OBJECTIVE: To describe real-world learnings from the launch of direct-to-consumer digital therapeutic in response to the FDA policy for digital health devices during COVID-19 prior to product’s FDA-cleared status.

METHODS: From April to August 2020, Endeavor^® 3-month access was provided to children who were 8-12 years old; with a parent-reported ADHD-diagnosis; in the US with access to an iPad^®/iPhone^® device. Parents agreed to contact their child’s health care provider before using Endeavor. Recommended product use was 5 days/week, ~25 minutes (5 missions) a day, for at least 4 weeks. Surveys were sent online at treatment start (Day 1) and after 1 month (Day 30). Surveys included: Child cognitive functioning: Patient Reported Outcomes Measurement Information System (PROMIS) parent-proxy 8 selected items. Surveys for ADHD-related impairment: Impairment Rating Scale (IRS) parent-report.

RESULTS: During this direct-to-consumer launch, Endeavor was activated 446 times, 419 children started the treatment and 357 children played at least one full Endeavor mission. Parents saw significant improvement in 6 of the 8 selected PROMIS cognitive functioning items. There was also improvement seen in the ADHD-related overall impairment severity.

CONCLUSIONS: This demonstration confirmed that Endeavor access under FDA emergency guidance via direct-to consumers was feasible, with approximately 20% of patients requesting reactivation. Compliance rates varied from those reported in the structured setting of previous clinical trials. Caregivers observed improvement in their child’s cognitive functioning and impairment severity. Future studies should provide real-world insights on compliance and efficacy as a prescription product.