UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023316 |
|---|---|
| Receipt number | 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 | 2020/05/11 12:13:17 |
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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 | Kazuko |
| Middle name | |
| Last name | Shiraishi |
Organization
Tokyo Woman's Medical University Hospital
Division name
Nursing Office
Zip code
162-8666
Address
8-1, Kawadacho,Shinjyuku-ku,Tokyo
TEL
03-3353-8111
shiraishi.kazuko@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Kazumi |
| Middle name | |
| Last name | Ishizuka |
Organization
Tokyo Woman's Medical University Hospital
Division name
Nursing Office
Zip code
162-8666
Address
8-1,Kawadacho,Shinjyuku-ku,Tokyo
TEL
03-3353-8111
Homepage URL
kazumi.cc@tmd.ac.jp
Sponsor or person
Institute
Tokyo Woman's Medical University Hospital
Institute
Department
Personal name
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
Tokyo Women's Medical University Ethics Committee
Address
8-1 Kawadacho, Shinjuku-ku, Tokyo, Japan
Tel
03-3353-8111
krinri.bm@twmu.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
| 2016 | Year | 07 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
10
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 | 06 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 24 | 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
-
Management information
Registered date
| 2016 | Year | 07 | Month | 24 | Day |
Last modified on
| 2020 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026862
