Vaccine Chatbot for Improving Influenza Vaccination Uptake

NCT06657573 | Not Yet Recruiting

• 1 other identifier: Fudan Univeristy
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the impact of a vaccine chatbot on improving influenza vaccination uptake among children aged between 6 and 59 months through a cluster randomized trial. Specifically, the main questions it seeks to answer are whether an AI-enabled vaccine chatbot will increase the uptake of influenza vaccine among children and their family members, and how it will influence parents' literacy and confidence towards influenza vaccine. It will explore the potential role of vaccine chatbot on vaccination services. A cluster randomization will be used to assign children to the intervention and control groups. Parents of children in the intervention group will be invited to use the influenza vaccine chatbot online through WeChat, the mostly widely used social media platform in mainland China, or any web browsers. They can ask any questions related to the influenza vaccine and receive validated answers from the chatbot immediately. The intervention will last one and a half months, with invitations sent every ten days to reinforce the engagement. The control group will not use the chatbot during the intervention duration. After the intervention, the uptake, literacy, and confidence towards influenza vaccine will be compared between the intervention and control groups to evaluate the impact of vaccine chatbot.

Conditions

Influenza Vaccines

Keywords

Influenza vaccine; vaccination; vaccine confidence; AI; Chatbot

Outcome Measures

Primary Outcomes (1)

• Influenza vaccination uptake for children

  whether the enrolled children receive an influenza vaccine. It will be measured in the survey at the end of the 1.5-month intervention, and be recorded from the vaccination registration system three months after the intervention begins.

  1.5 months and three months

Secondary Outcomes (5)

• Influenza vaccination uptake for children's family members

  1.5 months and three months

• Influenza vaccination-specific consultation

  1.5 months

• Influenza vaccine literacy

  1.5 months

• Influenza vaccine confidence

  1.5 months

• Sustained vaccination intention

  1.5 months

Other Outcomes (2)

• Cost of chatbot intervention

  1.5 months

• Chatbot Usability

  1.5 months

Study Arms (2)

Influenza Vaccine Chatbot Intervention group

EXPERIMENTAL

In this arm, participants will receive a vaccine chatbot intervention for one and a half months. The AI-enabled influenza vaccine chatbot can be accessed online through WeChat or any web browsers, where people can ask any questions related to the influenza vaccine and get previously validated answers from the chatbot immediately. The chatbot is available for use at their convenience during the 1.5-month intervention, with invitations sent every ten days to reinforce the engagement.

Behavioral: An AI-enabled chatbot tailored for influenza vaccine consultation

Control group

NO INTERVENTION

The control group will not use the chatbot during the intervention duration.

Interventions

An AI-enabled chatbot tailored for influenza vaccine consultation BEHAVIORAL

The AI-enabled influenza vaccine chatbot can be accessed online through WeChat or any web browsers. The foundation of this chatbot is an expansive knowledge database, constructed with information sourced exclusively from healthcare authorities such as China CDCs and Health Departments, and thoroughly verified by public health experts. This database integrates data on the disease's burden, susceptibility, and severity, along with in-depth details about the vaccines, including their importance, efficacy, safety, and recommended demographics and timing for vaccination. It also covers types and costs of vaccines, societal norms such as vaccination guidelines, expert recommendations, and vaccination trends both in China and internationally. It also includes misinformation and fact-checking contents and provides information about vaccination services such as locations and appointment scheduling.

Influenza Vaccine Chatbot Intervention group

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Parents of the child visiting clinics.
• Children aged between 6 and 59 months.
• Children who have not received an influenza vaccine in both the current and previous flu seasons and have not yet made an appointment for an influenza vaccine.
• Children who have no contraindications to receiving an influenza vaccine.
• Provide informed consent and willing to participate throughout the study.

You may not qualify if:

• Children vaccinated or appointed for influenza vaccination or with any contraindication to influenza vaccine.
• Parents with mental disorders or visual/reading impairments, and unable to cooperate with and undergo the intervention activities.
• Unwilling to participate.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Hangzhou Center for Disease Control and Prevention

Hangzhou, Zhejiang, 310025, China

Location

Related Publications (10)

• Xianming C, Wu L, Chunyan Z, et al. Study of coverage of influenza and pneumonia vaccinations in children and influencing factors in two areas, China. Chinese Journal of Epidemiology. 2023;44(11):1731-1737.

  BACKGROUND

• Nekrasova E, Stockwell MS, Localio R, Shults J, Wynn C, Shone LP, Berrigan L, Kolff C, Griffith M, Johnson A, Torres A, Opel DJ, Fiks AG. Vaccine hesitancy and influenza beliefs among parents of children requiring a second dose of influenza vaccine in a season: An American Academy of Pediatrics (AAP) Pediatric Research in Office Settings (PROS) study. Hum Vaccin Immunother. 2020 May 3;16(5):1070-1077. doi: 10.1080/21645515.2019.1707006. Epub 2020 Feb 4.

