UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054954 |
|---|---|
| Receipt number | R000062786 |
| Scientific Title | Study on the Development of an Application for Reducing Traffic Accidents Using Lifestyle and Physical Condition Information |
| Date of disclosure of the study information | 2024/07/13 |
| Last modified on | 2024/07/12 20:26:57 |
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Basic information
Public title
Study on the Development of an Application for Reducing Traffic Accidents Using Lifestyle and Physical Condition Information
Acronym
Study on the Development of an App for Reducing Traffic Accidents
Scientific Title
Study on the Development of an Application for Reducing Traffic Accidents Using Lifestyle and Physical Condition Information
Scientific Title:Acronym
Study on the Development of an App for Reducing Traffic Accidents
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the risk assessment of road traffic accidents through road traffic accident reduction applications and the habitual effects of sound, light and vibration.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Healthy adults aged 20 years and over are asked to wear a smart ring for 14 days and stress questionnaire scores are compared between groups that use a road accident reduction application before driving their own car (intervention group (using the application) and control group (not using the application)). We also compare the number of simulated accidents on a driving simulator before and after the intervention between the two groups.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Using the traffic accident reduction app before driving, for 5 or more days per week, over a period of 14 days.
Interventions/Control_2
Spending 10 minutes doing nothing before driving, 5 days a week, for 14 days.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Healthy adult participants
(2)Individuals drive a car at least once a week
(3)Individuals who possess a valid regular driver's license (both manual and automatic transmission are acceptable)
(4)Participants who can drive their own car for a minimum of 20 minutes continuously, at least 5 days a week during the study period
(5)Individuals who can provide written consent for participation in the study
(6)Individuals without metal allergies
Key exclusion criteria
(1)Individuals who cannot provide informed consent.
(2)Individuals who do not possess a valid regular driver's license.
(3)Individuals who do not possess driving skills.
(4)Individuals with severe cognitive impairment or severe higher brain dysfunction.
(5)Individuals with developmental disorders, dementia, or higher brain dysfunction.
(6)Individuals with metal allergies.
(7)Individuals currently participating in other clinical studies.
(8)Other individuals for whom conducting the study would be difficult.
(9)Individuals affiliated with the field of the principal investigator and research collaborators (including those affiliated with secondary occupations) (students, graduate students, and staff).
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Taki |
Organization
Tohoku University
Division name
Smart Ageing International Research Center
Zip code
980-8575
Address
4-1 Seiryo-Machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-8582
yasuyuki.taki.c7@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Keishi |
| Middle name | |
| Last name | Soga |
Organization
Tohoku University
Division name
Smart Ageing International Research Center
Zip code
980-8575
Address
4-1 Seiryo-Machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-8492
Homepage URL
keishi.soga.b4@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
SDNC Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Logic and Magic Technology Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2024 | Year | 07 | Month | 13 | 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
| 2024 | Year | 07 | Month | 04 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 25 | 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
| 2024 | Year | 07 | Month | 12 | Day |
Last modified on
| 2024 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062786
