- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07934888
Combining an Effective Rule-based Chatbot With ChatGPT-supported Real-time Question-answer Functions to Promote Seasonal Influenza Vaccination Among Community-dwelling People Aged 65 Years and Above
Combining an Effective Rule-based Chatbot With ChatGPT-supported Real-time Question-answer Functions to Promote Seasonal Influenza Vaccination Among Community-dwelling People Aged 65 Years and Above: a Partially Blinded Randomized Controlled Trial
This study is a partially blinded (outcome assessors and data analysts) and parallel-group randomized controlled trial. Community-dwelling people aged ≥65 years who have not received the SIV for the approaching flu season will be randomized evenly (1:1) into either the intervention group or the control group. During the intervention period, the intervention group will have access to the hybrid combination of a rule-based chatbot (SIV-Chatbot) with the ChatGPT-supported real-time Question & Answer (QA) functions, while the control group will have access only to the SIV-Chatbot.
The SIV-Chatbot will deliver the same interventions for both groups. The number of intervention sessions (four) and timing (week 0, 2, 4 & 6) will also be the same. In the intervention group, the hybrid Chatbot will invite the participants to raise open-ended questions related to SIV using flexible methods (such as voice messages, typing with keyboards, or handwriting) at each session. The ChatGPT will answer these questions immediately in the format of text messages. The functions can be used repeatedly throughout the intervention period (weeks 0-6), and participants will be free to spend as much time as they want on such functions.
Telephone interviews will be conducted at baseline (T0), after completion of the intervention (T1), and six months after T1 (T2). The primary outcome will be the self-reported SIV uptake measured at T2. The research team will validate that outcome by requesting the participants upload an image of their SIV receipt, while hiding their personal identification, via the WhatsApp account used in this study.
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
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- aged ≥65 years
- possession of a Hong Kong ID
- able to speak and comprehend Cantonese
- have a smartphone with internet access
- have either installed or are willing to install WhatsApp on their smartphone
- have not taken seasonal influenza vaccination for the approaching flu season
Exclusion Criteria:
- score ≤16 in the validated telephone version of the Cantonese Mini-Mental State Examination (T-CMMSE)
- either blindness or deafness
- with known contraindications to the SIV as indicated by the Hong Kong Centre for Health Protection (e.g., history of severe allergic reactions to any of the vaccine component or a previous dose of SIV and bleeding disorders)
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
Have access to the hybrid combination of a rule-based chatbot (SIV-Chatbot) with the ChatGPT-supported real-time QA functions |
After assessing participants' stage of change (SOC) regarding SIV uptake, the rule-based component (SIV-Chatbot) will deliver online interventions tailored to their current SOC. There will be four intervention sessions at week 0, 2, 4 and 6. In addition, the hybrid Chatbot will invite the participants to raise open-ended questions related to SIV using flexible methods at each session. The ChatGPT will answer these questions immediately in the format of text messages. The functions can be used repeatedly throughout the intervention period (weeks 0-6), and participants will be free to spend as much time as they want on such functions. |
|
Active Comparator: Control group
Have access only to a rule-based chatbot (SIV-Chatbot) |
After assessing participants' stage of change (SOC) regarding SIV uptake, the rule-based chatbot (SIV-Chatbot) will deliver online interventions tailored to their current SOC. There will be four intervention sessions at week 0, 2, 4 and 6. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Uptake of seasonal influenza vaccination
Time Frame: Six months after completion of the intervention
|
The primary outcome will be the self-reported seasonal influenza vaccination uptake measured at T2 (six months after completion of the intervention). The research team will validate that outcome by requesting the participants upload an image of their receipt. |
Six months after completion of the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stage of change related to seasonal influenza vaccination uptake
Time Frame: T0 (baseline), T1 (after completion of intervention), and T2 (six months after completion of the intervention)
|
Participants' SOC will be measured at T0 (baseline), T1 (after completion of intervention), and T2 (six months after completion of the intervention) by using validated questions |
T0 (baseline), T1 (after completion of intervention), and T2 (six months after completion of the intervention)
|
|
Knowledge and attitudes related to seasonal influenza vaccination
Time Frame: T0 (baseline) and T2 (6 months after completion of the intervention)
|
Knowledge and attitudes will be measured at T0 (baseline) and T2 (6 months after completion of the intervention) by validated tools |
T0 (baseline) and T2 (6 months after completion of the intervention)
|
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
- GRF14611325
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
The data presented in this study are available from the corresponding author upon request. The data are not publicly available as they contain sensitive personal information.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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