Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 11:10 PM
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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-25', 'studyFirstSubmitDate': '2023-08-04', 'studyFirstSubmitQcDate': '2023-08-04', 'lastUpdatePostDateStruct': {'date': '2024-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical and demographic characteristics', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Prescribing patterns', 'timeFrame': 'Months 1, 2, 3, and 6', 'description': '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).'}, {'measure': 'Treatment patterns', 'timeFrame': 'Baseline, Months 1, 2, 3, and 6', 'description': '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).'}, {'measure': 'Conners 3 ADHD Index - Parent Form', 'timeFrame': 'Baseline, Months 1, 2, 3, and 6', 'description': '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.'}, {'measure': 'Conners 3 ADHD Index - Teacher Form', 'timeFrame': 'Baseline, Months 1 and 3', 'description': '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.'}, {'measure': 'Global Impression of Perceived Difficulties (GIPD) assessment', 'timeFrame': 'Baseline, Months 1, 2, 3, and 6', 'description': '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.'}, {'measure': 'CAT-MH® ADHD module', 'timeFrame': 'Baseline, Months 1, 2, 3, and 6', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['ADHD', 'AKL-T01', 'EndeavorRx', 'Akili', 'Registry'], 'conditions': ['ADHD']}, 'descriptionModule': {'briefSummary': 'The EndeavorRx Prospective Product Registry aims to collect real world data from participants receiving the digital therapeutic, EndeavorRx, under conditions of routine clinical practice.', 'detailedDescription': "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.\n\nPatients 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.\n\nA valid and active EndeavorRx prescription is required to enroll. However, an active prescription throughout the entire 6 months of study participation is not required."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who are prescribed EndeavorRx and activates their prescription are eligible to participate in this study.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Are prescribed EndeavorRx by their healthcare provider as part of routine clinical practice\n* Provide informed consent/assent to participate in the registry\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT05991167', 'briefTitle': 'EndeavorRx® Prospective Product Registry ("Expedition EndeavorRx")', 'organization': {'class': 'INDUSTRY', 'fullName': 'Akili Interactive Labs, Inc.'}, 'officialTitle': 'EndeavorRx® Prospective Product Registry', 'orgStudyIdInfo': {'id': 'Akili-060'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'EndeavorRx Users', 'description': 'All participants with an active EndeavorRx prescription. Treatment regimen is as directed by their prescribing healthcare provider.', 'interventionNames': ['Device: EndeavorRx']}], 'interventions': [{'name': 'EndeavorRx', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['EndeavorRx Users']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02110', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Akili Interactive Labs, Inc.', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Scott H Kollins, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Akili Interactive Labs, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akili Interactive Labs, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}