UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000041260 |
|---|---|
| Receipt number | 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 | 2024/02/19 13:19:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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 | Obstetrics 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
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/
m.lopresti@intage.com
Sponsor or person
Institute
MSD K. K.
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/34871223/ and https://pubmed.ncbi.nlm.nih.gov/34933677/
Number of participants that the trial has enrolled
2532
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
We are now developping manuscript. After the publication, we will report the results here.
Date of the first journal publication of results
| 2022 | Year | 12 | Month | 31 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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 | 09 | Month | 14 | Day |
Date of closure to data entry
| 2020 | Year | 09 | Month | 14 | Day |
Date trial data considered complete
| 2020 | Year | 09 | Month | 18 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 14 | 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
| 2024 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_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 |
