UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058555 |
|---|---|
| Receipt number | R000064286 |
| Scientific Title | Exploratory study on health status and frailty prediction using questionnaires |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/07/23 10:51:20 |
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Basic information
Public title
Exploratory study on health status and frailty prediction using questionnaires
Acronym
Exploratory study on health status and frailty prediction using questionnaires
Scientific Title
Exploratory study on health status and frailty prediction using questionnaires
Scientific Title:Acronym
Exploratory study on health status and frailty prediction using questionnaires
Region
| Japan |
Condition
Condition
Frailty and malnutrition risk
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate health status and frailty risk in elderly citizens using questionnaires
Basic objectives2
Others
Basic objectives -Others
Epidemiology study
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of health status and frailty risk using questionnaires
Key secondary outcomes
Evaluation of malnutrition and frailty risk by gender and age group
Assessment of awareness of health knowledge and preventive 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
Elderly citizens who voluntarily consent to participate
Key exclusion criteria
Individuals with difficulties in reading or writing
Individuals unable to accurately respond to questionnaires due to dementia, etc.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kano |
Organization
Meiji Holdings Co., Ltd.
Division name
Wellness Science Lab
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji City, Tokyo, Japan
TEL
042-632-5847
hiroshi.kano@meiji.com
Public contact
Name of contact person
| 1st name | Tetsuzen |
| Middle name | |
| Last name | Rin |
Organization
Meiji Holdings Co., Ltd.
Division name
Wellness Science Lab
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji City, Tokyo, Japan
TEL
042-632-5847
Homepage URL
tetsuzen.rin@meiji.com
Sponsor or person
Institute
Meiji Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Meiji Human Research Ethics Committee
Address
1-29-1 Nanakuni, Hachioji City, Tokyo, Japan
Tel
042-632-5900
MEIJI.IRB@meiji.com
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 | 08 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2025 | Year | 07 | Month | 23 | Day |
Last modified on
| 2025 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064286
