Pediatric Heart FailureNCT07556185
MedlyPeds Feasibility Study
A study testing MedlyPeds App in people with Pediatric Heart Failure and Congenital Heart Disease (CHD), run by The Hospital for Sick Children at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Pediatric Heart Failure, Congenital Heart Disease (CHD), Acquired Heart Disease
- What is being tested?
- MedlyPeds App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2026to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
The Hospital for Sick Children
Toronto, Ontario, M5G1X8
Diana Balmer-Minnes, 4169316961, diana.balmer-minnes@sickkids.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Pediatric Heart Failure, Congenital Heart Disease (CHD), Acquired Heart Disease, Pulmonary Hypertension, Post Cardiac Surgery
- Being tested
- MedlyPeds App
- Keywords
- Medly, Telemonitoring
- Medical subject headings
- Heart Defects, Congenital, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MedlyPeds AppDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| MedlyPeds | Experimental | Not described Receives: Device: MedlyPeds App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 months
Secondary outcomes (5)
Attrition rate
Change in participants completing MedlyPeds check-ins at baseline compared to the final check-in at Month 3 timepoint
Measured: 3 Months
Medication compliance
Change in estimated number of missed doses of medication from baseline to final check-in
Measured: 3 Months
Global impression of change
Change in Patients' Global Impression of Change Scale (PGIC) from 1-7. Higher values at post-intervention represent a better outcome.
Measured: 3 Months
Quality of life related to heart disease
Change in Cardiac PedsQL (Pediatric Quality of Life Inventory) Uses a 5-point Likert scale (0=never, 4=almost always) with 27 questions.
Measured: 3 Months
Self-management
Change in Adolescent/Young Adult Self-Management and Independence (AMIS II) Scale
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study startJul 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto
- Responsible party
- Principal investigator, Aamir Jeewa, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556185
- Sponsor's protocol ID
- CTO 5454
- Status last verified
- Jun 2026
- First submitted
- 2 Apr 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MedlyPeds Feasibility Study: A Mobile, Smartdevice Based Telemonitoring for Pediatric Heart Disease, a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07556185
- Acronym / sponsor ID
- CTO 5454
- Conditions
- Pediatric Heart Failure, Congenital Heart Disease (CHD), Acquired Heart Disease, Pulmonary Hypertension, Post Cardiac Surgery
- Keywords
- Medly, Telemonitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- University Health Network, Toronto
- Study start
- Jul 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| MedlyPeds | Experimental | Device: MedlyPeds App |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MedlyPeds AppThe 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. | Device | MedlyPeds |
Primary outcome
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.
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MedlyPeds App in people with Pediatric Heart Failure and Congenital Heart Disease (CHD), run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diana Balmer-Minnes (416-813-7654 ext. 228624, diana.balmer-minnes@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of MedlyPeds App Daily Check-In Completion (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.