UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059345 |
|---|---|
| Receipt number | R000067820 |
| Scientific Title | International questionnaire survey on clinical practices and challenges in epilepsy care across countries |
| Date of disclosure of the study information | 2025/10/10 |
| Last modified on | 2025/10/08 21:17:56 |
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Basic information
Public title
Multinational survey on clinical practice for epilepsy care
Acronym
International Epilepsy Clinical Practice Survey
Scientific Title
International questionnaire survey on clinical practices and challenges in epilepsy care across countries
Scientific Title:Acronym
International questionnaire survey on clinical practices in epilepsy care
Region
| Japan | Asia(except Japan) | North America |
| South America | Australia | Europe |
| Africa |
Condition
Condition
epilepsy
Classification by specialty
| Neurology | Psychiatry | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the clinical practices of physicians involved in epilepsy care, focusing on pregnancy management, mental health, and guideline adherence, to identify current challenges and contribute to improving the quality of epilepsy care globally.
Basic objectives2
Others
Basic objectives -Others
To identify regional variations in clinical attitudes and treatment selection, and to explore associated factors such as physicians' specialty, years of practice, gender, and institutional characteristics.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adherence to international clinical guidelines and regional variations in clinical attitudes.
Evaluate physicians' adherence to internationally recommended practices and regional differences in treatment selection where no international guideline exists.
At survey completion; scored from vignette items.
Key secondary outcomes
Associations between clinician characteristics and attitudes
Associations between facility factors and attitudes
Attitudes toward pregnancy-related management
Attitudes toward mental health assessment and care
Attitudes regarding acute management (treatment thresholds and medication choices)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Physicians currently engaged in epilepsy care,who can understand the language used in the questionnaire and have internet access.
Key exclusion criteria
No exclusion criteria will be applied.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Yukako |
| Middle name | |
| Last name | Nakagami |
Organization
Kyoto University
Division name
Student Mental Health Center
Zip code
606-8317
Address
Yoshida-Honmachi, Sakyo-Ku, Kyoto City, Kyoto, Japan
TEL
075-753-2429
yes.ao.adult.epilepsy@gmail.com
Public contact
Name of contact person
| 1st name | Yukako |
| Middle name | |
| Last name | Nakagami |
Organization
Kyoto University
Division name
Student Mental Health Center
Zip code
606-8317
Address
Yoshida-Honmachi, Sakyo-Ku, Kyoto City, Kyoto, Japan
TEL
075-753-2429
Homepage URL
yes.ao.adult.epilepsy@gmail.com
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Kyoto University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University
Address
Yoshida-Honmachi, Sakyo-Ku, Kyoto City, Kyoto, Japan
Tel
075-753-2429
yes.ao.adult.epilepsy@gmail.com
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
| 2025 | Year | 10 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 05 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study initiated recruitment after approval by the ethics committee; however, due to a delay in database registration, it has been registered retrospectively.
Management information
Registered date
| 2025 | Year | 10 | Month | 08 | Day |
Last modified on
| 2025 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067820
