UMIN-CTR Clinical Trial

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