MedlyPeds Feasibility Study

April 21, 2026 updated by: Aamir Jeewa, The Hospital for Sick Children

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G1X8
        • The Hospital for Sick Children
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MedlyPeds
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 Months
Medication compliance
Time Frame: 3 Months
Change in estimated number of missed doses of medication from baseline to final check-in
3 Months
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.
3 Months
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.
3 Months
Self-management
Time Frame: 3 Months
Change in Adolescent/Young Adult Self-Management and Independence (AMIS II) Scale
3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Collaborators

University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

April 2, 2026

First Submitted That Met QC Criteria

April 21, 2026

First Posted (Actual)

April 29, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTO 5454

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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