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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000045747
Receipt No. R000052224
Scientific Title Impact of a LINE chatbot and a webinar on COVID-19 vaccine intention and confidence in Japan: a Randomized Controlled Trial
Date of disclosure of the study information 2021/10/14
Last modified on 2021/10/14

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Basic information
Public title Impact of a LINE chatbot and a webinar on COVID-19 vaccine intention and confidence in Japan: a Randomized Controlled Trial
Acronym Impact of a LINE chatbot and a webinar on COVID-19 vaccine intention and confidence in Japan: a Randomized Controlled Trial
Scientific Title Impact of a LINE chatbot and a webinar on COVID-19 vaccine intention and confidence in Japan: a Randomized Controlled Trial
Scientific Title:Acronym Impact of a LINE chatbot and a webinar on COVID-19 vaccine intention and confidence in Japan: a Randomized Controlled Trial
Region
Japan

Condition
Condition vaccine hesitancy
COVID-19
Classification by specialty
Medicine in general Infectious disease Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Objectives are: (A)to investigate whether a LINE chatbot and webinar increase COVID-19 vaccine intention and vaccine confidence among those aged 20 or over in Japan; (B)to examine which type of interventions (a chatbot or webinar) can be more effective in improving vaccine intention and confidence; and (C)to disseminate evidence and insights for national/local governments to utilize them in the design and execution of their COVID-19 vaccination distributions.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Whether they intend to get COVID-19 vaccination once available (Yes/Unsure/No)
Key secondary outcomes The reasons why they intend to (or not to) get COVID-19 vaccination, Vaccine Confidence Index, social media consumption

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 The participants in Group 1 will be provided with the LINE chatbot. The chatbot provides automatic preset answers to frequently asked questions on COVID-19 vaccines via text messages. The participants in Group 1 can utilize the chatbot anytime during the 4-week intervention period.
Interventions/Control_2 The webinars for Group 2 will be designed to address individuals concerns of vaccine-hesitant persons. The topics will range from routine clinical and vaccine safety information to concerns of the participants. Each webinar includes a brief lecture for 15 minutes, followed by Q and A sessions for 45 minutes. Participants are engaged to poll or ask questions throughout a webinar. We tentatively plan to deliver the webinars four times a week using Zoom in a total of 16 webinars. Participants in Group 2 will have to attend at least one or two webinars for 4 weeks.
Interventions/Control_3 No interventions
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) People who have not been vaccinated for COVID-19
(2) People who are unsure or not willing to get vaccinated for COVID-19
(3) People who are 20 years old or older
Key exclusion criteria (1) People who have used the chatbot 'Corowa-kun Consultation Room'
(2) People who don't have access to the internet
(3) People who cannot download the application called LINE
(4)People who are not willing to participate in webinars
Target sample size 600

Research contact person
Name of lead principal investigator
1st name Kanako
Middle name
Last name Inaba
Organization Kanto Chuo Hospital
Division name Department of Obstetrics and Gynecology
Zip code 158-8531
Address 6-25-1 Kamiyouga, Setagaya-ku, Tokyo
TEL 0334291171
Email kaaaaaaana@gmail.com

Public contact
Name of contact person
1st name Yumiko
Middle name
Last name Radi
Organization Corowa-kun Supporters
Division name Administrative Office
Zip code 141-0022
Address 2-16-2-1003 Higashi-Gotanda Shinagawa-ku Tokyo Japan
TEL +1-267-303-3531
Homepage URL
Email office.corowakun@gmail.com

Sponsor
Institute Corowa-kun Supporters
Institute
Department

Funding Source
Organization The Vaccine Confidence Fund
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization

Other related organizations
Co-sponsor The University of Hong Kong
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kanto Chuo Hospital Review Board
Address 6-25-1 Kamiyouga, Setagaya-ku, Tokyo
Tel 0334291171
Email office.corowakun@gmail.com

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2021 Year 10 Month 14 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2021 Year 10 Month 13 Day
Date of IRB
2021 Year 10 Month 01 Day
Anticipated trial start date
2021 Year 10 Month 20 Day
Last follow-up date
2022 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2022 Year 02 Month 28 Day

Other
Other related information

Management information
Registered date
2021 Year 10 Month 14 Day
Last modified on
2021 Year 10 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052224

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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