UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043757 |
|---|---|
| Receipt number | 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 19:06:06 |
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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
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
shoji.neuro@gmail.com
Sponsor or person
Institute
Fujita Health University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 |
