UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048350 |
|---|---|
| Receipt number | R000055103 |
| Scientific Title | Patient outcomes and profits from the nutrition support team activities in a general hospital-ITA analysis |
| Date of disclosure of the study information | 2022/09/01 |
| Last modified on | 2023/07/16 16:58:26 |
* 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
Patient outcomes and profits from the nutrition support team activities in a general hospital-ITA analysis
Acronym
Nutritional outcomes and profits produced by NST intervention
Scientific Title
Patient outcomes and profits from the nutrition support team activities in a general hospital-ITA analysis
Scientific Title:Acronym
Nutritional outcomes and profits produced by NST intervention
Region
| Japan |
Condition
Condition
Adult inpatients with malnutrition
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Nutritional support could improve hospitalized patients' nutritional status, reducing their long-term complications. The nutritional support team (NST) comprises multidisciplinary members who completed the prescribed training course, including physicians, nurses, dieticians, pharmacists, dentists, dental hygienists, clinical laboratory technicians, physical therapists, occupational therapists, and speech therapists. NST visits patients with nutritional risks in the wards weekly and supports their nutritional plan. NST activities could help reduce catheter-related infection, metabolic disorders, and inappropriate venous transfusions. In other words, NST interventions bring favorable effects on participants. However, the healthcare insurance system strictly limits the number of the insurance claim. Some NSTs lack human resources. These problems hinder efforts to increase participants in NST intervention.
On the other hand, NST activities indirectly influence the nutritional support of non-participants in the same wards. Still, there is no unified way of NST intervention. There is no report surveying the economic effect of NST activities on the wards. The main objective is to survey the total economic effect on the ward where NST intervenes on some inpatients by comparing before and after the intervention period.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Total profits are defined as a complete statement of medical expenses minus total expenses in the ward, including injections, medicine, and additional nutritional supplements per one inpatient for a half month.
Key secondary outcomes
Nutritional status is measured on participants of nutritional intervention to verify the effectiveness of NST activities. Nutritional status is evaluated with the circumference length of the upper arm, blood albumin, and body weight.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Weekly NST's intervention (menu change, recommendation for changing medicine)
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
| 18 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Nurses' subjective global assessment and/or physicians' consultation
Key exclusion criteria
Short term hospitalization less than 8 days
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Naohi |
| Middle name | |
| Last name | Isse |
Organization
Okayama Kyoritsu General Hospital
Division name
General Medicine
Zip code
7038511
Address
8-10 Akasaka-Honmachi, Naka-ku, Okayama City
TEL
0862722121
issenaohi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Naohi |
| Middle name | |
| Last name | Isse |
Organization
Okayama Kyoritsu General Hospital
Division name
General Medicine
Zip code
7038511
Address
8-10 Akasaka-Honmachi, Naka-ku, Okayama City
TEL
0862722121
Homepage URL
issenaohi@yahoo.co.jp
Sponsor or person
Institute
Okayama Kyoritsu General Hospital
Institute
Department
Personal name
Naohi Isse
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
NA
Name of secondary funder(s)
NA
IRB Contact (For public release)
Organization
Okayama Medical health Cooperation
Address
8-10 Akasaka-Honmachi, Naka-ku, Okayama City
Tel
0862722121
tfujioka@mb.okaky.or.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
総合病院 岡山協立病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 04 | Month | 19 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2025 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2025 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2025 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 12 | Day |
Last modified on
| 2023 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055103
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
