UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043950 |
|---|---|
| Receipt number | R000050195 |
| Scientific Title | Utility of real-time remote history taking and auscultation in a fever clinic for healthcare workers: open-label randomized controlled pilot trial |
| Date of disclosure of the study information | 2021/04/17 |
| Last modified on | 2024/04/18 12:28:18 |
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Basic information
Public title
Utility of real-time remote history taking and auscultation in a fever clinic for healthcare workers: open-label randomized controlled pilot trial
Acronym
Utility of real-time remote history taking and auscultation in a fever clinic for healthcare workers: open-label randomized controlled pilot trial
Scientific Title
Utility of real-time remote history taking and auscultation in a fever clinic for healthcare workers: open-label randomized controlled pilot trial
Scientific Title:Acronym
Utility of real-time remote history taking and auscultation in a fever clinic for healthcare workers: open-label randomized controlled pilot trial
Region
| Japan |
Condition
Condition
Infectious diseases
Classification by specialty
| Medicine in general | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study was conducted to assess the utility of real-time remote history-taking and auscultation in a fever clinic for healthcare workers, compared to that of classical history-taking and auscultation.
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 doctors' contact time for patients in each group
Key secondary outcomes
Safety 1-2 weeks after visiting, patient satisfaction, and the consumption of personal protect equipment 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
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervention group will have partial history-taking and auscultation 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_2
The control group will have all history-taking and auscultation session by classical style.
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 fever (the duration within 3 days) healthcare workers in Dokkyo Medical University Hospital who visit to the outpatient department of Diagnostic and Generalist Medicine of Dokkyo Medical University, and consent to participate in this study.
Key exclusion criteria
Those who are decided not to match to this study by the researchers are excluded from the subjects.
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 | 04 | Month | 17 | 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
Suspended
Date of protocol fixation
| 2021 | Year | 04 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 19 | Day |
Last follow-up date
| 2028 | Year | 04 | 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
| 2021 | Year | 04 | Month | 16 | Day |
Last modified on
| 2024 | 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=R000050195
