Clinical trial NCT06109051: EndeavorOTC™ Prospective Product Registry
Official title: EndeavorOTC™ Prospective Product Registry
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: ADHD
Lead sponsor: Akili Interactive Labs, Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-31
Enrollment: 198
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: EndeavorOTC users may enroll and participate in the product registry for the full year regardless of the length of their EndeavorOTC subscription.

Brief summary: The EndeavorOTC product registry aims to collect real world data from EndeavorOTC users. The objectives of this registry are to describe clinical and demographic characteristics, treatment patterns, clinical and quality of life outcomes, and healthcare utilization in EndeavorOTC users in a real-world setting.

Detailed description: All EndeavorOTC users who subscribe to EndeavorOTC are invited to participate in this product registry. Users must provide their informed consent and have an active subscription to the product at time of enrollment to participate. Study activities are emailed to participants at baseline, 1, 2, 3, 6, 9, and 12-months after enrollment. Study activities consist of an online survey and online ADHD assessment. All data are captured electronically and securely through commercial data capture platforms.

Eligibility criteria: Inclusion Criteria:

* Has an active EndeavorOTC™subscription
* Provide informed consent to participate in the registry

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Computerized Adaptive Test, Mental Health (CAT-MH®)
timeFrame: Baseline, Months 1, 2, 3, 6, 9, 12
measure: Conners' Adult ADHD Rating Scales-Self Report: Short Version (CAARS-S:S)
timeFrame: Baseline, Months 1, 2, 3, 6, 9, 12
measure: Adult ADHD Quality of Life (AAQoL)
timeFrame: Baseline, Months 1, 2, 3, 6, 9, 12
measure: Patient Health Questionnaire - 4 items (PHQ-4)
timeFrame: Baseline, Months 1, 2, 3, 6, 9, 12
measure: Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P)
timeFrame: Baseline, Months 3, 6, 9, 12
measure: Percent work time missed due to ADHD, as measured by Work Productivity and Activity Impairment Questionnaire plus Classroom Impairment Questions: Specific Health Problem (WPAI+CIQ:SHP), Version 2.0
timeFrame: Baseline, Months 1, 2, 3, 6, 9, 12
measure: Percent impairment while working due to ADHD, as measured by WPAI+CIQ:ADHD
timeFrame: Baseline, Months 1, 2, 3, 6, 9, 12
measure: Percent overall work impairment due to ADHD, as measured by WPAI+CIQ:ADHD
timeFrame: Baseline, Months 1, 2, 3, 6, 9, 12
measure: Percent class time missed due to ADHD, as measured by WPAI+CIQ:ADHD
timeFrame: Baseline, Months 1, 2, 3, 6, 9, 12
measure: Percent overall classroom impairment due to ADHD, as measured by WPAI+CIQ:ADHD
timeFrame: Baseline, Months 1, 2, 3, 6, 9, 12
measure: Percent activity impairment due to ADHD, as measured by WPAI+CIQ:ADHD
timeFrame: Baseline, Months 1, 2, 3, 6, 9, 12
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Akili Interactive Labs, Inc.
state: Massachusetts
Study officials:
affiliation: Akili Interactive Labs, Inc.
name: Scott H Kollins, PhD
role: PRINCIPAL_INVESTIGATOR
References: