MedlyPeds Feasibility Study

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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

Первичные конечные точки

• Percentage of MedlyPeds App Daily Check-In Completion [Срок оценки: 3 months]
• Feasibility and acceptability of Medly Peds [Срок оценки: 3 months]

Вторичные конечные точки (5)

• Attrition rate [Срок оценки: 3 Months]
• Medication compliance [Срок оценки: 3 Months]
• Global impression of change [Срок оценки: 3 Months]
• Quality of life related to heart disease [Срок оценки: 3 Months]
• Self-management [Срок оценки: 3 Months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Канада · 1 центр

• The Hospital for Sick Children — Toronto

Идентификаторы

NCT: NCT07556185 · CTO 5454

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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