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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043311
Receipt No. 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 2021/02/16

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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
Email 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
Email iwanami@enotsuka.co.jp

Sponsor
Institute Mental Clinic Minami
Institute
Department

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
Email 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 Open public recruiting
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 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information in practice

Management information
Registered date
2021 Year 02 Month 12 Day
Last modified on
2021 Year 02 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049452

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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