Strong Kidney Initiative Trial for Dialysis Care Quality

Study Overview
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Brief Summary
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Chronic kidney disease (CKD) is an important global health issue that imposes a substantial healthcare burden in both developing and developed economies. The global prevalence of CKD-related mortality was estimated from 9.6 per 100,000 in 1990 to 11.1 per 100,000 in 2010, and the global prevalence of end-stage kidney disease (ESRD) was estimated from 75.9 per 100,000 in 2005 to 100.7 per 100,000 in 2010. In Taiwan, a long-lasting epidemic of CKD has created critical economic and social challenges in its health care system. Over the past 20 years, the annual incidence and prevalence of ESRD in Taiwan have surged from 126 to 361 per million and from 382 to 2,584 per million, respectively. National Health Insurance Bureau in Taiwan has spent a huge budget to support healthcare for ESRD patients requiring maintenance dialysis therapy without observing significant improvement in ESRD prevention and management. The main challenge in effectively preventing and managing ESRD is to obtain the full-spectrum data, such as lifestyle, diet, over-the-counter medication use, Chinese herbal medication use, and the occurrence of unaware outpatient acute kidney injury, on patients with CKD. This unmeasured information regarding patient's daily life is crucial because patients spend most of their time outside the hospital, even for patients receiving hemodialysis 3-4 times per week spend only 10% of their daily life in the healthcare facility. With the digital transformation of the healthcare system and the blockchain technology brought by the advances in data storage, data transfer, data safety, and computing power, collecting and exchanging comprehensive data becomes possible. The investigators will establish a full-spectrum kidney database by re-organizing all kidney-related clinical data that were generated in China Medical University Healthcare System (CMUH) and Asia University Healthcare System (AUH), integrating data collected in the dialysis outpatient clinic at CMUH and AUH, such as gait data, grip data, and skin image, combining daily life data such as diet, exercise, and sleeping condition collected from the Strong Kidney Initiative APP (SKI APP) or wearable devices. The investigators will then use the SKI APP and blockchain technology to provide digital service to dialysis patients and to prospectively collect daily life data. The digital service would include the visualization of real-time kidney data, kidney care recommendations, and innovative artificial intelligence-based services for kidney health prediction and suggestion. This proposed clinical trial aims to evaluate the clinical effectiveness of SKI digital services regarding the outcomes of the rate of emergency department (ED) visits, inpatient admission rate, kidney function improvement, mortality, and healthcare utilization in dialysis patients in 12 months. The clinical trial will be conducted on the patients who regularly receive hemodialysis care from the CMUH and AUH Healthcare Systems. Patients assigned to the intervention arm will be provided the SKI APP and related digital services and patients assigned to the control arm will be provided the ordinary CMUH dialysis care APP. The investigators will provide an education program for the APP and monitor the utilization of APP. The investigators hypothesize that patients receiving the SKI APP will have lower ED and inpatient admission rates, better kidney function maintenance, lower mortality, and decreased healthcare utilization. The results of the SKI trial will provide solid evidence regarding the real-world effectiveness of a comprehensive intelligent kidney care digital service using blockchain technology.

Official Title
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A Randomized Controlled Clinical Trial for Dialysis Care Quality After Introducing Blockchain-based Strong Kidney Initiative

Conditions
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Hemodialysis Complication

Intervention / Treatment
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* Other: SKI App


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who receive hemodialysis care at CMUH and AUH Healthcare Systems and agree to participate in this trial. Exclusion Criteria: Patients who do not receive regular hemodialysis care at CMUH and AUH Healthcare Systems; Patients who do not have a mobile device; Patients who have the capacity/literacy of using an APP; Patients who do not agree to participate.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SKI App<br> | Other: SKI App<br>* The intervention for the SKI App digital service will include the visualization of real-time kidney data, the kidney care recommendation, and innovative artificial intelligence-based services for kidney health prediction and suggestion. The intervention for the CMUH Dialysis Care App digital service will include simple records of blood pressure, medication records, and routine health education information.<br>|
| Active Comparator: CMUH Dialysis Care App<br> | Other: SKI App<br>* The intervention for the SKI App digital service will include the visualization of real-time kidney data, the kidney care recommendation, and innovative artificial intelligence-based services for kidney health prediction and suggestion. The intervention for the CMUH Dialysis Care App digital service will include simple records of blood pressure, medication records, and routine health education information.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of emergency department admission | Admission to emergency department | 12 months after enrollment | 
| Number of hospital admission | Admission to hospital | 12 months after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in renal function | Change in eGFR value | 12 months after enrollment | 
| Number of clinical visit | Clinic visit, hospital length of stay, costs | 12 months after enrollment | 
| Number of hospital days | Cumulative days of hospital length of stay | 12 months after enrollment | 
| Medical costs | Cumulative medical costs | 12 months after enrollment | 
| Mortality | All-cause mortality and cause-specific mortality | 12 months after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis