UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038863 |
|---|---|
| Receipt number | R000044318 |
| Scientific Title | Intervention study of nutrition care and management at day-care facilities for the aged. |
| Date of disclosure of the study information | 2019/12/12 |
| Last modified on | 2019/12/12 13:10:49 |
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Basic information
Public title
Intervention study of nutrition care and management at day-care facilities for the aged.
Acronym
Intervention study of nutrition care and management at day-care facilities for the aged.
Scientific Title
Intervention study of nutrition care and management at day-care facilities for the aged.
Scientific Title:Acronym
Intervention study of nutrition care and management at day-care facilities for the aged.
Region
| Japan |
Condition
Condition
malnutrition
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to test the introduction and development of the "Comprehensive Nutrition Care and Management" system and activities, including activities for home visits and oral maintenance in the elderly's day-care facilities.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
activities of daily living "6 months"
Key secondary outcomes
nutritional states
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Nutrition care "6 months"
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
| 110 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
malnutrition
Key exclusion criteria
No concent
Target sample size
225
Research contact person
Name of lead principal investigator
| 1st name | Michiko |
| Middle name | |
| Last name | Sugiyama |
Organization
Kanagawa University of Human Services
Division name
School of Nutrition and Dietetics
Zip code
2388522
Address
1-10-1 Heiseicho, Yokosuka-city, Kanagawa, Japan
TEL
0468282500
takada-dn2@kuhs.ac.jp
Public contact
Name of contact person
| 1st name | Kento |
| Middle name | |
| Last name | Takada |
Organization
Kanagawa University of Human Services
Division name
School of Nutrition and Dietetics
Zip code
238-8522
Address
1-10-1 Heiseicho, Yokosuka-city, Kanagawa, Japan
TEL
046-828-2813
Homepage URL
takada-dn2@kuhs.ac.jp
Sponsor or person
Institute
Japanese Society on Nutrition Care and Management
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
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
Kanagawa University of Human Services
Address
1-10-1 Heiseicho, Yokosuka-city, Kanagawa, Japan
Tel
046-828-2500
takada-dn2@kuhs.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
| 2019 | Year | 12 | Month | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 08 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | 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
| 2019 | Year | 12 | Month | 12 | Day |
Last modified on
| 2019 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044318
| 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 |
