Self-Management Data and Disease Progression in Chronic Kidney Disease

This is a single-center, non-interventional, prospective observational study designed to collect clinical laboratory data and patient-generated self-management records in adults requiring chronic kidney disease (CKD) management.

Participants will undergo prospective observation for 1 year, involving 7 scheduled regular outpatient visits at 2-month intervals.

Data Collection:

• Patient-Generated Data: Participants will record home blood pressure (twice daily), blood glucose (twice daily, if applicable), medication intake, and diet logs (photographs taken 5 days prior to each visit) via a mobile application.
• Clinical Data: Clinical metrics including blood pressure, body weight, height, body mass index (BMI), routine lab results (chemistry, hematology, urinalysis), body composition analysis (BIA), ECG, and medication history will be extracted from the hospital information system (HIS). All clinical evaluations follow routine standard-of-care procedures, with no additional research-specific invasive procedures performed.
• User Experience: Satisfaction surveys regarding the CKD management app will be administered at 4, 8, and 12 months.

Statistical Analysis:

Continuous variables will be analyzed using one-way ANOVA, and categorical variables will be evaluated using chi-square tests. Associations between self-management adherence patterns, clinical metrics, and disease progression will be assessed.

Inclusion criteria

• 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).

Exclusion criteria

• 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.