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WeRoaM: Wearable Remote Monitoring in Heart Failure

NCT06969560 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-05-11

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • University of Alberta

    lead OTHER

Principal Investigators

  • Jennifer L Conway, MD, MSc · University of Alberta/Stollery Children's Hospital

  • Aamir Jeewa, MD · University of Toronto; The Hospital for Sick Children

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-24
Primary Completion
2026-12-31
Completion
2028-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06969560 on ClinicalTrials.gov