UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059052 |
|---|---|
| Receipt number | R000067548 |
| Scientific Title | A Cluster Randomized Controlled Trial on the Effectiveness of Real-Time Feedback and Video-Assisted Dispatch Systems for Cardiopulmonary Resuscitation Education in Laypersons |
| Date of disclosure of the study information | 2025/10/01 |
| Last modified on | 2025/09/10 20:46:42 |
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Basic information
Public title
A Cluster Randomized Controlled Trial on the Effectiveness of Real-Time Feedback and Video-Assisted Dispatch Systems for Cardiopulmonary Resuscitation Education in Laypersons
Acronym
A Study on the Utility of Real-Time Feedback Training and Video-Assisted Dispatch Systems
Scientific Title
A Cluster Randomized Controlled Trial on the Effectiveness of Real-Time Feedback and Video-Assisted Dispatch Systems for Cardiopulmonary Resuscitation Education in Laypersons
Scientific Title:Acronym
A Study on the Utility of Real-Time Feedback Training and Video-Assisted Dispatch Systems
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine the effectiveness of first aid training using real-time feedback manikins on the quality of bystander cardiopulmonary resuscitation (CPR), as well as the effectiveness of video-assisted dispatch systems in providing supplementary guidance during bystander CPR.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of chest compressions with appropriate depth immediately after training (number of compressions with adequate depth / total compressions).
Key secondary outcomes
1. Proportion of chest compressions with appropriate depth immediately after training (number of compressions with adequate depth / total compressions).
2. Compression rate (compressions per minute).
3. Self-efficacy regarding CPR performance, assessed by a Likert scale.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Training using feedback manikins(QCPR manikins)
Interventions/Control_2
Video-assisted CPR guidance via a video dispatch system
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
1. Non-healthcare professionals who provide informed consent to participate in the study
2. Participants in first aid training courses conducted by the Kobe City Fire Bureau and Kobe Gakuin University
3. Individuals aged 18 years or older, regardless of sex
4. Willingness to participate in Study 2 (evaluation of the video-assisted dispatch system)
Key exclusion criteria
1. Healthcare professionals or individuals with previous work experience as healthcare professionals
2. Individuals with severe visual, auditory, or upper limb impairments that make assessment or intervention implementation significantly difficult
3. Individuals with cognitive impairment that prevents adequate understanding of the study or provision of informed consent
4. Individuals unable to understand explanations provided in Japanese
5. Any other individuals deemed inappropriate for study participation by the principal investigator or co-investigators
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Joji |
| Middle name | |
| Last name | Kotani |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Disaster and Emergency Medicine
Zip code
650-0017
Address
7-5-1 Kusunoki-cho Chuo-ku Kobe city
TEL
078-382-6521
kobeqq@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Sugiyama |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Disaster and Emergency Medicine
Zip code
650-0017
Address
7-5-1 Kusunoki-cho Chuo-ku Kobe city
TEL
078-382-6521
Homepage URL
221m901m@stu.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Foundation for Emergency Medicine
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board for Interventional Studies, Kobe University Hospital
Address
7-5-1 Kusunoki-cho Chuo-ku Kobe city
Tel
078-382-6669
cerb@med.kobe-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
| 2025 | Year | 10 | Month | 01 | 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
| 2025 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 10 | Day |
Last modified on
| 2025 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067548
