UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048198 |
|---|---|
| Receipt number | R000054927 |
| Scientific Title | Regional differences in the prevalence of frailty and related factors: a cross-sectional study |
| Date of disclosure of the study information | 2022/06/30 |
| Last modified on | 2023/06/30 19:09:32 |
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Basic information
Public title
Regional differences in the prevalence of frailty and related factors: a cross-sectional study
Acronym
Regional differences in the prevalence of frailty and related factors: a cross-sectional study
Scientific Title
Regional differences in the prevalence of frailty and related factors: a cross-sectional study
Scientific Title:Acronym
Regional differences in the prevalence of frailty and related factors: a cross-sectional study
Region
| Japan |
Condition
Condition
Community-dwelling older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine regional differences in the prevalence of frailty.
Basic objectives2
Others
Basic objectives -Others
To determine factors associated with regional differences in the prevalence of frailty.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frailty
Key secondary outcomes
Subjective sense of health, eating habits, oral-related items, physical activity, interaction with their neighbors, social activity, environmental factors, health literacy
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Regional elderly in which activities of daily living is independent.
Key exclusion criteria
Person who is certified as requiring long-term care.
Target sample size
12000
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Nakakita |
Organization
Kio University
Division name
Division of Health Science, Graduate School
Zip code
635-2832
Address
4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara, JAPAN
TEL
0745-54-1601
satoshi.nakakita.0625@gmail.com
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Nakakita |
Organization
Kio University
Division name
Division of Health Science, Graduate School
Zip code
635-2832
Address
4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara, JAPAN
TEL
0745-54-1601
Homepage URL
satoshi.nakakita.0625@gmail.com
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Kio University
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
Kio University
Address
4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara, JAPAN
Tel
0745-54-1601
satoshi.nakakita.0625@gmail.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
| 2022 | Year | 06 | Month | 30 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 11 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 16 | Day |
Date of closure to data entry
| 2022 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2023 | Year | 01 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Measurement items
Kihon-check list, health literacy (CCHL), basic attributes (age, gender, BMI), place of residence, household composition, level of nursing care required, subjective sense of health, eating habits, oral-related items, physical activity, nteraction with their neighbors, social activities, and environmental factors.
Management information
Registered date
| 2022 | Year | 06 | Month | 29 | Day |
Last modified on
| 2023 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054927
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
