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RECRUITING
NCT06969560

WeRoaM: Wearable Remote Monitoring in Heart Failure

Sponsor: University of Alberta

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

8 Years - 18 Years

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2025-02-24

Completion Date

2028-12-31

Last Updated

2025-05-14

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Remote 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