Chronic Kidney Disease, CKD
Conditions
Keywords
Self-Management, Mobile Application, Personal Health Record, Hospital Information System, Prospective Observational Study
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. Participants will be recruited from outpatient clinics at Chungnam National University Hospital and followed prospectively for 1 year with regular follow-up visits.
Detailed description
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: 1. 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. 2. 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. 3. 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.
Interventions
BEHAVIORALCKD Self-Management Mobile Application
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.
Sponsors
Chungnam National University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to 84 Years
Healthy volunteers
No
Inclusion criteria
1. Adult patients aged 19 years or older and under 85 years. 2. Patients visiting the hospital for chronic kidney disease (CKD) management. 3. Patients diagnosed with CKD or identified as high-risk for CKD requiring continuous management (e.g., diabetes mellitus, hypertension, proteinuria, or decreased eGFR). 4. Patients capable of recording self-management data (blood pressure, diet, medication) independently or with assistance through the provided mobile application. 5. Patients whose clinical data can be collected from the Hospital Information System (HIS).
Exclusion criteria
1. Patients who do not sign the informed consent form or lack the capacity to fully understand the study protocol and express voluntary consent. 2. Patients currently undergoing maintenance dialysis (hemodialysis or peritoneal dialysis) for end-stage kidney disease (ESKD). 3. Patients deemed unsuitable for participation in the study by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-Management Data Recording Adherence and Quality | Up to 12 months (evaluated at Visit 1 through Visit 7 at 2-month intervals) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Association Between Self-Management Adherence and Clinical Metrics | Up to 12 months | 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. |
| User Satisfaction with the CKD Self-Management Mobile Application | At 4, 8, and 12 months | Patient satisfaction scores regarding app usability and feature feasibility, assessed using a structured questionnaire. |
Countries
South Korea
Contacts
CONTACTDae Eun Choi
Outcome results
None listed