UMIN-CTR Clinical Trial

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