EndeavorRx® Prospective Product Registry ("Expedition EndeavorRx")

NCT05991167 | Active Not Recruiting FDA Device

• 1 other identifier: Akili-060
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD

Keywords

ADHD; AKL-T01; EndeavorRx; Akili; Registry

Outcome Measures

Primary Outcomes (7)

• Clinical and demographic characteristics

  Socio-demographic and clinical characteristics of the registry population will be described using mean and standard deviation as well as median, minimum, maximum, and interquartile range, as appropriate for continuous variables, and counts with percentages for categorical variables. To explore changes in the profile of participants entering the registry over time, results may be stratified by enrollment date grouped by, for example, calendar month or quarter and year.

  Baseline

• Prescribing patterns

  Prescribing patterns will be summarized using count and percent of EndeavorRx prescriber types reported by registry participants. Analysis of treatment patterns will be repeated stratified by prescriber type to explore any potential differences in treatment approaches and/or adherence by prescribing healthcare provider specialty. To explore changes in prescribers over time, results may be stratified by enrollment date (e.g., calendar month or quarter and year).

  Months 1, 2, 3, and 6

• Treatment patterns

  Past and current treatments for ADHD will be summarized for registry participants using counts and percentages. Adherence to EndeavorRx treatment will be assessed using gameplay data and may be defined based on number of missions and/or days played, duration of gameplay, and/or patterns of gameplay (e.g., level of effort) in relation to the values that would be expected per product instructions for use. Measures will be described using mean, standard deviation, median, minimum, maximum, and interquartile range for continuous variables, and counts with percentages for categorical variables. Adherence will be summarized overall and for time intervals after commencing treatment (e.g., weekly, monthly).

  Baseline, Months 1, 2, 3, and 6

• Conners 3 ADHD Index - Parent Form

  Descriptive statistics for each continuous outcome at baseline and each follow-up timepoint, as well as change from baseline at each follow-up timepoint, will be calculated. Changes in continuous outcome measures may also be assessed using linear mixed model repeated measures analyses (MMRM) to assess the effect of EndeavorRx treatment over time and adjust for potential confounding factors as necessary. Stratified analyses by treatment characteristics (e.g., concomitant ADHD medications, treatment adherence) may be conducted to examine whether changes in assessments vary with different treatment patterns.

  Baseline, Months 1, 2, 3, and 6

• Conners 3 ADHD Index - Teacher Form

  Descriptive statistics for each continuous outcome at baseline and each follow-up timepoint, as well as change from baseline at each follow-up timepoint, will be calculated. Changes in continuous outcome measures may also be assessed using linear mixed model repeated measures analyses (MMRM) to assess the effect of EndeavorRx treatment over time and adjust for potential confounding factors as necessary. Stratified analyses by treatment characteristics (e.g., concomitant ADHD medications, treatment adherence) may be conducted to examine whether changes in assessments vary with different treatment patterns.

  Baseline, Months 1 and 3

• Global Impression of Perceived Difficulties (GIPD) assessment

  Descriptive statistics for each continuous outcome at baseline and each follow-up timepoint, as well as change from baseline at each follow-up timepoint, will be calculated. Changes in continuous outcome measures may also be assessed using linear mixed model repeated measures analyses (MMRM) to assess the effect of EndeavorRx treatment over time and adjust for potential confounding factors as necessary. Stratified analyses by treatment characteristics (e.g., concomitant ADHD medications, treatment adherence) may be conducted to examine whether changes in assessments vary with different treatment patterns.

  Baseline, Months 1, 2, 3, and 6

• CAT-MH® ADHD module

  Descriptive statistics for each continuous outcome at baseline and each follow-up timepoint, as well as change from baseline at each follow-up timepoint, will be calculated. Changes in continuous outcome measures may also be assessed using linear mixed model repeated measures analyses (MMRM) to assess the effect of EndeavorRx treatment over time and adjust for potential confounding factors as necessary. Stratified analyses by treatment characteristics (e.g., concomitant ADHD medications, treatment adherence) may be conducted to examine whether changes in assessments vary with different treatment patterns.

  Baseline, Months 1, 2, 3, and 6

Study Arms (1)

EndeavorRx Users

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

Device: EndeavorRx

Interventions

EndeavorRx DEVICE

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.

EndeavorRx Users

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who are prescribed EndeavorRx and activates their prescription are eligible to participate in this study.

You may qualify if:

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

You may not qualify if:

• N/A

Sponsors & Collaborators

• Akili Interactive Labs, Inc.: lead

Study Sites (1)

Akili Interactive Labs, Inc.

Boston, Massachusetts, 02110, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Scott H Kollins, PhD

  Akili Interactive Labs, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 14, 2023
• Study Start: June 1, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 27, 2024

Record last verified: 2024-06

Locations

US (1)