UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019528 |
|---|---|
| Receipt number | R000022586 |
| Scientific Title | Effectiveness of smartphone application "AED-FR" in the community : pilot study |
| Date of disclosure of the study information | 2015/10/28 |
| Last modified on | 2015/10/28 09:46:44 |
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Basic information
Public title
Effectiveness of smartphone application "AED-FR" in the community : pilot study
Acronym
AED-FR in the community
Scientific Title
Effectiveness of smartphone application "AED-FR" in the community : pilot study
Scientific Title:Acronym
AED-FR in the community
Region
| Japan |
Condition
Condition
Cardiac arrest
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effectiveness and harmful effect of "AED-FR" in the community.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of use of AED by a layperson before emergency medical services (EMS) personnel arrival.
Key secondary outcomes
1.The number of bystander CPR before EMS personnel arrival.
2.The number of AEDs at the emergency setting.
3.The number of responders who received a message about cardiac arrest at the emergency setting.
4.The number of responders who received a message about cardiac arrest and got an AED.
5.Time from call to send a message about cardiac arrest.
6.Time from receiving a message about cardiac arrest to acquisition of an AED by responders who received the message.
7.Time from receiving a message about cardiac arrest to arrival of responders who received the message.
8.The number of participants who received a message about cardiac arrest.
9.The number of participants who responded to a message about cardiac arrest.
10.One month survival of cardiac arrest patient.
11.One month survival with favorable neurologic outcome of cardiac arrest patient.
12.Feedback from AED-FR users.
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Out-of-hospital cardiac arrest treated with EMS personnel or cases with "AED -FR" activated in Owariasahi city
2.The Registrants of AED-FR.
Key exclusion criteria
Nothing
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Iwami Taku |
Organization
Kyoto University
Division name
Health service
Zip code
Address
Yoshida-Honmachi, Sakyo-ku, Kyoto, 606-8501
TEL
075-753-2426
iwami.taku.8w@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shimamoto Tomonari |
Organization
Kyoto University
Division name
Graduate school of medicine, school of public health, department of preventive services.
Zip code
Address
Yoshida-Honmachi, Sakyo-ku, Kyoto, 606-8501
TEL
075-753-2431
Homepage URL
tomo.shimamoto@gmail.com
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
JR-west Relief Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
1.Owariasahi city fire department
2.Coaido Inc
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
愛知県尾張旭市 Owariasahi city, Aichi prefecture （フィールドでの実施）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 28 | 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
| 2015 | Year | 10 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Case Report
Management information
Registered date
| 2015 | Year | 10 | Month | 28 | Day |
Last modified on
| 2015 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022586
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
