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

March 5, 2026 updated by: Claudio Rigatto, University of Manitoba

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

The main purpose of this trial is to determine whether the addition of the VIEWER virtual care platform to usual care will lead to a reduction in composite emergency department (ED) visits and/or hospitalizations/or increase the perceived safety of virtual care among patients and providers.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background: Chronic Kidney Disease (CKD) is an increasingly prevalent condition that represents a major national public health burden. The health transition from advanced CKD to the start of dialysis is a period of heightened vulnerability for many patients. Our data has demonstrated that during the 30-day period before the start of dialysis, there is a 10-fold increase in Emergency Department (ED) visits and hospitalizations related to kidney failure and its complications. Importantly, this spike occurs despite patients having frequent contact with their nephrology healthcare teams. For stable CKD patients, virtual monitoring could facilitate the communication of accurate and reliable data between patients and providers helping to avoid unnecessary ED visits and facilitate more optimal dialysis starts.

Design& Method: The VIEWER study is a national, pragmatic, multicenter randomized controlled trial across 5 Canadian sites from two provinces including:

  1. Seven Oaks General Hospital (SOGH), Winnipeg, Manitoba.
  2. St. Boniface hospital (SBH), Winnipeg, Manitoba.
  3. Health Sciences center (HSC), Winnipeg, Manitoba.
  4. Health Sciences Center, London, Ontario.
  5. Scarborough Health Network (SHN), Scarborough, Ontario.

VIEWER is a CKD-specific virtual care platform that integrates data from a wireless Blood Pressure (BP) cuff, weight scale, transcutaneous O2 sat monitor, and wearable motion tracker. The patient-facing component of VIEWER (patient portal), is a custom application based on a mobile tablet that guides patients through a daily self-assessment routine using the connected devices. BP measurements, weight and oxygenation (as surrogates of volume status), and step counts (as a surrogate of functional status), provide semi-continuous longitudinal data on patient physical status. Additionally, patients are prompted to fill out a weekly symptom survey (Edmonton Symptom Assessment Score- revised; ESAS-r), a validated instrument of kidney failure symptoms. Patient data and ESAS scores are automatically uploaded to fully PHIA/HIPPA compliant servers where they are made available to the patients' care team through a secure, web-based provider portal. Provider notifications (flags) are generated for out-of-range values (i.e. BP, weights for volume management) and a secure messaging component allows for direct patient-provider communication. Participants will be trained to use the VIEWER platform by a member of the research team. On the provider side, two members of the care team at each site will be trained as "superusers" of the provider portal. These users will check and respond as needed daily (Monday to Friday) for flags and patient messages, and will respond or communicate as needed to the health care team as per local clinic standard operating procedures. Trends in measurements will be reviewed at multidisciplinary team rounds, which typically occur weekly. During routine clinic visits, trends in all objective and subjective measures will be available to review to inform clinical decision making. Consistent with our pragmatic design, we will not be proscriptive in how monitoring data are interpreted; rather, we ask that care teams consider this enriched data stream and incorporate that information according to their own protocols and clinical judgement.

Patients randomized to the control group will see their multidisciplinary CKD care teams as per usual care.

Follow-up visits and Focus Groups (or individual interview): Patient Reported Experience Measures (PREM) and Kidney Disease Quality of Life-Short Form (KDQOL-SF) will be measured at baseline, 3, 6, 9 and 12 months in all paticipanats. Usability, acceptability, and patient and provider perspective on the intervention will be assessed at the end of the trial using the System Usability Scale (SUS). In addition, two virtual focus groups will be conducted at the end of the study with a subset of participants and healthcare providers who used the VIEWER platform.

Statistical Methods:The primary outcome (time to first hospitalization or ED visit, censoring at dialysis or death) will be assessed using univariate Cox proportional hazards models and a Kaplan-Meier analysis with a log-rank test, as will the secondary outcomes of all-cause mortality, ED visits, hospitalization, and acute inpatient dialysis initiation. Change in overall PREM, KDQOL-SF and SUS scores will be assessed with two-sided t-test or Wilcoxon Rank Sum test as distributionally appropriate, and interpreted relative to their minimal important differences. All outcomes will be assessed at a two-sided alpha= 0.05. Subgroup analyses will be prespecified and limited to 1) eGFR greater or less than 10ml/min, 2) sex and gender (described below) 3) diabetes.

