Ignite Creation Date:
2024-05-06 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05240573
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-05-06
First Post:
2022-01-25
Brief Title:
Strong Kidney Initiative Trial for Dialysis Care Quality
Sponsor:
China Medical University Hospital
Organization:
China Medical University Hospital
Study Overview
Official Title:
A Randomized Controlled Clinical Trial for Dialysis Care Quality After Introducing Blockchain-based Strong Kidney Initiative
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SKI
Brief 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 96 per 100000 in 1990 to 111 per 100000 in 2010 and the global prevalence of end-stage kidney disease ESRD was estimated from 759 per 100000 in 2005 to 1007 per 100000 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 2584 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 patients 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
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 patients 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None