EndeavorRx® Prospective Product Registry ("Expedition EndeavorRx")

Akili Interactive Labs

Status: Active, not recruiting

Conditions: ADHD

Treatments: Device: EndeavorRx

Study type: Observational

Funder types: Industry

Identifiers

NCT05991167

Akili-060

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Are prescribed EndeavorRx by their healthcare provider as part of routine clinical practice
• Provide informed consent/assent to participate in the registry

Exclusion criteria

• N/A

Trial design

150 participants in 1 patient group

EndeavorRx Users

Description:

All participants with an active EndeavorRx prescription. Treatment regimen is as directed by their prescribing healthcare provider.

Treatment:

Device: EndeavorRx