Chronic Kidney DiseaseNCT07754097
Self-Management Data and Disease Progression in Chronic Kidney Disease
An observational study of Chronic Kidney Disease and CKD, run by Chungnam National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 84 years
- Conditions the study is for
- Chronic Kidney Disease, CKD
- What is being tested?
- CKD Self-Management Mobile Application
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Jun 2026to 11 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatient population visiting the Division of Nephrology at Chungnam National University Hospital for chronic kidney disease (CKD) management.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Chungnam National University Hospital
Daejeon, DJ, 35015
Kyungho Park, +82-10-6485-7550, ds3ixc@gmail.com
About this study
Official title: 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:
Read more
- To observe patient self-management recording performance and adherence (continuity of recording blood pressure, blood glucose, medication, and diet).
- To explore associations between integrated self-management data and disease progression or acute exacerbations (e.g., acute kidney injury, hyperkalemia).
- 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:
- 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.
- Conditions
- Chronic Kidney Disease, CKD
- Being tested
- CKD Self-Management Mobile Application
- Keywords
- Self-Management, Mobile Application, Personal Health Record, Hospital Information System, Prospective Observational Study
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD Self-Management Mobile ApplicationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: CKD Self-Management Mobile Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: At 4, 8, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start11 Jun 2026
- Primary completion11 Jun 2029 (estimated)
- Study completion11 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chungnam National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754097
- Sponsor's protocol ID
- CNUH 2026-05-025
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07754097
- Acronym / sponsor ID
- CNUH 2026-05-025
- Conditions
- Chronic Kidney Disease, CKD
- Keywords
- Self-Management, Mobile Application, Personal Health Record, Hospital Information System, Prospective Observational Study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chungnam National University HospitalUniversity, hospital or other
- Study start
- 11 Jun 2026 (actual)
- Primary completion
- 11 Jun 2029 (estimated)
- Study completion
- 11 Jun 2029 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To observe patient self-management recording performance and adherence (continuity of recording blood pressure, blood glucose, medication, and diet).
- To explore associations between integrated self-management data and disease progression or acute exacerbations (e.g., acute kidney injury, hyperkalemia).
- 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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CKD Patient Cohort | – | Behavioral: CKD Self-Management Mobile ApplicationAdult 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. |
Who may qualify
- Ages
- 19 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatient population visiting the Division of Nephrology at Chungnam National University Hospital for chronic kidney disease (CKD) management.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CKD Self-Management Mobile ApplicationA 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. | Behavioural | CKD Patient Cohort |
Primary outcome
Self-Management Data Recording Adherence and Quality
Time frame: 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.
2 secondary outcomes
Association Between Self-Management Adherence and Clinical Metrics
Time frame: Up to 12 months
User Satisfaction with the CKD Self-Management Mobile Application
Time frame: At 4, 8, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease and CKD, run by Chungnam National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dae Eun Choi (+82-42-280-7141, daenii123@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Management Data Recording Adherence and Quality (time frame: Up to 12 months (evaluated at Visit 1 through Visit 7 at 2-month intervals)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.