UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061451 |
|---|---|
| Receipt number | R000070308 |
| Scientific Title | Verification of the effectiveness of home-visit nutritional guidance after discharge from a community-based integrated care ward. |
| Date of disclosure of the study information | 2026/05/05 |
| Last modified on | 2026/05/04 09:45:59 |
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Basic information
Public title
Verification of the effectiveness of home-visit nutritional guidance on nutritional improvement and the prevention of rehospitalization after discharge from a community-based integrated care ward.
Acronym
Nutritional improvement and prevention of readmission through home-visit nutritional guidance.
Scientific Title
Verification of the effectiveness of home-visit nutritional guidance after discharge from a community-based integrated care ward.
Scientific Title:Acronym
Verification of the effectiveness of home-visit nutritional guidance.
Region
| Japan |
Condition
Condition
Medicine in general/
general medicine/ Geriatrics/
geriatrics
Classification by specialty
| Medicine in general | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to verify whether providing regular home-visit nutritional and dietary guidance to elderly people who have been discharged from community-based integrated care wards and are living at home, in group homes, or in serviced senior housing can help maintain or improve their nutritional status and prevent readmission.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Nutritional status after three months
Key secondary outcomes
Old-age Research-style Functional Ability Indicators
Basic Checklist (KCL)
Versal Index
Vitality Index
SF-8
International Physical Activity Questionnaire
Mini Nutritional Assessment-Short Form (MNA-SF)
MDHQ (Simple Dietary Habit Assessment Tool: Meal-based Diet History Questionnaire)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
For patients discharged from the community-based integrated care ward, a registered dietitian will continue to provide nutritional and dietary guidance through home visits.
Interventions/Control_2
Patients who do not receive involvement from a registered dietitian after discharge from the community-based integrated care ward
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
Patients aged 65 and over who have been discharged from a community-based integrated care ward and are residing at home, in a group home, or in a service-assisted senior housing facility.
Key exclusion criteria
Terminally ill patients, patients with severe dementia or mental illness, and patients with severe impaired consciousness.
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Mutsuko |
| Middle name | Mutsuko |
| Last name | Sanai |
Organization
KuriyamaKuriyama Red Cross Hospital
Tenshi University Graduate School of Nursing and Nutrition, Department of Nutritional Management
Division name
department of medical technology, nutrition division doctoral program late stage
Zip code
0691513
Address
3-2 Asahi, Kuriyama-cho, Yubari-gun, Hokkaido
TEL
0123721015
eiyouka@kuriyama.jrc.or.jp
Public contact
Name of contact person
| 1st name | Junko |
| Middle name | Junko |
| Last name | Suzuki |
Organization
Angel University Graduate School
Division name
Graduate School of Nursing and Nutrition, Department of Nutritional Management
Zip code
0650013
Address
1-30, Kita 13-jo Higashi 3-chome, Higashi-ku, Sapporo City, Hokkaido
TEL
0117411051
Homepage URL
j-suzuki@tenshi.ac.jp
Sponsor or person
Institute
Angel University
Institute
Department
Personal name
Junko Suzuki
Funding Source
Organization
Angel University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Angel University Graduate School
Address
1-30, Kita 13-jo Higashi 3-chome, Higashi-ku, Sapporo City, Hokkaido
Tel
0117411051
j-suzuki@tenshi.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
| 2026 | Year | 05 | Month | 05 | 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
| 2026 | Year | 04 | Month | 13 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 13 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 13 | Day |
Date of closure to data entry
| 2027 | Year | 08 | Month | 30 | Day |
Date trial data considered complete
| 2027 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2028 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 04 | Day |
Last modified on
| 2026 | Year | 05 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070308
