- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05531058
The Impact of a Web-based Psychoeducation Programme with a Motivational AI Chatbot on Covid-19 Vaccine Hesitancy
[AI-driven Vaccine Communicator: the Impact of a Web-based Psychoeducation Programme with a Motivational AI-based Digital Assistant on Covid-19 Vaccine Hesitancy in Hong Kong's Population
Vaccine hesitancy is defined as 'delay in acceptance or refusal of vaccines, despite the availability of vaccine service' and was named one of the top ten global health threats by the World Health Organization in 2019.
Our proposed study will aim to develop and evaluate the effectiveness of a Web-based psychoeducation programme to address Covid-19 vaccine hesitancy, 'AI-driven Vaccine Communicator' (including educational materials, animations of vaccine research and development, and an MI communication skills-based AI, digital assistant).
Our goal is to standardise our intervention so that it can serve as an effective toolkit for clinicians/healthcare providers to increase Hong Kong residents' motivation to vaccinate and to ensure that the programme can be adapted to viral mutations and newly developed vaccines in the medium/long term.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is a two-arm, single-blind pilot randomized controlled trial, and it will be adopted to evaluate the efficacy of the 'AI-driven Vaccine Communicator' relative to being self-informed about Covid-19 vaccines.
Also, to address the widespread hesitancy among Hong Kong residents toward Covid-19 vaccines, we will develop a Web-based psychoeducation programme, 'AI-driven Vaccine Communicator,' driven by artificial intelligence (AI) techniques based on the Vaccine Hesitancy Determinants Matrix Model and MI communication skills and concepts (theoretical underpinnings). After developing and piloting this programme, we will test its effectiveness among members of the population who are hesitant about Covid-19 vaccines. The programme will then be refined further and standardised to use the most relevant information and effective communication skills to promote acceptance of Covid-19 vaccines among a wider Hong Kong population. Clinicians and healthcare providers will be able to utilise our programme as a toolkit in their usual practice when working with clients who are hesitant about Covid-19 vaccines.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Hong Kong, Hong Kong
- School of Nursing, The Hong Kong Polytechnic Unviersity
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 years or above;
- Hong Kong residents;
- Show vaccine hesitancy (not taking COVID-19 vaccines or receiving involuntary COVID-19 vaccines);
- have internet access
- able to read Chinese or English. Recruitment involved social media promotion and collaborating with community organizations
Exclusion Criteria:
- People with self-reported cognitive impairments or mental disorders that might interfere with their understanding of the intervention content;
- People who currently engaged in another clinical trial in relation to Covid-19 vaccines.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Self-learning of COVID-19 vaccine knowledge control group
Participants in the control group will be given HK government websites in COVID-19 vaccine and invite to join the online examination in relation to Covid-19 vaccine knowledge.
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Participants in the control group will be given HK government websites in COVID-19 vaccine and invite to join the online examination in relation to Covid-19 vaccine knowledge (using multiple choices questions similar to the intervention group), and this is to ensure that participants from the control group also use time to search relevant information of covid-19 vaccines, also this is to control the time effects.
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Experimental: AI-driven vaccine communicator intervention group
The intervention will include five modules web-based psychoeducation programme (two modules sessions weekly, each module lasts for 15-20 minutes) which includes educational materials, animations of vaccine research and development, and an MI communication skills-based AI, digital assistant.
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The intervention will include five modules web-based psychoeducation programme (two module sessions weekly, each module lasts for 15-20 minutes) and interact with an MI communication skills-based AI, digital assistant.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vaccine hesitancy at pre-test
Time Frame: Vaccine hesitancy will be assessed at pre-intervention.
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Vaccine hesitancy measured by Adult Vaccine Hesitancy scale and a single question 'plan for next dose'
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Vaccine hesitancy will be assessed at pre-intervention.
