NCT05991167

EndeavorRx® Prospective Product Registry ("Expedition EndeavorRx")

EndeavorRx® Prospective Product Registry

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: Akili Interactive Labs, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: —

Summary

The EndeavorRx Prospective Product Registry aims to collect real world data from participants receiving the digital therapeutic, EndeavorRx, under conditions of routine clinical practice.

Detailed description

The objectives of this registry are to describe clinical and demographic characteristics, prescribing patterns, treatment patterns, and outcomes in participants treated with EndeavorRx in a real-world setting. Patients and their caregivers will be informed about the registry as part of a series of product welcome emails following product activation. Patients/caregivers enroll into the study by providing their electronic informed consent (eConsent) and assent (eAssent). All data are captured electronically and securely through a commercial data capture platform. Participants can also invite their child's teacher to submit surveys of their observations of the child's ADHD symptoms for the study. Study activities are emailed to caregivers at baseline, 1, 2, 3, and 6-months after enrollment. A valid and active EndeavorRx prescription is required to enroll. However, an active prescription throughout the entire 6 months of study participation is not required.

Conditions

• ADHD

Interventions

Type	Name	Description
DEVICE	EndeavorRx	EndeavorRx® is an FDA cleared digital therapeutic indicated to improve attention function as measured by computer-based testing in children ages 8-12 years old with primarily inattentive or combined-type attention-deficit/hyperactivity disorder (ADHD), who have a demonstrated attention issue. EndeavorRx is deployed on mobile devices and incorporates adaptive, simultaneous cognitive tasks in a consumer-grade action videogame-based platform with high-quality graphics and reward mechanisms.

Timeline

• Start date: 2022-06-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2023-08-14
• Last updated: 2024-06-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study