UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017214
Receipt No. R000019963
Scientific Title A Randomized Controlled Trial for Extending Safety Driving Expectancy in the Elderly with Cognitive Decline
Date of disclosure of the study information 2015/04/22
Last modified on 2018/10/24

* 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 A Randomized Controlled Trial for Extending Safety Driving Expectancy in the Elderly with Cognitive Decline
Acronym Project for Extending Safety Driving Expectancy
Scientific Title A Randomized Controlled Trial for Extending Safety Driving Expectancy in the Elderly with Cognitive Decline
Scientific Title:Acronym Project for Extending Safety Driving Expectancy
Region
Japan

Condition
Condition mild cognitive impairment, global cognitive decline
Classification by specialty
Neurology Geriatrics Psychiatry
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of the study is to identify the effects of cognitive training, safety education, and safety driving skills training program on decreasing car accidents in older people.The mixed effect model and generalized linear model with intention-to-treat analysis are performed to examine the effects of intervention program.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 1. on-road driving ability
2. vehicle crash and traffic violation
Key secondary outcomes 1. cognitive function(memory, attention, executive function, processing speed)
2. measures of vision
3. neuroimaing data
4. driving cessation
5. disability incident

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 No treatment
Stratification NO
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:
twice-weekly program (once-weekly safe drive training and once-weekly cognitive training) for three months
Interventions/Control_2 Control group:
no 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 Subject who fulfill the following all criteria
1. Independent adults aged 65 years and older living within the community
2. objective mild cognitive impairment (indicated by an age- and education-adjusted score at least 1.5 SDs below the reference threshold in one or more specific cognitive domains including memory, attention, executive function, processing speed, and global cognition)
3. usual driving habit: 3 days/week and more
Key exclusion criteria 1. dementia diagnosis
2. serious neurological or musculoskeletal diagnoses, such as Parkinson&#39;s disease and others
3. Mini-Mental State Examination score 20 and below
4. incapable of taking cognitive performance tests
5. not having Japanese driver&#39;s license or having less driving habit (2days/week and less)
Target sample size 400

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, Aichi, Japan
TEL 0562-46-2311
Email shimada@ncgg.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryo Hotta
Organization National Center for Geriatrics and Gerontology
Division name Department of Preventive Gerontology
Zip code
Address 7-430 Morioka-cho, Obu, Aichi, Japan
TEL 0562-46-2311
Homepage URL
Email ryo-h@ncgg.go.jp

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

Funding Source
Organization TOYOTA MOTOR CORPORATION
Organization
Division
Category of Funding Organization Profit organization
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)、緑ヶ丘自動車学校(愛知県)

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 22 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
2015 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 30 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 04 Month 30 Day
Date trial data considered complete
2017 Year 05 Month 31 Day
Date analysis concluded
2017 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 04 Month 21 Day
Last modified on
2018 Year 10 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019963

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.