UMIN-ICDS Clinical Trial

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

Out of hospital cardiac arrest

Classification by specialty

Cardiology	Cardiovascular surgery	Emergency medicine

Classification by malignancy

Others

Genomic information

NO

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

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
The proportion of the above five items calculated by dividing by 220, which is the theoretically appropriate number of chest compressions in 2 minutes according to the JRC Resuscitation Guidelines.
Average chest compression depth
Average chest compression rate
Time from start of scenario to check for responsiveness
Time from start of scenario to start of chest compressions
Time from arrival of the AED to turning on the AED
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 Liv
Frequency of learning BLS using teaching materials other than Liv
Opinions on Liv teaching materials
Motivation for learning using Liv

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

Study type

Interventional

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

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Participant get a URL for Liv along with information encouraging self-study once 2 months during 6 months after the initial training and practice BLS skills at their own pace until the evaluate date.

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

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 one month.
- 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

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

Email

iwami.taku.8w@kyoto-u.ac.jp

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

Email

liv_rct@yobou.med.kyoto-u.ac.jp

Institute

Graduate School of Medicine, Kyoto University

Institute

Department

Personal name

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

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

Organization

Kyoto University Graduate School and Faculty of Medicine, Ethics Committee

Address

Yoshida-Konoe-cho, Sakyo-ku, Kyoto, JAPAN

Tel

075-753-4680

Email

ethcom@kuhp.kyoto-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

京都大学大学院医学研究科（京都府）

Date of disclosure of the study information

2024

Year

04

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

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

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2024

Year

04

Month

17

Day

Last modified on

2024

Year

04

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061591