UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056699 |
|---|---|
| Receipt number | R000064812 |
| Scientific Title | Establishment of an online medical system for chronic viral infectious diseases |
| Date of disclosure of the study information | 2025/01/14 |
| Last modified on | 2025/01/13 14:27:07 |
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Basic information
Public title
Establishment of an online medical system for chronic viral infectious diseases
Acronym
Establishment of an online medical system for chronic viral infectious diseases
Scientific Title
Establishment of an online medical system for chronic viral infectious diseases
Scientific Title:Acronym
Establishment of an online medical system for chronic viral infectious diseases
Region
| Japan |
Condition
Condition
HBV, HCV, HIV
Classification by specialty
| Hepato-biliary-pancreatic medicine | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study will build a foundation for implementing telemedicine for chronic viral infections, achieving results equivalent to face-to-face consultations in creating important application forms and certificates requiring specialist judgment, providing appropriate disclosure and prognosis, and selecting appropriate medications and tests based on the latest guidelines. This foundation development includes:
1) Establishing personnel and online environments to enable telemedicine.
2) Performance evaluation research on large language model (LLM) solutions that support the creation of specialized application forms and certificates.
The ultimate goal is to improve the efficiency of telemedicine through 1) and 2).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1a. To describe percentage of patients recalled with access to treatment patients. (for diagnosed but untreated patients)
1b.Evaluate the practicality of specialist support in telemedicine for diagnosis notification, assistance in preparing application forms and certificates, treatment support system based on clinical guidelines, and patient-reported outcomes (PRO) at cooperating hospitals without specialists.
2. Performance evaluation of Large Language Model (LLM) solutions for supporting the creation of specialized application forms and certificates
3. 3) Evaluate whether 1) + 2) improved the efficiency of telemedicine.
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients meeting the treatment criteria for chronic hepatitis B and C issued by the Japan Society of Hepatology. Patients with confirmed diagnosis of HIV infection.
Key exclusion criteria
Contraindications in drug package inserts (those with a history of hypersensitivity to the drugs used, those taking the following drugs: rifampicin, St. John's wort, carbamazepine, phenytoin, phenobarbital, atazanavir sulfate, atorvastatin calcium hydrate)
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Kouichi |
| Middle name | |
| Last name | Miura |
Organization
Jichi Medical University
Division name
Gastroenterology
Zip code
329-0498
Address
3311-1 Yakushiji Shomotsuke Tochigi
TEL
0285-58-7348
miura385@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Kouichi |
| Middle name | |
| Last name | Miura |
Organization
Jichi Medical University
Division name
Gastroenterology
Zip code
329-0498
Address
3311-1 Yakushiji Shomotsuke Tochigi
TEL
0285-58-7348
Homepage URL
miura385@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
other
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
Jichi Medical University Hospital
Address
3311-1 Yakushiji Shomotsuke Tochigi
Tel
0285-58-8933
rinri@jichi.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
| 2025 | Year | 01 | Month | 14 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 11 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2025 | Year | 01 | Month | 13 | Day |
Last modified on
| 2025 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064812
