- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07687719
Chatbot-delivered Theory-based Online Intervention in Increasing Seasonal Influenza Vaccination Uptake Among Children Aged 3-6 Years
A Randomized Controlled Trial Evaluating a Chatbot-delivered Theory-based Online Intervention in Increasing Seasonal Influenza Vaccination Uptake Among Children Aged 3-6 Years
This randomized controlled trial will compare the efficacy of a Chatbot-delivered stage-of-change-tailored online intervention versus a Chatbot-delivered non-stage-of-change-tailored online intervention for mothers in increasing seasonal influenza vaccination uptake of their children aged 3-6 years. Mothers of children aged 3-6 years will be randomized evenly into either the intervention or the control group.
In the intervention group, the Chatbot will assess mothers' stage of change regarding their children's seasonal influenza vaccination uptake and deliver SOC-tailored interventions through WhatsApp every two weeks for four times.
In the control group, the Chatbot will provide a standard and non-stage-of-change-tailored intervention every two weeks for four times.
All participants will complete three telephone surveys at baseline (T0), after completion of the intervention (T1) and three months after T1 (T2).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Zixin Wang, PhD
- Phone Number: +852 22528474
- Email: wangzx@cuhk.edu.hk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Mothers aged ≥18 years with at least one child aged 3-6 years studying in kindergarten in Hong Kong
- Cantonese speaking
- Having smartphone with internet access
- Already having WhatsApp on the smartphone
Exclusion Criteria:
- Blindness or deafness
- The index child has known medical contraindications for seasonal influenza vaccination
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
Participants in the intervention group will receive chatbot-delivered online interventions tailored to their current stage of change regarding their index child's seasonal influenza vaccination.
|
The Chatbot will deliver four intervention sessions tailored to participants' current stage of change regarding their index child's seasonal influenza vaccination uptake at Week 0, 2, 4, and 6.
Participants will also have access to real-time Question-and-Answer (QA) function provided by the chatbot to address their questions related to seasonal influenza vaccination during the intervention period (week 0-6), and they are free to spend as much time as they want on such function.
|
|
Active Comparator: Control group
Participants in the control group will receive chatbot-delivered standard and non-stage-of-change-tailored interventions
|
The Chatbot will automatically send participants a link to access a standard online video at week 0, 2, 4 and 6.
Participants will also have access to real-time Question-and-Answer (QA) function provided by the chatbot to address their questions related to seasonal influenza vaccination during the intervention period (week 0-6), and they are free to spend as much time as they want on such function.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Index child's seasonal influenza vaccination uptake reported by his/her mother with validation
Time Frame: 3 months after completion of the interventions (T2)
|
The research team will ask the participants whether their index children have taken up seasonal influenza vaccination at T2 (3 months after completion of the interventions) using a validated question through telephone interview.
The research team will validate the outcome by requesting participants uploading an image of SIV receipt, while hiding personal identification, via the WhatsApp account used in this project.
|
3 months after completion of the interventions (T2)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HMRF24230092
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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