Children’s Mercy CHAMP App vs PREP Self

CAUTION –CHAMP® App is an investigational device. Limited by Federal law to investigational use only. The CHAMP® App is an investigational (research) software application that was developed by Children’s Mercy Kansas City. The CHAMP App can only be used after signing an informed consent and HIPAA Research Authorization. The CHAMP® App is a tool parents and legally authorized representatives (LAR) of children with complex diseases can use to assist with communicating health information about the child to the health care team. The CHAMP® App sends the information you collect to your child’s health care team. CHAMP® sends you a notification reminder whenever a recorded measurement still needs to be shared with your child's health care team. The CHAMP® App research studies (each called a “Research Study”) will evaluate whether communication between parents and the health care team is improved by the use of the CHAMP® App. The information sent to the health care team may vary, depending on the Research Study. The CHAMP® App is not intended to be used in an emergency. If you are worried that your child could be experiencing severe or life-threatening condition, call 911 immediately. The CHAMP® App is not a real-time communication system and is not intended to be an active patient monitoring device. Your child’s health care team may not see information from the CHAMP® App right away. The CHAMP® App is not intended to diagnose, cure, treat, mitigate or prevent disease or health conditions. The app is not intended to diagnose, cure, treat, mitigate or prevent disease or health conditions. The app is a tool caregivers can use at home to assist with disease management of inter-stage babies. Your child must be actively enrolled in a CHAMP Research Study at Children’s Mercy Kansas City or another participating health care provider in order to use the CHAMP® App. More details about the CHAMP App and each Research Study are available through the informed consent process. The CHAMP App is available in eleven languages, including: English, Spanish, French, German, Arabic, Filipino, Korean, Chinese, Burmese, Somali, and Vietnamese.

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