UMIN-CTR Clinical Trial

Basic information
Public title	The Utility of Clinical Decision Support from Machine Learning Model for Auscultation: Open-Label Randomized Controlled Pilot Trial
Acronym	The Utility of Clinical Decision Support from Machine Learning Model for Auscultation: Open-Label Randomized Controlled Pilot Trial
Scientific Title	The Utility of Clinical Decision Support from Machine Learning Model for Auscultation: Open-Label Randomized Controlled Pilot Trial
Scientific Title:Acronym	The Utility of Clinical Decision Support from Machine Learning Model for Auscultation: Open-Label Randomized Controlled Pilot Trial
Region	Japan

Condition
Condition	cardiopulmonary diseases
Classification by specialty	Medicine in general Cardiology Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We developed the clinical decision support system of machine learning model to assist cardiopulmonary auscultation. We hypothesized the system improve the correct answer rate of auscultation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Total rate of correct answer
Key secondary outcomes	Correct answer rate for each sound Self-confidence in the answer

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	The participant of intervention group auscultate the previous recorded sounds with clinical decision support system from machine learning model. They completed the types of sounds they recognized and the self-confidence in a structured questionnaire.
Interventions/Control_2	The participant of control group auscultate the previous recorded sounds. They completed the types of sounds they recognized and the self-confidence in a structured questionnaire.
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	We recruit junior resident doctors and general internal medicine doctors from Dokkyo Medical University Hospital.
Key exclusion criteria	We exclude the doctors with hearing loss, and the doctors who was unsuitable to participate this study.
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Takanobu Middle name Last name Hirosawa
Organization	Dokkyo Medical University
Division name	Department of Diagnostic and Generalist Medicine
Zip code	321-0293
Address	880 Kitakobayashi, Mibu-cho, Shimotsuga-gun, Tochigi
TEL	0282861111
Email	hirosawa@dokkyomed.ac.jp

Public contact
Name of contact person	1st name Takanobu Middle name Last name Hirosawa
Organization	Dokkyo Medical University
Division name	Department of Diagnostic and Generalist Medicine
Zip code	321-0293
Address	880 Kitakobayashi, Mibu-cho, Shimotsuga-gun, Tochigi
TEL	0282861111
Homepage URL
Email	hirosawa@dokkyomed.ac.jp

Sponsor
Institute	Dokkyo Medical University
Institute
Department

Funding Source
Organization	Dokkyo Medical University
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	The Ethics Committee of Dokkyo Medical University
Address	880 Kitakobayashi, Mibu-cho, Shimotsuga-gun, Tochigi
Tel	0282861111
Email	r-kenkyu@dokkyomed.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	2022 Year 08 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	Preinitiation
Date of protocol fixation	2022 Year 07 Month 25 Day
Date of IRB
Anticipated trial start date	2022 Year 07 Month 29 Day
Last follow-up date	2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 07 Month 28 Day
Last modified on	2022 Year 07 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055270

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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