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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05531058
• Other study ID #: P0039051
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: October 1, 2023

Study information

• Verified date: August 2022
• Source: The Hong Kong Polytechnic University
• Contact: Yan Li, Dr
• Phone: 2766 6388
• Email: yan-nursing.li[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 168
• Est. completion date: October 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Vaccine Hesitancy

Intervention

Behavioral:
• AI-driven Vaccine Communicator
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.
• Self-learning of COVID-19 vaccine knowledge
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

References & Publications (5)

Gagneur A, Lemaître 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. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaccine hesitancy at pre-test	Vaccine hesitancy measured by adult Vaccine Hesitancy Index	Vaccine hesitancy will be assessed at pre-intervention.
Primary	Vaccine hesitancy at one month follow-up	Vaccine hesitancy measured by adult Vaccine Hesitancy Index	Vaccine hesitancy will be assessed at post-intervention.
Primary	Vaccine hesitancy at three months follow-up	Vaccine hesitancy measured by adult Vaccine Hesitancy Index	Vaccine hesitancy will be assessed after three months follow-up.
Primary	Vaccine hesitancy at six months follow-up	Vaccine hesitancy measured by adult Vaccine Hesitancy Index	Vaccine hesitancy will be assessed after six months follow-up.
Secondary	Vaccine confidence at pre-test	Vaccine confidence assessed by Vaccine Confidence Index	Vaccine confidence will be assessed at pre-intervention.
Secondary	Vaccine confidence at one month follow-up	Vaccine confidence assessed by Vaccine Confidence Index	Vaccine confidence will be assessed at post-intervention.
Secondary	Vaccine confidence at three months follow-up	Vaccine confidence assessed by Vaccine Confidence Index	Vaccine confidence will be assessed after three months follow-up.
Secondary	Vaccine confidence at six months follow-up	Vaccine confidence assessed by Vaccine Confidence Index	Vaccine confidence will be assessed after six months follow-up.