UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057151 |
|---|---|
| Receipt number | R000063596 |
| Scientific Title | An examination of factors influencing social participation on the health of community-dwelling older adults |
| Date of disclosure of the study information | 2025/02/27 |
| Last modified on | 2025/08/29 13:40:12 |
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Basic information
Public title
An examination of factors influencing social participation on the health of community-dwelling older adults
Acronym
An examination of factors influencing social participation on the health of community-dwelling older adults
Scientific Title
An examination of factors influencing social participation on the health of community-dwelling older adults
Scientific Title:Acronym
An examination of factors influencing social participation on the health of community-dwelling older adults
Region
| Japan |
Condition
Condition
Healthy older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the health status of community-dwelling older adults over time and to identify the factors that contribute to the maintenance of health for those who participate in society and those who do not participate in society.
Basic objectives2
Others
Basic objectives -Others
Investigation of related factors
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Health-related QOL (EQ-5D-5L)
Key secondary outcomes
Long-term care certification rate
Subjective Health Perception
Kihon check list
Degree of performance and satisfaction with important 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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
People 65 years of age or older living in the community
Key exclusion criteria
People certified for long-term care
People admitted to a hospital or facility
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Mutai |
Organization
Shinshu University
Division name
Division of occupational therapy, School of health sciences, Faculty of Medicine
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-2405
hitmutai@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Mutai |
Organization
Shinshu University
Division name
Division of occupational therapy, School of health sciences, Faculty of Medicine
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL
0263372405
Homepage URL
hitmutai@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Japanese Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University Life Science and Medical Sciences Research Ethics Committee
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
Tel
0263-37-2572
mdrinri@shinshu-u.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
| 2025 | Year | 02 | Month | 27 | 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 | 09 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 10 | 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
We will examine whether factors related to the health of older adults differ between older adults who participate in society and those who do not participate in society.
We hypothesize that the different associations may be due to participant characteristics, lifestyle habits, or health-related items.
Management information
Registered date
| 2025 | Year | 02 | Month | 27 | Day |
Last modified on
| 2025 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063596
