Real-world Epilepsy Study Completes Data Capture 12 Months Ahead of Schedule

Situation

A fast-growing biotech needed to gain a better understanding of the prevalence, severity, and impact of seizures on children with Dravet Syndrome, a rare form of epilepsy. Capturing frequent, event-driven eDiaries from multiple caregivers was essential to build a natural history understanding of the disease. To support data integrity, the study needed to ensure that data could be attributed to specific caregivers.

Risk

All seizures had to be captured and documented to support accurate study conclusions. Researchers needed to attribute data to the specific caregiver who entered it and avoid the potential of duplicate questionnaire completion by multiple caregivers.

Diagnosis

uMotif identified the need for seizure diaries supported by conditional questionnaires, alongside a simple way for multiple caregivers to identify themselves quickly so that all data remained attributable to the person entering it. Schedules had to align to the patient rather than the caregiver, ensuring that scheduled one-off questionnaires could only be completed once per patient.

Actions

uMotif designed a unique new eCOA Caregiver Module to support the setup and identification of caregivers, aligned around the patient’s schedule. uMotif also designed a simple, low-burden experience for capturing seizure diaries.

Result

The 58 families taking part captured far more data than expected. The study achieved its required volume of data 12 months earlier than expected and participants captured almost 90% of the core study ePRO data, alongside 19,000 seizure diary days. Early completion saved the sponsor significant time and cost through strong compliance and the capture of higher quality, more complete data.

Lessons Learned

Seizure diaries can be complex and high-burden. They must be designed to capture the required data but delivered in a low-burden way that a family member can follow and manage. Bring-your-own-device (BYOD)-based solutions can support multiple caregivers, aligned around a patient’s schedule.

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