UMIN-CTR Clinical Trial

Basic information
Public title	A study on the change of perception of cardiac arrest and behavioral barriers by using a cardiac arrest recognition device in the general public
Acronym	The change of perception of cardiac arrest and behavioral barriers by using a cardiac arrest recognition device
Scientific Title	A study on the change of perception of cardiac arrest and behavioral barriers by using a cardiac arrest recognition device in the general public
Scientific Title:Acronym	The change of perception of cardiac arrest and behavioral barriers by using a cardiac arrest recognition device
Region	Japan

Condition
Condition	Healthy adult citizens who work in places where sudden cardiac arrest is expected
Classification by specialty	Cardiology Emergency medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether general citizen can recognize cardiac arrest early and reduce psychological barriers for determining cardiac arrest, by using the cardiac arrest recognition device.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Psychological barriers to lifesaving before and after possession of the cardiac arrest recognition device, and confidence in cardiopulmonary resuscitation
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	possession of the cardiac arrest recognition device
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	(1) Adult general citizens who work in places where sudden cardiac arrest is expected (2) Over 20 years old (3) After the informed consent is sufficient for participation in this study, the study subject's own approval has been obtained.
Key exclusion criteria	citizens who have national medical qualification
Target sample size	35

Research contact person
Name of lead principal investigator	1st name Taku Middle name Last name Iwami
Organization	Kyoto University
Division name	Health Service
Zip code	606-8501
Address	Yoshida-Honmachi, Sakyo-ku, Kyoto
TEL	075-753-2426
Email	iwami.taku.8w@kyoto-u.ac.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Kobayashi
Organization	Kyoto University
Division name	Health Service
Zip code	606-8501
Address	Yoshida-Honmachi, Sakyo-ku, Kyoto
TEL	075-753-2426
Homepage URL
Email	kobayashi.daisuke.2e@kyoto-u.ac.jp

Sponsor
Institute	Kyoto University
Institute
Department

Funding Source
Organization	Nihon Kohden Corp.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address	Yoshida-Honmachi, Sakyo-ku, Kyoto
Tel	075-753-4680
Email	ethcom@kuhp.kyoto-u.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	2020 Year 05 Month 07 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	No longer recruiting
Date of protocol fixation	2020 Year 03 Month 06 Day
Date of IRB	2020 Year 05 Month 27 Day
Anticipated trial start date	2020 Year 05 Month 07 Day
Last follow-up date	2023 Year 05 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 03 Month 19 Day
Last modified on	2020 Year 09 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045446

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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