UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042848 |
|---|---|
| Receipt number | R000048912 |
| Scientific Title | Realization of specialized outpatient clinics at core hospitals on remote island regions with remote support of specialists using local 5G |
| Date of disclosure of the study information | 2020/12/25 |
| Last modified on | 2020/12/25 14:24:27 |
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Basic information
Public title
Realization of specialized outpatient clinics at core hospitals on remote island regions with remote support of specialists using local 5G
Acronym
Realization of specialized outpatient clinics at core hospitals on remote island regions with remote support of specialists using local 5G
Scientific Title
Realization of specialized outpatient clinics at core hospitals on remote island regions with remote support of specialists using local 5G
Scientific Title:Acronym
Realization of specialized outpatient clinics at core hospitals on remote island regions with remote support of specialists using local 5G
Region
| Japan |
Condition
Condition
neurological disorder, skin disorders, digestive disease
Classification by specialty
| Hepato-biliary-pancreatic medicine | Neurology | Dermatology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to verify the clinical usefulness and reliability of local 5G in telemedicine with providing D to D to P format telemedicine support from specialists at Nagasaki University Hospital.
Basic objectives2
Others
Basic objectives -Others
usefulness
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
diagnosis
Key secondary outcomes
neurological examination findings, EASI PASI, operability, image accuracy, voice intelligibility, satisfaction level
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Telemedicine using local 5G, one day, one time
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
Patients who are out of or hospitalized in the Department of Neurology, Goto Central Hospital and have no urgency
Age: 20 years and over.
Gender: No matter.
Key exclusion criteria
Patients who have difficulty in confirming their free will, such as consciousness disorder, mental retardation, and cognitive dysfunction
Patients with urgency
Patients judged by researchers to be unable to ensure safety
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Tsujino |
Organization
Nagasaki University Hospital
Division name
Department of Neurostrokology
Zip code
8528501
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture
TEL
0958197200
akrtjn@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Teiichirou |
| Middle name | |
| Last name | Miyazaki |
Organization
Nagasaki University Hospital
Division name
Department of Neurostrokology
Zip code
8528501
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture, Japan
TEL
0958197200
Homepage URL
tmiyazaki-ngs@umin.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Internal Affairs and Communications
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Neurostrokology, Nagasaki University Hospital
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture, Japan
Tel
0958197200
akrtjn@nagasaki-u.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
| 2020 | Year | 12 | Month | 25 | 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
| 2020 | Year | 12 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 12 | Month | 28 | Day |
Last follow-up date
| 2021 | Year | 03 | 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
| 2020 | Year | 12 | Month | 25 | Day |
Last modified on
| 2020 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048912
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
