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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038780
Receipt No. 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

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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
Email 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
Email k_tomohiro73@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044213

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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