CHAMP App Cardiac Study: Evaluation of Software Functions for Asynchronous Monitoring of Children With Complex Congenital Heart Disease in the Home Setting and Data Repository
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 1,000
- 试验地点
- 18
- 主要终点
- Human factors/usability engineering: Login failures
研究概览
简要总结
This is a multi-site research study with an optional research repository that will consist of clinically derived data and photographic or video images of patients in the home setting with complex health conditions to evaluate the safety and efficacy of the CHAMP® software platform, with data and photographic or video images input and/or uploaded by the parent or other legally authorized representative (LAR) of patients with complex congenital heart disease as a target population.
详细描述
Study objectives
- To evaluate whether data collection and transmission through the CHAMP software platform improves communication between health care providers and parents/LAR that positively affects the care of children with complex congenital heart disease in which asynchronous monitoring in the home setting is indicated
- To determine the accuracy of data obtained regarding observation by parent or caregiver of the condition of children with complex congenital heart disease in which asynchronous monitoring in the home setting is indicated.
- To evaluate the use of the CHAMP App for clinical purposes, including user satisfaction with the data entry, parental self-management, and transmission capabilities.
- To evaluate the real-world performance analytics (RWPA) of the CHAMP software platform for transfer of parent-entered data for children with complex congenital heart disease in which asynchronous monitoring in the home setting is indicated.
Endpoints
- To demonstrate that parents and caregivers for children with complex congenital heart disease in which asynchronous monitoring in the home setting is indicated can accurately identify and transmit to healthcare providers specific health-related data including intake of food, fluids and mediations; output, including urination, defecation, and vomiting; weight; vital signs including oxygen saturation as measured by pulse oximetry; heart rate as measured either by a heart rate monitor or manually by the parent or caregiver; and temperature, measured by a reliable thermometer; and the value and reliability of videos provided by parents and caregivers regarding behavior of pediatric study participants for use in evaluating participant's health status.
- To demonstrate that data obtained through the use of devices such as pulse oximeters, as entered into the app by parents and caregivers, provide valuable information regarding the health status of children with Complex Diagnoses in a home setting.
- To demonstrate characteristics of CHAMP through real world health analytics (RWHA), user experience analytics (UX), and product performance analytics (PPA).
The study duration is open-ended for safety, effectiveness, and performance of the CHAMP app. Unless consent is withdrawn, data will be kept and used for data analysis and, if consented to the research repository for multi-site research purposes indefinitely. At age 18, previously pediatric patients may be approached for reconsent.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 0-17 years with a parent/Legally authorized representative
- •Diagnosed with a complex health condition in which asynchronous monitoring in the home setting is appropriate.
- •Pediatric patient's cardiac care team has decided that the patient's treatment plan may benefit from remote home monitoring.
- •Institution that the subject is followed through clinically has been an approved as site for the CHAMP app study with Children's Mercy Kansas City.
- •Adult participants
- •Parents/Legally authorized representatives of pediatric subject.
- •Healthcare team users at an institution that is an approved site for the CHAMP app Study with Children's Mercy Kansas City.
排除标准
- •Inability to be discharged to care in the home setting.
- •Those not meeting the above inclusion criteria.
结局指标
主要结局
Human factors/usability engineering: Login failures
时间窗: Over a 3 month period
Rate of attempts of log-in failures
Clinical Safety: Event resolution- unanticipated
时间窗: Time in days, reported over the last 3 months
Time to resolve unanticipated adverse events
Human factors/usability engineering: Imprecision
时间窗: Over a 3 month period
Rate of data values reported with imprecision
Clinical Safety: Anticipated adverse events
时间窗: Over a 3 month period
Anticipated Adverse event rates
Health Benefits: Adherence
时间窗: Measurement of adherence to daily data entry per each patient/parent over 3 month period on non-hospitalized days, during the study period
Rate of adherence to daily data entry
User Satisfaction: Complaints
时间窗: Over a 3 month period
Complaint rates via the healthcare team web portal
Clinical Safety: Event resolution- anticipated
时间窗: Time in days, reported over the last 3 months
Time to resolve anticipated adverse events
Clinical Safety: Unanticipated Adverse events
时间窗: Time in days, reported over the last 3 months
Unanticipated adverse event rates
User Satisfaction CHAMP Video
时间窗: through study completion, an average of 9 months
Feedback from healthcare team will be received via treatment endpoint survey questions. Likert scale questions 1-strongly disagree to 5 strongly agree (Using CHAMP videos for the interstage monitoring of this patient improved clinical decisions for the home monitoring team). Available to put in comments.
CHAMP app performance: Cybersecurity
时间窗: Over a 3 month period
Product Performance Analytics measured through Any reported breaches
User Satisfaction: Communication
时间窗: through study completion, an average of 9 months
Feedback from healthcare team will be received via treatment endpoint survey questions Likert scale questions 1-strongly disagree to 5 strongly agree ( Using CHAMP for the interstage monitoring of this patient improved communication with the parents at home.) Available to put in comments.
User Engagement
时间窗: Over a 3 month perriod
Total number of registered users (Active, treatment endpoint reached) and data totals per parent entered measure. De-identified Demographics and age areas utilization -Utilization across the number of pediatric sites, healthcare teams
CHAMP app performance: Downtime
时间窗: Over a 3 month period
Product Performance Analytics measured through Any system downtime
CHAMP app performance
时间窗: Quarterly review of CHAMP App Performance will be measure over the preceding 3 months for frequency of changes required
Product Performance Analytics measured through --Bug/defect rate or Version failure rates
次要结局
未报告次要终点
研究者
Lori Erickson
Director, Remote Health Solutions
Children's Mercy Hospital Kansas City