UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045775
Receipt number R000051434
Scientific Title Impacts of a Smartphone App NSER mobile as a Sharing System of Patient Information Real-timely between EMS teams and hospitals
Date of disclosure of the study information 2021/10/17
Last modified on 2023/01/16 14:54:21

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Basic information

Public title

Impacts of a Smartphone App NSER mobile as a Sharing System of Patient Information Real-timely between EMS teams and hospitals

Acronym

NEXT INSPIRE Study

Scientific Title

Impacts of a Smartphone App NSER mobile as a Sharing System of Patient Information Real-timely between EMS teams and hospitals

Scientific Title:Acronym

NEXT INSPIRE Study

Region

Japan


Condition

Condition

all patients transported to the participating sites by the fire department

Classification by specialty

Medicine in general Surgery in general Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Investigate the impact on the pre-hospital activity of the ambulance service:.
We will investigate the activity of the introduced fire department after the introduction of NSER mobile (breakdown time from the time of arrival at the scene to the time of arrival at the hospital and the time spent during that time for on-site medical examination, selection of the transport destination, etc., as well as the time spent using the application). As a comparison, we will study the activities of the same fire and ambulance service in the past, before the introduction of NSER mobile, and study their activities in the same way.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The time it takes for the fire and ambulance service to arrive at the scene, gather information, decide on the destination and depart for each transport (arrival time to departure time).

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Introduction of NSER mobile, patient information sharing mobile application distributed to each fire and ambulance service to strengthen information sharing links between local fire services and destination hospitals.

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 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

All emergency patients transported from fire department with NSER mobile to each collaborating institution

Key exclusion criteria

Defuse from patient


Target sample size

50000


Research contact person

Name of lead principal investigator

1st name Tadahiro
Middle name
Last name Goto

Organization

TXP Medical Co. Ltd

Division name

TXP Research Group

Zip code

113-0033

Address

252, South Research Building, University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-5615-8433

Email

tadahiro.goto@txpmedical.com


Public contact

Name of contact person

1st name Tadahiro
Middle name
Last name Goto

Organization

TXP Medical Co. Ltd

Division name

TXP Research Group

Zip code

113-0033

Address

252, South Research Building, University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-5615-8433

Homepage URL


Email

tadahiro.goto@txpmedical.com


Sponsor or person

Institute

TXP Medical Co. Ltd.

Institute

Department

Personal name



Funding Source

Organization

NA

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

252, South Research Building, University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan

Tel

03-5615-8433

Email

tadahiro.goto@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

1. 北海道大学病院 救急科 
2. 日立総合病院 救急集中治療科 
3. 湘南鎌倉総合病院 救急総合診療科 
4. トヨタ記念病院 救急科 
5. 豊田厚生病院 救命救急センター 
6. みやぎ県南中核病院 救急科 


Other administrative information

Date of disclosure of the study information

2021 Year 10 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

Open public recruiting

Date of protocol fixation

2021 Year 07 Month 30 Day

Date of IRB

2021 Year 07 Month 30 Day

Anticipated trial start date

2021 Year 11 Month 01 Day

Last follow-up date

2030 Year 12 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 10 Month 16 Day

Last modified on

2023 Year 01 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051434