UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031717 |
|---|---|
| Receipt number | R000036225 |
| Scientific Title | Multiplex and multilayered epilepsy care network in Japan |
| Date of disclosure of the study information | 2018/03/14 |
| Last modified on | 2022/09/19 12:21:34 |
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Basic information
Public title
Multiplex and multilayered epilepsy care network in Japan
Acronym
Epilepsy care network in Japan
Scientific Title
Multiplex and multilayered epilepsy care network in Japan
Scientific Title:Acronym
Epilepsy care network in Japan
Region
| Japan |
Condition
Condition
Epilepsy
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Provide appropriate medical, social, and educational opportunities and, then, to improve quality of life for persons with epilepsy
Basic objectives2
Others
Basic objectives -Others
Examine the current status of medical and social systems for people with epilepsy, and, then, make a proposal of the tools to bridge the gaps among these systems
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate the number of person with epilepsy accessing the consultation and/or finding employment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
tools producing in the current study to bridge the gaps among various systems
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
institutions for people with epilepsy
Key exclusion criteria
none
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Kiyohito |
| Middle name | |
| Last name | TERADA |
Organization
NHO Shizuoka Institute of Epilepsy and Neurological Disorders
Division name
Department of Neurology
Zip code
4208688
Address
886 Urushiyama, Aoi-ku, Shizuoka
TEL
0542455446
kyht-terada@umin.net
Public contact
Name of contact person
| 1st name | Kiyihito |
| Middle name | |
| Last name | TERADA |
Organization
Shizuoka Institute of Epilepsy and Neurological Disorders
Division name
Department of Neurology
Zip code
4208688
Address
886 Urushiyama, Aoi-ku, Shizuoka
TEL
0542455446
Homepage URL
kyht-terada@umin.net
Sponsor or person
Institute
Japan Agency for Medical Research and Development
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shizuoka Institute of Epilepsy and Neurological Disorders
Address
886 Urushiyama, Aoi-ku, Shizuoka
Tel
0542455446
shizuoka@shizuokamind.org
Secondary IDs
Secondary IDs
YES
Study ID_1
17dk0307068h0001
Org. issuing International ID_1
Japan Agency for Medical Research and Development
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 14 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/epdf/10.1002/epi4.12390
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/epdf/10.1002/epi4.12390
Number of participants that the trial has enrolled
900
Results
They knew more about their students' seizures than those without medi-cal information. Existing forms for communicating information on students with epilepsy between schools and physicians were not actively utilized. Responses to open questions converged on safety at school.
Results date posted
| 2022 | Year | 09 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We mailed a questionnaire to 900 nurse teachers all over Japan.
Participant flow
We mailed a questionnaire to 900 nurse teachers all over Japan.
Adverse events
none
Outcome measures
It in-cluded six items on general epilepsy knowledge and 15 items on information about each student with epilepsy in their schools.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 14 | Day |
Last modified on
| 2022 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036225
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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