ADHDNCT05991167
EndeavorRx® Prospective Product Registry ("Expedition EndeavorRx")
An observational study of ADHD, run by Akili Interactive Labs, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ADHD
- What is being tested?
- EndeavorRx
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 31 Dec 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: All patients who are prescribed EndeavorRx and activates their prescription are eligible to participate in this study.
Who may be able to join
- Are prescribed EndeavorRx by their healthcare provider as part of routine clinical practice
- Provide informed consent/assent to participate in the registry
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
Akili Interactive Labs, Inc.
Boston, Massachusetts, 02110
About this study
Official title: EndeavorRx® Prospective Product Registry
The EndeavorRx Prospective Product Registry aims to collect real world data from participants receiving the digital therapeutic, EndeavorRx, under conditions of routine clinical practice.
Read the 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
- Being tested
- EndeavorRx
- Keywords
- ADHD, AKL-T01, EndeavorRx, Akili, Registry
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndeavorRxDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| EndeavorRx Users | All participants with an active EndeavorRx prescription. Treatment regimen is as directed by their prescribing healthcare provider. Receives: Device: EndeavorRx |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Months 1, 2, 3, and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Jun 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Akili Interactive Labs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott H Kollins, PhD, Principal investigator, Akili Interactive Labs, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05991167
- Sponsor's protocol ID
- Akili-060
- Status last verified
- Jun 2024
- First submitted
- 4 Aug 2023
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EndeavorRx® Prospective Product Registry
- ClinicalTrials.gov ID
- NCT05991167
- Acronym / sponsor ID
- Akili-060
- Conditions
- ADHD
- Keywords
- ADHD, AKL-T01, EndeavorRx, Akili, Registry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Akili Interactive Labs, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EndeavorRx Users | – | Device: EndeavorRxAll participants with an active EndeavorRx prescription. Treatment regimen is as directed by their prescribing healthcare provider. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who are prescribed EndeavorRx and activates their prescription are eligible to participate in this study.
Key inclusion criteria (2 listed)
- Are prescribed EndeavorRx by their healthcare provider as part of routine clinical practice
- Provide informed consent/assent to participate in the registry
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EndeavorRxEndeavorRx® 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. | Device | EndeavorRx Users |
Primary outcome
Clinical and demographic characteristics
Time frame: Baseline
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.
Prescribing patterns
Time frame: Months 1, 2, 3, and 6
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).
Treatment patterns
Time frame: Baseline, Months 1, 2, 3, and 6
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).
Conners 3 ADHD Index - Parent Form
Time frame: Baseline, Months 1, 2, 3, and 6
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.
Conners 3 ADHD Index - Teacher Form
Time frame: Baseline, Months 1 and 3
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.
Global Impression of Perceived Difficulties (GIPD) assessment
Time frame: Baseline, Months 1, 2, 3, and 6
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.
CAT-MH® ADHD module
Time frame: Baseline, Months 1, 2, 3, and 6
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott H Kollins, PhD principal investigator
Akili Interactive Labs, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ADHD, run by Akili Interactive Labs, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical and demographic characteristics (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.