UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051385 |
|---|---|
| Receipt number | R000058621 |
| Scientific Title | Establishment of a telemedicine system supported by neurologist in remote islands |
| Date of disclosure of the study information | 2023/06/22 |
| Last modified on | 2023/06/20 07:02:04 |
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Basic information
Public title
Establishment of a telemedicine system supported by neurologist in remote islands
Acronym
Establishment of a telemedicine system supported by neurologist
Scientific Title
Establishment of a telemedicine system supported by neurologist in remote islands
Scientific Title:Acronym
Establishment of a telemedicine system supported by neurologist
Region
| Japan |
Condition
Condition
neurological disorders
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish a telemedicine system supported by neurologist in D to D to P format that can be used with less labor and time in remote islands in Nagasaki Prefecture
Basic objectives2
Others
Basic objectives -Others
convenience, satisfaction
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Time spent on telemedicine support
Items collected as a result of telemedicine support
Questionnaire for patients, local physicians, and specialists: Satisfaction survey for this form of telemedicine support
Key secondary outcomes
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients who visited Tsushima Hospital with suspected neurological disease between the date of approval by the director of the research institute and February 29, 2024, and who agreed to receive remote medical support outpatient service.
(2) Inpatient/outpatient: Any.
(3) Gender: Any gender.
(4) Age: 15 years old or older.
(5) Patients who have been fully informed about their participation in this study, and who have given their (or their surrogate's) free and voluntary written consent based on full understanding of the subject.
Key exclusion criteria
(i) Patients who do not consent to outpatient telemedicine support.
(ii) Other patients who are deemed inappropriate as research subjects by the investigators.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Teiichiro |
| Middle name | |
| Last name | Miyazaki |
Organization
Nagasaki University Hospital
Division name
Department of Neurology and Strokology
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture
TEL
095-819-7265
tmiyazaki@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Teiichiro |
| Middle name | |
| Last name | Miyazaki |
Organization
Nagasaki University Hospital
Division name
Department of Neurology and Strokology
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture
TEL
095-819-7265
Homepage URL
tmiyazaki@nagasaki-u.ac.jp
Sponsor or person
Institute
Teiichiro Miyazaki, Department of Neurology and Strokology, Nagasaki University Hospital
Institute
Department
Personal name
Teiichiro Miyazaki
Funding Source
Organization
Department of Neurology and Strokology, Nagasaki University Hospital
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
Department of Neurology and Strokology, Nagasaki University Hospital
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture
Tel
095-819-7265
tmiyazaki@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
| 2023 | Year | 06 | Month | 22 | 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
| 2023 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 07 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 15 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 16 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient background: gender, age, life history, family history
Patient's chief complaint, medical history, and medication history: chief complaint, medical history, and medication history (dosage and duration)
Patient's findings: Findings that may be necessary in the medical examination. Specific items may vary depending on the patient.
Laboratory findings: Findings considered necessary for medical examination, such as laboratory tests, imaging tests, etc. Specific items may vary from patient to patient. The specific items vary from patient to patient.
Time required for telemedicine support: From greeting to leaving the patient's room.
Results of telemedicine support: initial outpatient diagnosis, final diagnosis (after completion of necessary tests or diagnosis at the referral site), and treatment plan (end of consultation, continuation of outpatient care, referral to a specialist, hospitalization, etc.)
Questionnaire for patients, local physicians, and specialists: Satisfaction survey on this form of telemedicine support
Management information
Registered date
| 2023 | Year | 06 | Month | 20 | Day |
Last modified on
| 2023 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058621
