UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000032547
Receipt No. R000037117
Scientific Title Relationship between subjective driving skills in elderly drivers and pain during driving and fear of driving
Date of disclosure of the study information 2018/06/01
Last modified on 2020/05/11 (Ver. 4)

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Basic information
Public title Relationship between subjective driving skills in elderly drivers and pain during driving and fear of driving
Acronym Relationship between subjective driving skills and physical and mental functions of elderly drivers
Scientific Title Relationship between subjective driving skills in elderly drivers and pain during driving and fear of driving
Scientific Title:Acronym Relationship between subjective driving skills and physical and mental functions of elderly drivers
Region
Japan

Condition
Condition Healthy elderly people
Classification by specialty
Geriatrics Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this research is to conduct a survey on the relationship between self-evaluation on driving skills in elderly drivers and the existence of chronic pain site and anxiety about driving.
Basic objectives2 Others
Basic objectives -Others Obtain data that contributes to screening evaluation of high risk drivers.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Subjective driving skill score by questionnaire survey.
Key secondary outcomes Anxiety about driving
Presence or absence of chronic pain during driving.
Past accident history.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Questionnaire survey for healthy elderly.
Interventions/Control_2
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
100 years-old >
Gender Male and Female
Key inclusion criteria Elderly people who understand the research contents and are driving a car on a daily basis.
Key exclusion criteria Person who has obvious cognitive decline or central nervous system disorder.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Katsuhiko
Middle name
Last name Takatori
Organization Kio University
Division name Faculty of Health Science, Department of Physical Therapy
Zip code 6300137
Address 4-2-2 Umami-naka, Koryo, Kitakatsuragi-gun, Nara
TEL 0745541601
Email k.takatori@kio.ac.jp

Public contact
Name of contact person
1st name Katsuhiko
Middle name
Last name Takatori
Organization Kio University
Division name Faculty of Health Science, Department of Physical Therapy
Zip code 6350832
Address 4-2-2 Umami-naka, Koryo, Kitakatsuragi-gun, Nara
TEL 0745541601
Homepage URL
Email k.takatori@kio.ac.jp

Sponsor
Institute Kio University
Institute
Department

Funding Source
Organization Kio University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kio University
Address 4-2-2 Umami-naka, Koryo, Kitakatsuragi-gun, Nara
Tel 0745541601
Email k.takatori@kio.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
2018 Year 06 Month 01 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 124
Results 
Focusing on physical function, elderly people had a significantly higher proportion of the following questions than non-elderly people: "It is difficult for the neck to go backward when directly checking the back." "It's difficult to get in and out of the car because the body is less flexible."  As for the importance of cars in daily life, more elderly people needed cars than non-elderly people.There was no difference in the fear of driving a car between the elderly and non-elderly.
Results date posted
2020 Year 05 Month 11 Day
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
2018 Year 05 Month 10 Day
Date of IRB
2019 Year 04 Month 01 Day
Anticipated trial start date
2018 Year 06 Month 25 Day
Last follow-up date
2020 Year 03 Month 30 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 05 Month 10 Day
Last modified on
2020 Year 05 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037117