UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060526 |
|---|---|
| Receipt number | R000069239 |
| Scientific Title | Effectiveness of a Health Prevention Program for Older Adults Who Have Surrendered Their Drivers Licenses in Urban Areas |
| Date of disclosure of the study information | 2026/01/30 |
| Last modified on | 2026/01/30 17:03:48 |
* 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
Effectiveness of a Health Promotion Program for Older Adults Who Have Surrendered Their Drivers Licenses in Urban Areas
Acronym
Healthy Living After Driving Cessation Program
Scientific Title
Effectiveness of a Health Prevention Program for Older Adults Who Have Surrendered Their Drivers Licenses in Urban Areas
Scientific Title:Acronym
Urban Driving Cessation Health Program Study
Region
| Japan |
Condition
Condition
Healthy Older Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to develop a preventive occupational therapy program for individuals with driving cessation in urban areas and to evaluate its effects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CAOD and SF-36 (at baseline, 1.5 months, and 3 months)
Key secondary outcomes
MoCA, Functional Reach Test, Life Space Assessment, Geriatric depression scale 15, Kihon Checklist, Frequency of public transportation use
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
A health maintenance program based on an occupational therapy perspective
Interventions/Control_2
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
Residing in one of the 23 wards of Tokyo
Having surrendered their drivers license within the past three years
Key exclusion criteria
Not certified as requiring long-term care under the Japanese Long-Term Care Insurance system
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tatsunori |
| Middle name | |
| Last name | Sawada |
Organization
Tokyo University of Technology
Division name
School of Health Sciences
Zip code
144-8535
Address
5-23-22, NishiKamata
TEL
0364242148
sawadatn@stf.teu.ac.jp
Public contact
Name of contact person
| 1st name | Tatsunori |
| Middle name | |
| Last name | Sawada |
Organization
Tokyo University of Technology
Division name
School of Health Sciences
Zip code
144-8535
Address
5-23-22, Nishi-kamata Ota-city, Tokyo
TEL
0364242148
Homepage URL
sawadatn@stf.teu.ac.jp
Sponsor or person
Institute
Tokyo University of technology
Institute
Department
Personal name
Tatsunori Sawada
Funding Source
Organization
Japan Science and Technology Agency (JST)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo University of Technology
Address
5-23-22, Nishi-kamata Ota-city, Tokyo
Tel
0364242148
sawadatn@stf.teu.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
Tokyo
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 30 | 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
13
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
| 2024 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2025 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 30 | Day |
Last modified on
| 2026 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069239
