UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034709
Receipt No. 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 2019/05/08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
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
2. Driving a manual car
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
Email 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
Email ishii-h@ncgg.go.jp

Sponsor
Institute Department of Preventive Gerontology, National Center for Geriatrics and Gerontology
Institute
Department

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
Email

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
2024 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
2019 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039574

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.