UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048754 |
|---|---|
| Receipt number | R000055542 |
| Scientific Title | A simple and accurate noninvasive nutritional assessment method for providing appropriate medical cure and care to older inpatients |
| Date of disclosure of the study information | 2022/09/01 |
| Last modified on | 2023/02/24 10:05:34 |
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Basic information
Public title
Proposed brief nutritional assessment method for older inpatients.
Acronym
Proposed brief nutritional assessment method for older inpatients.
Scientific Title
A simple and accurate noninvasive nutritional assessment method for providing appropriate medical cure and care to older inpatients
Scientific Title:Acronym
A simple and accurate noninvasive nutritional assessment method for older inpatients
Region
| Japan |
Condition
Condition
Rehabilitation unit inpatients (regardless of disease)
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to calculate age- and disease-specific nutritional impairment cutoff values for Phase angle, a potential noninvasive and objective nutritional indicator, and to examine the minimum clinically meaningful difference in Phase angle in nutritional assessment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Phase angle
Geriatric Nutritional Risk Index
The above evaluations are performed within one week of admission for the initial evaluation, and one month later.
Key secondary outcomes
Age, sex, disease, height, weight, period of admission from the onset of the disease to the hospital, coexisting diseases, CRP value, ability to perform activities of daily living
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
rehabilitation unit inpatients
Key exclusion criteria
Persons with pacemakers
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yuta |
| Middle name | |
| Last name | Kubo |
Organization
Seijoh University
Division name
Faculty of Rehabilitation and Care
Zip code
476-8588
Address
2-172 Fukinodai, Tokai, Aichi
TEL
+81(0)526016451
kubo-yu@seijoh-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Kubo |
Organization
Seijoh University
Division name
Faculty of Rehabilitation and Care
Zip code
476-8588
Address
2-172 Fukinodai, Tokai, Aichi
TEL
+81(0)526016451
Homepage URL
kubo-yu@seijoh-u.ac.jp
Sponsor or person
Institute
Seijoh University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
he research ethics committee of Seijoh University
Address
2-172 Fukinodai, Tokai, Aichi
Tel
+81(0)526016451
kubo-yu@seijoh-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
| 2022 | Year | 09 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 06 | Month | 29 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | 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
Data will be collected at admission and one month after admission. Based on the collected data, we will determine the cutoff values for nutritional impairment at the phase angle and the minimum clinically meaningful difference.
Management information
Registered date
| 2022 | Year | 08 | Month | 25 | Day |
Last modified on
| 2023 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055542
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