Study Type

Interventional

Enrollment (Estimated)

340

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2V 3M3
        • Recruiting
        • Chronic Disease Innovation Centre, Seven Oaks Hospital
        • Contact:
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • Recruiting
        • St. Boniface Hospital
        • Contact:
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Recruiting
        • Health Sciences Centre
        • Contact:
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Recruiting
        • London Health Sciences Centre
        • Contact:
      • Scarborough Village, Ontario, Canada, M1P 2V5
        • Recruiting
        • Scarborough Health Network - General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Participants randomized to the intervention group will be provided with a wireless BP cuff, weight scale, transcutaneous O2 sat monitor, wearable motion tracker and mobile tablet with the VIEWER application. Patients will be trained to use the VIEWER platform either virtually or in person. Patients will be guided through a daily self-assessment routine via the app (BP, weight, O2 saturation, step count upload) and weekly ESAS-r survey. Participants will use the VIEWER platform for 12 months ( or until dialysis initiation) in addition to receiving usual care. Additionally, participants will complete the UK Kidney PREM score (adapted to CKD) and the Health related QOL using KDQOL-SF via REDCap or paper form at baseline, 3, 6, 9 and 12 months (or every 3 months until dialysis initiation), and the System Usability Scale (SUS) at 12 months.
Device: VIEWER virtual care platform
VIEWER is a tablet based, CKD specific home telemonitoring platform developed by our team of patients and researchers that integrates data from a wireless blood pressure cuff, weigh scale, transcutaneous O2 sat monitor and wearable motion tracker via a tablet and custom app.
No Intervention: Control Group
Participants randomized to the control group will continue to receive usual care either virtually via telephone or video call or in person depending on COVID-19 restrictions in place. Participants will complete the UK Kidney PREM score (adapted to CKD) and the Health related QOL using KDQOL-SF via REDCap or paper form at baseline, 3, 6, 9 and 12 months (or every 3 months until dialysis initiation).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of first hospitalization or emergency department (ED) visit
Time Frame: 12 months or until dialysis initiation
It's defined as an inpatient admission to hospital or a visit to the emergency department, whatever is first". So, we will compare the time of the first hospital admission /and or ED visit between two groups.
12 months or until dialysis initiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 12 months or until dialysis initiation
The mortality rate will be compared between the intervention and control group.
12 months or until dialysis initiation
Proportion of patients who have an acute inpatient initiation of dialysis.
Time Frame: 12 months or until dialysis initiation
the rate of patients who started dialysis in the intervention and control groups during 1 year of follow-up.
12 months or until dialysis initiation
Frequency of Emergency Department Visit
Time Frame: 12 months or until dialysis initiation
The average frequency of ED visit will be compared in two study groups.
12 months or until dialysis initiation
Frequency of formal clinic visits
Time Frame: 12 months or until dialysis initiation
The average frequency of formal clinic visits will be compared between two study groups
12 months or until dialysis initiation
UK Kidney PREM score (adapted to CKD)
Time Frame: baseline, 3, 6, 9 and 12 months (or every 3 months until dialysis initiation)
The UK Kidney Patient Reported Experience Measure is a validated, self-reported scale that focuses on how kidney patients experience care. The UK Kidney PREM used for this trial consists of questions abstracted from the 2019 Kidney PREM. Possible scores range from 1 (strongly disagree) to 10 (strongly agree). The average total scores will be compared between intervention and control group.
baseline, 3, 6, 9 and 12 months (or every 3 months until dialysis initiation)
Health related QOL using KQOL-SF
Time Frame: baseline, 3,6,9 and 12 months (or every 3 months until dialysis initiation)
Kidney Disease Quality of Life- Short Form is a self-reported measure developed for individuals with kidney disease and those on dialysis. It includes 43 kidney disease targeted items, and 36 items that provide a measure of physical and mental health and 1 overall health rating item ranging from 0 (worst possible health) to 10 (best possible health).The average total scores will be compared between intervention and control groups.
baseline, 3,6,9 and 12 months (or every 3 months until dialysis initiation)
System Usability Scale (SUS)
Time Frame: 12 months ( or at the time of dialysis initiation)
The System Usability Scale measures the usability of a wide range of products and services including hardware and software. It consists of a 10 item questionnaire with 5 response options ranging from 1 (strongly disagree) to 5 (strongly agree). This will be assessed via focus groups held with a subset of patients.
12 months ( or at the time of dialysis initiation)
Provider Perspectives towards intervention (qualitative) focus groups
Time Frame: 12 months (or end of study)
Assessed via focus groups held with a subset of providers
12 months (or end of study)
Patient Perspectives towards intervention (qualitative) focus groups (or individual interview)
Time Frame: 12 months (or end of study)
Assessed via focus groups held with a subset of patients
12 months (or end of study)
Proportion of patients greater than 80% adherence
Time Frame: 12 months (or end of study)
tracked via VIEWER app
12 months (or end of study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Investigators

  • Principal Investigator: Claudio Rigatto, MD, University of Manitoba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2022

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

March 30, 2028

Study Registration Dates

First Submitted

August 16, 2021

First Submitted That Met QC Criteria

February 2, 2023

First Posted (Actual)

February 14, 2023

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS25046 (B2021:066)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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