340 Participants Needed

Telemonitoring Platform for Chronic Kidney Disease

(VIEWER Trial)

Recruiting at 2 trial locations
CR
ZS
GZ
Overseen ByGhazaleh Zakipour, MSc
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Manitoba
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the VIEWER virtual care platform treatment for chronic kidney disease?

Research on remote patient management (RPM) for home dialysis shows that telehealth platforms can improve patient outcomes by enabling real-time monitoring and communication with healthcare providers. This approach helps detect early issues, ensures treatment compliance, and reduces patient anxiety, which could be beneficial for managing chronic kidney disease.12345

Is the telemonitoring platform for chronic kidney disease safe for humans?

The research suggests that telemedicine, including platforms like the VIEWER virtual care platform, can help improve patient safety by allowing CKD patients to communicate safety-related issues to their healthcare providers. However, some patients may face challenges using these technologies, which could impact their effectiveness in preventing safety events.678910

How does the telemonitoring platform for chronic kidney disease differ from other treatments?

The telemonitoring platform for chronic kidney disease is unique because it allows patients to monitor their health from home and communicate with healthcare professionals remotely. This approach can improve patient adherence to treatment plans and enable early detection of health issues, potentially preventing hospitalizations.111121314

What is the purpose of this trial?

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.

Research Team

CR

Claudio Rigatto, MD

Principal Investigator

University of Manitoba

Eligibility Criteria

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.
See 3 more

Exclusion Criteria

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

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment1 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 GroupActive Control1 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).

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials
628
Recruited
209,000+

Findings from Research

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.
Remote Patient Management in Peritoneal Dialysis: An Answer to an Unmet Clinical Need.John, O., Jha, V.[2021]
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.
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]
The Doctor Plusยฎ 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.
[Impact of remote monitoring in home dialysis: 5-year observation results].Morosetti, M., Peccerillo, M., Frattarelli, D., et al.[2023]

References

Remote Patient Management in Peritoneal Dialysis: An Answer to an Unmet Clinical Need. [2021]
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. [2022]
[Impact of remote monitoring in home dialysis: 5-year observation results]. [2023]
Health Economic Implications of Remote Patient Management. [2021]
Effectiveness of IT-based interventions on self-management in adult kidney transplant recipients: a systematic review. [2021]
Telemedicine to Promote Patient Safety: Use of Phone-Based Interactive Voice-Response System to Reduce Adverse Safety Events in Pre-dialysis CKD. [2022]
Use, Perceived Usability, and Barriers to Implementation of a Patient Safety Dashboard Integrated within a Vendor EHR. [2021]
Digital Applications Targeting Medication Safety in Ambulatory High-Risk CKD Patients: Randomized Controlled Clinical Trial. [2023]
AdEPro: Animation of Adverse Event Profiles-Presentation of an Easy-to-Use App for Visually Exploring Individual Study Data. [2021]
Predictors of Care Gaps in Home Dialysis: The Home Dialysis Virtual Ward Study. [2020]
Telemonitoring is acceptable amongst community dwelling older Australians with chronic conditions. [2019]
[Will telemonitoring be adopted by patients with chronic heart failure?]. [2018]
Usage of a Web-Based Platform for Home Care Providers in the Pandemic Context. [2021]
Cost-effectiveness of home telemonitoring in chronic kidney disease patients at different stages by a pragmatic randomized controlled trial (eNephro): rationale and study design. [2022]
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