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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025242
Receipt No. R000029035
Scientific Title The association between health literacy of caregiver and the symptoms of children visiting emergency department.
Date of disclosure of the study information 2016/12/13
Last modified on 2018/06/20

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Basic information
Public title The association between health literacy of caregiver and
the symptoms of children visiting emergency department.
Acronym Health Literacy of caregiver in emergency department
Scientific Title The association between health literacy of caregiver and
the symptoms of children visiting emergency department.
Scientific Title:Acronym Health Literacy of caregiver in emergency department
Region
Japan

Condition
Condition caregivers of children visiting emergency department
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the association between health literacy of caregivers and non-urgent emergency department visit of children in Japan.
Basic objectives2 Others
Basic objectives -Others health literacy of caregivers and non-urgent emergency department visit
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The association between low NSV score (less than 4) and non urgent visit
Key secondary outcomes the proportion of non-urgent visit stratified by NVS score
NSV scorestratified by triage level
The association between NVS score and judgement of pediatrician (admission, examination, procedure, prescription)

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
18 years-old <=
Age-upper limit
60 years-old >
Gender Male and Female
Key inclusion criteria caregivers of sick-children whose mother tongue is thought to be Japanese.
Key exclusion criteria caregiver visiting for specific reasons
(letters, instruction from doctor etc)
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shiro Sugiura
Organization Aichi Children's Health and Medical Center
Division name department of allergy
Zip code
Address 7-426, Morioka, Obu, Aichi 474-8710, Japan
TEL 0562-43-0500
Email shirou_sugiura@sk00106.achmc.pref.aichi.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shiro Suigura
Organization Aichi Children's Health and Medical Center
Division name department of allergy
Zip code
Address 7-426, Morioka, Obu, Aichi 474-8710, Japan
TEL 0562-43-0500
Homepage URL
Email shirou_sugiura@sk00106.achmc.pref.aichi.jp

Sponsor
Institute Aichi Children's Health and Medical Center
Institute
Department

Funding Source
Organization self-procurement
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 12 Month 13 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 No longer recruiting
Date of protocol fixation
2016 Year 11 Month 02 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 13 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
2019 Year 12 Month 31 Day
Date trial data considered complete
2019 Year 12 Month 31 Day
Date analysis concluded
2019 Year 12 Month 31 Day

Other
Other related information Nothing to mention

Management information
Registered date
2016 Year 12 Month 13 Day
Last modified on
2018 Year 06 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029035

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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