RecruitingNCT06969560

WeRoaM: Wearable Remote Monitoring in Heart Failure

There's No Place Like Home…Feasibility of Remote Physiological Monitoring in Childhood Heart Failure


Sponsor

University of Alberta

Enrollment

100 participants

Start Date

Feb 24, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

Remote physiologic monitoring (RPM) of heart failure (HF) patients with a virtual platform is well established in adult care. However, this technology remains untested in pediatrics and care continues to rely on a hospital-based model which presents challenges in providing equitable access to care for those with lower socio-economic status or living remotely. Telemonitoring technology tailored for children with machine-based algorithms to predict deterioration is needed to facilitate the equitable provision of safe, home-based care, especially in vulnerable populations. This study will enroll 100 pediatric outpatients with or at risk of deteriorating HF from 4 tertiary pediatric heart failure care centres in Canada. We will use a wearable Bluetooth enabled textile (Skiin device), developed by Myant Inc (Toronto, ON), that can monitor heart rate, heart rhythm, respiratory rate and activity, together with additional home-based monitoring of blood pressure (BP), oxygen saturations and weight. The smart textile will be paired to an RPM platform, SphygmoTM (mmHG Inc). The goal of this project is to assess the feasibility and acceptability of RPM in pediatrics and validate a RPM-based risk prediction model for pediatric HF patients.


Eligibility

Min Age: 8 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a small wearable patch that monitors heart function remotely in children and teens at risk for heart failure, to see whether continuous home monitoring can help doctors catch problems earlier and manage care more proactively. **You may be eligible if...** - You are between 8 and 18 years old - You are being managed as an outpatient (not currently hospitalized) - Your chest circumference is at least 69.85 cm (the minimum size for the device to fit) - You have been identified as being at risk for heart failure (American Heart Association Stage B, C, or D) **You may NOT be eligible if...** - You are under 8 or over 18 years old - You are currently hospitalized - Your chest size is too small for the device - You or your guardian decline to participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICERemote Physiologic Monitoring (RPM)

The intervention consists of a remote physiologic monitoring (RPM) program which makes use of a wearable Skiin chest band and ECG device, a blood pressure monitor, a pulse oximeter, and a weight scale; the RPM program will occur for 12 weeks Participants will wear the Skiin device continuously for the first 48-hours and then for a 12-hour span each day following that. Participants will measure their blood pressure, oxygen saturation, and weight once a day for the full 12 weeks.


Locations(4)

Stollery Children's Hospital

Edmonton, Alberta, Canada

BC Children's Hospital

Vancouver, British Columbia, Canada

The Hospital for Sick Children

Toronto, Ontario, Canada

CHU Sainte-Justine

Montreal, Quebec, Canada

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NCT06969560


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