WeRoaM: Wearable Remote Monitoring in Heart Failure

NCT06969560 | Recruiting

• 1 other identifier: Pro00126084
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 4

Brief 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

Heart Failure

Keywords

remote physiologic monitoring; heart failure; at-risk; telemonitoring technology; pediatric

Outcome Measures

Primary Outcomes (4)

• Feasibility of Remote Physiologic Monitoring (RPM) Program- Recruitment

  Feasibility will be assessed by recruitment rates (the number of participants recruited

  2 years

• Feasibility of Remote Physiologic Monitoring (RPM) Program- Retention

  Feasibility will be assessed by retention rate (the number of participants who complete measures at baseline and at follow up post intervention)

  2 years

• Feasibility of Remote Physiologic Monitoring (RPM) Program- Access

  Feasibility will be assessed by the percentage of people with access to Wi-Fi and smart device

  2 years

• Acceptability of Remote Physiologic Monitoring (RPM) Program

  Acceptability will be assessed by compliance defined as \>80% of the physiologic monitoring requested has been captured twice daily for a period of 12 weeks; completion of the Medtech 20 questionnaire will also inform on acceptability.

  2 years

Secondary Outcomes (1)

• Composite End-Point Assessing Remote Physiologic Monitoring (RPM) Program

  2 years

Study Arms (1)

paediatric outpatients (8 to 18 years old) with diagnosis of cardiomyopathy

This study will enroll 100 paediatric outpatients (8 to 18 years old) with diagnosis of cardiomyopathy (with systolic or diastolic dysfunction), subjects with congenital heart disease with biventricular or univentricular physiology plus systemic ventricular dysfunction from 4 tertiary heart failure care centres. Patients will participate in a remote physiologic monitoring program using bluetooth enabled devices for 12 weeks. Devices as part of the study intervention include: Skiin chest band and ECG device; blood pressure monitor; pulse oximeter; weight scale.

Device: Remote Physiologic Monitoring (RPM)

Interventions

Remote Physiologic Monitoring (RPM) DEVICE

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.

paediatric outpatients (8 to 18 years old) with diagnosis of cardiomyopathy

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This study will enroll 100 paediatric outpatients (8 to 18 years old) with diagnosis of cardiomyopathy (with systolic or diastolic dysfunction), subjects with congenital heart disease with biventricular or univentricular physiology plus systemic ventricular dysfunction from 4 tertiary heart failure care centres.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (4)

Stollery Children's Hospital

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

BC Children's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

NOT YET RECRUITING

The Hospital for Sick Children

Toronto, Ontario, M5G 1E8, Canada

NOT YET RECRUITING

CHU Sainte-Justine

Montreal, Quebec, QC H3T, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Jennifer L Conway, MD, MSc

  University of Alberta/Stollery Children's Hospital

  PRINCIPAL INVESTIGATOR

• Aamir Jeewa, MD

  University of Toronto; The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer L Conway, MD, MSc

CONTACT

780-407-4848; jennifer.conway2@ahs.ca

Tara L Pidborochynski, MSc

CONTACT

780-407-1899; tara.pidborochynski@ahs.ca

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 14, 2025
• Study Start: February 24, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)