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Vaccine hesitancy at three months follow-up
Time Frame: Vaccine hesitancy will be assessed after three months follow-up.
|
Vaccine hesitancy measured by Adult Vaccine Hesitancy scale and a single question 'plan for next dose'
|
Vaccine hesitancy will be assessed after three months follow-up.
|
|
Vaccine hesitancy at six months follow-up
Time Frame: Vaccine hesitancy will be assessed after six months follow-up.
|
Vaccine hesitancy measured by Adult Vaccine Hesitancy scale and a single question 'plan for next dose'
|
Vaccine hesitancy will be assessed after six months follow-up.
|
|
Vaccine hesitancy at post-intervention
Time Frame: Vaccine hesitancy will be assessed five weeks post the commencement of the intervention (at post-intervention).
|
Vaccine hesitancy measured by Adult Vaccine Hesitancy scale and a single question 'plan for next dose'
|
Vaccine hesitancy will be assessed five weeks post the commencement of the intervention (at post-intervention).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vaccine confidence at pre-test
Time Frame: Vaccine confidence will be assessed at pre-intervention.
|
Vaccine confidence assessed by Vaccine Confidence Index scale
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Vaccine confidence will be assessed at pre-intervention.
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Vaccine confidence at three months follow-up
Time Frame: Vaccine confidence will be assessed after three months follow-up.
|
Vaccine confidence assessed by Vaccine Confidence Index scale
|
Vaccine confidence will be assessed after three months follow-up.
|
|
Vaccine confidence at six months follow-up
Time Frame: Vaccine confidence will be assessed after six months follow-up.
|
Vaccine confidence assessed by Vaccine Confidence Index scale
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Vaccine confidence will be assessed after six months follow-up.
|
|
Vaccine-Related Health Literacy at pre-test
Time Frame: Vaccine-Related Health Literacy will be assessed at pre-intervention.
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Vaccine-Related Health Literacy assessed by Chinese version of the European Health Literacy Survey Questionnaire
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Vaccine-Related Health Literacy will be assessed at pre-intervention.
|
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Vaccine-Related Health Literacy at three months follow up
Time Frame: Vaccine-Related Health Literacy will be assessed after three months follow-up.
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Vaccine-Related Health Literacy assessed by Chinese version of the European Health Literacy Survey Questionnaire
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Vaccine-Related Health Literacy will be assessed after three months follow-up.
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Vaccine-Related Health Literacy at six months follow up
Time Frame: Vaccine-Related Health Literacy will be assessed after six months follow-up.
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Vaccine-Related Health Literacy assessed by Chinese version of the European Health Literacy Survey Questionnaire
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Vaccine-Related Health Literacy will be assessed after six months follow-up.
|
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Vaccine confidence at post-intervention
Time Frame: Vaccine confidence will be assessed five weeks post the commencement of the intervention (at post-intervention).
|
Vaccine confidence assessed by Vaccine Confidence Index scale
|
Vaccine confidence will be assessed five weeks post the commencement of the intervention (at post-intervention).
|
|
Vaccine readiness at pre-test
Time Frame: Vaccine readiness will be assessed at pre-intervention.
|
Participants' perception of their degree of attitudinal change using three one-item measures of readiness for vaccine perception: How important is it for you to receive a COVID-19 vaccine?; How ready are you to receive a COVID-19 vaccine?; How confident are you about receiving a COVID-19 vaccine?
|
Vaccine readiness will be assessed at pre-intervention.
|
|
Vaccine readiness at post-intervention
Time Frame: Vaccine readiness will be assessed five weeks post the commencement of the intervention (at post-intervention).
|
Participants' perception of their degree of attitudinal change using three one-item measures of readiness for vaccine perception: How important is it for you to receive a COVID-19 vaccine?; How ready are you to receive a COVID-19 vaccine?; How confident are you about receiving a COVID-19 vaccine?
|
Vaccine readiness will be assessed five weeks post the commencement of the intervention (at post-intervention).
|
|
Vaccine readiness at three months follow up
Time Frame: Vaccine readiness will be assessed after three months follow-up.
