UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063130 |
|---|---|
| Receipt number | R000072246 |
| Scientific Title | Renal Care Delivery and Telemedicine Utilization in Areas with Limited Access to Specialized Nephrology Care: A Questionnaire and Interview Survey |
| Date of disclosure of the study information | 2026/10/03 |
| Last modified on | 2026/10/01 16:32:57 |
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Basic information
Public title
Renal Care Delivery and Telemedicine Utilization in Areas with Limited Access to Specialized Nephrology Care: A Questionnaire and Interview Survey
Acronym
Current Status of Nephrology Care Systems and Telemedicine in Underserved Areas: A Questionnaire and Interview Study
Scientific Title
Renal Care Delivery and Telemedicine Utilization in Areas with Limited Access to Specialized Nephrology Care: A Questionnaire and Interview Survey
Scientific Title:Acronym
Current Status of Nephrology Care Systems and Telemedicine in Underserved Areas: A Questionnaire and Interview Study
Region
| Japan |
Condition
Condition
Kidney diseases
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the current state of nephrology care systems in areas with limited access to specialized kidney care, such as remote and island regions, and to evaluate the actual utilization and utility of telemedicine in this field.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
[Primary Outcomes]
The following endpoints at participating facilities regarding care for adult patients with pre-dialysis chronic kidney disease (CKD) and dialysis:
Quantitative assessment (Questionnaire survey): The actual conditions of the nephrology care system (e.g., collaboration status with specialized medical institutions) and the utilization of telemedicine (adoption rate and utility).
Qualitative assessment (Interview survey): Identification of operational challenges and best practices regarding the actual nephrology care system and telemedicine utilization.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Questionnaire Survey
Physicians involved in the management of internal medicine services at facilities that meet all of the following criteria (one physician per facility).
A. Facilities operated by the Regional Medical Promotion Association (https://www.jadecom.or.jp/hospital/index.html), or medical facilities located in Hokkaido, Tokyo, Nara Prefecture, Nagasaki Prefecture, or Okinawa Prefecture
B. Facilities that qualify as remote-area clinics or remote-area medical hub hospitals, or facilities where the research collaborators determined that physicians are involved in the treatment of adult CKD, lifestyle-related diseases, and dialysis in regions with limited nephrology care.
Note: In some cases, this selection process may be conducted in collaboration with local governments.
2. Interview Survey
Staff members from facilities that responded to the questionnaire survey and meet any of the following criteria, and who indicated their willingness to participate in the interview survey within the questionnaire (up to 10 facilities, with a maximum of 5 participants per facility).
A. Facilities that, based on their questionnaire responses, are believed to face challenges regarding their nephrology care systems or the utilization of telemedicine
B. Facilities that, based on their questionnaire responses, are implementing initiatives considered best practices regarding their nephrology care systems or the utilization of telemedicine
Key exclusion criteria
Facilities meeting any of the following criteria will be excluded from the study:
1) Facilities that refuse the use of their information for this study.
2) Facilities deemed inappropriate for participation by the investigators.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Masaomi |
| Middle name | |
| Last name | Nangaku |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Division of Nephrology and Endocrinology
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5800-8969
mnangaku@m.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Sugawara |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Division of Nephrology and Endocrinology
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5800-8969
Homepage URL
jinnai.research.assist@gmail.com
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
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
Research Ethics Committee of the Faculty of Medicine of the University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.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
| 2026 | Year | 10 | Month | 03 | 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
| 2026 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Overview: A cross-sectional questionnaire survey of facilities in remote and island areas with limited access to nephrology care, assessing in-person kidney care, the current contribution of telemedicine, and its future potential, followed by semi-structured interviews at selected facilities.
Questionnaire respondents: About 500 facilities, including those operated by the Japan Association for Development of Community Medicine and remote/island facilities in Hokkaido, Tokyo, Nara, Nagasaki, and Okinawa, receive the questionnaire and information sheet by post and/or email. One physician responsible for internal medicine answers on behalf of the facility (about 15-20 min); return of the questionnaire is deemed consent. Items cover facility attributes, in-person kidney care, current telemedicine use, future potential and challenges, and willingness to be interviewed. Responses are returned via Google Form, email, fax, or post.
Interview participants: Selected facilities (max 10) are invited by email or phone and give written consent after written and oral explanation. Up to 5 staff per facility join a 30-60 min interview online, by phone, or in person on care systems and the background, adaptations, and challenges of telemedicine adoption. Interviews are recorded and transcribed with consent. Facility names are disclosed only within the agreed scope; if any participant objects, the facility is treated as not consenting.
Study office: With collaborating institutions and local governments, identifies target facilities and distributes questionnaires. Summarizes responses descriptively, selects facilities with challenges or good practices for interviews, and performs thematic analysis of transcripts. Data are managed by study ID with a separate linkage table; results are published in aggregate without identifying facilities.
Discontinuation: A facility's data are excluded upon withdrawal request. No discontinuation criteria are set for the study as a whole.
Management information
Registered date
| 2026 | Year | 10 | Month | 01 | Day |
Last modified on
| 2026 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072246
