UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056901 |
|---|---|
| Receipt number | R000065036 |
| Scientific Title | Evaluation of the Effects of University-Community Collaboration in Providing "Kayoinoba" |
| Date of disclosure of the study information | 2025/02/15 |
| Last modified on | 2025/02/15 20:44:20 |
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Basic information
Public title
Evaluation of the Effects of University-Community Collaboration in Providing "Kayoinoba"
Acronym
Evaluation of the Effects of University-Community Collaboration in Providing "Kayoinoba"
Scientific Title
Evaluation of the Effects of University-Community Collaboration in Providing "Kayoinoba"
Scientific Title:Acronym
Evaluation of the Effects of University-Community Collaboration in Providing "Kayoinoba"
Region
| Japan |
Condition
Condition
concerns about falling
Classification by specialty
| Geriatrics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Lifestyle diseases and frailty pose significant risks to the well-being of older adults. This study aims to establish a new form of Kayoinoba as a university-community collaborative facility that provides a comprehensive intervention program for individuals with such concerns. By implementing Kayoinoba, the study seeks to improve the well-being of community residents.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcomes of this study include the Kihon Checklist score and the achievement of proposed health actions, which will be assessed through participant self-reports. These assessments include the frequency of outings and exercise in the past two weeks, knowledge about exercise and dietary habits, sources of health information, awareness of oral hygiene practices, engagement with the health advice application (intervention group only), participation in self-selected health activities, interest in community health programs such as Kayoinoba and wellness classes, and other indicators related to the achievement of health-related goals.
Key secondary outcomes
Secondary outcomes include medication use for lifestyle diseases, blood test results from health check-ups or local clinics (HbA1c, LDL cholesterol), physical function evaluations such as grip strength, gait speed, and isometric knee extension strength, responses from various questionnaires including dietary diversity and the UCLA Loneliness Scale, and sleep monitoring results such as total sleep time and sleep score.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Behavior,custom | Other |
Interventions/Control_1
The intervention in this study does not involve medical procedures. At the JAMBASE facility, participants will engage in a community-based program that includes facility-based activities, consultations with healthcare professionals, and ongoing support. Additionally, research evaluations will be conducted to assess the effectiveness of the intervention. Participants will take part in facility-based activities once a month and undergo research evaluations every six months. They will also use a home sleep monitoring device (Active Sleep ANALYZER by PARAMOUNT BED) and receive consultations with healthcare professionals during their visits to the JAMBASE facility. Furthermore, ongoing support for health-related activities will be provided through a comprehensive health application.
Interventions/Control_2
The control group will participate in facility-based activities every six months and undergo research evaluations every six months.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals who own a smartphone and hold a My Number Card.
Individuals aged 65 to 85 years at the time of consent.
Among those who meet the above criteria, participants must have self-reported concerns about falling in a pre-screening questionnaire.
Key exclusion criteria
Individuals restricted from exercise by their primary care physician.
Individuals who have undergone pacemaker implantation surgery.
Individuals who have been certified for long-term care or support (i.e., those with official nursing care levels).
Any other individuals deemed unsuitable for participation by the principal or co-investigators.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Yamamoto |
Organization
Osaka University Graduate School of Medicine
Division name
Geriatric and General Medicine
Zip code
565-0871
Address
2-2, Yamada-oka, Suita, Osaka
TEL
06-6879-3852
kyamamoto@geriat.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Taku |
| Middle name | |
| Last name | Fujimoto |
Organization
Osaka University Graduate School of Medicine
Division name
Geriatric and General Medicine
Zip code
565-0871
Address
2-2, Yamada-oka, Suita, Osaka
TEL
06-6879-3852
Homepage URL
takufuji@geriat.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
The Society 5.0 Implementation Research Hub Support Program, The Nissei Foundation's Young Practical Research Grant
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
Osaka university Hospital Ethics Review Committee
Address
2-2, Yamadaoka, Suita, Osaka
Tel
06-6210-8296
rinri@hp-crc.med.osaka-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 | 15 | 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
| 2024 | Year | 12 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 02 | Day |
Last modified on
| 2025 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065036
