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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044492
Receipt No. 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

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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
Email 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
Email keibun.liu@txpmedical.com

Sponsor
Institute TXP Medical Co. Ltd.
Institute
Department

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
Email 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
URL(English) https://upload.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


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