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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Disease; CKD
• Intervention / Treatment: Behavioral: CKD Self-Management Mobile Application

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Dae Eun Choi; Phone Number: +82-42-280-7141; Email: daenii123@gmail.com

Study Locations

• South Korea
  • DJ
    • Daejeon, DJ, South Korea, 35015
      • Recruiting
      • Chungnam National University Hospital
      • Contact: Kyungho Park; Phone Number: +82-10-6485-7550; Email: ds3ixc@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Outpatient population visiting the Division of Nephrology at Chungnam National University Hospital for chronic kidney disease (CKD) management.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Behavioral: CKD 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 12 months
User Satisfaction with the CKD Self-Management Mobile Application	Patient satisfaction scores regarding app usability and feature feasibility, assessed using a structured questionnaire.	At 4, 8, and 12 months

Collaborators and Investigators

• Sponsor: Chungnam National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2026
• Primary Completion (Estimated): June 11, 2029
• Study Completion (Estimated): June 11, 2029

Study Registration Dates

• First Submitted: August 4, 2026
• First Submitted That Met QC Criteria: August 4, 2026
• First Posted (Actual): August 10, 2026

Study Record Updates

• Last Update Posted (Actual): August 10, 2026
• Last Update Submitted That Met QC Criteria: August 4, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Self-Management; Mobile Application; Personal Health Record; Prospective Observational Study; Hospital Information System
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic
• Other Study ID Numbers: CNUH 2026-05-025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No