Recruiting

Wearable Monitoring

Sponsor:

University of Alberta

Code:

NCT06969560

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 8 - 18

Healthy Volunteers: Not accepted

Interventions

Remote Physiologic Monitoring (RPM)

Study Details

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

Study ID

NCT06969560

Start date

Feb 24, 2025

Status verified date

May, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Feasibility of Remote Physiologic Monitoring (RPM) Program- Recruitment [ Time Frame: 2 years ]
  • Feasibility of Remote Physiologic Monitoring (RPM) Program- Retention [ Time Frame: 2 years ]
  • Feasibility of Remote Physiologic Monitoring (RPM) Program- Access [ Time Frame: 2 years ]
  • Acceptability of Remote Physiologic Monitoring (RPM) Program [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Jennifer L Conway, MD, MSc

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

Tara L Pidborochynski, MSc

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

Locations

Stollery Children's Hospital

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

Contacts

Jennifer L Conway, MD, MSc

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

Tara L Pidborochynski, MSc

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

Principal Investigator:

Jennifer L Conway, MD, MSc

More Information

Sponsor

University of Alberta

Last update posted

May 11, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-05-11.