UMIN-CTR Clinical Trial

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

Suicide attempt

Classification by specialty

Psychiatry

Emergency medicine

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Sapporo Medical University

Institute

Department

Personal name

Organization

Japan Agency for Medical Research Development (AMED)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Sapporo Medical University IRB

Address

S-1 W-16, Chuoku, Sapporo, Japan

Tel

011-611-2111

Email

ishitaka@sapmed.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2016

Year

10

Month

20

Day

URL releasing protocol

Publication of results

Published

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

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 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)

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