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

Heart Failure

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

Inclusion Criteria4

Patients from 8-18 years of age who are outpatients at time of study enrollment.
Patients with a chest size of at least 69.85 cm in perimeter/circumference (as measured under the pectoral muscles)
Patients at-risk for heart failure and with American Heart Association (AHA) Stage B-D Heart Failure will be included in this study irrespective of heart failure medication use.
HF etiologies include: congenital cardiac malformation with systemic ventricular systolic dysfunction, idiopathic cardiomyopathy, familial/inherited and/or genetic cardiomyopathy, history of myocarditis with persistent ventricular dysfunction, neuromuscular disorder, inborn error of metabolism, mitochondrial disorder, acquired (chemotherapy, iatrogenic, infection, rheumatic, or nutritional), ischemic (e.g., Kawasaki disease and post-operative HF), and left ventricular non-compaction, restrictive cardiomyopathy and HCM with systolic or diastolic dysfunction.

Exclusion Criteria6

Patients within 3 months of a surgery.
Patients supported by ventricular assist device at study onset.
Inability to use technology due to physical or cognitive impairment in the patient or caregiver.
Non-English speaking.
Patients who have an implantable cardiac defibrillator or pacemaker
Patients whose chest size is too large or small to fit available sizes of the Skiin device.

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.