  PMID: 32017643 BACKGROUND

• Szilagyi PG, Albertin CS, Saville AW, Valderrama R, Breck A, Helmkamp L, Zhou X, Vangala S, Dickinson LM, Tseng CH, Campbell JD, Whittington MD, Roth H, Rand CM, Humiston SG, Hoefer D, Kempe A. Effect of State Immunization Information System Based Reminder/Recall for Influenza Vaccinations: A Randomized Trial of Autodialer, Text, and Mailed Messages. J Pediatr. 2020 Jun;221:123-131.e4. doi: 10.1016/j.jpeds.2020.02.020.

  PMID: 32446470 BACKGROUND

• Williams SE, Adams LE, Sommer EC. Improving Vaccination for Young Children (IVY): A Stepped-Wedge Cluster Randomized Trial. Acad Pediatr. 2021 Sep-Oct;21(7):1151-1160. doi: 10.1016/j.acap.2021.06.001. Epub 2021 Jun 10.

  PMID: 34118498 BACKGROUND

• Lerner C, Albertin C, Casillas A, Duru OK, Ong MK, Vangala S, Humiston S, Evans S, Sloyan M, Fox CR, Bogard JE, Friedman S, Szilagyi PG. Patient Portal Reminders for Pediatric Influenza Vaccinations: A Randomized Clinical Trial. Pediatrics. 2021 Aug;148(2):e2020048413. doi: 10.1542/peds.2020-048413.

  PMID: 34321338 BACKGROUND

• Stockwell MS, Shone LP, Nekrasova E, Wynn C, Torres A, Griffith M, Shults J, Unger R, Ware LA, Kolff C, Harris D, Berrigan L, Montague H, Localio AR, Fiks AG. Text Message Reminders for the Second Dose of Influenza Vaccine for Children: An RCT. Pediatrics. 2022 Sep 1;150(3):e2022056967. doi: 10.1542/peds.2022-056967.

  PMID: 35965283 BACKGROUND

• Howell-Jones R, Gold N, Bowen S, Bunten A, Tan K, Saei A, Jones S, MacDonald P, Watson R, Bennett KF, Chadborn T. Can uptake of childhood influenza immunisation through schools and GP practices be increased through behaviourally-informed invitation letters and reminders: two pragmatic randomized controlled trials. BMC Public Health. 2023 Jan 20;23(1):143. doi: 10.1186/s12889-022-14439-4.

  PMID: 36670376 BACKGROUND

• Szilagyi PG, Casillas A, Duru OK, Ong MK, Vangala S, Tseng CH, Albertin C, Humiston SG, Ross MK, Friedman SR, Evans S, Sloyan M, Bogard JE, Fox CR, Lerner C. Evaluation of behavioral economic strategies to raise influenza vaccination rates across a health system: Results from a randomized clinical trial. Prev Med. 2023 May;170:107474. doi: 10.1016/j.ypmed.2023.107474. Epub 2023 Mar 2.

  PMID: 36870572 BACKGROUND

• Tuckerman J, Harper K, Sullivan TR, Cuthbert AR, Fereday J, Couper J, Smith N, Tai A, Kelly A, Couper R, Friswell M, Flood L, Blyth CC, Danchin M, Marshall HS. Short Message Service Reminder Nudge for Parents and Influenza Vaccination Uptake in Children and Adolescents With Special Risk Medical Conditions: The Flutext-4U Randomized Clinical Trial. JAMA Pediatr. 2023 Apr 1;177(4):337-344. doi: 10.1001/jamapediatrics.2022.6145.

  PMID: 36806893 BACKGROUND

• Szilagyi PG, Duru OK, Casillas A, Ong MK, Vangala S, Tseng CH, Albertin C, Humiston SG, Clark E, Ross MK, Evans SA, Sloyan M, Fox CR, Lerner C. Text vs Patient Portal Messaging to Improve Influenza Vaccination Coverage: A Health System-Wide Randomized Clinical Trial. JAMA Intern Med. 2024 May 1;184(5):519-527. doi: 10.1001/jamainternmed.2024.0001.

  PMID: 38497955 BACKGROUND

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Zhiyuan Hou, PhD

  School of Public Health，Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiyuan Hou, PhD

CONTACT

86-21-33563935; zyhou@fudan.edu.cn

Anting Xu, BS

CONTACT

23211020203@m.fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 24, 2024
• Study Start: October 26, 2024
• Primary Completion: February 15, 2025
• Study Completion: March 31, 2025
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 12 months and ending 36 months following article publication
• Access Criteria: Researchers who provide a methodologically sound proposal for meta analysis. Proposals should be directed to zyhou@fudan.edu.cn; to gain access, data requestors will need to sign a data access agreement.

Locations

CN (1)