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Telemonitoring Platform for Chronic Kidney Disease (VIEWER Trial)

Q: Are there any unfilled vacancies for this trial's participants?

<p>Affirmative, clinicaltrials.gov indicates that this trial is currently seeking subjects to enroll in the study. The listing was initially uploaded on June 30th 2022 and recently updated February 2nd 2023. 340 patients will be recruited from a single site for participation.</p>

Q: How many individuals can take part in the experiment?

<p>Affirmative. An examination of information on clinicaltrials.gov reveals that, as of June 30th 2022 and last updated February 2nd 2023, this trial is actively recruiting patients from one facility with a total number of 340 participants sought.</p>

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

Awards & highlights

VIEWER Trial 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.Check my eligibility

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.See study design

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.

VIEWER Trial 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.

VIEWER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3,6,9 and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3,6,9 and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3,6,9 and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Composite of first hospitalization or emergency department (ED) visit

Secondary outcome measures

All-cause mortality

Frequency of Emergency Department Visit

Frequency of formal clinic visits

+7 more

VIEWER 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 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, 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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ManitobaLead Sponsor

595 Previous Clinical Trials

199,141 Total Patients Enrolled

2 Trials studying Kidney Failure

70 Patients Enrolled for Kidney Failure

Claudio Rigatto, MDPrincipal InvestigatorUniversity of Manitoba

Media Library

Intervention Group Clinical Trial Eligibility Overview. Trial Name: NCT05726526 — N/A

Kidney Failure Research Study Groups: Intervention Group, Control Group

Kidney Failure Clinical Trial 2023: Intervention Group Highlights & Side Effects. Trial Name: NCT05726526 — N/A

Intervention Group 2023 Treatment Timeline for Medical Study. Trial Name: NCT05726526 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any unfilled vacancies for this trial's participants?

"Affirmative, clinicaltrials.gov indicates that this trial is currently seeking subjects to enroll in the study. The listing was initially uploaded on June 30th 2022 and recently updated February 2nd 2023. 340 patients will be recruited from a single site for participation."

Answered by AI

How many individuals can take part in the experiment?

"Affirmative. An examination of information on clinicaltrials.gov reveals that, as of June 30th 2022 and last updated February 2nd 2023, this trial is actively recruiting patients from one facility with a total number of 340 participants sought."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Claudio Rigatto 2022. "CKD Specific Telemonitoring Platform to Minimize Adverse Outcomes in High Risk CKD Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05726526.

All > Chronic Kidney Disease