UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035192
Receipt number 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 12:06:46

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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

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

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 or person

Institute

Showa university

Institute

Department

Personal name



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

Value
https://center6.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