Self-Management Data and Disease Progression in Chronic Kidney Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19-84
SponsorChungnam National University Hospital
About this trial
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.
Participants will be recruited from outpatient clinics at Chungnam National University Hospital and followed prospectively for 1 year with regular follow-up visits.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Outpatient population visiting the Division of Nephrology at Chungnam National University Hospital for chronic kidney disease (CKD) management.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
CKD Self-Management Mobile Application
BehavioralA 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.
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: CKD Patient Cohort1 intervention
Trial outcomes
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.
Time frame
Up to 12 months (evaluated at Visit 1 through Visit 7 at 2-month intervals)Secondary outcomes
1
Association Between Self-Management Adherence and Clinical Metrics
Change in clinical parameters extracted from the Hospital Information System (HIS), including laboratory values (eGFR, serum potassium, urinalysis), blood pressure, and body composition analysis (BIA), to evaluate disease progression and acute exacerbations.
Time frame
Up to 12 months2
User Satisfaction with the CKD Self-Management Mobile Application
Patient satisfaction scores regarding app usability and feature feasibility, assessed using a structured questionnaire.
Time frame
At 4, 8, and 12 monthsSponsors and contacts
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Source ClinicalTrials.gov