UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038780 |
|---|---|
| Receipt number | R000044213 |
| Scientific Title | Effectiveness of Musculoskeletal ultrasound for improvement in joint examination skills of Japanese junior residents |
| Date of disclosure of the study information | 2019/12/16 |
| Last modified on | 2019/12/04 01:37:02 |
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Basic information
Public title
Effectiveness of Musculoskeletal ultrasound for improvement in joint examination skills of Japanese junior residents
Acronym
Effectiveness of Musculoskeletal ultrasound for improvement in joint examination skills of Japanese junior residents
Scientific Title
Effectiveness of Musculoskeletal ultrasound for improvement in joint examination skills of Japanese junior residents
Scientific Title:Acronym
Effectiveness of Musculoskeletal ultrasound for improvement in joint examination skills of Japanese junior residents
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Medicine in general | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate whether junior residents can identify echo-defined synovitis as a swollen joint through feedback by ultrasonography after physical examination of rheumatoid arthritis patients more accurately than without feedback.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concordance rate between the clinical detection of arthritis by the residents and the presence of ultrasound-defined synovitis
Key secondary outcomes
Qualitative evaluation based on pre-post questionnaire (only for junior resident)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Residents in Intervention group are given feedback from ultrasound result as a reference after joint physical examination for RA patients.
Interventions/Control_2
Residents in control group perform only joint physical examination for RA patients.
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
Junior residents during our rotation who agreed to participate in this study.
Key exclusion criteria
Junior residents during our rotation who disagreed to participate in this study.
Junior residents who are unable to achieve the target number of patients in this study.
Junior residents who are unable to perform joint examination due to injury etc.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | |
| Last name | Ohmura |
Organization
Kyoto University Hospital
Division name
Clinical immunology and Rheumatology
Zip code
606-8507
Address
54 Kawaharacho, Shogoin, Sakyo-ku Kyoto,606-8507, JAPAN
TEL
075-751-4380
ohmurako@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Kozuki |
Organization
Kyoto University Hospital
Division name
Clinical immunology and Rheumatology
Zip code
606-8507
Address
54 Kawaharacho, Shogoin, Sakyo-ku Kyoto,606-8507, JAPAN
TEL
075-751-4380
Homepage URL
k_tomohiro73@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-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
京都大学医学部附属病院(京都府)
Kyoto University Hospital(Kyoto)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 12 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 04 | Day |
Last modified on
| 2019 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044213
| 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 |
