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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001046
Receipt No. R000001246
Scientific Title Randomized controlled trial of 1-hour cardiac-only resuscitation training using a self-learning video material.
Date of disclosure of the study information 2008/02/22
Last modified on 2008/02/21

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Basic information
Public title Randomized controlled trial of 1-hour cardiac-only resuscitation training using a self-learning video material.
Acronym RCT of resuscitation training using a self-learning video material
Scientific Title Randomized controlled trial of 1-hour cardiac-only resuscitation training using a self-learning video material.
Scientific Title:Acronym RCT of resuscitation training using a self-learning video material
Region
Japan

Condition
Condition Cardiac arrest
Classification by specialty
Cardiology Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effectiveness of simplified 1-hour cardiac-only resuscitation training program with or without self-learning video material.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Number of whole chest compressions during 2-min test period.
Evaluating by use of CPR training manikin.
Key secondary outcomes 1. Proportion of calls for help (119).
2. Proportion of calls for AED.
3.Proportion of chest compression attempt.
4.Number of correct chest compressions.
5.Time to CPR.
6.Time without chest compression.
7.Proportion of AED operation attempt.
8. Correct positioning of defibrillator pads.
9.Time to first defibrillation.
Evaluating by use of CPR training manikin.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Maneuver
Interventions/Control_1 Video group = Self-learning video material + 1-hour practical course (Cardiac only resuscitation + AED use).
Interventions/Control_2 Control group = 1-hour practical course (Cardiac only resuscitation + AED use)
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
18 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria General public aged 18 years or more living in Japan
Key exclusion criteria 1.Healthcare professionals (medical doctors, nurses, pharmacists, nutritionists, medical technicians, radiographers, occupational therapists, physical therapists, medical engineers, paramedics).
2. Students majoring healthcare.
3. Those who are considered to be unsuitable for CPR training.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Nonogi
Organization National Cardiovascular Center
Division name Division of Cardiology
Zip code
Address National Cardiovascular Centre, 5-7-1 Fujishiro-dai, Suita, Osaka 565-8565, Japan
TEL 06-6833-5012
Email

Public contact
Name of contact person
1st name
Middle name
Last name Chika Nishiyama
Organization Kyoto University
Division name Department of Preventive Services, Kyoto University School of Public Health
Zip code
Address Yoshida-Honmachi, Sakyo-ku, Kyoto. 606-8501
TEL 075-753-2400
Homepage URL
Email c-nishi@st.pbh.med.kyoto-u.ac.jp

Sponsor
Institute National Cardiovascular Center
Institute
Department

Funding Source
Organization Japanese Ministry of Health,Labor,and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Kyoto University
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
2008 Year 02 Month 22 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
1. A short-time self-learning video material encouraged people to attempt to perform CPR.
2. 1-hour practical training helped people acquire CPR skills. 
3. We recommend general public undergo practical training course, even if short, to acquire CPR skills.
4. To increase bystander CPR, a self-learning video material is one of the options for general public who cannot attend a practical training course.
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 Completed
Date of protocol fixation
2006 Year 06 Month 09 Day
Date of IRB
Anticipated trial start date
2006 Year 08 Month 01 Day
Last follow-up date
2007 Year 01 Month 01 Day
Date of closure to data entry
2007 Year 01 Month 01 Day
Date trial data considered complete
2007 Year 01 Month 01 Day
Date analysis concluded
2007 Year 10 Month 01 Day

Other
Other related information Chika Nishiyama, Taku Iwami, Takashi Kawamura et al: Effectiveness of Cardiac-only CPR Training by Self-learning Video, 1-Hour Program, or Both. AHA Scientific Session 2007 Resuscitation Science Symposium (ReSS) Nov. 2007 Orlando.

Management information
Registered date
2008 Year 02 Month 21 Day
Last modified on
2008 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001246

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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