SickKids and UHN have developed MedlyPeds which is a smart phone application designed to remotely monitor patients with heart disease. This is a feasibility study which will enroll up to 30 patients with different types of heart disease to see which patient types may benefit the most from MedlyPeds if it were to be used for clinical monitoring. The study is gathering feedback about the app from patients, parents and clinicians to confirm how it needs to be modified to better serve the purpose in a future trial.
Consent provided.
Aged 8-18 years of age.
Ability to comply with using Medly (ex. able to stand on the weight scale, able to answer symptom questions, etc.)
Heart failure of any etiology
Unable to read or write in English.
Participating in another clinical trial that may confound the results.* *Participant may be re-screened for eligibility at a later date.
Single group
MedlyPeds App
DeviceThe mobile phone-based telemonitoring system (MedlyPeds) will enable cardiac patients to monitor their weight, blood pressure, and heart rate, using wireless home medical devices. In addition, they will answer questions about their symptoms and wellness using their mobile phone. The device measurements will be automatically and wirelessly transmitted to the mobile phone and then to a data server. Automated and individualized self-care messages, developed with the assistance of healthcare providers, will subsequently be sent to the patient based on the readings and reported symptoms.
Percentage of MedlyPeds App Daily Check-In Completion
The primary outcome for this study is overall app engagement measured by completion of symptom check-ins and entry of clinical information (i.e physiologic parameters) by the subject into the app. The feasibility and acceptability of MedlyPeds will be assessed from feedback from patients, parents and clinicians through the end of study questionnaire and interviews.
Feasibility and acceptability of Medly Peds
The feasibility and acceptability of MedlyPeds will be assessed from feedback from patients, parents and clinicians through the scoring of usefullness and relevance on the end of study questionnaire.
Attrition rate
Change in participants completing MedlyPeds check-ins at baseline compared to the final check-in at Month 3 timepoint
Medication compliance
Change in estimated number of missed doses of medication from baseline to final check-in
Global impression of change
Change in Patients' Global Impression of Change Scale (PGIC) from 1-7. Higher values at post-intervention represent a better outcome.
Quality of life related to heart disease
Change in Cardiac PedsQL (Pediatric Quality of Life Inventory) Uses a 5-point Likert scale (0=never, 4=almost always) with 27 questions.
Click on the lead sponsor to view all of their trials.
The Hospital for Sick Children
Lead sponsor
University Health Network, Toronto
Collaborator
