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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040451
Receipt No. R000046169
Scientific Title COVID 19 - What Families Think and Do? A Survey for Families Visiting the Pediatric Emergency Department
Date of disclosure of the study information 2020/05/20
Last modified on 2020/05/22

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Basic information
Public title COVID 19 - What Families Think and Do? A Survey for Families Visiting the Pediatric Emergency Department
Acronym COVID 19 - A Survey for Families Visiting the Pediatric Emergency Department
Scientific Title COVID 19 - What Families Think and Do? A Survey for Families Visiting the Pediatric Emergency Department
Scientific Title:Acronym COVID 19 - A Survey for Families Visiting the Pediatric Emergency Department
Region
Japan North America Europe

Condition
Condition COVID-19
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The novel coronavirus COVID-19 is affecting 176 countries and territories around the world and the outbreak was declared a global pandemic by the World Health Organization (WHO). Many States and Provinces declared a public health emergency. At the time of writing this study proposal, there are several hundred patients with COVID-19 in British Columbia and several thousand patients in Washington State. The numbers are increasing rapidly [https://www.cdc.gov/coronavirus/2019-nCoV/index.html]. The outbreak may be stressful for parents and children alike, and may lead some families to seek medical advice in a pediatric emergency department (ED). Furthermore, children with flu-like symptoms may be taken to the ED to be evaluated, with parental concerns that they were infected with COVID-19. The objective of this timely study is to assess parental attitudes towards COVID-19, to understand the reasons they decided to come to the ED and to learn about their attitudes about vaccination during a time of a global pandemic.
Basic objectives2 Others
Basic objectives -Others to assess parental attitudes towards COVID-19
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes to assess parental attitudes towards COVID-19
Key secondary outcomes DEMOGRAPHICS
Which category best describes your child?
EMERGENCY VISIT
PROTECTION
IMMUNIZATIONS/VACCINES/SHOTS
SOURCE OF INFORMATION

Base
Study type Others,meta-analysis etc

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
1 years-old <=
Age-upper limit
18 years-old >
Gender Male and Female
Key inclusion criteria We plan to provide a standardized questionnaire online to all families coming to the Emergency Department at participating sites.
Key exclusion criteria Nil
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Naoki
Middle name
Last name Shimizu
Organization St. Marianna University School of Medicine
Division name Department of Paediatrics
Zip code 216-8511
Address 2-16-1 Sugao, Miyamae, Kawasaki, Kanagawa
TEL +81-(0)44-977-8111
Email naoki.shimizu@marianna-u.ac.jp

Public contact
Name of contact person
1st name Tomohiro
Middle name
Last name Katsuta
Organization St. Marianna University School of Medicine
Division name Department of Paediatrics
Zip code 216-8511
Address 2-16-1 Sugao, Miyamae, Kawasaki, Kanagawa
TEL +81-(0)44-977-8111
Homepage URL
Email katsuta-7-@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor University of British Columbia, BC Children's Hospital, Vancouver, Canada
Name of secondary funder(s)

IRB Contact (For public release)
Organization St. Marianna University School of Medicine
Address 2-16-1 Sugao, Miyamae, Kawasaki, Kanagawa
Tel +81-(0)44-977-8111
Email naoki.shimizu@marianna-u.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 20 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
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 Preinitiation
Date of protocol fixation
2020 Year 03 Month 30 Day
Date of IRB
2020 Year 05 Month 22 Day
Anticipated trial start date
2020 Year 05 Month 22 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Nil

Management information
Registered date
2020 Year 05 Month 19 Day
Last modified on
2020 Year 05 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046169

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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