UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness of installation of the telemedicine system using private 5G networks at the elderly care facilities and aged care homes
Acronym	Effectiveness of installation of the telemedicine system using private 5G networks at the elderly care facilities and aged care homes
Scientific Title	Effectiveness of installation of the telemedicine system using private 5G networks at the elderly care facilities and aged care homes
Scientific Title:Acronym	Effectiveness of installation of the telemedicine system using private 5G networks at the elderly care facilities and aged care homes
Region	Japan

Condition
Condition	Users of elderly care facilities and aged care homes/ Families/ Physicians/ Facility staffs
Classification by specialty	Medicine in general Geriatrics Surgery in general Dermatology Psychiatry Orthopedics Emergency medicine Rehabilitation medicine Nursing Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To install the private 5G-based telemedicine system and examine its effectiveness and impact on facility users, families, physicians, and facility staffs.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in the time and frequency of health care access (pre vs. post of intervention)
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Perform medical consultations online utilizing private 5G networks
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Those who are eligible below with the written consent [Users and Families] a. Users of elderly care facilities: The users for whom the physician at the research site is the family physician, and their families b. Users of aged care homes: The users going to the medical institution at the research site with the assistance of family members or others, and their families c. Users whose condition is stable at the time of study participation [Facility staffs] All staff members of elderly care facilities and aged care homes [physicians] Physicians who work at the research site and in charge of the users of the facilities.
Key exclusion criteria	1. If the participant requests cancellation 2. If the participant requests a change in treatment 3. Other cases in which the researcher decides that it is inappropriate for the participant to continue the research
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Takahiro Middle name Last name Maeda
Organization	Nagasaki University
Division name	Department of General Medicine, Graduate School of Biomedical Sciences
Zip code	852-8501
Address	1-7-1, Sakamoto, Nagasaki city, Nagasaki, Japan
TEL	+81-95-819-7591
Email	tmaeda@nagasaki-u.ac.jp

Public contact
Name of contact person	1st name Takahiro Middle name Last name Maeda
Organization	Nagasaki University
Division name	Department of General Medicine, Graduate School of Biomedical Sciences
Zip code	852-8501
Address	1-7-1, Sakamoto, Nagasaki city, Nagasaki, Japan
TEL	+81-95-819-7591
Homepage URL
Email	tmaeda@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University
Institute
Department

Funding Source
Organization	Ministry of Internal Affairs and Communications (MIC)
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	Graduate School of Biomedical Sciences Administration Department, Nagasaki University
Address	1-12-4, Sakamoto, Nagasaki city, Nagasaki, Japan
Tel	+81-95-819-7195
Email	gakujutu_gakuji@ml.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	長崎大学（長崎県） 長崎県五島中央病院（長崎県） 井上内科小児科医院（長崎県） 社会福祉法人なごみ会　かけはし木場（長崎県）

Other administrative information
Date of disclosure of the study information	2020 Year 12 Month 11 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	Completed
Date of protocol fixation	2020 Year 12 Month 07 Day
Date of IRB	2020 Year 12 Month 10 Day
Anticipated trial start date	2020 Year 12 Month 11 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 10 Day
Last modified on	2022 Year 03 Month 15 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048750