NCT05240573: SKI

Strong Kidney Initiative Trial for Dialysis Care Quality

Terminated NA Last updated 9 April 2026

What this trial tests

NA trial testing SKI App in Hemodialysis Complication in 181 participants. Terminated before completion.

Timeline

1 May 2023

Primary endpoint
19 March 2024

31 December 2025

Quick facts

Lead sponsor	China Medical University Hospital
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	181
Start date	1 May 2023
Primary completion	19 March 2024
Estimated completion	31 December 2025
Sites	1 location across Taiwan

Drugs / interventions tested

• SKI App

Conditions studied

• Hemodialysis Complication — all drugs for Hemodialysis Complication →

Sponsor

China Medical University Hospital

Who can join

20 and older, any sex, with Hemodialysis Complication. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Current application of blockchain technology in healthcare and its potential roles in Urology.
   Felemban S, Yiu TW, Harvey M, Lim H, et al · · 2025 · PMID 40396272 · DOI 10.1111/bju.16757