arms (2)

Conversational AI system

EXPERIMENTAL
Device: Conversational AI system

Educational brochure

ACTIVE COMPARATOR
Other: Printed educational Brochure

Interventions

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).

Conversational AI system
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).

Educational brochure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals aged 18 or above
  • Owning a smartphone/tablet capable of using the study app
  • Willing to provide informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Vaccination Hesitancy

Condition Hierarchy (Ancestors)

Vaccination RefusalTreatment RefusalTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 16, 2023

First Posted

January 18, 2023

Study Start

May 1, 2023

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

January 19, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)