A pharmaceutical manufacturer wanted to use an existing connected system mobile app with a pediatric population.
The FDA requested verification that the app would work with this new pediatric patient population.
The initial study was to identify major showstoppers (if any) and if using the existing mobile app was possible with these patients.
For this exploratory research, we simulated at-home environments in a lab setting, including a mock living room, bedroom, and bathroom. Set up in the same test space, we used room dividers, furniture, sink, and mirrors to make it feel as realistic as possible. The goal was to encourage the pediatric patient and caregiver to do what they do at home with the medical system and accompanying mobile app. They simulated the entire process to interact with the app and medication system. Test preparations unique to this study included informal interviews with child specialists familiar with this population to ensure the lab setup would make the participants feel comfortable; modifications included stress relief balls, sensory bin, and wall signs. This specialized population also required we have an on-site clinician throughout the test sessions.
Our preliminary research revealed that working with pediatrics with this diagnosis required a heightened level of moderator sensitivity as the patient may not be aware of their diagnosis. This required modifications to the test protocol. Working with clinical sites prior to testing was crucial to uncovering this foundational knowledge.
We learned our simulated in-home setup supported data collection; patients and caregivers adapted well to the simulated environments. We also learned to include a kitchen in future studies as there was a tendency for patients and/or caregivers to utilize these areas when prepping the medication. We provided recommendations based on the study data.