Telemonitoring Platform for Chronic Kidney Disease

(VIEWER Trial)

Recruiting at 5 trial locations

Overseen By Haley Farion, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Manitoba

Disqualifiers: Inability of self-monitoring

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

340 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a virtual care platform called VIEWER to determine if it can help people with severe chronic kidney disease (CKD) avoid emergency visits and hospital stays. Participants will use devices like a blood pressure cuff and a weight scale at home, entering results into the VIEWER app alongside their usual care. The trial aims to assess whether this approach increases confidence in virtual care for both patients and doctors. It suits those with stage 5 CKD who are already under specialized care and can use technology for health tracking. As an unphased trial, it offers a unique opportunity to contribute to innovative care solutions for CKD.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the VIEWER virtual care platform is safe for chronic kidney disease patients?

Research has shown that the VIEWER virtual care platform is generally safe for people with chronic kidney disease (CKD). In past studies, this platform was used alongside regular medical care to track patients' health, monitoring blood pressure, weight, oxygen levels, and physical activity.

No major safety problems have been reported with VIEWER. The platform aims to help patients manage their health better at home, potentially reducing emergency visits and hospital stays. Although detailed safety data specifically for VIEWER is limited, telemedicine tools like this are designed to enhance patient care safety and effectiveness. Overall, the VIEWER platform is considered well-tolerated for managing CKD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the VIEWER virtual care platform because it's a fresh approach to managing chronic kidney disease (CKD) using technology. Unlike traditional treatments that mainly involve regular clinic visits and medication, this platform empowers patients with tools like a wireless blood pressure cuff, weight scale, oxygen saturation monitor, and a wearable motion tracker, all connected through a mobile app. This setup allows for continuous self-assessment and real-time data sharing with healthcare providers, which could lead to more personalized and timely care. By integrating these tech tools, the VIEWER platform aims to enhance patient engagement and potentially improve health outcomes, making it a promising innovation in CKD management.

What evidence suggests that the VIEWER virtual care platform is effective for chronic kidney disease?

In this trial, participants in the intervention group will use the VIEWER telehealth platform to manage chronic kidney disease (CKD) by tracking key health metrics such as blood pressure, weight, oxygen levels, and physical activity. Research has shown that platforms like VIEWER can enhance patients' quality of life and improve control over blood pressure and kidney health. Specifically, patients using VIEWER have reported feeling more in control of their health, potentially reducing emergency room visits and hospital stays. Overall, VIEWER offers a promising method to support individuals with CKD by simplifying and enhancing health monitoring. ^{3 4 5 6 7}

Who Is on the Research Team?

Claudio Rigatto, MD

Principal Investigator

University of Manitoba

Are You a Good Fit for This Trial?

This trial is for adults over 18 with stage 5 chronic kidney disease (CKD), who are likely to need dialysis within two years. Participants or their caregivers must be able to read and speak English, give informed consent, and use the VIEWER app for self-monitoring tasks like measuring weight and blood pressure.

Inclusion Criteria

My kidney function is very low, with an eGFR under 15.

I am being treated at a specialized clinic for chronic kidney disease.

I or someone who makes decisions for me can give informed consent.

Exclusion Criteria

You can't use VIEWER to monitor yourself, even with help from someone else.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants use the VIEWER platform for daily self-assessment and weekly symptom surveys, in addition to usual care

12 months or until dialysis initiation

Daily self-assessment via app, weekly symptom survey

Control

Participants receive usual care either virtually or in person, depending on COVID-19 restrictions

12 months or until dialysis initiation

Regular clinic visits as per usual care

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months or until dialysis initiation

Follow-up visits at baseline, 3, 6, 9, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• VIEWER virtual care platform

Trial Overview The study tests if adding the VIEWER virtual care platform to regular treatment helps reduce emergency visits, hospital stays, or improves feelings of safety with virtual care among high-risk CKD patients compared to usual care without this technology.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

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 II: Control Group Active Control 1 Intervention

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).

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

Published Research Related to This Trial

A pilot trial involving 52 patients with advanced chronic kidney disease (CKD) tested the feasibility of using online electronic patient-reported outcome measures (ePROMs) for real-time symptom monitoring, showing high retention (96%) and adherence (74% at 180 days).

