Self-Management Data and Disease Progression in Chronic Kidney Disease
A Non-Interventional, Prospective Observational Study to Evaluate Disease Progression and Management Characteristics for the Development of an Integrated Self-Management Data Application in Chronic Kidney Disease
1 other identifier
observational
300
1 country
1
Brief Summary
This study evaluates disease progression and management characteristics in patients with chronic kidney disease (CKD) using an integrated mobile application and hospital information system (HIS) clinical data. The main goals of this study are:
- 1.To observe patient self-management recording performance and adherence (continuity of recording blood pressure, blood glucose, medication, and diet).
- 2.To explore associations between integrated self-management data and disease progression or acute exacerbations (e.g., acute kidney injury, hyperkalemia).
- 3.To gather foundational evidence for optimizing and improving future digital health applications for CKD management.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2026
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 11, 2026
CompletedFirst Submitted
Initial submission to the registry
August 4, 2026
CompletedFirst Posted
Study publicly available on registry
August 10, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 11, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 11, 2029
August 10, 2026
August 1, 2026
3 years
August 4, 2026
August 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Self-Management Data Recording Adherence and Quality
Continuity and completion rate of patient-entered self-management logs, including home blood pressure (twice daily), blood glucose (twice daily, if applicable), medication adherence, and meal photographs.
Up to 12 months (evaluated at Visit 1 through Visit 7 at 2-month intervals)
Secondary Outcomes (2)
Association Between Self-Management Adherence and Clinical Metrics
Up to 12 months
User Satisfaction with the CKD Self-Management Mobile Application
At 4, 8, and 12 months
Study Arms (1)
CKD Patient Cohort
Adult patients with chronic kidney disease (CKD) or at high risk of CKD attending outpatient clinics. All participants will log self-management data (home blood pressure, blood glucose, medication, diet) via a dedicated mobile app and undergo prospective observation for 1 year with routine clinical data collection from the hospital information system.
Interventions
A mobile application used by participants to log home blood pressure (twice daily), blood glucose (twice daily, if applicable), medication adherence, and meal photographs (5 days prior to visits). The application also integrates with the hospital information system (HIS) to provide lab test results for disease monitoring.
Eligibility Criteria
Outpatient population visiting the Division of Nephrology at Chungnam National University Hospital for chronic kidney disease (CKD) management.
You may qualify if:
- Adult patients aged 19 years or older and under 85 years.
- Patients visiting the hospital for chronic kidney disease (CKD) management.
- Patients diagnosed with CKD or identified as high-risk for CKD requiring continuous management (e.g., diabetes mellitus, hypertension, proteinuria, or decreased eGFR).
- Patients capable of recording self-management data (blood pressure, diet, medication) independently or with assistance through the provided mobile application.
- Patients whose clinical data can be collected from the Hospital Information System (HIS).
You may not qualify if:
- Patients who do not sign the informed consent form or lack the capacity to fully understand the study protocol and express voluntary consent.
- Patients currently undergoing maintenance dialysis (hemodialysis or peritoneal dialysis) for end-stage kidney disease (ESKD).
- Patients deemed unsuitable for participation in the study by the investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chungnam National University Hospital
Daejeon, DJ, 35015, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2026
First Posted
August 10, 2026
Study Start
June 11, 2026
Primary Completion (Estimated)
June 11, 2029
Study Completion (Estimated)
June 11, 2029
Last Updated
August 10, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share