CKD Specific Telemonitoring Platform to Minimize Adverse Outcomes in High Risk CKD Patients
VIEWER
A Pragmatic Randomized Controlled Trial of a CKD Specific Telemonitoring Platform to Minimize Adverse Outcomes in High Risk CKD Patients
1 other identifier
interventional
340
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2022
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2021
CompletedStudy Start
First participant enrolled
June 30, 2022
CompletedFirst Posted
Study publicly available on registry
February 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 30, 2028
March 9, 2026
July 1, 2025
4.8 years
August 16, 2021
March 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite of first hospitalization or emergency department (ED) visit
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 Outcomes (10)
All-cause mortality
12 months or until dialysis initiation
Proportion of patients who have an acute inpatient initiation of dialysis.
12 months or until dialysis initiation
Frequency of Emergency Department Visit
12 months or until dialysis initiation
Frequency of formal clinic visits
12 months or until dialysis initiation
UK Kidney PREM score (adapted to CKD)
baseline, 3, 6, 9 and 12 months (or every 3 months until dialysis initiation)
- +5 more secondary outcomes
Study Arms (2)
Intervention Group
EXPERIMENTALParticipants 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.
Control Group
NO INTERVENTIONParticipants 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).
Interventions
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.
Eligibility Criteria
You may qualify if:
- \>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
You may not qualify if:
- Inability of self or caregiver assisted self-monitoring using VIEWER
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
St. Boniface Hospital
Winnipeg, Manitoba, R2H 2A6, Canada
Chronic Disease Innovation Centre, Seven Oaks Hospital
Winnipeg, Manitoba, R2V 3M3, Canada
Health Sciences Centre
Winnipeg, Manitoba, R3A 1R9, Canada
London Health Sciences Centre
London, Ontario, N6A 5W9, Canada
Scarborough Health Network - General Hospital
Scarborough Village, Ontario, M1P 2V5, Canada
Related Publications (1)
Solati Z, Komenda P, Tangri N, Saul S, Bohm C, Ferguson T, Hager D, Barr B, Mysore P, Hougen I, Meraz-Munoz A, Jain AK, Tam P, Rigatto C. 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. Can J Kidney Health Dis. 2025 Oct 5;12:20543581251359736. doi: 10.1177/20543581251359736. eCollection 2025.
PMID: 41058978DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claudio Rigatto, MD
University of Manitoba
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Given the nature of the intervention, patients and care providers will not be blinded; outcome assessment and statistical analysis will be blinded
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 16, 2021
First Posted
February 14, 2023
Study Start
June 30, 2022
Primary Completion (Estimated)
March 30, 2027
Study Completion (Estimated)
March 30, 2028
Last Updated
March 9, 2026
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share