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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035192
Receipt No. R000039959
Scientific Title Effectiveness of the "Questionnaires on extracting intension of presenting options for organ donation" to make organ-donation decisions by proxy - The randomized controlled trial in emergency room -
Date of disclosure of the study information 2019/01/01
Last modified on 2018/11/29

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Basic information
Public title Effectiveness of the "Questionnaires on extracting intension of presenting options for organ donation" to make organ-donation decisions by proxy
- The randomized controlled trial in emergency room -
Acronym Effectiveness of the "Questionnaires on extracting intension of presenting options for organ donation" to make organ-donation decisions by proxy
Scientific Title Effectiveness of the "Questionnaires on extracting intension of presenting options for organ donation" to make organ-donation decisions by proxy
- The randomized controlled trial in emergency room -
Scientific Title:Acronym Effectiveness of the "Questionnaires on extracting intension of presenting options for organ donation" to make organ-donation decisions by proxy
Region
Japan

Condition
Condition Cardiopulumonary Arrest
Classification by specialty
Nursing Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Consider of change in emotion and behavior related to organ donation by "Questionnaires on extracting intension of presenting options for organ donation" targeting families of patients in emergency room
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in emotion and behavior related to organ donation by "Questionnaires on extracting intension of presenting options for organ donation" targeting families of patients who died within 1 week after delivery to the emergency room
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Questionnaires
Interventions/Control_2 Intervention is when visiting the emergency room
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 of patients who were discharged from the hospital within one week after being transported to the emergency room
Key exclusion criteria Family who could not conduct questionnaire on odd days

A family whose mailing address is unknown
Target sample size 320

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Eiichi Geshi
Organization Showa university
Division name Graduate School of Health Science
Zip code
Address 1865 Tokaichiba Midori-ku, Yokohama, Kanagawa
TEL 045-985-6500
Email eigeshi2@nr.showa-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Mayumi Kumazawa
Organization Showa University Fujigaoka Hospital
Division name Emergency Nursing
Zip code
Address 1-30 Hujigaoka Aoba-ku, Yokohama, Kanagawa
TEL 045-971-1151
Homepage URL
Email koichinext@yahoo.co.jp

Sponsor
Institute Showa university
Institute
Department

Funding Source
Organization Showa university
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
2019 Year 01 Month 01 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 Preinitiation
Date of protocol fixation
2018 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 12 Month 01 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
2018 Year 12 Month 10 Day
Last modified on
2018 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039959

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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