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NCT Number: NCT07556185

MedlyPeds Feasibility Study

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.

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Key information

Conditions

Pediatric Heart Failure Acquired Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital Heart Disease (CHD) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Hypertension Hypertension, Pulmonary Lung Diseases Post Cardiac Surgery Pulmonary Hypertension Respiratory Tract Diseases Vascular Diseases

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location status: Recruiting

Location contact

Diana Balmer-Minnes

CONTACT

[email protected]

4169316961

About this study

This is a prospective cohort study that will enroll up to 30 patients with various types of heart disease and up to 10 clinicians in the MedlyPeds program and follow the participants for 3 months. Quality of life questionnaires will be completed at baseline and 3 months or end of study. Patient participants will complete a questionnaire about MedlyPeds and their experience using the app at 3 month or end of study. A subset of patient participants and clinicians will be asked to complete an interview at the end of the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Percentage of MedlyPeds App Daily Check-In Completion

    Time frame: 3 months

    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.

  2. Feasibility and acceptability of Medly Peds

    Time frame: 3 months

    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.

Secondary outcomes

  1. Attrition rate

    Time frame: 3 Months

    Change in participants completing MedlyPeds check-ins at baseline compared to the final check-in at Month 3 timepoint

  2. Medication compliance

    Time frame: 3 Months

    Change in estimated number of missed doses of medication from baseline to final check-in

  3. Global impression of change

    Time frame: 3 Months

    Change in Patients' Global Impression of Change Scale (PGIC) from 1-7. Higher values at post-intervention represent a better outcome.

  4. Quality of life related to heart disease

    Time frame: 3 Months

    Change in Cardiac PedsQL (Pediatric Quality of Life Inventory) Uses a 5-point Likert scale (0=never, 4=almost always) with 27 questions.

  5. Self-management

    Time frame: 3 Months

    Change in Adolescent/Young Adult Self-Management and Independence (AMIS II) Scale

Study contacts

Contact information is provided by the study sponsor or research team.

Diana Balmer-Minnes

CONTACT

[email protected]

416-813-7654 ext. 228624

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • University Health Network, Toronto

Registry information

Official study title

MedlyPeds Feasibility Study: A Mobile, Smartdevice Based Telemonitoring for Pediatric Heart Disease, a Prospective Cohort Study

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Apr 29, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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