MedlyPeds Feasibility Study

NCT07556185 | Not Yet Recruiting

• 1 other identifier: CTO 5454
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Congenital Heart Disease (CHD); Acquired Heart Disease; Pulmonary Hypertension; Post Cardiac Surgery; Pediatric Heart Failure

Keywords

Medly; Telemonitoring

Outcome Measures

Primary Outcomes (2)

• 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.

  3 months

• 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.

  3 months

Secondary Outcomes (5)

• Attrition rate

  3 Months

• Medication compliance

  3 Months

• Global impression of change

  3 Months

• Quality of life related to heart disease

  3 Months

• Self-management

  3 Months

Study Arms (1)

MedlyPeds

EXPERIMENTAL

Device: MedlyPeds App

Interventions

MedlyPeds App DEVICE

The 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.

MedlyPeds

Eligibility Criteria

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

You may qualify if:

• 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.)
• Followed at the Hospital for Sick Children Cardiology Clinic for any of the following reasons:
• Heart failure of any etiology
• Congenital heart disease
• Acquired heart disease (eg. Kawasaki disease, rheumatic heart disease, connective tissue disorders etc)
• Pulmonary hypertension
• Post-cardiac surgery including heart transplant and ventricular assist devices

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• University Health Network, Toronto: collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

MeSH Terms

Conditions

Heart Defects, Congenital; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases

Central Study Contacts

Diana Balmer-Minnes

CONTACT

416-813-7654; dianabalmer@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist

Model Details: The study will enroll up to 30 participants and their parents in total ensure that at least 15 participants complete the full 3-month duration of interaction with the MedlyPeds app.

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 29, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)