UMIN-CTR Clinical Trial

Basic information
Public title	A pilot study for establishing the outcome measures of hospitalization for assessment in the Medical Treatment and Supervision Act
Acronym	A pilot study for measuring hospitalization for asssessment
Scientific Title	A pilot study for establishing the outcome measures of hospitalization for assessment in the Medical Treatment and Supervision Act
Scientific Title:Acronym	A pilot study for measuring hospitalization for asssessment
Region	Japan

Condition
Condition	All of mental disorders
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Establishing the outcome measures of hospitalization for asssessment
Basic objectives2	Others
Basic objectives -Others	Examining the reliability and validity of each outcome measure of hospitalization for assessment
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Reliability and validity of each outcome measure of hospitalization for assessment
Key secondary outcomes

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients hospitalized for assessment according to the MTS act, the closest relative of them, doctor in charge, examiner psychiatrist, primary nurses, leader of the MDT, rehabilitation coordinator, lawyer, and medical staff of the designated hospital to which the patient will be sent.
Key exclusion criteria	When excluded by the doctor in charge.
Target sample size	180

Research contact person
Name of lead principal investigator	1st name Akihiro Middle name Last name Shiina
Organization	Chiba University Center for Forensic Mental Health
Division name	Division of Treatment and Rehabilitation
Zip code	2608670
Address	Inohana 1-8-1, Chuoh-ku, Chiba-shi, Chiba, Japan
TEL	043-222-7171
Email	shiina-akihiro@faculty.chiba-u.jp

Public contact
Name of contact person	1st name Akihiro Middle name Last name Shiina
Organization	Chiba University Center for Forensic Mental Health
Division name	Division of Treatment and Rehabilitation
Zip code	2608670
Address	Inohana 1-8-1, Chuoh-ku, Chiba-shi, Chiba, Japan
TEL	043-222-7171
Homepage URL
Email	shiina-akihiro@faculty.chiba-u.jp

Sponsor
Institute	Chiba University Center for Forensic Mental Health
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Chiba University Graduate School of Medicine
Address	Inohana 1-8-1, Chuoh-ku, Chiba-shi, Chiba ken, Japan
Tel	0432227171
Email	igaku-rinri@office.chiba-u.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	2016 Year 10 Month 27 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	http://www.m.chiba-u.ac.jp/class/shakai/jp/syakaifukki/doc/seika2019.07.pdf
Number of participants that the trial has enrolled	20
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	2016 Year 07 Month 08 Day
Date of IRB	2016 Year 07 Month 22 Day
Anticipated trial start date	2016 Year 07 Month 22 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 05 Month 23 Day

Other
Other related information	The researchers will analyze each outcome measure obtained from the participants.

Management information
Registered date	2016 Year 10 Month 27 Day
Last modified on	2019 Year 09 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028296