UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024584 |
|---|---|
| Receipt number | R000028296 |
| Scientific Title | A pilot study for establishing the outcome measures of hospitalization for assessment in the Medical Treatment and Supervision Act |
| Date of disclosure of the study information | 2016/10/27 |
| Last modified on | 2019/09/11 15:55:13 |
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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
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
shiina-akihiro@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba University Center for Forensic Mental Health
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028296
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
