UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058489 |
|---|---|
| Receipt number | R000066871 |
| Scientific Title | Cognitive function and driving |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/07/16 14:23:13 |
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Basic information
Public title
Cognitive function and driving
Acronym
Cognitive function and driving
Scientific Title
Cognitive function and driving
Scientific Title:Acronym
Cognitive function and driving
Region
| Japan |
Condition
Condition
n/a
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the association between cognitive function and driving.
Basic objectives2
Others
Basic objectives -Others
To examine the interaction between cognitive function and driving.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function
Key secondary outcomes
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants aged 70 years or older in the cohort study who drive a car at least one day a week and who agree with the secondary use of their health check-up data.
Key exclusion criteria
Those who meet the criteria articulated in the cohort study guidelines or those judged inappropriate.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Masao |
| Middle name | |
| Last name | Ichikawa |
Organization
University of Tsukuba
Division name
Institute of Medicine
Zip code
305-8577
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3423
masao@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Masao |
| Middle name | |
| Last name | Ichikawa |
Organization
University of Tsukuba
Division name
Institute of Medicine
Zip code
305-8577
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3423
Homepage URL
masao@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Masao Ichikawa
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee, University of Tsukuba Hospital
Address
2-1-1 Amakubo, Tsukuba, Ibaraki
Tel
-
rinshokenkyu@un.tsukuba.ac.jp
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 | 08 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To examine the association between cognitive function and driving among the cohort study participants aged 70 years or older who drive at least one day a week, using their health check-up data and telematics.
Management information
Registered date
| 2025 | Year | 07 | Month | 16 | Day |
Last modified on
| 2025 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066871
