UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046265
Receipt number R000052735
Scientific Title Educational Short Video Intervention for COVID-19 Vaccine Uptake
Date of disclosure of the study information 2021/12/06
Last modified on 2022/04/09 23:33:06

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Basic information

Public title

Educational Short Video Intervention for COVID-19 Vaccine Uptake

Acronym

Educational Short Video Intervention for COVID-19 Vaccine Uptake

Scientific Title

Educational Short Video Intervention for COVID-19 Vaccine Uptake

Scientific Title:Acronym

Educational Short Video Intervention for COVID-19 Vaccine Uptake

Region

Japan


Condition

Condition

COVID-19

Classification by specialty

Infectious disease Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to examine the impact of educational short videos on vaccine uptake intentions.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Intentions for Vaccine Uptake

Key secondary outcomes

Sure Test Score(Decisional Conflict Scale)
Perceived Effectiveness and Safety of COVID-19 Vaccine
Impression about the educational materials


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Educational Short Video

Interventions/Control_2

Short Video without Educational Materials

Interventions/Control_3


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

39 years-old >=

Gender

Male and Female

Key inclusion criteria

1.Considering to have a child in the near future

Key exclusion criteria

1. People who already had vaccine at least for one time
2.People who already made a reservation for the vaccine

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Shota
Middle name
Last name Endo

Organization

Fukushima Medical University

Division name

Department of Hygiene and Preventive Medicine

Zip code

960-1295

Address

Fukushima City, Hikarigaoka 1

TEL

024-547-1174

Email

shota-e@fmu.ac.jp


Public contact

Name of contact person

1st name Shota
Middle name
Last name Endo

Organization

Fukushima Medical University

Division name

Department of Hygiene and Preventive Medicine

Zip code

960-1295

Address

Fukushima City, Hikarigaoka 1

TEL

024-547-1174

Homepage URL


Email

shota-e@fmu.ac.jp


Sponsor or person

Institute

Fukushima Medical University

Institute

Department

Personal name



Funding Source

Organization

The Occupational Health Promotion Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Fukushima Medical University Institutional Review Board

Address

Fukushima City, Hikarigaoka 1

Tel

024-547-1825

Email

rs@fmu.ac.jp


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 12 Month 06 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

300

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

Completed

Date of protocol fixation

2021 Year 12 Month 06 Day

Date of IRB

2021 Year 11 Month 22 Day

Anticipated trial start date

2022 Year 01 Month 20 Day

Last follow-up date

2022 Year 01 Month 27 Day

Date of closure to data entry

2022 Year 01 Month 27 Day

Date trial data considered complete

2022 Year 01 Month 27 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 12 Month 03 Day

Last modified on

2022 Year 04 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052735


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name