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

Sponsor
University of Manitoba
Study ID
NCT05726526
Status
Recruiting
Apply to this trial

Conditions

  • Chronic Kidney Disease Stage 5
  • End Stage Renal Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VIEWER virtual care platform — 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.

Study Details

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.

Key Dates

First listed
Feb 14, 2023
Start date
Jun 30, 2022
Status verified
Jul 2025
Primary completion
Mar 30, 2027
Completion
Mar 30, 2028

Study Design

Enrollment
340 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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).

Primary Outcome Measure

Composite of first hospitalization or emergency department (ED) visit [ Time Frame: 12 months or until dialysis initiation ]

Central Contacts

Related Studies