UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036880 |
|---|---|
| Receipt number | R000042027 |
| Scientific Title | Intervention study on Specific Health Checkups and Specific Health Guidance for frailty in community-dwelling adults |
| Date of disclosure of the study information | 2019/05/29 |
| Last modified on | 2019/11/28 10:18:12 |
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Basic information
Public title
Intervention study on Specific Health Checkups and Specific Health Guidance for frailty in community-dwelling adults
Acronym
Intervention study on Specific Health Checkups and Specific Health Guidance for frailty
Scientific Title
Intervention study on Specific Health Checkups and Specific Health Guidance for frailty in community-dwelling adults
Scientific Title:Acronym
Intervention study on Specific Health Checkups and Specific Health Guidance for frailty
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to evaluate whether the approach of interventions including health guidance for frailty and providing health information improve prevalence of frailty and sarcopenia, deficiency of protein intake, oral frailty, and social cognitive function in community-dwelling adults.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Prevalence of frailty (kihon checklist)
Key secondary outcomes
1) Appendicular skeletal muscle mass
2) Score of kihon checklist
3) Lifestyle
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Health guidance for frailty (frail adult)
Providing health information (no frail adult)
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Person who hope to participate in this study
2) Informed consent
Key exclusion criteria
1) Person who cannot an independent daily life
2) Person who have certification of Needed Long-Term Care and Certification of Needed Support in baseline
3) Person who have serious disease (stroke, heart disease and cancer etc)
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | keiichi |
| Middle name | |
| Last name | Abe |
Organization
National Institute of Health and Nutrition, National Institutes of Biomedical Innovation, Health and Nutrition
Division name
Section of Healthy Longevity Research
Zip code
162-8636
Address
1-23-1 Toyama, Shinjuku-ku, Tokyo
TEL
03-3203-5721
k-abe@nibiohn.go.jp
Public contact
Name of contact person
| 1st name | Motohiko |
| Middle name | |
| Last name | Miyachi |
Organization
National Institute of Health and Nutrition, NIBIOHN
Division name
Department of Health Promotion and Exercise
Zip code
162-8636
Address
1-23-1 Toyama, Shinjuku-ku, Tokyo
TEL
03-3203-8061
Homepage URL
miyachi@nibiohn.go.jp
Sponsor or person
Institute
National Institute of Health and Nutrition, National Institutes of Biomedical Innovation, Health and Nutrition
Institute
Department
Personal name
Funding Source
Organization
Osaka prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Osaka Prefectural Government Department of Health and Medical Care
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institutes of Biomedical Innovation, Health and Nutrition
Address
7-6-8 Saito-Azaki, Ibaraki-shi, Oosaka 567-0085
Tel
072-641-9811
proj14@nibiohn.go.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
| 2019 | Year | 05 | Month | 29 | 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
100
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
Completed
Date of protocol fixation
| 2019 | Year | 05 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 11 | Month | 14 | Day |
Date analysis concluded
| 2019 | Year | 11 | Month | 26 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 29 | Day |
Last modified on
| 2019 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042027
| 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 |
