UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044492 |
|---|---|
| Receipt number | R000050633 |
| Scientific Title | Impact of a Smartphone App (NSER mobile) on the pre-hospital emergency care system. |
| Date of disclosure of the study information | 2021/06/10 |
| Last modified on | 2021/06/10 14:45:09 |
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Basic information
Public title
Impact of a Smartphone App (NSER mobile) on the pre-hospital emergency care system.
Acronym
Impact of a Smartphone App (NSER mobile) on the pre-hospital emergency care system.
Scientific Title
Impact of a Smartphone App (NSER mobile) on the pre-hospital emergency care system.
Scientific Title:Acronym
Impact of a Smartphone App (NSER mobile) on the pre-hospital emergency care system.
Region
| Japan |
Condition
Condition
Patients who are transferred by the emergency transport system
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the impact of a smartphone app (NSER mobile) on patiets' outcome and the pre-hospital emergency care system
Basic objectives2
Others
Basic objectives -Others
To describe the number and rate of use of voice input or OCR technology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
time required for patient transportation (time course before hospital arrival, especially from arrival at the scene to departure from the scene)
Key secondary outcomes
time required for data entry, number of cases refused for emergency transport, name of the disease at the time of transport, clinical outcome (admission, use of ventilator, and death), number and rate of use of voice input or OCR technology
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 1 | days-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All patients who were transported to Hitachi General Hospital by the emergency transport system from April 1, 2020 to March 31, 2022.
Key exclusion criteria
Patients who expresses their refusal to allow their clinical data to be used in research.
Patients who are judged by the principal investigator to be unsuitable as subjects.
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Keibun |
| Middle name | |
| Last name | Liu |
Organization
TXP Medical Co. Ltd.
Division name
Clinical Research Division
Zip code
113-8485
Address
South Research Building, University of Tokyo, 252, 3-1, Hongo 7-chome, Bunkyo-ku, Tokyo, Japan
TEL
08047907701
keiliu0406@gmail.com
Public contact
Name of contact person
| 1st name | Keibun |
| Middle name | |
| Last name | Liu |
Organization
TXP Medical Co. Ltd.
Division name
Clinical Research Division
Zip code
113-8485
Address
South Research Building, University of Tokyo, 252, 3-1, Hongo 7-chome, Bunkyo-ku, Tokyo, Japan
TEL
03-5615-8433
Homepage URL
keibun.liu@txpmedical.com
Sponsor or person
Institute
TXP Medical Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
Not applicable
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
TXP Medical Co. Ltd.
Address
South Research Building, University of Tokyo, 252, 3-1, Hongo 7-chome, Bunkyo-ku, Tokyo, Japan
Tel
03-5615-8433
txp-ethics@txpmedical.com
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 | 06 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
time required for patient transportation (time course before hospital arrival, especially from arrival at the scene to departure from the scene)
Management information
Registered date
| 2021 | Year | 06 | Month | 10 | Day |
Last modified on
| 2021 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050633
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
