Strong Kidney Initiative Trial for Dialysis Care Quality - Trial NCT05240573

Timeline & Enrollment

Primary Outcome

Number of emergency department admission,Number of hospital admission

Summary

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.

ICD-10 Classifications