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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043757
Receipt No. R000049951
Scientific Title A Multicenter Prospective Observational Study on the Effect of Introducing a Medical Task Management System to Acute Stroke Care on Clinical Efficiency
Date of disclosure of the study information 2021/03/26
Last modified on 2021/03/26

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Basic information
Public title A Study on the Effect of Introducing an ICT System to Acute Stroke Care
Acronym A Study on the Effect of Introducing an ICT System to Acute Stroke Care
Scientific Title A Multicenter Prospective Observational Study on the Effect of Introducing a Medical Task Management System to Acute Stroke Care on Clinical Efficiency
Scientific Title:Acronym A Multicenter Prospective Observational Study on the Effect of Introducing a Medical Task Management System to Acute Stroke Care on Clinical Efficiency
Region
Japan

Condition
Condition acute ischemic stroke
Classification by specialty
Neurology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the effect of introducing a medical task management system for acute stroke care.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Door to Needle time
Key secondary outcomes Door to Puncture time
to CT time
Door to CBC time
Door to puncture time
mRS at discharge
mRS at the month

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Stroke patients with a diagnosis of cerebral infarction who received rt-PA or endovascular treatment
Key exclusion criteria Refused to participate in this study
Target sample size 300

Research contact person
Name of lead principal investigator
1st name SHOJI
Middle name
Last name MATSUMOTO
Organization Fujita Health University School of Medicine
Division name Department of Comprehensive Strokology
Zip code 470-1192
Address Dengakugakubo, Kutsukake, Toyoake, Aichi 470-1192, Japan
TEL 0562939759
Email shoji.neuro@gmail.com

Public contact
Name of contact person
1st name SHOJI
Middle name
Last name MATSUMOTO
Organization Fujita Health University School of Medicine
Division name Department of Comprehensive Strokology
Zip code 470-1192
Address Dengakugakubo, Kutsukake, Toyoake, Aichi 470-1192, Japan
TEL 0562939759
Homepage URL
Email shoji.neuro@gmail.com

Sponsor
Institute Fujita Health University School of Medicine
Institute
Department

Funding Source
Organization Fujita Health University School of Medicine
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 Fujita Health University School of Medicine
Address 1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi 470-1192, Japan
Tel 0562932865
Email f-irb@fujita-hu.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 03 Month 26 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 Preinitiation
Date of protocol fixation
2021 Year 01 Month 12 Day
Date of IRB
Anticipated trial start date
2021 Year 03 Month 12 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Opt-out consent was obtained instead of written informed consent, which was approved by the Ethics Committee of Fujita Health University School of Medicine. We provided patients with information explaining the proposed research plan (the purpose, required individual data, and duration of the study) via the website of Fujita Health University School of Medicine, and gave them the opportunity to opt out.

Management information
Registered date
2021 Year 03 Month 26 Day
Last modified on
2021 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049951

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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