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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023316
Receipt No. R000026862
Scientific Title Experience and current condition of the families who made a decision as a surrogate in emergency medical care center ICU.
Date of disclosure of the study information 2016/07/24
Last modified on 2016/07/24

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Basic information
Public title Experience and current condition of the families who made a decision as a surrogate in emergency medical care center ICU.
Acronym Experience and current condition of the families who made a decision as a surrogate in emergency medical care center ICU.
Scientific Title Experience and current condition of the families who made a decision as a surrogate in emergency medical care center ICU.
Scientific Title:Acronym Experience and current condition of the families who made a decision as a surrogate in emergency medical care center ICU.
Region
Japan

Condition
Condition Families who made a decision as a surrogate in emergency medical care center ICU.
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to clarify experience and current condition of the families who made a decision about do not attempt resuscitation(DNAR) as a surrogate in emergency medical care center ICU.
Basic objectives2 Others
Basic objectives -Others -
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Experience of the families who made a decision about do not attempt resuscitation(DNAR) as a surrogate in emergency medical care center ICU.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Families who made a decision about do not attempt resuscitation(DNAR) as a surrogate in emergency medical care center ICU.
Key exclusion criteria 1. The family of patient who was a victim or attempted suicide
2. The family of patient who was an infan t under the age of 15
3. The family who can't communicate in Japanese
4. The family who has problems in communicating with a researcher because of their health conditions
5. The family who shows distrust to a medical staff
6. The family who is under 20 years old
7. Judged as inappropriate participants by researcher in charge
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomomi Sakamoto
Organization Tokyo Woman's Medical University Hospital
Division name Nursing Office
Zip code
Address 8-1, Kawadacho,Shinjyuku-ku,Tokyo
TEL 03-3353-8111
Email sakamoto.tomomi@twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazumi Ishizuka
Organization Tokyo Woman's Medical University Hospital
Division name Nursing Office
Zip code
Address 8-1,Kawadacho,Shinjyuku-ku,Tokyo
TEL 03-3353-8111
Homepage URL
Email kazumi.cc@tmd.ac.jp

Sponsor
Institute Tokyo Woman's Medical University Hospital
Institute
Department

Funding Source
Organization Tokyo Woman's Medical University Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 07 Month 24 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 Enrolling by invitation
Date of protocol fixation
2016 Year 06 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information -

Management information
Registered date
2016 Year 07 Month 24 Day
Last modified on
2016 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026862

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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