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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041601
Receipt No. R000047136
Scientific Title The Utility of Real-Time Remote Heart Auscultation Using a Bluetooth-Connected Electronic Stethoscope: Open-Label Randomized Controlled Pilot Trial
Date of disclosure of the study information 2020/09/01
Last modified on 2020/08/29

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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 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
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
2020 Year 08 Month 29 Day


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

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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