UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054176 |
|---|---|
| Receipt number | R000061591 |
| Scientific Title | Effectiveness of retraining on CPR skills using digital self-learning materials - a randomized controlled trial |
| Date of disclosure of the study information | 2024/04/17 |
| Last modified on | 2025/01/21 11:29:30 |
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Basic information
Public title
Effectiveness of retraining on CPR skills using digital self-learning materials
Acronym
CPR skills using digital self-learning materials
Scientific Title
Effectiveness of retraining on CPR skills using digital self-learning materials - a randomized controlled trial
Scientific Title:Acronym
Liv RCT
Region
| Japan |
Condition
Condition
Out of hospital cardiac arrest
Classification by specialty
| Cardiology | Cardiovascular surgery | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to clarify the skill retention of six months after the 45-min chest compression-only CPR training between those who used or did not use a digital self-learning material called Liv to relearn after the initial training.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The number of appropriate chest compressions during a 2-min test period 6 months after the initial training. The appropriate chest compressions are defined as one with a depth of 5.0 to 6.0 cm, an interval of 0.5 to 0.6 seconds from the previous compression, and complete recoiling according to the JRC resuscitation guidelines.
Key secondary outcomes
Items obtained in the simulation test at the 6-month mark after the initial training
A. Items to be obtained during 2-min test period
Number of chest compressions
Number of chest compressions with depth of 5.0 to 6.0 cm
Number of chest compressions performed at intervals of 0.5 to 0.6 seconds
Number of chest compressions with complete recoiling
Number of chest compressions performed with appropriate hand position
Average chest compression depth
Average chest compression rate
Time from start of scenario to start of chest compressions
Time from arrival of the AED to defibrillation by AED
Verify scene safety
Check for responsiveness
Call for help (119 calls)
Check for breathing
Call for AED
Defibrillation by AED
Position of attached AED pad
B. Items to be obtained via the WEB form
Confidence in performing BLS and change before and after the research period
Willingness to perform BLS and change before and after the research period
Whether or not participants encountered any situations that required CPR or AED
Whether or not participants actually performed CPR or used an AED
Whether or not the BLS course was taken
Frequency of learning BLS using teaching materials other than Liv
Opinions on Liv teaching materials
C. Items automatically obtained via Liv
Number of completion
Number of accesses
Percentage of compliance with monthly Liv learning
Average access time
Percentage of chest compressions that were performed at an appropriate rate in each simulation
Average rate of chest compressions in each chest compression simulation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
The intervention group will receive a personal URL for digital learning material "Liv" via email 3 months after taking the CPR course.
They will be instructed to retrain on BLS using Liv at their own timing within one week of receiving the email.
Interventions/Control_2
No intervention
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- At the time of participation, those who have taken a 45-minute face-to-face course on chest compressions and AED (PUSH course) within three months.
- Those whose native language is Japanese
- Those who can access the Internet on a smartphone or tablet
Key exclusion criteria
- Persons with medical qualifications (physicians, dentists, nurses, associate nurses, pharmacists, nutritionists, physical therapists, occupational therapists, clinical engineers, emergency medical technicians)
- Those who responded in a questionnaire survey that they were concerned about performing a BLS simulation that included 2 minutes of chest compressions due to health reasons.
- Those who are judged to be inappropriate by the researcher
Target sample size
168
Research contact person
Name of lead principal investigator
| 1st name | Taku |
| Middle name | |
| Last name | Iwami |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Preventive Services, School of Public Health
Zip code
606-8501
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto, JAPAN
TEL
075-753-4400
iwami.taku.8w@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Chinatsu |
| Middle name | |
| Last name | Nakai |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Preventive Services, School of Public Health
Zip code
606-8501
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto, JAPAN
TEL
075-753-4400
Homepage URL
liv_rct@yobou.med.kyoto-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science KAKENHI Grant-in-Aid for Scientific Research(C)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Ritsumeikan University
Osaka Ohtani University
Name of secondary funder(s)
Department of Preventive Services, School of Public Health, Kyoto University Graduate School of Medicine
Laerdal Foundation
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto, JAPAN
Tel
075-753-4680
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
京都大学大学院医学研究科（京都府）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 17 | 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
170
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
Completed
Date of protocol fixation
| 2024 | Year | 04 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 05 | Day |
Date of closure to data entry
| 2024 | Year | 10 | Month | 06 | Day |
Date trial data considered complete
| 2024 | Year | 10 | Month | 07 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 17 | Day |
Last modified on
| 2025 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061591
