UMIN-ICDS Clinical Trial

Public title

A comparative study of regional differences in the psychological burden and employment status of epilepsy patients following changes in transportation before and after diagnosis

Acronym

A comparative study of regional differences in the psychological burden and employment status of epilepsy patients following changes in transportation before and after diagnosis

Scientific Title

A comparative study of regional differences in the psychological burden and employment status of epilepsy patients following changes in transportation before and after diagnosis

Scientific Title:Acronym

A comparative study of regional differences in the psychological burden and employment status of epilepsy patients following changes in transportation before and after diagnosis

Region

Japan

Condition

epilepsy

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Previous studies on the prohibition of driving in epilepsy patients have focused on those who have caused traffic accidents. However, regarding the impact of the driving ban due to diagnosis on life, including employment, only case reports, including case series of less than 10 cases, were found, and no statistically verified studies were found within the scope of the search. Since epilepsy patients also live social lives, it is necessary to clarify the extent to which the prohibition of driving due to the diagnosis interferes with their social lives. In an anonymous questionnaire survey "Verification of changes in transportation and employment status in epilepsy patients before and after diagnosis," it was found that there is a psychological burden due to the prohibition of driving, and it was suggested that there may be differences in psychological burden between the three major metropolitan areas, especially the Tokyo wards, and other cities (presented at the 65th General Meeting of the Japanese Society of Neurology in 2024). This may be due to regional disparities in whether or not transportation can be relied on public transportation, and may lead to a reconsideration of public assistance for subsidies associated with driving bans.

Basic objectives2

Others

Basic objectives -Others

This is a socio-medical study.

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Primary outcomes

The burden of not being able to drive before and after a diagnosis of epilepsy and the difference between urban areas

Key secondary outcomes

Differences between urban areas in employment status before and after a diagnosis of epilepsy, the relationship between whether this change is due to the inability to drive, and the relationship between this and the burden of not being able to drive
Differences between urban areas in driver's license ownership before and after a diagnosis of epilepsy, the relationship between whether this change is due to the inability to drive, and the relationship between this and the burden of not being able to drive
Differences between urban areas in age and the burden of not being able to drive
Differences between urban areas in biological sex and the burden of not being able to drive
Differences between urban areas in the status of obtaining medical assistance for persons with disabilities and the burden of not being able to drive
Differences between urban areas in mental disability certificates and the burden of not being able to drive
Differences between urban areas in alternative means of transportation and the burden of not being able to drive

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

18

years-old

<=

Age-upper limit

65

years-old

>=

Gender

Male and Female

Key inclusion criteria

1. People who have been diagnosed with epilepsy.
2. People who are prohibited from driving due to being diagnosed with epilepsy.
3. People between the ages of 18 and 65.
4. People who are independent in activities of daily living (ADL).
5. People who are able to answer the questionnaire via the internet using a smartphone or personal computer.
6. People who are able to communicate in Japanese.

Key exclusion criteria

1. Those who are in a state specified by government ordinance as a state in which cognitive function has declined to the extent that it interferes with daily life due to Alzheimer's disease or other neurodegenerative diseases, cerebrovascular disease, or other diseases (Parkinson's disease, dementia with Lewy bodies, progressive supranuclear palsy, vascular dementia, Huntington's disease, normal pressure hydrocephalus, cerebrovascular disorders accompanied by neurological deficits or structural brain abnormalities).
2. Those who are addicted to alcohol, narcotics, cannabis, opium, or stimulants.
3. Those who have schizophrenia accompanied by hallucinations.
4. Those who have experienced recurrent syncope.
5. Those who have unaware hypoglycemia (excluding those whose blood sugar can be artificially regulated).
6. Those who suffer from manic-depressive disorder (excluding those who do not exhibit symptoms that may result in a loss of cognitive ability necessary for safe driving of a motor vehicle, etc.).
7. Those who have a sleep disorder accompanied by severe symptoms of drowsiness, such as narcolepsy.
8. Individuals who are blind or have other physical disabilities specified by government ordinance that may impede the safe operation of a motor vehicle, etc.
9. Individuals who are unable to sit down due to impaired trunk function.
10. Individuals who have lost all of their limbs or have completely lost the use of their limbs.
11. Individuals who will otherwise lack either the cognitive or operational abilities necessary for the safe operation of a motor vehicle, etc. (excluding those in whom it is clear that such abilities can be restored by attaching conditions to their driver's license).
12. Individuals who have not given consent to participate in this study.

Target sample size

60

Name of lead principal investigator

1st name	Naoko
Middle name
Last name	MAKISHI

Organization

Medical Corporation Koyukai Musashino Hospital

Division name

Department of Neurology

Zip code

187-0031

Address

1-23-10 Ogawa-Higashimachi Kodaira city Tokyo

TEL

042-313-5520

Email

nmakishi.ryk@gmail.com

Name of contact person

1st name	Naoko
Middle name
Last name	MAKISHI

Organization

Medical Corporation Koyukai Musashino Hospital

Division name

Department of Neurology

Zip code

184-0031

Address

1-23-10 Ogawa-Higashimachi Kodaira city Tokyo

TEL

042-313-5520

Homepage URL

Email

nmakishi.ryk@gmail.com

Institute

Medical Corporation Koyukai Musashino Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethics Committee of Musashino Hospital, Koyukai Medical Corporation

Address

1-23-10 Ogawa-higashimachi Kodaiira city, Tokyo

Tel

042-313-5520

Email

musashino.hosp-irb@koyu-kai.jp

Secondary IDs

YES

Study ID_1

20240003

Org. issuing International ID_1

Ethics Committee of Musashino Hospital, Koyukai Medical Corporation

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2024

Year

07

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2024

Year

05

Month

24

Day

Date of IRB

2024

Year

05

Month

24

Day

Anticipated trial start date

2024

Year

07

Month

01

Day

Last follow-up date

2025

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This is a cross-sectional study that retrospectively analyzed the means of transportation and employment status of epilepsy patients before and after diagnosis using a questionnaire.
The psychological burden of not being able to drive depends on whether or not you have a driver's license (``Yes, held before diagnosis,'' ``Yes, held since diagnosis,'' ``No, not obtained before diagnosis,'' ``None, returned after diagnosis.'') , employment status, and changes in transportation expenses among Tokyo wards, three major metropolitan areas outside of Tokyo wards, regional metropolitan areas, and other cities.
Musashino Hospital and Research Collaborating Institutions Among patients undergoing treatment for epilepsy, all research subjects who meet the eligibility criteria for this study will be extracted from electronic medical records and will be contacted by the research director or research partner institutions at the end of their next consultation. The research collaborators will explain the outline of this research in writing, and for research subjects who have expressed an interest in participating in the research, the purpose of the research will be explained to them verbally and in writing.
After obtaining voluntary consent from research subjects to participate in the research, they are given a form containing a questionnaire code and a link to the questionnaire form in the form of a QR code, and asked to respond in a form that does not identify their individuals.

Registered date

2024

Year

07

Month

21

Day

Last modified on

2024

Year

07

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062349