UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025242 |
|---|---|
| Receipt number | 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 | 2024/02/03 14:13:25 |
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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
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
shirou_sugiura@sk00106.achmc.pref.aichi.jp
Sponsor or person
Institute
Aichi Children's Health and Medical Center
Institute
Department
Personal name
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
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
200
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Due to lack of time.
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
| 2016 | Year | 11 | Month | 02 | Day |
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
| 2022 | 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
| 2024 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029035
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
