Recruiting

MedlyPeds

Sponsor:

The Hospital for Sick Children

Code:

NCT07556185

Conditions

Pediatric Heart Failure

Congenital Heart Disease (CHD)

Acquired Heart Disease

Pulmonary Hypertension

Post Cardiac Surgery

Eligibility Criteria

Sex: All

Age: 8 - 18

Healthy Volunteers: Not accepted

Interventions

MedlyPeds App

Study Details

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

Pediatric Heart Failure

Congenital Heart Disease (CHD)

Acquired Heart Disease

Pulmonary Hypertension

Post Cardiac Surgery

Study ID

NCT07556185

Start date

Jul, 2026

Status verified date

Jun, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Consent provided.
2. Aged 8-18 years of age.
3. Ability to comply with using Medly (ex. able to stand on the weight scale, able to answer symptom questions, etc.)
4. Followed at the Hospital for Sick Children Cardiology Clinic for any of the following reasons:

1. Heart failure of any etiology
2. Congenital heart disease
3. Acquired heart disease (eg. Kawasaki disease, rheumatic heart disease, connective tissue disorders etc)
4. Pulmonary hypertension
5. Post-cardiac surgery including heart transplant and ventricular assist devices

Exclusion Criteria:

1. Unable to read or write in English.
2. Participating in another clinical trial that may confound the results.\* \*Participant may be re-screened for eligibility at a later date.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: MedlyPeds

Interventions

MedlyPeds App

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.

Primary outcome measure

  • Percentage of MedlyPeds App Daily Check-In Completion [ Time Frame: 3 months ]
  • Feasibility and acceptability of Medly Peds [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Diana Balmer-Minnes

416-813-7654diana.balmer-minnes@sickkids.ca

Locations

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G1X8

Contacts

Diana Balmer-Minnes

4169316961diana.balmer-minnes@sickkids.ca

More Information

Sponsor

The Hospital for Sick Children

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Keywords

  • Medly
  • Telemonitoring

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by The Hospital for Sick Children on 2026-06-26. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.