UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034709 |
|---|---|
| Receipt number | R000039574 |
| Scientific Title | Study on safe driving skill and traffic accident in the older adults |
| Date of disclosure of the study information | 2018/10/31 |
| Last modified on | 2020/05/01 17:57:28 |
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Basic information
Public title
Study on safe driving skill and traffic accident in the older adults
Acronym
Program for Extending of Safety Driving Expectancy
Scientific Title
Study on safe driving skill and traffic accident in the older adults
Scientific Title:Acronym
Program for Extending of Safety Driving Expectancy
Region
| Japan |
Condition
Condition
Community-dwelling older people
Classification by specialty
| Geriatrics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study is to identify the effects of safety education and safety driving skills training program on improving driving skill and preventing traffic accident among community-dwelling older people.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Vehicle crash and traffic violation
Key secondary outcomes
1. On-road driving skill
2. Driving characteristics (frequency, distance, driving questionnaire)
3. Medical history, lifestyle habit, activity level, psychological state
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Intervention group: safe drive training (four sessions)
Interventions/Control_2
Control group: safety education (one session during intervention)
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. Community-dwelling older people over 65 years old
2. Usual driving habit
3. Cognitive function is not impaired, slightly impaired, and impaired (not dementia by medical doctor) in cognitive impairment screening test for senior drivers
4. Informed written consent
Key exclusion criteria
1. Not having Japanese car driving license
Target sample size
1314
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Shimada |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Preventive Gerontology
Zip code
Address
7-430 Morioka-cho, Obu city, Aichi prefecture, Japan
TEL
0562-46-2311
shimada@ncgg.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Ishii |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Preventive Gerontology
Zip code
Address
7-430 Morioka-cho, Obu city, Aichi prefecture, Japan
TEL
0562-46-2311
Homepage URL
ishii-h@ncgg.go.jp
Sponsor or person
Institute
Department of Preventive Gerontology, National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
National Center for Geriatrics and Gerontology
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
国立長寿医療研究センター（愛知県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 31 | 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
| 2018 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 31 | 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
Management information
Registered date
| 2018 | Year | 10 | Month | 30 | Day |
Last modified on
| 2020 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039574
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
