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A Pragmatic Randomized Controlled Trial of a CKD Specific Telemonitoring Platform to Minimize Adverse Outcomes in High Risk CKD Patients

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• \>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

Locations
Other Locations
Canada
London Health Sciences Centre
RECRUITING
London
Scarborough Health Network - General Hospital
RECRUITING
Scarborough Village
Chronic Disease Innovation Centre, Seven Oaks Hospital
RECRUITING
Winnipeg
Health Sciences Centre
RECRUITING
Winnipeg
St. Boniface Hospital
RECRUITING
Winnipeg
Contact Information
Primary
Claudio Rigatto, MD
crigatto@sogh.mb.ca
204-631-3834
Backup
Zahra Solati, PhD
ZSOLATI@SOGH.MB.CA
204-632-3662
Time Frame
Start Date: 2022-06-30
Estimated Completion Date: 2028-03-30
Participants
Target number of participants: 340
Treatments
Experimental: 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.
No_intervention: 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).
Related Therapeutic Areas
Sponsors
Leads: University of Manitoba

This content was sourced from clinicaltrials.gov