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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028128
Receipt No. R000032202
Scientific Title Early intervention for mental health for victim of disaster is useful ?
Date of disclosure of the study information 2017/07/07
Last modified on 2019/07/10

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Basic information
Public title Early intervention for mental health for victim of disaster is useful ?
Acronym Early intervention for mental health for victim of disaster is useful ?
Scientific Title Early intervention for mental health for victim of disaster is useful ?
Scientific Title:Acronym Early intervention for mental health for victim of disaster is useful ?
Region
Japan

Condition
Condition metal reaction
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy of providing text which describes time course of briefing reaction for family of patients with sudden death
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes mental reaction
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 providing text
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
20 years-old <=
Age-upper limit
99 years-old >=
Gender Male and Female
Key inclusion criteria Family of patients with sudden death
Key exclusion criteria Age
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Youichi
Middle name
Last name Yanagaa
Organization Juntendo University
Division name Acute Critical Care Medicine
Zip code 4102295
Address 1129 Nagaoka Izunokuni Shizuoka
TEL 055-948-3111
Email yyanaga@juntendo.ac.jp

Public contact
Name of contact person
1st name Youichi
Middle name
Last name Yanagawa
Organization Dr.
Division name Acute Critical Care Medicine
Zip code 4102295
Address 1129 Nagaoka Izunokuni Shizuoka
TEL 055-948-3111
Homepage URL
Email yyanaga@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
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 Juntendo Shizuoka Hospital
Address 1129 Nagaoka
Tel 0559483111
Email yyanaga@juntendo.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

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 07 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 54
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
2017 Year 04 Month 01 Day
Date of IRB
2017 Year 04 Month 01 Day
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
2019 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 07 Day
Last modified on
2019 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032202

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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