UMIN-CTR Clinical Trial

Basic information
Public title	A survey on the actual situation of driving support by occupational therapists in Okinawa Prefecture
Acronym	A survey on the actual situation of driving support by occupational therapists in Okinawa Prefecture
Scientific Title	A survey on the actual situation of driving support by occupational therapists in Okinawa Prefecture
Scientific Title:Acronym	A survey on the actual situation of driving support by occupational therapists in Okinawa Prefecture
Region	Japan

Condition
Condition	Cerebrovascular disease, head trauma, dementia, spinal cord injury, Parkinson's disease, rheumatoid arthritis, multiple sclerosis, amputation, schizophrenia mood disorder, neurosis, personality disorder, addiction, developmental disorder, others
Classification by specialty	Neurology Psychosomatic Internal Medicine Geriatrics Psychiatry Neurosurgery Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Okinawa Prefecture is one of the areas in Japan where the need for driving support is high, but the current status of support is not clear; therefore, this study will conduct a survey of driving support by occupational therapists in the prefecture, targeting medical institutions and local facilities, with the aim of understanding the actual status of support and clarifying problems and issues in providing support.
Basic objectives2	Others
Basic objectives -Others	To understand the efforts of occupational therapists in the prefecture to support motorists. To be able to know the needs of the subject. Organize problems and issues, and help occupational therapists in the prefecture to provide smooth support in line with the community. To disseminate information about reference approaches to occupational therapists in the prefecture.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	As a statistical method, the selected items of the questionnaire will be subjected to X2 independent test.
Key secondary outcomes	Free response items will be text-mined.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
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Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Facilities in Okinawa Prefecture where there are likely to be people who need driving support. Medical institutions, nursing care insurance facilities and offices, and welfare facilities for the disabled.
Key exclusion criteria	Target facilities that do not require driving assistance. Children's facilities, nursing homes, and elderly care facilities.
Target sample size	163

Research contact person
Name of lead principal investigator	1st name Hayashi Middle name Last name Tamanaha
Organization	Kibi University of International Studies(Communication System)
Division name	Graduate School of Health Sciences studies Department of Occupational Therapy, master's Course
Zip code	716-8508
Address	8 Iga-machi, Takahashi City, Okayama Prefecture
TEL	0886-22-9454
Email	tama.moya2016@gmail.com

Public contact
Name of contact person	1st name Hayashi Middle name Last name Tamanaha
Organization	Minei daiichi Hospital
Division name	Rehabilitation Medicine
Zip code	901-2113
Address	466 Ohira, Urasoe City, Okinawa, Japan
TEL	098-877-5806
Homepage URL
Email	tama.moya2016@gmail.com

Sponsor
Institute	Minei daiichi Hospital
Institute
Department

Funding Source
Organization	Minei daiichi Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Minei daiichi Hospital
Address	466 Ohira, Urasoe City, Okinawa, Japan
Tel	098-877-5806
Email	moyahaya2011@i.softbank.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	2022 Year 01 Month 07 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	Preinitiation
Date of protocol fixation	2021 Year 12 Month 15 Day
Date of IRB
Anticipated trial start date	2022 Year 02 Month 01 Day
Last follow-up date	2023 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

(1) Questionnaire survey by mail or internet (2) Questionnaire respondent: One occupational therapist who is in charge of the facility or the main person in charge of the support. (3) Content of the questionnaire: 41 questions about 1) the percentage of driving support provided by occupational therapists in the prefecture in the community, 2) the targets of driving support in medical institutions and facilities, and the content of their efforts, and 3) questions and problems with driving support. The survey asked 41 questions about the following topics The answers will be selective and open-ended.

Management information
Registered date	2022 Year 01 Month 07 Day
Last modified on	2022 Year 01 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053129

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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