UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053188 |
|---|---|
| Receipt number | R000060701 |
| Scientific Title | validation study |
| Date of disclosure of the study information | 2023/12/21 |
| Last modified on | 2023/12/21 20:10:21 |
* 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
Research to verify the effect of reducing nursing care costs by strengthening local community activities centered on mutual aid.
Acronym
Research to verify the effectiveness of long-term care cost containment
Scientific Title
validation study
Scientific Title:Acronym
validation study
Region
| Japan |
Condition
Condition
Sarcopenia, frailty, cardiovascular disease, digestive system disease, oral hypofunction, lifestyle-related diseases
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Cardiology |
| Geriatrics | Laboratory medicine | Rehabilitation medicine |
| Dental medicine | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will conduct health checkups focusing on geriatric syndromes (sarcopenia and frailty) and verify the effects of controlling and improving geriatric syndromes by strengthening local community activities and distributing tablets equipped with artificial intelligence for the detected diseases (including lifestyle-related diseases).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment and trends in diseases detected by medical examinations and in body size, fitness, and nutritional status during the follow-up period.
Analysis of contributing factors for sarcopenia frailty.
Analysis of contributing factors to oral frailty.
Analysis of the association between sarcopenia frailty and sleep apnea.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
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
Treatment
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Nutritional guidance
Interventions/Control_2
exercise guidance
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Residents of Wakasa Town, Mikata-Kaminaka County, Fukui Prefecture
Key exclusion criteria
(1) Residents who did not give consent for this study
(2) Residents who are hospitalized or admitted to a medical institution
(3) Other residents deemed inappropriate by the researcher.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yamamura |
| Middle name | |
| Last name | Osamu |
Organization
Faculty of Medical Science, University of Fukui
Division name
Deparement of Community Medicine
Zip code
910-1193
Address
23-3, Shimoaizuki, Matsuoka, Eiheiji, Yoshida, Fukui
TEL
0776-61-3111
kapi@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Onishi |
| Middle name | |
| Last name | Hidenori |
Organization
Faculty of Medical Science, University of Fukui
Division name
Deparement of Community Medicine
Zip code
910-1193
Address
23-3, Shimoaizuki, Matsuoka, Eiheiji, Yoshida, Fukui
TEL
0776-61-3111
Homepage URL
o-hide68@u-fukui.ac.jp
Sponsor or person
Institute
Faculty of Medical Science, University of Fukui
Institute
Department
Personal name
Funding Source
Organization
Fukui prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Research Ethics Committee of University of Fukui
Address
23-3 Shimoaizuki Matsuoka Eiheiji Yoshida Fukui
Tel
0776-61-8529
chiken@ml.u-fukui.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
| 2023 | Year | 12 | Month | 21 | 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
| 2022 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 21 | Day |
Last modified on
| 2023 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060701
