MedlyPeds Feasibility Study: A Mobile, Smartdevice Based Telemonitoring for Pediatric Heart Disease, a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percentage of MedlyPeds App Daily Check-In Completion
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Percentage of MedlyPeds App Daily Check-In Completion
时间窗: 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
时间窗: 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.
次要结局
- Attrition rate(3 Months)
- Medication compliance(3 Months)
- Global impression of change(3 Months)
- Quality of life related to heart disease(3 Months)
- Self-management(3 Months)
研究者
Aamir Jeewa
Cardiologist
The Hospital for Sick Children