Clinical Trial: Development of an ultrasound training program using self-performed ultrasound techniques and remote hands-on instruction (Japan)

Tokyo, Nov. 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059794) titled 'Development of an ultrasound training program using self-performed ultrasound techniques and remote hands-on instruction' on Nov. 16.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Jichi Medical University

Condition: Condition - Healthy adults Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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).

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 Size - 42

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068367

Disclaimer: Curated by HT Syndication.