Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 12:56 AM
Study NCT ID:
NCT05991167
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2023-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EndeavorRx® Prospective Product Registry ("Expedition EndeavorRx")
Sponsor:
Akili Interactive Labs, Inc.
Organization:
Study Overview
Official Title:
EndeavorRx® Prospective Product Registry
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: