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
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
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
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
