UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057350 |
|---|---|
| Receipt number | R000063693 |
| Scientific Title | A Non-Randomized Trial of Community Participation Support for People with Acquired Brain Injury After Driving Cessation in Japan |
| Date of disclosure of the study information | 2025/03/25 |
| Last modified on | 2026/03/12 07:20:44 |
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Basic information
Public title
Community Participation Support for People with Acquired Brain Injury After Driving Cessation in Japan
Acronym
Community Participation Support After Driving Cessation
Scientific Title
A Non-Randomized Trial of Community Participation Support for People with Acquired Brain Injury After Driving Cessation in Japan
Scientific Title:Acronym
"The Effect of Community Participation Support for Individuals Following Driving Cessation After Acquired Brain Injury
Region
| Japan |
Condition
Condition
Acquired brain injury
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine the intervention effects of a community life support program for individuals who have had to stop driving due to illness or injury, using the "Person-Occupation-Environment" theory to develop the "Model of Experiences for Individuals and Families After Driving Cessation." This participatory program, titled the Community Life Support Program for Individuals with Acquired Brain Injury after Driving Cessation (CLASP-AID), is designed to support community living for individuals after driving cessation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Change in occupational performance measured using the Canadian Occupational Performance Measure (COPM). The COPM is a client-centered semi-structured interview used to identify occupational performance problems that are important to the individual and to rate both performance and satisfaction on a 10-point scale. In this study, the change in the performance score will be treated as the primary outcome, while satisfaction scores will be analyzed as a secondary indicator. COPM assessments will be conducted at baseline and post-intervention, and changes in scores will be evaluated.
Key secondary outcomes
Readiness for driving cessation and mobility transition
Readiness for mobility transition will be assessed using the Japanese version of the Assessment of Readiness for Mobility Transition (ARMT-J), which evaluates emotional and attitudinal readiness for mobility changes associated with aging and driving cessation.
Health-related quality of life
Health-related quality of life will be assessed using the Medical Outcomes Study 12-Item Short-Form Health Survey version 2 (SF-12), a validated questionnaire measuring eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health.
Depressive symptoms
Depressive symptoms will be assessed using the 15-item Geriatric Depression Scale (GDS-15), a validated screening tool for depression in older adults. Scores >= 5 indicate depressive tendency and >= 10 suggest probable depression.
Environmental factors
Environmental factors will be assessed using the Comprehensive Environmental Questionnaire for the Elderly (CEQ), consisting of 14 items across three domains (safe living environment, social interaction environment, and family environment). Items are rated on a 4-point scale, with higher scores indicating more supportive environments.
Life-space mobility
Life-space mobility will be assessed using the Life-Space Assessment (LSA). The LSA measures the extent of mobility from within the home to outside the town, considering frequency and level of independence (score range: 0-120).
Evaluation of powered mobility devices
Training and evaluation of powered mobility devices will be conducted on a dedicated course at the study site. When community use is considered, participants will undergo further evaluation by certified mobility equipment providers to determine suitability for device use.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention will utilize CLASP-AID, which we have developed. Specifically, a driving cessation program will be conducted with participants over four sessions and with family members in one session. For participants, the program will cover four themes:
"Support for driving cessation provided by research institutions," "Considerations in case driving cannot be immediately resumed," "Alternative means of transportation to replace driving," "Planning for daily life after ceasing to drive." Educational materials will be created based on these four themes, providing participants with an opportunity to reflect on life after stopping driving. In addition, a single lecture for family members of the participants will cover the topic: 5. "Key points on how family and relatives can provide support."
Each session will last approximately 40 minutes. The primary and secondary outcomes will be assessed before the first session and after the completion of the fifth session.
Interventions/Control_2
The intervention will utilize the standard driving cessation support typically provided. Specifically, each staff member will be responsible for conducting the driving cessation support as they see fit. No educational materials will be used in this process.
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
| 55 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Informed consent: Patients who have received a sufficient explanation of the study, fully understand it, and have provided written consent of their own free will.
2. Age requirement: Patients who are between 55 and 90 years old at the time of consent.
3. Driving cessation: Patients who have ceased driving with a valid ordinary driver's license.
Key exclusion criteria
Disqualification due to medical conditions: Individuals with conditions such as epilepsy, schizophrenia, dementia, or other disqualifying conditions for driving resumption as determined by the Public Safety Commission.
Cognitive impairment: Individuals with a Mini-Mental State Examination (MMSE) score of 24 or below, indicating significant cognitive impairment.
Aphasia: Individuals with aphasia who are unable to fully understand the tests.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Satonori |
| Middle name | |
| Last name | Nasu |
Organization
JA Kyosai Nakaizu Rehabilitation Center
Division name
The Rehabilitation Department of Occupational Therapy
Zip code
410-2507
Address
1523-108 Hiekawa, Izu City, Shizuoka Prefecture, Japan
TEL
+81-558-83-2204
sa-nasu@janrc.or.jp
Public contact
Name of contact person
| 1st name | Satonori |
| Middle name | |
| Last name | Nasu |
Organization
JA Kyosai Nakaizu Rehabilitation Center
Division name
The Rehabilitation Department of Occupational Therapy
Zip code
410-2507
Address
1523-108 Hiekawa, Izu City, Shizuoka Prefecture, Japan
TEL
+81-558-83-2204
Homepage URL
sa-nasu@janrc.or.jp
Sponsor or person
Institute
JA Kyosai Nakaizu Rehabilitation Center
Institute
Department
Personal name
Funding Source
Organization
The Toyota Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
JA Kyosai Nakaizu Rehabilitation Center
Address
1523-108, Hiekawa, Izu City, Shizuoka Prefecture, Japan
Tel
+81-558-83-2204
sa-nasu@janrc.or.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
農協共済中伊豆リハビリテーションセンター/JA Kyosai Nakaizu Rehabilitation Center
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 25 | 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
| 2024 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 10 | 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
| 2025 | Year | 03 | Month | 20 | Day |
Last modified on
| 2026 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063693
