UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043311 |
|---|---|
| Receipt number | R000049452 |
| Scientific Title | Retrospective Cohort Study to investigate psychiatry consultation patients for whom enteral formulas were prescribed and to explore factors affecting persistence of nutritional treatment |
| Date of disclosure of the study information | 2021/02/15 |
| Last modified on | 2022/05/16 13:13:34 |
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Basic information
Public title
Investigation of psychiatry consultation patients for whom enteral formulas were prescribed, and exploration of factors affecting persistence of the prescription
Acronym
Investigation of psychiatry consultation patients for whom enteral formulas were prescribed
Scientific Title
Retrospective Cohort Study to investigate psychiatry consultation patients for whom enteral formulas were prescribed and to explore factors affecting persistence of nutritional treatment
Scientific Title:Acronym
Investigation of psychiatry consultation patients for whom enteral formulas were prescribed and exploration of the risk factors
Region
| Japan |
Condition
Condition
psychiatric disease
Classification by specialty
| Medicine in general | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To survey the prescription status (continuation, discontinuation, completion) of enteral formulas for patients in Mental Clinic Minami.
Basic objectives2
Others
Basic objectives -Others
(1)Patient characteristics/ profile
(2)Continuation of prescribed enteral formulas
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Rate of discontinuation of enteral formulas
Key secondary outcomes
Adverse events related to enteral formulas
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have attended the clinic from January 1 to December 31, 2020 (both dates inclusive)
Key exclusion criteria
(1)Patients for whom the specified enteral formulas have NOT been prescribed
(2)Patients who have been judged as inadequate to entry in this study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kouichi |
| Middle name | |
| Last name | Banno |
Organization
Mental Clinic Minami
Division name
Psychiatry
Zip code
459-8016
Address
Minami-seikyo yottette-yokochou 2F, 2-701, Minami-Odaka, Midori-ku, Nagoya City, Aichi Prefecture
TEL
062-625-1026
kb19790723@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yoshihito |
| Middle name | |
| Last name | Iwanami |
Organization
EN Otsuka Pharmaceutical, Co., Ltd.
Division name
R&D Application Office Research & Development Division
Zip code
025-0312
Address
4-3-5, Nimaibashi, Hanamaki City, Iwate Prefecture
TEL
0198-26-5261
Homepage URL
Iwanami.Yoshihito@otsuka.jp
Sponsor or person
Institute
Mental Clinic Minami
Institute
Department
Personal name
Funding Source
Organization
EN Otsuka Pharmaceutical, 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
Minami Medical Health Cooperative General Hospital Minami-Seikyo Hospital ethics committee
Address
2-204, Minami-Odaka, Midori-ku, Nagoya City, Aichi Prefecture
Tel
052-625-0373
n-hara@minami.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | Month | 15 | 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
Completed
Date of protocol fixation
| 2020 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 05 | Month | 12 | Day |
Date trial data considered complete
| 2021 | Year | 05 | Month | 17 | Day |
Date analysis concluded
| 2021 | Year | 10 | Month | 05 | Day |
Other
Other related information
Paper published
Management information
Registered date
| 2021 | Year | 02 | Month | 12 | Day |
Last modified on
| 2022 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049452
| 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 |