The ePROM intervention was well-accepted by patients, indicating potential for improving patient engagement in managing CKD, although strategies are needed to maintain long-term participation beyond 270 days.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of a pilot feasibility randomised controlled trial exploring the use of an electronic patient-reported outcome measure in the management of UK patients with advanced chronic kidney disease. Kyte, D., Anderson, N., Bishop, J., et al.[2022]

In a randomized controlled trial with 710 chronic heart failure patients, over 80% adherence to telemonitoring was achieved, indicating strong patient engagement in managing their health through daily measurements of vital signs.

The high adherence rates were consistent across various demographics and disease severities, suggesting that effective patient training and user-friendly telemonitoring systems can support long-term adoption of remote patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Will telemonitoring be adopted by patients with chronic heart failure?]. Prescher, S., Deckwart, O., Koehler, K., et al.[2018]

The platform developed for home care providers incorporates telemonitoring features, which became increasingly important during the COVID-19 pandemic to ensure patient safety and continuous care.

This integration allows for better monitoring of patients' health remotely, potentially improving outcomes and reducing the need for in-person visits during times of health crises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usage of a Web-Based Platform for Home Care Providers in the Pandemic Context. Sandulescu, V., Puscoci, S., Petre, M., et al.[2021]

The Patient Safety Dashboard was utilized 70% of the time it was available, indicating a good level of engagement among healthcare providers, particularly among nurses and physician assistants during specific times like morning rounds.

Providers generally found the Dashboard easy to use, with attendings rating it highly for usability (4.23), but nurses expressed concerns about its impact on their quality of work life, rating it lower (2.88), highlighting areas for improvement in future implementations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use, Perceived Usability, and Barriers to Implementation of a Patient Safety Dashboard Integrated within a Vendor EHR. Bersani, K., Fuller, TE., Garabedian, P., et al.[2021]

In a 1-year study involving 182 outpatients with advanced chronic kidney disease (CKD), the eKidneyCare app significantly reduced medication discrepancies compared to the MyMedRec app, indicating better medication management.

eKidneyCare not only lowered the total number of discrepancies but also reduced the severity of clinically relevant discrepancies, including those that could potentially cause serious harm, highlighting its effectiveness in improving medication safety for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Applications Targeting Medication Safety in Ambulatory High-Risk CKD Patients: Randomized Controlled Clinical Trial. Ong, SW., Jassal, SV., Porter, EC., et al.[2023]

The Home Dialysis Virtual Ward (HDVW) trial, involving 193 patients, effectively identified potential care gaps, particularly for those recently discharged from the hospital, indicating a need for enhanced support during transitional states.

Patient satisfaction with the HDVW was high, with a median rating of 8 out of 10, suggesting that this intervention positively impacted their overall health, understanding of treatment, and access to nephrology care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Care Gaps in Home Dialysis: The Home Dialysis Virtual Ward Study. Nadeau-Fredette, AC., Chan, CT., Bargman, JM., et al.[2020]

A study involving 21 older adults with chronic conditions showed that telemonitoring significantly improved their perceptions of health management, with participants feeling more secure and confident in managing their health after the intervention.

Participants reported that telemonitoring helped them understand changes in their condition and believed it could become a standard method of healthcare delivery in the future, indicating its potential for widespread acceptance among older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemonitoring is acceptable amongst community dwelling older Australians with chronic conditions. Halcomb, E., Purcell, R., Hickman, L., et al.[2019]

AdEPro is an interactive app designed to simplify the exploration of adverse event data from clinical trials, allowing users to visualize data on individual subjects and treatment groups without needing extensive programming skills.

The app serves as a 'hypothesis generator' for users to quickly investigate questions about adverse events, such as their onset and severity, while ensuring that patient data is processed locally for privacy and security.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AdEPro: Animation of Adverse Event Profiles-Presentation of an Easy-to-Use App for Visually Exploring Individual Study Data. Mentenich, N., Tasto, C., Becker, B.[2021]

Remote patient management and telemedicine can significantly enhance the care of patients with end-stage kidney disease on peritoneal dialysis by enabling early detection of issues and ensuring treatment compliance.

Implementing these technologies may lead to better health outcomes and increased adoption of home dialysis therapies, highlighting the need for clinical trials to evaluate their economic and clinical benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Economic Implications of Remote Patient Management. Rosner, MH., Khan, S.[2021]

The eNephro study is a randomized controlled trial involving 840 chronic kidney disease (CKD) patients across three stages, designed to evaluate the effectiveness of home telemonitoring compared to usual care over a 12-month period.

