UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059794 |
|---|---|
| Receipt number | R000068367 |
| Scientific Title | Development of an ultrasound training program using self-performed ultrasound techniques and remote hands-on instruction |
| Date of disclosure of the study information | 2025/11/16 |
| Last modified on | 2025/11/16 16:33:34 |
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Basic information
Public title
Development of an ultrasound training program using self-performed ultrasound techniques and remote hands-on instruction
Acronym
Development of an ultrasound training program using self-performed ultrasound techniques and remote hands-on instruction
Scientific Title
Development of an ultrasound training program using self-performed ultrasound techniques and remote hands-on instruction
Scientific Title:Acronym
Development of an ultrasound training program using self-performed ultrasound techniques and remote hands-on instruction
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify whether remote ultrasound education, combining pre-learning consisting of e-learning (lectures) and self-performed ultrasound examination (performing ultrasound on one's own body) with remote hands-on instruction, is feasible and useful for medical students, clinical residents, and clinicians who are learning focused cardiac ultrasound (FOCUS), a simplified cardiac ultrasound examination.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We will examine whether FOCUS OSCE (objective structured clinical examination) scores improve before and after pre-learning, and whether FOCUS OSCE scores improve before and after remote hands-on instruction.
Key secondary outcomes
We will evaluate the quality of the best images obtained through self-performed ultrasound examination conducted as pre-learning.
We will examine whether multiple-choice question (MCQ) scores improve before and after pre-learning.
We will compare, via questionnaire, the usefulness of pre-learning alone versus the combination of pre-learning and remote hands-on instruction for OSCE performance.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
This is a prospective, multicenter interventional study designed to evaluate the educational effects of pre-learning and remote hands-on instruction for FOCUS. The study targets FOCUS beginners, including medical students, clinical residents, and clinicians. For each seminar, three participants will attend as learners. A total of 14 seminars will be held, targeting 42 participants in total. Each seminar involves two institutions, with one institution responsible for the participants (learners) and the other for providing remote hands-on instruction. On day 1, an in-person orientation and questionnaire (1) will be conducted, followed by the first multiple-choice question (MCQ 1) assessment. A lecture will then cover the use of a portable ultrasound device (Vscan Air SL, GE HealthCare), an overview of FOCUS, and scanning techniques, after which OSCE (1) will be performed. The period until the next in-person session will serve as the pre-learning period. During this time, participants will study using e-learning materials at home or other locations. Participants will also practice self-performed ultrasound examination using the portable device provided to them to develop their scanning skills. Between days 7 and 14, an in-person session will be held to evaluate the effects of pre-learning. Participants will complete the same MCQ (2) and OSCE (2) as before, followed by questionnaire (2). Next, remote hands-on ultrasound instruction will be conducted using a different model subject from that used in the OSCE. To assess the effectiveness of the remote hands-on instruction, participants will then complete OSCE (3) in the same format, followed by questionnaire (3).
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Among FOCUS beginners, the participants will include:
1) medical students (third-year or above, who have passed the written examination in cardiology at their respective universities)
2) clinical residents (postgraduate years 1 and 2)
3) clinicians (including specialty trainees, regardless of specialty or age)
Key exclusion criteria
1) medical students who have experience providing FOCUS instruction to their peers (peer teaching)
2) clinical residents and clinicians who routinely perform FOCUS independently in clinical practice, or are capable of doing so
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Kameda |
Organization
Jichi Medical University
Division name
Department of Clinical Laboratory Medicine
Zip code
329-0498
Address
3311-1, Yakushiji, Simotsuke, Tochigi, Japan
TEL
0285-58-7386
torukameda@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Kameda |
Organization
Jichi Medical University
Division name
Department of Clinical Laboratory Medicine
Zip code
329-0498
Address
3311-1, Yakushiji, Simotsuke, Tochigi, Japan
TEL
0285-58-7386
Homepage URL
torukameda@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Jichi Medical University Hospital
Address
3311-1, Yakushiji, Simotsuke, Tochigi, Japan
Tel
0285-44-2111
rinri@jichi.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 | 11 | Month | 16 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | 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 | 11 | Month | 16 | Day |
Last modified on
| 2025 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068367
