A Pragmatic Randomized Controlled Trial of a CKD-Specific Virtual Monitoring Platform to Minimize Adverse Outcomes in High-Risk CKD Patients: A Clinical Research Protocol.

Abstract

Background: The transition from advanced Chronic Kidney Disease (CKD) to dialysis is a period of heightened vulnerability for many patients. Virtual monitoring of these patients could facilitate the communication of accurate and reliable data between patients and health care providers, helping to avoid unnecessary emergency department (ED) visits and facilitate more optimal dialysis starts.

Objective: To determine whether the addition of the VIEWER (Virtual Ward Incorporating Electronic Wearables) platform to usual care will lead to a reduction in ED visits and hospitalizations and lead to an increase in perceived safety of virtual care among patients and providers.

Design: This study is a national, pragmatic, multicenter randomized controlled trial comparing usual care alone vs usual care plus the VIEWER virtual care platform in patients with advanced CKD. Given the nature of the intervention, patients and care providers will not be blinded; outcome assessment and statistical analysis will be blinded.

Setting: Five CKD clinics in 2 Canadian provinces (Manitoba and Ontario).

Participants: Patients with advanced CKD not on dialysis (eGFR <15 mL/min/1.73 m², 2-year kidney failure risk >40%).

Measurements: Participants randomized to the intervention group will be provided with the VIEWER platform, comprised of a wireless blood pressure (BP) monitor, weight scale, transcutaneous O₂ sat (SpO2) monitor, wearable motion tracker, and mobile tablet running the VIEWER application. The intervention group will be trained to use the VIEWER platform to complete a daily self-assessment via the app (BP, weight, O₂ saturation, step count) and weekly Edmonton Symptom Assessment System Revised (ESAS-r) survey. These assessments will be integrated into clinical decision-making in multidisciplinary kidney health clinics. Participants will use the VIEWER platform for 12 months (or until dialysis initiation) in addition to receiving usual care.

Methods: Intention-to-treat (ITT) approach will be used to compare the primary outcome between 2 study groups. Time to primary and secondary outcomes will be assessed using univariate Cox proportional hazards models and a Kaplan-Meier analysis with a log-rank test. The primary outcome is the time to first hospital admission and/or ED visit. The control is usual care (no exposure to VIEWER platform).

Limitations: Some individuals may face challenges with technology adoption, which could affect participation. Those without Internet access are limited in their ability to take part in this study.

Conclusions: This study will help determine whether virtual monitoring in advanced CKD patients can reduce ED visits and hospitalization.

Trial registration: Clinicaltrials.gov; identifier: NCT05726526.