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RecruitingNCT07754097Updated Aug 10, 2026

Self-Management Data and Disease Progression in Chronic Kidney Disease

An observational study in Chronic Kidney Disease and CKD, sponsored by Chungnam National University Hospital. Recruiting at 1 site in South Korea. Open to participants aged 19 Years to 84 Years. Per ClinicalTrials.gov, last updated 2026-08-10.

Sponsored by Chungnam National University Hospital · Observational

From the registry’s dates

  • Started Jun 2026; still recruiting 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
19 Years to 84 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Kidney Disease
  • CKD

Keywords

  • Self-Management
  • Mobile Application
  • Personal Health Record
  • Hospital Information System
  • Prospective Observational Study
03

In context

Renal Insufficiency, Chronic

3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.

This study's planned enrollment of 300 is above the median of 213 across 834 observational studies indexed under Renal Insufficiency, Chronic.

Browse Renal Insufficiency, Chronic studies →

Lead sponsor

Chungnam National University Hospital is the lead sponsor of 20 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 84 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 ).
  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

Exclusion Criteria:

  1. Patients who do not sign the 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

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.

06

What researchers measure

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 months

  2. 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 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07754097
Lead sponsor
Chungnam National University Hospital
Responsible party
Sponsor
First posted
Aug 10, 2026
Start date
Jun 11, 2026
Primary completion
Jun 11, 2029 (estimated)
Completion
Jun 11, 2029 (estimated)
Last update
Aug 10, 2026

Study contacts

Dae Eun Choi
Contact
daenii123@gmail.com
+82-42-280-7141

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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