NCT07754097

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. 1.To observe patient self-management recording performance and adherence (continuity of recording blood pressure, blood glucose, medication, and diet).
  2. 2.To explore associations between integrated self-management data and disease progression or acute exacerbations (e.g., acute kidney injury, hyperkalemia).
  3. 3.To gather foundational evidence for optimizing and improving future digital health applications for CKD management.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
35mo left

Started Jun 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Jun 2026Jun 2029

Study Start

First participant enrolled

June 11, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 10, 2026

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2029

Last Updated

August 10, 2026

Status Verified

August 1, 2026

Enrollment Period

3 years

First QC Date

August 4, 2026

Last Update Submit

August 4, 2026

Conditions

Keywords

Self-ManagementMobile ApplicationPersonal Health RecordHospital Information SystemProspective Observational Study

Outcome Measures

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.

    Up to 12 months (evaluated at Visit 1 through Visit 7 at 2-month intervals)

Secondary Outcomes (2)

  • Association Between Self-Management Adherence and Clinical Metrics

    Up to 12 months

  • User Satisfaction with the CKD Self-Management Mobile Application

    At 4, 8, and 12 months

Study Arms (1)

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

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.

CKD Patient Cohort

Eligibility Criteria

Age19 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chungnam National University Hospital

Daejeon, DJ, 35015, South Korea

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2026

First Posted

August 10, 2026

Study Start

June 11, 2026

Primary Completion (Estimated)

June 11, 2029

Study Completion (Estimated)

June 11, 2029

Last Updated

August 10, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations