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Telemonitoring Platform for Chronic Kidney Disease (VIEWER Trial)

N/A

Recruiting

Led By Claudio Rigatto, MD

Research Sponsored by University of Manitoba

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have stage 5 CKD (2 measurements of eGFR <15ml/min/1.73m2); eGFR will be calculated with the CKD-EPI equation.

Patient or patients substitute decision maker is able to provide informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3,6,9 and 12 months (or every 3 months until dialysis initiation)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if using a virtual care platform can reduce hospital visits and make virtual care safer for patients and providers.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves a telemonitoring platform rather than medication, traditional side effects aren't expected. However, participants may experience issues related to using technology such as stress or frustration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I am older than 18 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3,6,9 and 12 months (or every 3 months until dialysis initiation)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3,6,9 and 12 months (or every 3 months until dialysis initiation)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3,6,9 and 12 months (or every 3 months until dialysis initiation) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Composite of first hospitalization or emergency department (ED) visit

Secondary study objectives

All-cause mortality

Frequency of Emergency Department Visit

Frequency of formal clinic visits

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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).

0 / 3Eligibility criteria met