UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054371 |
|---|---|
| Receipt number | R000062024 |
| Scientific Title | Wireless Handheld Echo Utilization Toward Refined Telemedicine in Japanese Hilly and Mountainous, Island Rural Areas - Optimize echocardiographic skill in trainee doctors, student doctors and nurses. |
| Date of disclosure of the study information | 2024/06/01 |
| Last modified on | 2025/11/11 09:08:37 |
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Basic information
Public title
Wireless Handheld Echo Utilization Toward Refined Telemedicine in Japanese Hilly and Mountainous, Island Rural Areas - Optimize echocardiographic skill in trainee doctors, student doctors and nurses.
Acronym
Wireless Handheld Echo Utilization Toward Refined Telemedicine in Japanese Hilly and Mountainous, Island Rural Areas - Optimize echocardiographic skill in trainee doctors, student doctors and nurses.
Scientific Title
Wireless Handheld Echo Utilization Toward Refined Telemedicine in Japanese Hilly and Mountainous, Island Rural Areas - Optimize echocardiographic skill in trainee doctors, student doctors and nurses.
Scientific Title:Acronym
Wireless Handheld Echo Utilization Toward Refined Telemedicine in Japanese Hilly and Mountainous, Island Rural Areas - Optimize echocardiographic skill in trainee doctors, student doctors and nurses.
Region
| Japan |
Condition
Condition
Heart faillure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To make assess if telemedicine using Vscan Air and MyRemoteShare is useful or not to optimize echocardiographic skills in trainee doctors, student doctors and nurses.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Echocardiographic skill for enrolled trainee doctors, student doctors and visiting nurses evaluated by check-list 6 months after starting this study.
Check items are as follows
1/ Parasternal long axis view
2/ Parasternal short axis view (aortic valve level)
3/ Parasternal short axis view (mitral valve level)
4/ Parasternal short axis view (papillary muscle level)
5/ Parasternal short axis view (apex level)
6/ Apex four-chamber cross-sectional image
7/ Apical two-chamber cross-sectional image
8/ Apex three-chamber cross-sectional image
Key secondary outcomes
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
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Echocardiography performed by trainee doctors, student doctors and visiting nurses. Echocardiography will be performed to bout 100 patients within 6 months.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who visit emergency department or in hospital for suspected heart failure
Key exclusion criteria
Case in which informed consent is not obtained.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Tsujita |
Organization
Kumamoto University
Division name
Department of cardiovascular medicine
Zip code
860-8556
Address
1-1-1, Honjo, Chuo-ku, Kumamoto
TEL
096-373-5175
h-usuku@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Usuku |
Organization
Kumamoto University Hospital
Division name
Department of laboratory medicine
Zip code
86.-8556
Address
1-1-1, Honjo, Chuo-ku, Kumamoto
TEL
096-373-5706
Homepage URL
h-usuku@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
GE Healthcare Japan
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kumamoto University
Address
1-1-1, Honjo, Chuo-ku, Kumamoto
Tel
096-373-5657
byi-senshin@jimu.kumamoto-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
| 2024 | Year | 06 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Because the recruiting is delayed, the schedule is also delayed.
Management information
Registered date
| 2024 | Year | 05 | Month | 11 | Day |
Last modified on
| 2025 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062024
