UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047177 |
|---|---|
| Receipt number | R000053815 |
| Scientific Title | A pilot RCT of educational effects of remote (non-face-to-face) and face-to-face BLS training |
| Date of disclosure of the study information | 2022/03/20 |
| Last modified on | 2025/03/12 10:27:15 |
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Basic information
Public title
A pilot RCT of educational effects of remote (non-face-to-face) and face-to-face BLS training
Acronym
A pilot RCT of educational effects of remote (non-face-to-face) and face-to-face BLS training
Scientific Title
A pilot RCT of educational effects of remote (non-face-to-face) and face-to-face BLS training
Scientific Title:Acronym
A pilot RCT of educational effects of remote (non-face-to-face) and face-to-face BLS training
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the non-inferiority of educational effects of adult BLS training in remote (non-face-to-face) using online video conference systems against the standard face-to-face training
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Average compression depth, average compression rate, skill check sheet evaluation (score, pass /fail)
Key secondary outcomes
Compression score and parameters other than the above (rate of appropriate compression recoil, rate of appropriate compression depth, total number of compressions, rate of proper compression rate, ratio of correct hand position), ventilation score and parameters (total ventilation frequency, appropriate ventilation volume percentage, hypo/hyperventilation percentage, average ventilation volume, average inspiration time)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
| Maneuver |
Interventions/Control_1
BLS practical training in a remote setting (in a separate room at the simulation centre, connected to the instructor and face-to-face participants using Zoom)
Interventions/Control_2
BLS practical training in a standardized face-to-face setting.
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
medical students who applied for volunteers to participate in the research (Second-year college student (M0) and third-year college student (M1) )
Key exclusion criteria
Those who cannot do practical BLS training
Target sample size
86
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Eto |
Organization
Graduate School of Medicine,
The University of Tokyo,
The University of Tokyo Hospital
Division name
Department of Medical Education Studies, InternationalResearch Center for Medical Education, General Education Center
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3583
meto-tky@umin.ac.
Public contact
Name of contact person
| 1st name | Hirkoko |
| Middle name | |
| Last name | Mori |
Organization
The University of Tokyo Hospital
Division name
General Education Center
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3583
Homepage URL
mori-hiroko0114@g.ecc.u-tokyo.ac.jp
Sponsor or person
Institute
Department of Medical Education Studies,
International Research Center for Medical Education,
Graduate School of Medicine,
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Office for Human Research Studies(OHRS), Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.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
東京大学医学部附属病院(東京)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 20 | 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
| 2022 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
[Progress]
As of March 12, 2025, still the recruitment of students still remains before started due to revision of the research plan.
Management information
Registered date
| 2022 | Year | 03 | Month | 15 | Day |
Last modified on
| 2025 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053815
