UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058562 |
|---|---|
| Receipt number | R000066466 |
| Scientific Title | Research on nutrition management and clinical outcomes in older adult inpatients admitted to acute care hospitals in Japan: The multicenter prospective registry study. |
| Date of disclosure of the study information | 2025/07/24 |
| Last modified on | 2025/07/23 14:39:01 |
* 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
A survey on nutrition management and clinical outcomes for older adult inpatients admitted to acute care hospitals
Acronym
Nutrition management and clinical outcomes for older adult inpatients in acute care hospitals
Scientific Title
Research on nutrition management and clinical outcomes in older adult inpatients admitted to acute care hospitals in Japan: The multicenter prospective registry study.
Scientific Title:Acronym
Nutrition research for old adults in acute care hospitals: Nut-REACH project
Region
| Japan |
Condition
Condition
Patients aged 65 and older admitted to acute care hospitals for acute illness
Classification by specialty
| Not applicable |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the current status of nutrition adequacy and nutrition therapy and the associations between nutrition adequacy or nutrition status and clinical outcomes in older adult inpatients admitted to acute care hospitals.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical adverse events (mortality, admission to ICUs, unexpected readmission, subsequent complications, and/or decline of ADL)
Key secondary outcomes
(1) Mortality
(2) Admission to ICUs
(3) Subsequent complications
(4) Length of hospital stay
(5) Unexpected readmission
(6) Food texture, FOIS
(7) Activity of daily living, Katz Index
(8) Quality of life, EQ-5D
(9) Body weight
(10) Appetite, SNAQ
(11) Meal intake, based on the questionnaire
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
(1) Patients aged 65 and older at admission
(2) Patients admitted due to acute illness
(3) Patients admitted to general acute care wards on the admission day
Key exclusion criteria
(1) Patients admitted to intensive care units on the admission day
(2) Patients admitted by inspection or elective surgery
(3) Patients are going to be discharged within 7 days
(4) Patients receiving withheld therapy or palliative care
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Maeda |
Organization
Aichi Medical University
Division name
Nutrition Therapy Support Center
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute, Aichi
TEL
0561-62-3311
kskmaeda1701@gmail.com
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Maeda |
Organization
Aichi Medical University
Division name
Nutrition Therapy Support Center
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute, Aichi
TEL
0561-62-3311
Homepage URL
kskmaeda1701@gmail.com
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Factory, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
NTT Medical Center Tokyo
Chikamori Hospital
Osaka Rosai Hospital
Saiseikai Kure Hospital
Otsuka Pharmaceutical Factory, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Aichi Medical University School of Medicine
Address
1-1 Yazakokarimata, Nagakute, Aichi, 480-1195
Tel
0561-62-3311
amu_ethics@aichi-med-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
| 2025 | Year | 07 | Month | 24 | 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
| 2025 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2028 | Year | 01 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Study Design
This is a multicenter, prospective registry study.
2. Survey
(1) Survey on Nutrition Management
Daily data are collected regarding nutrition route, nutrition dose, nutrition adequacy, nutrition therapy, oral care, rehabilitation, and treatment or therapy from admission to day 14. In addition, risk factors for low nutrition adequacy are examined.
(2) Association Between Nutrition Adequacy and Clinical Outcomes
The association between the adequacy of energy and protein intake and clinical outcomes are analyzed using multivariate analysis.
(3) Association Between Malnutrition and Clinical Outcomes
The association between malnutrition, as determined by the GLIM criteria, and clinical outcomes is analyzed using multiple analyses.
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=R000066466
