UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054019 |
|---|---|
| Receipt number | R000061672 |
| Scientific Title | Practice and Effectiveness of a Community Co-created Mobility and Outing Support Project by Occupational Therapists: An Action Research Approach |
| Date of disclosure of the study information | 2024/05/01 |
| Last modified on | 2025/05/25 03:28:13 |
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Basic information
Public title
Practice and Effectiveness of a Community Co-created Mobility and Outing Support Project by Occupational Therapists: An Action Research Approach
Acronym
Practice and Effectiveness of a Community Co-created Mobility and Outing Support Project by Occupational Therapists
Scientific Title
Practice and Effectiveness of a Community Co-created Mobility and Outing Support Project by Occupational Therapists: An Action Research Approach
Scientific Title:Acronym
Practice and Effectiveness of a Community Co-created Mobility and Outing Support Project by Occupational Therapists: An Action Research Approach
Region
| Japan |
Condition
Condition
local residents
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to organize the practical contents of the community-created transportation and outing support project by OTR, which will start operation in July 2024, and to clarify its issues. The study also aims to clarify the impact of the community-created transportation and outing support project by OTR on the social participation, health, and quality of life of both users and cooperating persons. By clarifying these issues, we can propose a new model that can be practiced by OTRs involved in community support.
Translated with DeepL.com (free version)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Satisfaction with the project, impressions and opinions after using the project
Key secondary outcomes
Frequency of going out, change in lifestyle, subjective health perspective, frailty judgment by basic checklist, change in participation in social activities
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
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The subjects of this study are residents who use the transportation and outing support service, residents who cooperate with the service, relevant local government officials, and the principal investigator.
Basically, both users and collaborators must be able to go out from their homes by themselves, and must be able to answer the questionnaires.
Key exclusion criteria
For subjects who are unable to respond to the questionnaire due to illnesses such as dementia or cognitive dysfunction, we will ask a proxy (e.g., a family member accompanying the subject) to respond to the questionnaire to the extent possible. If this is difficult, they will be excluded from the analysis.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Obuchi |
Organization
Department of Rehabilitation, Nagano Matsushiro General Hospital
Division name
Department of Rehabilitation, Nagano Matsushiro General Hospital
Zip code
381-1231
Address
183 Matsushiro, Matsushiro-cho, Nagano, Nagano.
TEL
0262782031
23hm204g@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Obuchi |
Organization
Nagano Matsudai General Hospital
Division name
Education and Training Section
Zip code
3811231
Address
183 Matsushiro, Matsushiro-cho, Nagano, Nagano.
TEL
0262782031
Homepage URL
23hm204g@shinshu-u.ac.jp
Sponsor or person
Institute
Department of Health Sciences, Graduate School of Medicine, Science and Technology, Shinshu University
Institute
Department
Personal name
KOUHEI
Funding Source
Organization
Driving and Occupational Therapy Study Group
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagano Matsushiro General Hospital
Address
183 Matsushiro, Matsushiro-cho, Nagano, Nagano.
Tel
0262782031
kindai0707@yahoo.co.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
| 2024 | Year | 05 | 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
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 | 04 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The research design was action research, aiming to clarify the implementation and results of the project. It is also a longitudinal study based on a questionnaire survey.
Management information
Registered date
| 2024 | Year | 03 | Month | 31 | Day |
Last modified on
| 2025 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061672
