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

NCT ID: NCT05726526

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 340 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-30
• Study Completion Date: 2026-03-30

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.

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.

Conditions

Chronic Kidney Disease Stage 5; End Stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

VIEWER virtual care platform

Intervention Type: DEVICE

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.

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Claudio Rigatto

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claudio Rigatto, MD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

St. Boniface Hospital

Winnipeg, Manitoba, Canada

Site Status: RECRUITING

Chronic Disease Innovation Centre, Seven Oaks Hospital

Winnipeg, Manitoba, Canada

Site Status: RECRUITING

Health Sciences Centre

Winnipeg, Manitoba, Canada

Site Status: RECRUITING

London Health Sciences Centre

London, Ontario, Canada

Site Status: RECRUITING

Scarborough Health Network - General Hospital

Scarborough Village, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Claudio Rigatto, MD

Role: CONTACT

crigatto@sogh.mb.ca

204-631-3834

Haley Farion, MSc

Role: CONTACT

hfarion@sogh.mb.ca

204-632-3662

Facility Contacts

Reid Whitlock, MSc

Role: primary

rwhitlock@sogh.mb.ca

(204) 631-3834

Reid Whitlock

Role: primary

rwhitlock@sogh.mb.ca

(204) 631-3834

Reid Whitlock, MSc

Role: primary

rwhitlock@sogh.mb.ca

2046313834

Kathleen Koyle

Role: primary

Kathleen.Koyle@lhsc.on.ca

519-685-8500 ext. 56214

Harika Kuppala

Role: primary

hkuppala@shn.ca

References

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.

Reference Type: DERIVED

PMID: 41058978 (View on PubMed)

Other Identifiers

HS25046 (B2021:066)

Identifier Type: -

Identifier Source: org_study_id