Tokyo, July 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062234) titled 'A Pilot Study on Web-Based Telemedicine Consultations for the Diagnosis and Treatment of Kidney Diseases, with a Focus on Designated Intractable Diseases' on July 17.
Study Type:
Observational
Primary Sponsor:
Institute - The University of Tokyo
Condition:
Condition - kidney disease
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Chronic kidney disease (CKD) and other renal disorders comprise a wide range of conditions, including designated intractable diseases, and their diagnosis and treatment require a high level of specialized expertise. Kidney specialists tend to be concentrated in major urban hospitals, and access to specialized care and renal pathology diagnosis is particularly limited in rural areas and regions facing physician shortages.
In its Second Five-Year Plan formulated in 2022, the Japanese Society of Nephrology emphasized the development and implementation of support systems for underserved regions through telemedicine and related services. Advances in ICT technologies have further expanded the potential for remote case consultations and the sharing of pathological images.
This study aims to reduce disparities in medical care caused by regional imbalances in the availability of nephrology specialists and renal pathology diagnostic systems. To achieve this, we will develop a remote consultation framework and evaluate its usefulness and feasibility for real-world implementation.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Inclusion Criteria for Questioners
Subjects must meet all of the following:
Status: Physicians practicing in Japan (self-reported; verified via checkbox at informed consent).
Consent: Received study explanation and provided appropriate consent.
Registration: Completed registration after email verification.
Note: Strict credential verification is difficult due to system nature. To prevent non-physician access, the form (URL/QR code) will not be public and will only be shared via:Staff areas in certified facilities (e.g., Japanese Society of Internal Medicine), physician-only websites and the Japan Kidney Association CKD Committee network.
2. Inclusion Criteria for Responders
Physicians must meet all of the following:
Qualifications: Board-certified nephrologists (JSN), board-certified pathologists (JSP), or physicians with equivalent expertise.
Consent: Received study explanation and provided informed consent.
Registration: Completed registration after email verification.
3. Inclusion Criteria for Patients (Pathological Consultation)
Patients must meet all of the following:Target:
Requiring consultation utilizing pathological images.
Consent: Received the URL/QR code from their physician, reviewed the study webpage, and provided informed consent.
Age: Being 18 years of age or older at the time of providing consent.
Note on Roles
An individual may act as both a questioner and a responder, but cannot answer their own questions.
Key exclusion criteria - Exclusion Criteria
Individuals who meet any of the following criteria will be excluded from the study or the data analysis.
Investigator's Discretion: Anyone judged by the investigator to be unsuitable for participation in this study.
No Active Participation (Exclusion from Analysis): Questioners who do not post any inquiries regarding renal disease care during the study period (these individuals will be excluded from the data analysis).
Target Size - 5430
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 06 Month 17 Day
Date of IRB - 2026 Year 07 Month 14 Day
Anticipated trial start date - 2026 Year 07 Month 27 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071001
Disclaimer: Curated by HT Syndication.
