UMIN-CTR Clinical Trial

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
Email	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
Email	tmiyazaki-ngs@umin.ac.jp

Sponsor
Institute	Nagasaki University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048912