UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042711 |
|---|---|
| Receipt number | R000048750 |
| Scientific Title | Effectiveness of installation of the telemedicine system using private 5G networks at the elderly care facilities and aged care homes |
| Date of disclosure of the study information | 2020/12/11 |
| Last modified on | 2022/03/15 14:29:03 |
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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
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
tmaeda@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048750
