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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041260
Receipt No. R000046787
Scientific Title Awareness and knowledge of congenital cytomegalovirus infection among healthcare professionals and non-healthcare professionals: a web-based survey in Japan
Date of disclosure of the study information 2020/07/31
Last modified on 2020/07/30

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Basic information
Public title Awareness and knowledge of congenital cytomegalovirus infection among healthcare professionals and non-healthcare professionals: a web-based survey in Japan
Acronym Awareness and knowledge of congenital cytomegalovirus infection: a web-based survey
Scientific Title Awareness and knowledge of congenital cytomegalovirus infection among healthcare professionals and non-healthcare professionals: a web-based survey in Japan
Scientific Title:Acronym Awareness and knowledge of congenital cytomegalovirus infection: a web-based survey
Region
Japan

Condition
Condition congenital cytomegalovirus infection
Classification by specialty
Medicine in general Obsterics and gynecology Pediatrics
Oto-rhino-laryngology Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 - To assess awareness of cCMVi among HCPs in Japan
- To assess awareness of cCMVi among non-HCPs in Japan
Basic objectives2 Others
Basic objectives -Others For pregnant women;
- To assess the precautious practices during pregnancy.
For participants who have heard of cCMVi;
- To assess the level of knowledge about cCMVi.
- To assess the current practice and attitude/opinion about cCMVi prevention or screening.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Awareness about cCMVi
Key secondary outcomes knowledge, clinical practice, experience, and attitude/opinion about cCMVi

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Medical doctors: Mainly engaged in Pediatrics, Obstetrics, Otolaryngology or Internal medicine
Midwives: Work experience as a midwife
Nurses: Work experience as a nurse in obstetrics or pediatrics including neonatology
Pregnant women/Others (men and non-pregnant women):
-Aged between 20 and 45 years
-Pregnant/Not Pregnant at informed consent
-No experience of working (or receiving education) as a healthcare professional
Key exclusion criteria Medical doctors with experiences of less than 2 years after graduation from medical school (during initial clinical training)
Target sample size 2110

Research contact person
Name of lead principal investigator
1st name Masayuki
Middle name
Last name Kobayashi
Organization MSD K. K.
Division name Medical Affairs
Zip code 102-8667
Address KIATNOMARU SQUARE, 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo 102-8667, JAPAN
TEL +81362722049
Email ldgproject@merck.com

Public contact
Name of contact person
1st name Michael
Middle name
Last name LoPresti
Organization INTAGE Healthcare Inc.
Division name Health Economics & Outcomes Research Division
Zip code 101-0062
Address 13F Ochanomizu SolaCity, 4-6 Kanda-Surugadai, Chiyoda-ku, Tokyo
TEL +815036401444
Homepage URL https://www.intage-healthcare.co.jp/
Email m.lopresti@intage.com

Sponsor
Institute MSD K. K.
Institute
Department

Funding Source
Organization MSD K. K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Medical Corporation Tou-kei-kai Kitamachi Clinic
Address 1-1-3 Kichijoji Kitamachi, Musashino City, 180-0001 Tokyo
Tel +817050118550
Email shingo-namiki@cmicgroup.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 NA(Web調査)

Other administrative information
Date of disclosure of the study information
2020 Year 07 Month 31 Day

Related information
URL releasing protocol NA
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 Enrolling by invitation
Date of protocol fixation
2020 Year 07 Month 08 Day
Date of IRB
2020 Year 07 Month 15 Day
Anticipated trial start date
2020 Year 07 Month 31 Day
Last follow-up date
2020 Year 08 Month 31 Day
Date of closure to data entry
2020 Year 09 Month 12 Day
Date trial data considered complete
2020 Year 09 Month 18 Day
Date analysis concluded
2020 Year 12 Month 18 Day

Other
Other related information Since this is web-based survey, there is no follow-up period and the cross-sectional study.

Management information
Registered date
2020 Year 07 Month 30 Day
Last modified on
2020 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046787

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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