Acquired Heart Disease, Congenital Heart Disease (CHD), Pediatric Heart Failure, Post Cardiac Surgery, Pulmonary Hypertension
Conditions
Keywords
Medly, Telemonitoring
Brief 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 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
DEVICEMedlyPeds 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.
Sponsors
The Hospital for Sick Children
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of MedlyPeds App Daily Check-In Completion | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Attrition rate | 3 Months | Change in participants completing MedlyPeds check-ins at baseline compared to the final check-in at Month 3 timepoint |
| Medication compliance | 3 Months | Change in estimated number of missed doses of medication from baseline to final check-in |
| Global impression of change | 3 Months | Change in Patients' Global Impression of Change Scale (PGIC) from 1-7. Higher values at post-intervention represent a better outcome. |
| Quality of life related to heart disease | 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. |
| Self-management | 3 Months | Change in Adolescent/Young Adult Self-Management and Independence (AMIS II) Scale |
Countries
Canada
Contacts
CONTACTDiana Balmer-Minnes
Outcome results
None listed