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Recruiting NCT07556185

MedlyPeds Feasibility Study

No phase Interventional Pediatric Heart Failure Congenital Heart Disease (CHD) Acquired Heart Disease Pulmonary Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MedlyPeds App.
Who it may be relevant to
Registry conditions: Pediatric Heart Failure, Congenital Heart Disease (CHD), Acquired Heart Disease, Pulmonary Hypertension. Basic parameters: 8 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

  • 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 provide

Primary outcome measures

  • Percentage of MedlyPeds App Daily Check-In Completion [Time frame: 3 months]
  • Feasibility and acceptability of Medly Peds [Time frame: 3 months]
Secondary outcome measures (5)
  • Attrition rate [Time frame: 3 Months]
  • Medication compliance [Time frame: 3 Months]
  • Global impression of change [Time frame: 3 Months]
  • Quality of life related to heart disease [Time frame: 3 Months]
  • Self-management [Time frame: 3 Months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Canada · 1 center
  • The Hospital for Sick Children — Toronto

Identifiers

NCT: NCT07556185 · CTO 5454

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