Wearable remote monitoring for pediatric heart failure patients
There's No Place Like Home…Feasibility of Remote Physiological Monitoring in Childhood Heart Failure
This study is testing a new wearable device that helps track the health of kids with heart failure to see if it can improve their care at home and reduce hospital visits.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 8 Years to 18 Years |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (Edmonton, Alberta and 3 other locations) |
| Trial ID | NCT06969560 on ClinicalTrials.gov |
What this trial studies
This study focuses on the use of wearable remote physiologic monitoring (RPM) technology to track the health of pediatric patients with heart failure or those at risk of developing it. By enrolling 100 outpatients aged 8-18 from four tertiary pediatric heart failure centers in Canada, the study aims to utilize a Bluetooth-enabled textile device to monitor vital signs such as heart rate, respiratory rate, and blood pressure. The goal is to improve home-based care and reduce reliance on hospital visits, particularly for vulnerable populations. The study will also explore the integration of machine learning algorithms to predict health deterioration based on collected data.
Who should consider this trial
Good fit: Ideal candidates are pediatric outpatients aged 8-18 with or at risk of deteriorating heart failure.
Not a fit: Patients who are not outpatients or do not meet the specified age and health criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide safer, more equitable home-based care for children with heart failure.
How similar studies have performed: While RPM has been successful in adult populations, this approach is novel and untested in pediatric heart failure care.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Edmonton, Alberta and 3 other locations
- Stollery Children's Hospital — Edmonton, Alberta, Canada (Recruiting)
- BC Children's Hospital — Vancouver, British Columbia, Canada (Not_yet_recruiting)
- The Hospital for Sick Children — Toronto, Ontario, Canada (Not_yet_recruiting)
- CHU Sainte-Justine — Montreal, Quebec, Canada (Not_yet_recruiting)
Study contacts
- Principal investigator: Jennifer L Conway, MD, MSc — University of Alberta/Stollery Children's Hospital
- Study coordinator: Jennifer L Conway, MD, MSc
- Email: jennifer.conway2@ahs.ca
- Phone: 780-407-4848
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.