UMIN-CTR Clinical Trial

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
Email	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
Email	kyht-terada@umin.net

Sponsor
Institute	Japan Agency for Medical Research and Development
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036225