UMIN-CTR Clinical Trial

Basic information
Public title	The Utility of Real-Time Remote Heart Auscultation Using a Bluetooth-Connected Electronic Stethoscope: Open-Label Randomized Controlled Pilot Trial
Acronym	The Utility of Real-Time Remote Heart Auscultation Using a Bluetooth-Connected Electronic Stethoscope: Open-Label Randomized Controlled Pilot Trial
Scientific Title	The Utility of Real-Time Remote Heart Auscultation Using a Bluetooth-Connected Electronic Stethoscope: Open-Label Randomized Controlled Pilot Trial
Scientific Title:Acronym	The Utility of Real-Time Remote Heart Auscultation Using a Bluetooth-Connected Electronic Stethoscope: Open-Label Randomized Controlled Pilot Trial
Region	Japan

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

Objectives
Narrative objectives1	This study was conducted to assess the utility of real-time auscultation, using a Bluetooth-connected electronic stethoscope compared to that of classical auscultation, using a heart simulator.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The primary outcome measure was the test score in each group.
Key secondary outcomes	The rates of correct answers for each heart sound were the secondary outcome measures.

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	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Remote auscultation group (intervention group) will have test session using electronic stethoscope (JPES-01, MEMS CORE Co, Miyagi, Japan), Bluethooth transmitter (TROND 2-in-1 Bluetooh Transmitter & Receiver, BT-DUO, TROND), and wireless noise canceling stereo headset (WH-1000XM3, Sony Co, Tokyo, Japan).
Interventions/Control_2	The classical auscultation group (control group) will have test session using the classical stethoscope(Littman Cardiology 3).
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	This study's participants will consist of junior resident in Dokkyo Medical University and physicians in Department of Diagnostic and Generalist Medicine of Dokkyo Medical University.
Key exclusion criteria	Those who do not consent to participate in this study are excluded from the subjects.
Target sample size	20

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	0282-86-1111
Email	t.hirosawa1983@gmail.com

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	0282-86-1111
Homepage URL
Email	t.hirosawa1983@gmail.com

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	80 Kitakobayashi, Mibu-cho, Shimotsuga-gun, Tochigi
Tel	0282-86-1111
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	2020 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	20
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	2020 Year 08 Month 20 Day
Date of IRB	2020 Year 08 Month 20 Day
Anticipated trial start date	2020 Year 09 Month 01 Day
Last follow-up date	2021 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 08 Month 29 Day
Last modified on	2021 Year 06 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047136