UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054222 |
|---|---|
| Receipt number | R000061908 |
| Scientific Title | Prevention of malnutrition and pressure injury by continuous intervention of dietitians for older people in home care settings |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2025/04/22 09:32:45 |
* 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
Prevention of malnutrition and pressure injury by continuous intervention of dietitians for older people in home care settings
Acronym
Prevention of malnutrition and pressure injury by intervention of dietitians in home care settings
Scientific Title
Prevention of malnutrition and pressure injury by continuous intervention of dietitians for older people in home care settings
Scientific Title:Acronym
Prevention of malnutrition and pressure injury by intervention of dietitians in home care settings
Region
| Japan |
Condition
Condition
malnutrition, pressure ulcer
Classification by specialty
| Medicine in general | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether continuous intervention by dietitians improves adherence of oral nutritional supplement and nutritional status and prevent incidence of pressure injury for older people in home care settings, group homes and Serviced Senior Housing Facilities
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
adherence for oral nutritional supplement, Vitaliry index, Barthel index, risk of pressure ulcer incidence, pressure ulcer status
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Registered dietitians receiving prior training conduct nutritional and dietary guidance using the manual to use ONS once a month or more in home care settings or outpatient clinics.
Interventions/Control_2
Registered dietitians receiving prior training conduct nutritional and dietary guidance using the manual to use ONS at baseline
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)an individual aged 65 and older living in home, group home, serviced senior housing facilities or fee-based homes
2) an individual who has risk of malnutrition or are malnourished with 3.5g/dL or less of serum albumin level or 11 or less of MNA-SF
3)an individual who uses oral nutritional supplement to maintain or improve nutritional or physical status
Key exclusion criteria
An individual who did not need artificial nutritional; severe mental illness, severe dementia, or cancer cachexia
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Kunio |
| Middle name | |
| Last name | Tsukada |
Organization
The Japanese Society of Pressure Ulcers Homecare Association
Division name
President
Zip code
169-0072
Address
Shunkosha Inc. Lamdax Building, 2-4-12 Ohkubo, Shinjuku-ku, Tokyo
TEL
03-5291-6231
ekinan@p1.coralnet.or.jp
Public contact
Name of contact person
| 1st name | Shinji |
| Middle name | |
| Last name | Iizaka |
Organization
Shukutoku University
Division name
College of Nursing and Nutrition
Zip code
260-8703
Address
673 Nitonacho, Chuo-ku, Chiba-shi, Chiba
TEL
0433051888
Homepage URL
iizaka.tky@gmail.com
Sponsor or person
Institute
The Japanese Society of Pressure Ulcers Homecare Association
Institute
Department
Personal name
Funding Source
Organization
MORINAGA MILK INDUSTRY CLINICO CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Association of Health Care Initiative
Address
6-8, Nihonbashiyokoyamacho, Chuo-ku, Tokyo
Tel
03-6810-8511
care@zaitaku-jokusou.info
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
| 2024 | Year | 07 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 02 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 07 | 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
| 2024 | Year | 04 | Month | 22 | Day |
Last modified on
| 2025 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061908
