UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057249 |
|---|---|
| Receipt number | R000065438 |
| Scientific Title | The effectiveness of multidisciplinary dietary support for elderly people in need of care at home who are facing malnutrition |
| Date of disclosure of the study information | 2025/03/10 |
| Last modified on | 2025/03/10 14:12:54 |
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Basic information
Public title
The effectiveness of multidisciplinary dietary support for elderly people in need of care at home who are facing malnutrition
Acronym
The effectiveness of multidisciplinary dietary support for elderly people in need of care at home who are facing malnutrition
Scientific Title
The effectiveness of multidisciplinary dietary support for elderly people in need of care at home who are facing malnutrition
Scientific Title:Acronym
The effectiveness of multidisciplinary dietary support for elderly people in need of care at home who are facing malnutrition
Region
| Japan |
Condition
Condition
Undernutrition
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop individual dietary support plans by a multidisciplinary team for elderly people who require care at home, and to verify the effectiveness of dietary support based on these plans.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum albumin level
Key secondary outcomes
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
Treatment
Type of intervention
| Food | Device,equipment |
Interventions/Control_1
whistle
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
(1) Subjects were defined as those who were at risk of malnutrition, with an assessment score of 8 to 11 on the MNA-SF (Ameumi, 2011), or those who were in a state of malnutrition, with a score of 7 or less.
(2)Ingestible
Key exclusion criteria
(1) Those using enteral nutrition
(2) Those using parenteral nutrition
(3) Those who may experience psychological stress as a result of the survey
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Naomi Ran |
| Middle name | |
| Last name | ran |
Organization
Kanazawa Medical University
Division name
School of Nursing
Zip code
9200293
Address
1-1 1-1Daigaku,Uchinada,Kahoku,Ishikawa
TEL
09094431552
ran@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | naomi |
| Middle name | |
| Last name | ran |
Organization
Kanazawa Medical University
Division name
School of Nursing
Zip code
9200293
Address
1-1 1-1Daigaku,Uchinada,Kahoku,Ishikawa 920-0293,JAPAN
TEL
09094431552
Homepage URL
ran@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical University
Institute
Department
Personal name
Funding Source
Organization
none
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
The Ethics Review Committee of Kanazawa Medical University
Address
1-1 1-1Daigaku,Uchinada,Kahoku,Ishikawa 920-0293,JAPAN
Tel
0762862211
ran@kanazawa-med.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 | 03 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
15
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
| 2018 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 10 | Day |
Last modified on
| 2025 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065438
