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| Name | Class |
|---|---|
| University Health Network, Toronto | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MedlyPeds | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Attrition rate | Change in participants completing MedlyPeds check-ins at baseline compared to the final check-in at Month 3 timepoint | 3 Months |
| Medication compliance | Change in estimated number of missed doses of medication from baseline to final check-in |
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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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diana Balmer-Minnes | Contact | 416-813-7654 | 228624 | diana.balmer-minnes@sickkids.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Recruiting | Toronto | Ontario | M5G1X8 | Canada |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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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.
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| 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. | 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. | 3 Months |
| Self-management | Change in Adolescent/Young Adult Self-Management and Independence (AMIS II) Scale | 3 Months |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |