UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052880 |
|---|---|
| Receipt number | R000060339 |
| Scientific Title | Effectiveness of smart driver courses to extend driving life |
| Date of disclosure of the study information | 2023/11/24 |
| Last modified on | 2024/10/17 10:46:16 |
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Basic information
Public title
Effectiveness of smart driver courses to extend driving life
Acronym
Effectiveness of smart driver courses to extend driving life
Scientific Title
Effectiveness of smart driver courses to extend driving life
Scientific Title:Acronym
Effectiveness of smart driver courses to extend driving life
Region
| Japan |
Condition
Condition
Older people living in the community
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The project examines the impact of a smart driver course designed to improve the driving skills of older drivers living in the community.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
driving skill(Conforms to driver's license skill test standards)
Key secondary outcomes
Grip strength, lower limb muscle strength, visual function, reaction speed, cognitive function, attention function, daily life activity status, and driving awareness,, gaze analysis (VR).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
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
Conduct a smart driver course with driving skill improvement content once a month for three months.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Must not have dementia (MMSE score of 24 or more)
(2) Have a valid driver's license
(3) Able to participate in the Smart Driver Course
(4) Able to take pre- and post-measurements
Key exclusion criteria
Under 65 years old
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yuta |
| Middle name | |
| Last name | Noguchi |
Organization
Suzuka University of Medical Science
Division name
Department of Rehabilitation, Faculty of Health Science
Zip code
510-0293
Address
Kishioka 1001-1, Suzuka City, Mie
TEL
059-383-8991
reha.noguchi.ot@gmail.com
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Noguchi |
Organization
Suzuka University of Medical Science
Division name
Department of Rehabilitation, Faculty of Health Science
Zip code
510-0293
Address
Kishioka 1001-1, Suzuka City, Mie
TEL
059-383-8991
Homepage URL
reha.noguchi.ot@gmail.com
Sponsor or person
Institute
Suzuka University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Others
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
Suzuka University of Medical Science
Address
Minamitamagaki 3500-3, Suzuka City, Mie
Tel
059-340-0550
mayumi@suzuka-u.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
| 2023 | Year | 11 | Month | 24 | 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
Completed
Date of protocol fixation
| 2023 | Year | 11 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 11 | Month | 23 | Day |
Last modified on
| 2024 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060339
