Vaccine Chatbot for Improving Influenza Vaccination Uptake
NCT ID: NCT06657573
Last Updated: 2024-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
1200 participants
INTERVENTIONAL
2024-10-26
2025-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Nudge and Motivational Interviewing Interventions to Improve Influenza Vaccine Uptake Among Healthcare Workers in China
NCT07157163
Childhood Influenza Immunisation in General Practice Invitation Trial
NCT02921633
Impact of Patient Education on Influenza Vaccine Uptake Among Community-dwelling Chinese Elderly
NCT02741843
Influenza Vaccine Attitudes, Intent, and Receipt: Pediatric
NCT02907580
Collaborative Efforts to Increase Flu Vaccination
NCT01403649
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The sample size is calculated based on the primary outcome - the influenza vaccination uptake among children, and the main analysis method, which involves the comparison of differences in vaccination rates between the intervention and control groups after the intervention. According to the vaccination data of study sites, the uptake of influenza vaccine among children aged 6-59 months is around 20% in the previous flu season. In China, influenza vaccination starts in September, and has been available for two months before this trial. Therefore, we assume that the baseline vaccination rate is 10% without the intervention during this trial, and the chatbot intervention would raise this rate by 6 percentage points to 16% at least. We assume a cluster size of 15 children per day per clinic based on routine visiting data. To have 80% power to detect a difference between the group proportions of 0.06, it requires 35 clusters and 525 participants per arm, assuming an intracluster correlation coefficient of 0.005 and a two-sided test with the 0.05 significance level. Assuming at least 10% loss to follow-up, the sample size is 600 participants per arm and 1,200 in total.
Multi-stage sampling will be utilized. Firstly, three representative regions (an urban district, a suburban district, and a rural county) will be selected to represent different economic development levels in China. In each region, four clinics will be selected based on geographical location, economic development, and patient volume. In each clinic, the 6-8 working days will be chosen to conduct this trial, resulting in 72-96 clinic-days (clusters) in 12 clinics in total. In these selected clinic-days, children and their parents regularly visit primary care clinics. All eligible children presenting in the selected clinic-days will be invited to participate by medical staff, and one of their parents will be included in this trial.
Stratified cluster randomized grouping will be employed. All clinic-days will be randomly allocated into intervention group or control group at a 1:1 ratio, stratified by region and clinic, resulting with 36-48 clinic-days per arm. Approximately 400 participants (200 in intervention group; 200 in control group) are expected to participate in this trial in each region, with a total sample size of 1,200 participants, meeting the sample size requirement.
The intervention group will engage with influenza vaccine chatbot for one and a half months, while the control group will receive the standard of care according to the local context, without additional intervention. On the day of the visit, the intervention group will be invited to use the influenza vaccine chatbot online through WeChat or any web browsers, where they can ask any questions related to the influenza vaccine and get validated answers from the chatbot immediately. Staff will be on site to help them use vaccine chatbot for the intervention group. Then, during the 1.5-month intervention, participants in the intervention group will be informed that the chatbot is available for use at their convenience, with coordinators sending the chatbot link every ten days to remind them to use. Conversely, the control group will not use the chatbot, without additional intervention during the trial, but will gain access after the trial ends.
At the end of the 1.5-month intervention, all participants from both intervention and control groups will be invited to complete a questionary survey. Three months after the intervention begins, influenza vaccination status of children and their parents will be collected from the vaccination registration system of local CDCs.
Difference in outcomes between the intervention and control groups will be assessed using t-tests and/or analysis of variance (ANOVA) for normally distributed continuous variables, and the Chi-square or Fisher's exact test will be used for categorical variables. When continuous variables do not meet normal distribution, the Wilcoxon rank-sum test will be employed. Multivariate regression models will be employed to evaluate the effectiveness of the chatbot intervention on the primary and secondary outcomes, adjusting for potential confounders. Given that participants in the intervention group will have varying frequencies and durations of using the chatbot, a dose-response relationship will be employed to evaluate the intervention effects by intervention intensity.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Influenza Vaccine Chatbot Intervention group
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.
An AI-enabled chatbot tailored for influenza vaccine consultation
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.
Control group
The control group will not use the chatbot during the intervention duration.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
An AI-enabled chatbot tailored for influenza vaccine consultation
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* Parents with mental disorders or visual/reading impairments, and unable to cooperate with and undergo the intervention activities.
* Unwilling to participate.
6 Months
59 Months
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fudan University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zhiyuan Hou
Associate professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Zhiyuan Hou, PhD
Role: PRINCIPAL_INVESTIGATOR
School of Public Health，Fudan University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hangzhou Center for Disease Control and Prevention
Hangzhou, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Wenwen Gu, MS
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Fudan Univeristy
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.