UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017214 |
|---|---|
| Receipt number | 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 09:04:04 |
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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'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'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
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
ryo-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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019963
| 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 |
