UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040286
Receipt number R000045966
Scientific Title Study on risk perception and behavioral change related to COVID-19
Date of disclosure of the study information 2020/05/11
Last modified on 2021/11/01 13:31:52

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Basic information

Public title

Study on risk perception and behavioral change related to COVID-19

Acronym

Study on risk perception and behavioral change related to COVID-19

Scientific Title

Study on risk perception and behavioral change related to COVID-19

Scientific Title:Acronym

Study on risk perception and behavioral change related to COVID-19

Region

Japan


Condition

Condition

behavioral change

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Examine a message type that is highly effective in promoting self-restraint regarding COVI-19.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

behavioral intention

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

5

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Reading a message that encourage to stay at home

Interventions/Control_2

Reading a message that encourage to stay at home

Interventions/Control_3

Reading a message that encourage to stay at home

Interventions/Control_4

Reading a message that encourage to stay at home

Interventions/Control_5

Reading a message that encourage to stay at home

Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit

60 years-old >=

Gender

Male and Female

Key inclusion criteria

men and women aged 18 to 69 years

Key exclusion criteria

individuals who cannot go out due to illness or disability, who have been diagnosed with a mental illness, and who or whose family members have been infected with COVID-19.

Target sample size

1980


Research contact person

Name of lead principal investigator

1st name Tsuyoshi
Middle name
Last name Okuhara

Organization

The University of Tokyo

Division name

Department of Health Communication, School of Public Health

Zip code

113-8655

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan

TEL

03-5800-6549

Email

okuhara-ctr@umin.ac.jp


Public contact

Name of contact person

1st name Tsuyoshi
Middle name
Last name Okuhara

Organization

The University of Tokyo

Division name

Department of Health Communication, School of Public Health

Zip code

113-8655

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan

TEL

03-5800-6549

Homepage URL


Email

okuhara-ctr@umin.ac.jp


Sponsor or person

Institute

The University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

The Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Office for Human Research Studies, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan

Tel

03-5841-0818

Email

ethics@m.u-tokyo.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

2020 Year 05 Month 11 Day


Related information

URL releasing protocol

https://www.sciencedirect.com/science/article/pii/S0738399120304432?via%3Dihub

Publication of results

Published


Result

URL related to results and publications

https://www.sciencedirect.com/science/article/pii/S0738399120304432?via%3Dihub

Number of participants that the trial has enrolled

1980

Results

The message from a physician increased participants intention to stay at home significantly more than other narrators messages.The message from a physician increased participants perceived severity, response efficacy, and self-efficacy significantly more than other narrators messages.

Results date posted

2021 Year 11 Month 01 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2020 Year 08 Month 21 Day

Baseline Characteristics

The eligibility criterion was men and women aged 18 to 69 years. Exclusion criteria were individuals who answered screening questions by stating that they cannot go out because of illness or disability, that they have been diagnosed with a mental illness, or and that they or their family members have been infected with COVID-19.

Participant flow

Participants were recruited from people registered in a survey company database in Japan. Participants were randomly assigned either to a group that received an intervention message (i.e., from a governor, a public health expert, a physician, a patient, and a resident of the outbreak area) or to one that received a control message.

Adverse events

None.

Outcome measures

The primary outcome was intention to stay at home. The secondary outcomes were Protection Motivation Theory constructs (i.e., perceived severity, vulnerability, response efficacy, and self-efficacy).

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2020 Year 05 Month 01 Day

Date of IRB

2020 Year 05 Month 01 Day

Anticipated trial start date

2020 Year 05 Month 12 Day

Last follow-up date

2020 Year 05 Month 14 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 05 Month 01 Day

Last modified on

2021 Year 11 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045966


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name