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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024474
Receipt No. 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 2020/04/21

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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
Email 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
Email ishitaka@sapmed.ac.jp

Sponsor
Institute Sapporo Medical University
Institute
Department

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
Email 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 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 No longer recruiting
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
2020 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
2020 Year 04 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028170

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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