Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05726526

A Pragmatic Randomized Controlled Trial of a CKD Specific Telemonitoring Platform to Minimize Adverse Outcomes in High Risk CKD Patients

Led by University of Manitoba · Updated on 2026-03-09

340

Participants Needed

5

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether adding the VIEWER virtual care platform to usual care can reduce emergency department visits and hospitalizations or improve the perceived safety of virtual care for patients with advanced Chronic Kidney Disease (CKD). This study focuses on patients at high risk during the vulnerable period before starting dialysis, aiming to improve communication between patients and healthcare providers through remote monitoring. The trial is a national, pragmatic, multicenter randomized controlled study conducted at five Canadian sites. The VIEWER platform includes a wireless blood pressure cuff, weight scale, oxygen saturation monitor, wearable motion tracker, and a tablet with a custom app guiding patients through daily self-assessments. Patients in the intervention group use these devices and complete weekly symptom surveys over 12 months or until they begin dialysis, in addition to receiving usual care. The control group receives usual care alone, which may be virtual or in person. Healthcare providers receive alerts for out-of-range measurements and communicate with patients through a secure portal, integrating this data into clinical decision-making. Participants will be monitored over 12 months or until dialysis starts, completing surveys on patient experience, quality of life, and usability at regular intervals. Researchers will track hospitalizations, emergency visits, mortality, dialysis initiation, adherence to monitoring, and provider and patient perspectives through focus groups. Data collected via the VIEWER platform and standard assessments will help evaluate the impact of this telemonitoring approach on health outcomes and care experience.

CONDITIONS

Brief Title

CKD Specific Telemonitoring Platform to Minimize Adverse Outcomes in High Risk CKD Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Over 18 years of age
  • Patient or primary caregiver can read and speak English
  • Patient or substitute decision maker can provide informed consent
  • Patient or caregiver is able and willing to use the VIEWER app and perform self-measurements
  • Have stage 5 CKD confirmed by specific kidney function tests or high risk of starting dialysis in 2 years
  • Followed by a multidisciplinary CKD care clinic
Not Eligible

You will not qualify if you...

  • Unable to perform self-monitoring or caregiver-assisted monitoring using the VIEWER platform

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation

Duration - Up to 12 months or until dialysis initiation

Participants randomized to the intervention group will be trained to use the VIEWER telemonitoring platform and guided through daily self-assessments with connected devices, while control participants continue usual care.

Daily self-assessments via app and weekly symptom surveys; routine clinic visits as usual care

Long-term Monitoring

Duration - Up to 12 months or until dialysis initiation

Participants are monitored for adverse outcomes such as hospitalization or emergency visits, with patient-reported experience and quality of life questionnaires completed at multiple timepoints.

Questionnaires at baseline, 3, 6, 9, and 12 months or until dialysis initiation

Follow-up

Duration - At 12 months or end of study

At the end of the trial, usability and perspectives on the intervention are assessed through surveys and focus groups or interviews.

Focus groups or interviews and usability survey

Trial Site Locations

Total: 5 locations

1

St. Boniface Hospital

Winnipeg, Manitoba, Canada, R2H 2A6

Actively Recruiting

2

Chronic Disease Innovation Centre, Seven Oaks Hospital

Winnipeg, Manitoba, Canada, R2V 3M3

Actively Recruiting

3

Health Sciences Centre

Winnipeg, Manitoba, Canada, R3A 1R9

Actively Recruiting

4

London Health Sciences Centre

London, Ontario, Canada, N6A 5W9

Actively Recruiting

5

Scarborough Health Network - General Hospital

Scarborough Village, Ontario, Canada, M1P 2V5

Actively Recruiting

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Research Team

C

Claudio Rigatto, MD

Z

Zahra Solati, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

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.

Zahra Solati, Paul Komenda, Navdeep Tangri...

https://pubmed.ncbi.nlm.nih.gov/41058978