UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021455 |
|---|---|
| Receipt number | R000024646 |
| Scientific Title | Assessment of Learning Effect of Transthoracic Echocardiography Simulator |
| Date of disclosure of the study information | 2016/03/14 |
| Last modified on | 2017/08/25 16:22:34 |
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Basic information
Public title
Assessment of Learning Effect of Transthoracic Echocardiography Simulator
Acronym
Assessment of Learning Effect of Transthoracic Echocardiography Simulator
Scientific Title
Assessment of Learning Effect of Transthoracic Echocardiography Simulator
Scientific Title:Acronym
Assessment of Learning Effect of Transthoracic Echocardiography Simulator
Region
| Japan |
Condition
Condition
Heart Disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study evaluates the Learning Effect of Transthoracic Echocardiography Simulator for Medical Students.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The skill of obtaining echocardiographic images just after learning
Key secondary outcomes
1)The skill of reading echocardiographic images just after learning
2)Operability of echocardiography simulator
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Learning for one hour by transthoracic echocardiography simulator (Vimedix,CAE Healthcare)
Interventions/Control_2
Learning for one hour by real machine (Aplio XG,Toshiba Medical Systems Corporation) and lecture
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
1)Students who participate in clinical clerkship program at Chiba University Hospital.
2)Students who consent in writing to this study with enough understanding.
Key exclusion criteria
1)Students who experienced professional education about echocardiography.
2)Students judged as being inappropriate for the subjects of the study by investigators.
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshio Kobayashi |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, Japan
TEL
043-222-7171
yoshio.kobayashi@wonder.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiichiro Miura |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, Japan
TEL
043-222-7171
Homepage URL
markone@hospital.chiba-u.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Mitsubishi Tanabe Pharma Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Ciba University Hospital Health Professional Development Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 03 | Month | 14 | 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
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 14 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 12 | Day |
Last modified on
| 2017 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024646
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
