UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045271 |
|---|---|
| Receipt number | R000051710 |
| Scientific Title | The Utility of Phonocardiogram in Real-Time Remote Cardiac Auscultation Using an Internet-Connected Electronic Stethoscope: Open-Label Randomized Controlled Pilot Trial |
| Date of disclosure of the study information | 2021/08/27 |
| Last modified on | 2023/04/18 09:06:01 |
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Basic information
Public title
The Utility of Phonocardiogram in Real-Time Remote Cardiac Auscultation Using an Internet-Connected Electronic Stethoscope: Open-Label Randomized Controlled Pilot Trial
Acronym
The Utility of Phonocardiogram in Real-Time Remote Cardiac Auscultation Using an Internet-Connected Electronic Stethoscope: Open-Label Randomized Controlled Pilot Trial
Scientific Title
The Utility of Phonocardiogram in Real-Time Remote Cardiac Auscultation Using an Internet-Connected Electronic Stethoscope: Open-Label Randomized Controlled Pilot Trial
Scientific Title:Acronym
The Utility of Phonocardiogram in Real-Time Remote Cardiac Auscultation Using an Internet-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
The study was conducted to assess the utility of the phonocardiogram to improve an real-time remote auscultation with internet-connected electronic stethoscope, using a cardiology patient simulators.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome was total test score in each groups.
Key secondary outcomes
The secondary outcome was each sound scores.
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
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Remote auscultation + phonocardiogram group (intervention group) will have all session using an electronic stethoscope (JPES-01, MEMS CORE Co., Ltd.), a wireless module for electronic stethoscope option (BioCMOS Co., Ltd.), and an online medical care program (Smart Cure, Smart Gate Inc.) with phonocardiogram application, WavePlot (BioCMOS Co., Ltd.).
Interventions/Control_2
Remote auscultation group (control group) will have all session using an electronic stethoscope (JPES-01, MEMS CORE Co., Ltd.), a wireless module for electronic stethoscope option (BioCMOS Co., Ltd.), and an online medical care program (Smart Cure, Smart Gate Inc.).
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
The study 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
The exclusion criteria were refusal to participate in this study and hearing loss.
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
0282-86-1111
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
0282-86-1111
Homepage URL
hirosawa@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
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
0282-86-1111
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
| 2021 | Year | 08 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://journals.sagepub.com/doi/10.1177/20552076231161945?url_ver=Z39.88-2003&rfr_id=ori:rid:crossr
Number of participants that the trial has enrolled
24
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 03 | Month | 05 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 03 | 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
| 2021 | Year | 08 | Month | 26 | Day |
Last modified on
| 2023 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051710
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
