Clinical trial NCT05531058: 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
Overall status: COMPLETED
Phase: NA
Conditions: Vaccine Hesitancy
COVID-19
Keywords: Vaccine Hesitancy
COVID-19
Motivational Intervention
AI Chatbot
Artificial Intelligence
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Vaccine hesitancy at pre-test
timeFrame: Vaccine hesitancy will be assessed at pre-intervention.
measure: Vaccine hesitancy at post-intervention
timeFrame: Vaccine hesitancy will be assessed five weeks post the commencement of the intervention (at post-intervention).
measure: Vaccine hesitancy at three months follow-up
timeFrame: Vaccine hesitancy will be assessed after three months follow-up.
measure: Vaccine hesitancy at six months follow-up
timeFrame: Vaccine hesitancy will be assessed after six months follow-up.
Secondary outcomes:
measure: Vaccine confidence at pre-test
timeFrame: Vaccine confidence will be assessed at pre-intervention.
measure: Vaccine confidence at post-intervention
timeFrame: Vaccine confidence will be assessed five weeks post the commencement of the intervention (at post-intervention).
measure: Vaccine confidence at three months follow-up
timeFrame: Vaccine confidence will be assessed after three months follow-up.
measure: Vaccine confidence at six months follow-up
timeFrame: Vaccine confidence will be assessed after six months follow-up.
measure: Vaccine readiness at pre-test
timeFrame: Vaccine readiness will be assessed at pre-intervention.
measure: Vaccine readiness at post-intervention
timeFrame: Vaccine readiness will be assessed five weeks post the commencement of the intervention (at post-intervention).
measure: Vaccine readiness at three months follow up
timeFrame: Vaccine readiness will be assessed after three months follow-up.
measure: Vaccine readiness at six months follow up
timeFrame: Vaccine readiness will be assessed after six months follow-up.
measure: Vaccine-Related Health Literacy at pre-test
timeFrame: Vaccine-Related Health Literacy will be assessed at pre-intervention.
measure: Vaccine-Related Health Literacy at post-intervention
timeFrame: Vaccine-Related Health Literacy will be assessed five weeks post the commencement of the intervention (at post-intervention).
measure: Vaccine-Related Health Literacy at three months follow up
timeFrame: Vaccine-Related Health Literacy will be assessed after three months follow-up.
measure: Vaccine-Related Health Literacy at six months follow up
timeFrame: Vaccine-Related Health Literacy will be assessed after six months follow-up.
measure: Trust in government at pre-test
timeFrame: Trust in government will be assessed at pre-intervention.
measure: Trust in government at post-test
timeFrame: Trust in government will be assessed five weeks post the commencement of the intervention (at post-intervention).
measure: Trust in government at three-months follow up
timeFrame: Trust in government will be assessed after three-months follow up.
measure: Trust in government at six-months follow up
timeFrame: Trust in government will be assessed after six-months follow up.
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Nursing, The Hong Kong Polytechnic Unviersity
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Yan Li, Dr
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.