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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Self-Management Data Recording Adherence and Quality
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: CKD Self-Management Mobile Application (Behavioral)
结局指标
主要结局
Self-Management Data Recording Adherence and Quality
时间窗: 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.
次要结局
- 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)