UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024474 |
|---|---|
| Receipt number | R000028170 |
| Scientific Title | A registry study on patients who are given the assertive case management for attempted suicide and other mental health problems after admitted to hospital emergency departments in Japan (Action-J) |
| Date of disclosure of the study information | 2016/10/20 |
| Last modified on | 2023/08/17 13:01:34 |
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Basic information
Public title
A registry study on patients who are given the assertive case management for attempted suicide and other mental health problems after admitted to hospital emergency
departments in Japan (Action-J)
Acronym
Patient registry study on implementation of ACTION-J
Scientific Title
A registry study on patients who are given the assertive case management for attempted suicide and other mental health problems after admitted to hospital emergency
departments in Japan (Action-J)
Scientific Title:Acronym
Patient registry study on implementation of ACTION-J
Region
| Japan |
Condition
Condition
Suicide attempt
Classification by specialty
| Psychiatry | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study object is to register patients who are given the assertive case management for attempted suicide and other mental health problems after admitted to hospital emergency departments in Japan (Action-J)
Basic objectives2
Others
Basic objectives -Others
Effectiveness, Implementations of the invervention
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Proportion of the implementation of case-management at 24 weeks (6 months) after entry
Key secondary outcomes
At 24 weeks (6 months) after entry
1) Incidence proportion of death (suicide and other any cause of death), suicide attempt and self-harm (all and each one)
2) Quality indicators of the case-management
3) Adherence of treatment
4) Buss-Perry Aggression Questionnaire(BAQ)
5) Barratt Impulsiveness Scale(BIS)
6) Columbia-Suicide Severity Rating Scale (C-SSRS)
7) Beck Depression Inventory II (BDI-II)
At 18 months after entry
8) Incidence proportion of death (suicide and other any causes), suicide attempt and self-harm
(All and each one)
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
1) Patients confirmed as suicide attempt by a physician on admitted to emergency department
2) Patients confirmed on several occasions with intents of suicide by psychiatrist as clinical decision
3) Patients accepted the implementation of the assertive case management (ACTION-J)
Key exclusion criteria
1) Patients with impaired consciousness at informed consent
2) Patients on impossible communications with Japanese
3) Patients with other inappropriate reasons for registered this study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Chiaki |
| Middle name | |
| Last name | Kawanishi |
Organization
Sapporo Medical University
Division name
Department of Neuropsychiatry,School of Medicine
Zip code
0600061
Address
S-1 W-16, Chuoku, Sapporo, Japan
TEL
011-611-2111
chiaki.kawanishi@gmail.com
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Ishii |
Organization
Sapporo Medical University
Division name
Department of Neuropsychiatry,School of Medicine
Zip code
0600061
Address
S-1 W-16, Chuoku, Sapporo, Japan
TEL
011-611-2111
Homepage URL
ishitaka@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research Development (AMED)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Medical University IRB
Address
S-1 W-16, Chuoku, Sapporo, Japan
Tel
011-611-2111
ishitaka@sapmed.ac.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
札幌医科大学（北海道）
岩手医科大学（岩手県）
関西医科大学（大阪府）
近畿大学（大阪府）
熊本医療センター（熊本県）
慶應義塾大学（東京都）
産業医科大学（福岡県）
奈良県立医科大学（奈良県）
日本医科大学（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1002/pcn5.106
Number of participants that the trial has enrolled
144
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 | 08 | Month | 24 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective registry study on patients who are given the assertive case management for attempted suicide and other mental health problems after admitted to hospital emergency
departments in Japan (Action-J)
Management information
Registered date
| 2016 | Year | 10 | Month | 18 | Day |
Last modified on
| 2023 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028170
