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The Impact of a Web-based Psychoeducation Programme With a Motivational AI Chatbot on Covid-19 Vaccine Hesitancy

Primary Purpose

Vaccine Hesitancy, COVID-19

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
AI-driven Vaccine Communicator
Self-learning of COVID-19 vaccine knowledge
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Vaccine Hesitancy focused on measuring Vaccine Hesitancy, COVID-19, Motivational Intervention, AI Chatbot, Artificial Intelligence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18 years old;
  • Hong Kong residents;
  • Show hesitancy toward Covid-19 vaccines;
  • Participants will be defined as covid-19 vaccine-hesitant if they meet one of the following conditions: 1) no plan for a date to receive the available Covid-19 vaccines either 1st, 2nd, or 3rd dose,46, or; 2) completed three doses of covid-19 vaccines not based on their willingness and are hesitant for future 4th or regular vaccines

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    AI-driven vaccine communicator intervention group

    Self-learning of COVID-19 vaccine knowledge control group

    Arm Description

    The intervention will include six 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.

    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.

    Outcomes

    Primary Outcome Measures

    Vaccine hesitancy at pre-test
    Vaccine hesitancy measured by adult Vaccine Hesitancy Index
    Vaccine hesitancy at one month follow-up
    Vaccine hesitancy measured by adult Vaccine Hesitancy Index
    Vaccine hesitancy at three months follow-up
    Vaccine hesitancy measured by adult Vaccine Hesitancy Index
    Vaccine hesitancy at six months follow-up
    Vaccine hesitancy measured by adult Vaccine Hesitancy Index

    Secondary Outcome Measures

    Vaccine confidence at pre-test
    Vaccine confidence assessed by Vaccine Confidence Index
    Vaccine confidence at one month follow-up
    Vaccine confidence assessed by Vaccine Confidence Index
    Vaccine confidence at three months follow-up
    Vaccine confidence assessed by Vaccine Confidence Index
    Vaccine confidence at six months follow-up
    Vaccine confidence assessed by Vaccine Confidence Index

    Full Information

    First Posted
    August 28, 2022
    Last Updated
    September 5, 2022
    Sponsor
    The Hong Kong Polytechnic University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05531058
    Brief Title
    The Impact of a Web-based Psychoeducation Programme With a Motivational AI Chatbot on Covid-19 Vaccine Hesitancy
    Official Title
    [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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2022 (Anticipated)
    Primary Completion Date
    August 1, 2023 (Anticipated)
    Study Completion Date
    October 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Hong Kong Polytechnic University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vaccine Hesitancy, COVID-19
    Keywords
    Vaccine Hesitancy, COVID-19, Motivational Intervention, AI Chatbot, Artificial Intelligence

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    We aim to have two study group, including the AI-driven vaccine communicator intervention group and the self-learning of COVID-19 vaccine knowledge control group.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    168 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    AI-driven vaccine communicator intervention group
    Arm Type
    Experimental
    Arm Description
    The intervention will include six 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.
    Arm Title
    Self-learning of COVID-19 vaccine knowledge control group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    AI-driven Vaccine Communicator
    Intervention Description
    The intervention will include six modules web-based psychoeducation programme (two module sessions weekly, each module lasts for 15-20 minutes). And the content of the intervention includes six modules sessions, including Module 1- What is COVID-19, Module 2- Basic knowledge of vaccine; Module 3- Risk and benefit; Module 4- Fear & myth; Module 5- Vaccine policy; Module 6- Review the intervention and end the programme. Also with an MI communication skills-based AI, digital assistant.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Self-learning of COVID-19 vaccine knowledge
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Vaccine hesitancy at pre-test
    Description
    Vaccine hesitancy measured by adult Vaccine Hesitancy Index
    Time Frame
    Vaccine hesitancy will be assessed at pre-intervention.
    Title
    Vaccine hesitancy at one month follow-up
    Description
    Vaccine hesitancy measured by adult Vaccine Hesitancy Index
    Time Frame
    Vaccine hesitancy will be assessed at post-intervention.
    Title
    Vaccine hesitancy at three months follow-up
    Description
    Vaccine hesitancy measured by adult Vaccine Hesitancy Index
    Time Frame
    Vaccine hesitancy will be assessed after three months follow-up.
    Title
    Vaccine hesitancy at six months follow-up
    Description
    Vaccine hesitancy measured by adult Vaccine Hesitancy Index
    Time Frame
    Vaccine hesitancy will be assessed after six months follow-up.
    Secondary Outcome Measure Information:
    Title
    Vaccine confidence at pre-test
    Description
    Vaccine confidence assessed by Vaccine Confidence Index
    Time Frame
    Vaccine confidence will be assessed at pre-intervention.
    Title
    Vaccine confidence at one month follow-up
    Description
    Vaccine confidence assessed by Vaccine Confidence Index
    Time Frame
    Vaccine confidence will be assessed at post-intervention.
    Title
    Vaccine confidence at three months follow-up
    Description
    Vaccine confidence assessed by Vaccine Confidence Index
    Time Frame
    Vaccine confidence will be assessed after three months follow-up.
    Title
    Vaccine confidence at six months follow-up
    Description
    Vaccine confidence assessed by Vaccine Confidence Index
    Time Frame
    Vaccine confidence will be assessed after six months follow-up.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 18 years old; Hong Kong residents; Show hesitancy toward Covid-19 vaccines; Participants will be defined as covid-19 vaccine-hesitant if they meet one of the following conditions: 1) no plan for a date to receive the available Covid-19 vaccines either 1st, 2nd, or 3rd dose,46, or; 2) completed three doses of covid-19 vaccines not based on their willingness and are hesitant for future 4th or regular vaccines 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yan Li, Dr
    Phone
    2766 6388
    Email
    yan-nursing.li@polyu.edu.hk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kit Ching Lee, Miss
    Phone
    3400 3792
    Email
    kchinlee@polyu.edu.hk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yan Li, Dr
    Organizational Affiliation
    The Hong Kong Polytechnic University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25896377
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    25896383
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    33192883
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    29954370
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22882349
    Citation
    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.
    Results Reference
    background

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    The Impact of a Web-based Psychoeducation Programme With a Motivational AI Chatbot on Covid-19 Vaccine Hesitancy

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