xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05991167</url>
    </required_header>
    <id_info>
      <org_study_id>Akili-060</org_study_id>
      <nct_id>NCT05991167</nct_id>
    </id_info>
    <brief_title>EndeavorRx® Prospective Product Registry (&quot;Expedition EndeavorRx&quot;)</brief_title>
    <official_title>EndeavorRx® Prospective Product Registry</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Akili Interactive Labs, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Akili Interactive Labs, Inc.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The EndeavorRx Prospective Product Registry aims to collect real world data from participants&#xD;
        receiving the digital therapeutic, EndeavorRx, under conditions of routine clinical practice.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The objectives of this registry are to describe clinical and demographic characteristics,&#xD;
        prescribing patterns, treatment patterns, and outcomes in participants treated with&#xD;
        EndeavorRx in a real-world setting.&#xD;
  &#xD;
        Patients and their caregivers will be informed about the registry as part of a series of&#xD;
        product welcome emails following product activation. Patients/caregivers enroll into the&#xD;
        study by providing their electronic informed consent (eConsent) and assent (eAssent). All&#xD;
        data are captured electronically and securely through a commercial data capture platform.&#xD;
        Participants can also invite their child's teacher to submit surveys of their observations of&#xD;
        the child's ADHD symptoms for the study. Study activities are emailed to caregivers at&#xD;
        baseline, 1, 2, 3, and 6-months after enrollment.&#xD;
  &#xD;
        A valid and active EndeavorRx prescription is required to enroll. However, an active&#xD;
        prescription throughout the entire 6 months of study participation is not required.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">June 1, 2022</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>1 Year</target_duration>
    <primary_outcome>
      <measure>Clinical and demographic characteristics</measure>
      <time_frame>Baseline</time_frame>
      <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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Prescribing patterns</measure>
      <time_frame>Months 1, 2, 3, and 6</time_frame>
      <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).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Treatment patterns</measure>
      <time_frame>Baseline, Months 1, 2, 3, and 6</time_frame>
      <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).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Conners 3 ADHD Index - Parent Form</measure>
      <time_frame>Baseline, Months 1, 2, 3, and 6</time_frame>
      <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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Conners 3 ADHD Index - Teacher Form</measure>
      <time_frame>Baseline, Months 1 and 3</time_frame>
      <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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Global Impression of Perceived Difficulties (GIPD) assessment</measure>
      <time_frame>Baseline, Months 1, 2, 3, and 6</time_frame>
      <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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>CAT-MH® ADHD module</measure>
      <time_frame>Baseline, Months 1, 2, 3, and 6</time_frame>
      <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.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">500</enrollment>
    <condition>ADHD</condition>
    <arm_group>
      <arm_group_label>EndeavorRx Users</arm_group_label>
      <description>All participants with an active EndeavorRx prescription. Treatment regimen is as directed by their prescribing healthcare provider.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>EndeavorRx</intervention_name>
      <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.</description>
      <arm_group_label>EndeavorRx Users</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          All patients who are prescribed EndeavorRx and activates their prescription are eligible to&#xD;
          participate in this study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Are prescribed EndeavorRx by their healthcare provider as part of routine clinical&#xD;
               practice&#xD;
  &#xD;
            -  Provide informed consent/assent to participate in the registry&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  N/A&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Scott H Kollins, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Akili Interactive Labs, Inc.</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Akili Interactive Labs, Inc.</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02110</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>ADHD</keyword>
    <keyword>AKL-T01</keyword>
    <keyword>EndeavorRx</keyword>
    <keyword>Akili</keyword>
    <keyword>Registry</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05991167
  org study id: Akili-060
  nct id: NCT05991167
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  The EndeavorRx Prospective Product Registry aims to collect real world data from participants
        receiving the digital therapeutic, EndeavorRx, under conditions of routine clinical practice.
  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.
  observational model: Cohort
  time perspective: Prospective
  measure: Clinical and demographic characteristics
  time frame: 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
  time frame: 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
  time frame: 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
  time frame: 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
  time frame: 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
  time frame: 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
  time frame: 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.
  arm group label: EndeavorRx Users
  description: All participants with an active EndeavorRx prescription. Treatment regimen is as directed by their prescribing healthcare provider.
  intervention type: Device
  intervention name: EndeavorRx
  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.
  arm group label: EndeavorRx Users
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  last name: Scott H Kollins, PhD
  role: Principal Investigator
  affiliation: Akili Interactive Labs, Inc.
  facility: 
  country: United States
  responsible party type: Sponsor