Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06657573
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-23
Brief Title:
Vaccine Chatbot for Improving Influenza Vaccination Uptake
Sponsor:
None
Organization:
None
Study Overview
Official Title:
AI-enabled Vaccine Chatbot for Improving Influenza Vaccination Uptake in Children a Cluster Randomized Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
This is a cluster randomized trial CRTs consisting of two arms to evaluate the effectiveness of an AI-enabled vaccine chatbot on influenza vaccination uptake among children aged between 6 and 59 months Participants regularly visit primary care clinics when they are invited to participate in this trial and with clinic-days as clusters a cluster randomization will be used to assign clinic days to the intervention and control groups
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 006 it requires 35 clusters and 525 participants per arm assuming an intracluster correlation coefficient of 0005 and a two-sided test with the 005 significance level Assuming at least 10 loss to follow-up the sample size is 600 participants per arm and 1200 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 11 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 1200 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 15-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 15-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 andor analysis of variance ANOVA for normally distributed continuous variables and the Chi-square or Fishers 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
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 006 it requires 35 clusters and 525 participants per arm assuming an intracluster correlation coefficient of 0005 and a two-sided test with the 005 significance level Assuming at least 10 loss to follow-up the sample size is 600 participants per arm and 1200 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 11 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 1200 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 15-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 15-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 andor analysis of variance ANOVA for normally distributed continuous variables and the Chi-square or Fishers 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None