Telemonitoring platform for high-risk chronic kidney disease patients
A Pragmatic Randomized Controlled Trial of a CKD Specific Telemonitoring Platform to Minimize Adverse Outcomes in High Risk CKD Patients
This study is testing if a new virtual care platform can help people with advanced kidney disease stay healthier and avoid trips to the emergency room or hospital.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 340 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Manitoba Academic / other |
| Locations | 5 sites (Winnipeg, Manitoba and 4 other locations) |
| Trial ID | NCT05726526 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate the effectiveness of the VIEWER virtual care platform in reducing emergency department visits and hospitalizations among patients with advanced chronic kidney disease (CKD) stage 5. The study will involve a multicenter randomized controlled design across five sites in Canada, where patients will use the VIEWER platform to monitor their health metrics, such as blood pressure and weight. By facilitating better communication between patients and healthcare providers, the trial seeks to optimize the transition to dialysis and improve patient safety during this critical period.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with stage 5 CKD who are capable of using the VIEWER platform and have a high risk of starting dialysis within the next two years.
Not a fit: Patients who are unable to perform self-monitoring or use the VIEWER application may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce hospital visits and enhance the management of patients transitioning to dialysis.
How similar studies have performed: Other studies have shown promise in using telemonitoring for chronic conditions, suggesting that this approach could be beneficial, although the specific application for CKD is still being explored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \>18 years of age * Patient or primary caregiver can read and speak English * Patient or patients substitute decision maker is able to provide informed consent * Patient or primary care giver cognitively and physically capable and willing to use the VIEWER mobile application and perform self-measurements (i.e. weight, BP, etc.) * Have stage 5 CKD (2 measurements of eGFR \<15ml/min/1.73m2); eGFR will be calculated with the CKD-EPI equation, or have \>40% chance of beginning dialysis in the next 2 years based on the Kidney Failure Risk Equation * Followed in a multidisciplinary CKD clinic Exclusion Criteria: * Inability of self or caregiver assisted self-monitoring using VIEWER
Where this trial is running
Winnipeg, Manitoba and 4 other locations
- St. Boniface Hospital — Winnipeg, Manitoba, Canada (Recruiting)
- Chronic Disease Innovation Centre, Seven Oaks Hospital — Winnipeg, Manitoba, Canada (Recruiting)
- Health Sciences Centre — Winnipeg, Manitoba, Canada (Recruiting)
- London Health Sciences Centre — London, Ontario, Canada (Recruiting)
- Scarborough Health Network - General Hospital — Scarborough Village, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Claudio Rigatto, MD — University of Manitoba
- Study coordinator: Claudio Rigatto, MD
- Email: crigatto@sogh.mb.ca
- Phone: 204-631-3834
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.