The study aims to demonstrate that home telemonitoring can improve clinical and biological parameters, enhance patients' perceived health status, and ultimately reduce healthcare costs by decreasing emergency visits and hospitalizations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of home telemonitoring in chronic kidney disease patients at different stages by a pragmatic randomized controlled trial (eNephro): rationale and study design. Thilly, N., Chanliau, J., Frimat, L., et al.[2022]

Remote patient management (RPM) can significantly enhance the effectiveness of home peritoneal dialysis (PD) by providing virtual clinical oversight, which helps reduce patient anxiety and improve adherence to treatment.

RPM allows for real-time monitoring and feedback between patients and clinicians, enabling early detection of complications and timely interventions, potentially preventing hospitalizations and improving overall patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote Patient Management in Peritoneal Dialysis: An Answer to an Unmet Clinical Need. John, O., Jha, V.[2021]

IT-based interventions, such as mobile health applications and computer systems, significantly improve self-management in kidney transplant recipients, with 80% of evaluated outcomes showing positive effects.

While these interventions positively impacted care processes and some clinical outcomes, further studies are needed to fully understand their long-term effects on clinical outcomes, healthcare costs, and patients' quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of IT-based interventions on self-management in adult kidney transplant recipients: a systematic review. Eslami, S., Khoshrounejad, F., Golmakani, R., et al.[2021]

Chronic kidney disease (CKD) patients face a high risk of adverse safety events due to factors like impaired kidney function and polypharmacy, which can lead to serious outcomes such as hospitalization and accelerated kidney function loss.

Telemedicine, particularly through interactive voice-response systems, offers a promising way for CKD patients to communicate safety-related issues to healthcare providers, although many patients face challenges in accessing these technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine to Promote Patient Safety: Use of Phone-Based Interactive Voice-Response System to Reduce Adverse Safety Events in Pre-dialysis CKD. Weiner, S., Fink, JC.[2022]

The Doctor Plus® Nephro telemedicine system effectively monitored the health of 26 home dialysis patients over an average of 2.3 years, identifying health anomalies and facilitating timely interventions, which improved patient outcomes.

Patients reported significant improvements in their quality of life, with a notable increase in health perception scores and a reduction in hospital admissions and lost workdays, demonstrating the system's efficacy in managing home dialysis care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Impact of remote monitoring in home dialysis: 5-year observation results]. Morosetti, M., Peccerillo, M., Frattarelli, D., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05726526

NCT05726526 | CKD Specific Telemonitoring Platform to ... VIEWER is a CKD-specific virtual care platform that integrates data from a wireless Blood Pressure (BP) cuff, weight scale, transcutaneous O2 sat monitor ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12497972/

A Pragmatic Randomized Controlled Trial of a CKD-Specific ... VIEWER Description. The VIEWER is a CKD-specific virtual care platform that integrates data from a wireless blood pressure (BP) cuff, weight ...

3. withpower.com withpower.com/trial/phase-kidney-diseases-5-2022-36d39

Telemonitoring Platform for Chronic Kidney Disease 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 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2949761224001111

The Effectiveness of Telehealth Intervention on Chronic ... To evaluate the effectiveness of telehealth programs on dietary habits, quality of life, renal function, and blood pressure in adults with chronic kidney ...

5. clinicaltrial.be clinicaltrial.be/en/details/191966?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

CKD Specific Telemonitoring Platform to Minimize Adverse... VIEWER is a CKD-specific virtual care platform that integrates data from a wireless Blood Pressure (BP) cuff, weight scale, transcutaneous ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41058978/

A Pragmatic Randomized Controlled Trial of a CKD ... Design: This study is a national, pragmatic, multicenter randomized controlled trial comparing usual care alone vs usual care plus the VIEWER ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05726526/ckd-specific-telemonitoring-platform-to-minimize-adverse-outcomes-in-high-risk-ckd-patients

CKD Specific Telemonitoring Platform to Minimize Adverse ... VIEWER is a CKD-specific virtual care platform that integrates data from a wireless Blood Pressure (BP) cuff, weight scale, transcutaneous ...