|
Participants' perception of their degree of attitudinal change using three one-item measures of readiness for vaccine perception: How important is it for you to receive a COVID-19 vaccine?; How ready are you to receive a COVID-19 vaccine?; How confident are you about receiving a COVID-19 vaccine?
|
Vaccine readiness will be assessed after three months follow-up.
|
|
Vaccine readiness at six months follow up
Time Frame: Vaccine readiness will be assessed after six months follow-up.
|
Participants' perception of their degree of attitudinal change using three one-item measures of readiness for vaccine perception: How important is it for you to receive a COVID-19 vaccine?; How ready are you to receive a COVID-19 vaccine?; How confident are you about receiving a COVID-19 vaccine?
|
Vaccine readiness will be assessed after six months follow-up.
|
|
Vaccine-Related Health Literacy at post-intervention
Time Frame: Vaccine-Related Health Literacy will be assessed five weeks post the commencement of the intervention (at post-intervention).
|
Vaccine-Related Health Literacy assessed by Chinese version of the European Health Literacy Survey Questionnaire
|
Vaccine-Related Health Literacy will be assessed five weeks post the commencement of the intervention (at post-intervention).
|
|
Trust in government at pre-test
Time Frame: Trust in government will be assessed at pre-intervention.
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Trust in government will be measured with the four-item Vaccine Confidence Index.
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Trust in government will be assessed at pre-intervention.
|
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Trust in government at post-test
Time Frame: Trust in government will be assessed five weeks post the commencement of the intervention (at post-intervention).
|
Trust in government will be measured with the four-item Vaccine Confidence Index.
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Trust in government will be assessed five weeks post the commencement of the intervention (at post-intervention).
|
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Trust in government at three-months follow up
Time Frame: Trust in government will be assessed after three-months follow up.
|
Trust in government will be measured with the four-item Vaccine Confidence Index.
|
Trust in government will be assessed after three-months follow up.
|
|
Trust in government at six-months follow up
Time Frame: Trust in government will be assessed after six-months follow up.
|
Trust in government will be measured with the four-item Vaccine Confidence Index.
|
Trust in government will be assessed after six-months follow up.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Yan Li, Dr, The Hong Kong Polytechnic University
Publications and helpful links
General Publications
- MacDonald NE; SAGE Working Group on Vaccine Hesitancy. Vaccine hesitancy: Definition, scope and determinants. Vaccine. 2015 Aug 14;33(34):4161-4. doi: 10.1016/j.vaccine.2015.04.036. Epub 2015 Apr 17.
- Jarrett C, Wilson R, O'Leary M, Eckersberger E, Larson HJ; SAGE Working Group on Vaccine Hesitancy. Strategies for addressing vaccine hesitancy - A systematic review. Vaccine. 2015 Aug 14;33(34):4180-90. doi: 10.1016/j.vaccine.2015.04.040. Epub 2015 Apr 18.
- Taylor S, Landry CA, Paluszek MM, Groenewoud R, Rachor GS, Asmundson GJG. A Proactive Approach for Managing COVID-19: The Importance of Understanding the Motivational Roots of Vaccination Hesitancy for SARS-CoV2. Front Psychol. 2020 Oct 19;11:575950. doi: 10.3389/fpsyg.2020.575950. eCollection 2020.
- Gagneur A, Lemaitre T, Gosselin V, Farrands A, Carrier N, Petit G, Valiquette L, De Wals P. A postpartum vaccination promotion intervention using motivational interviewing techniques improves short-term vaccine coverage: PromoVac study. BMC Public Health. 2018 Jun 28;18(1):811. doi: 10.1186/s12889-018-5724-y.
- Leung SF, Ma J, Russell J. Enhancing motivation to change in eating disorders with an online self-help program. Int J Ment Health Nurs. 2013 Aug;22(4):329-39. doi: 10.1111/j.1447-0349.2012.00870.x. Epub 2012 Aug 6.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- P0039051
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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