UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039814
Receipt number R000045379
Scientific Title Randomized comparison of several messages for increasing the rate of hepatitis virus testing
Date of disclosure of the study information 2020/03/15
Last modified on 2020/03/13 21:39:06

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Basic information

Public title

Randomized comparison of several messages for increasing the rate of hepatitis virus testing

Acronym

RCT for increasing rate of Hepatitis virus testing

Scientific Title

Randomized comparison of several messages for increasing the rate of hepatitis virus testing

Scientific Title:Acronym

RCT for increasing rate of Hepatitis virus testing

Region

Japan


Condition

Condition

Viral Hepatitis

Classification by specialty

Hepato-biliary-pancreatic medicine Infectious disease Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effects of leaflets developed for increasing the rate of hepatitis virus testing

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III


Assessment

Primary outcomes

Hepatitis virus testing rate

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Numbered container method


Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

"Fear appeal-Reassuring" type leaflet

Interventions/Control_2

"Barrier removing" type leaflet

Interventions/Control_3

Standard leaflet

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

Employees of study partner companies

Key exclusion criteria

Those who have experience of hepatitis virus testing

Target sample size

600


Research contact person

Name of lead principal investigator

1st name Seiichiro
Middle name
Last name Yamamoto

Organization

National Cancer Center

Division name

Center for Cancer Control and Information Services

Zip code

104-0045

Address

5-1-1, Tsukiji, Chuo, Tokyo, Japan 104-0045

TEL

03-3542-2511

Email

siyamamo@ncc.go.jp


Public contact

Name of contact person

1st name Seiichiro
Middle name
Last name Yamamoto

Organization

National Cancer Center

Division name

Center for Cancer Control and Information Services

Zip code

104-0045

Address

5-1-1, Tsukiji, Chuo, Tokyo, Japan 104-0045

TEL

03-3542-2511

Homepage URL


Email

siyamamo@ncc.go.jp


Sponsor or person

Institute

National Cancer Center

Institute

Department

Personal name



Funding Source

Organization

National Cancer Center

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Saga University

Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Cancer Center

Address

5-1-1, Tsukiji, Chuo, Tokyo, Japan 104-0045

Tel

03-3542-2511

Email

irst@ml.res.ncc.go.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

医療法人社団如水会今村病院(佐賀県)


Other administrative information

Date of disclosure of the study information

2020 Year 03 Month 15 Day


Related information

URL releasing protocol

Not available

Publication of results

Unpublished


Result

URL related to results and publications

Study on going

Number of participants that the trial has enrolled

872

Results

On going

Results date posted

2020 Year 03 Month 13 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2022 Year 12 Month 31 Day

Baseline Characteristics

On going

Participant flow

On going

Adverse events

Not applicable

Outcome measures

On going

Plan to share IPD

Shareble

IPD sharing Plan description

Will be planned after study finished


Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2019 Year 01 Month 21 Day

Date of IRB

2019 Year 01 Month 24 Day

Anticipated trial start date

2019 Year 04 Month 01 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry

2020 Year 05 Month 31 Day

Date trial data considered complete

2020 Year 08 Month 31 Day

Date analysis concluded

2021 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2020 Year 03 Month 13 Day

Last modified on

2020 Year 03 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045379


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name