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/NCT06033066</url>
    </required_header>
    <id_info>
      <org_study_id>UP-22-01037</org_study_id>
      <nct_id>NCT06033066</nct_id>
    </id_info>
    <brief_title>Financial Incentives and Recruitment to the APT Webstudy</brief_title>
    <acronym>FIND-AD</acronym>
    <official_title>A Randomized Trial of Financial Incentives for the Recruitment of County Health System Patients to the Alzheimer Prevention Trials (APT) Webstudy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Southern California</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>American Heart Association</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Schaeffer Center for Health Policy &amp; Economics</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Alzheimer's Therapeutic Research Institute</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Southern California</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This single-blind, three-arm, randomized, controlled trial will assess the impact of messages&#xD;
        and financial incentives on the enrollment of demographically diverse individuals to the&#xD;
        Alzheimer Prevention Trials (APT) Webstudy. The APT Webstudy is a novel, online registry that&#xD;
        employs quarterly cognitive testing using validated platforms. The APT Webstudy implements&#xD;
        fully remote assessments, coordinated by the Alzheimer's Therapeutic Research Institute&#xD;
        (ATRI) under USC IRB #HS-17-00746. The purpose of the current study is to test whether we can&#xD;
        increase enrollment of diverse individuals into the registry. To do this, we will work with&#xD;
        Contra Costa Regional Medical Center (CCRMC), the county public hospital and its affiliated&#xD;
        health centers in Contra Costa County, California, to test whether sending messages with and&#xD;
        without financial incentives to patients who receive primary care with the health system can&#xD;
        increase enrollment to the APT Webstudy. The investigators hypothesize that 1) a certain&#xD;
        small financial incentive and an award opportunity based incentive (or a drawing with a&#xD;
        prize) will increase enrollment rates of CCHS members into the APT Webstudy relative to the&#xD;
        control group. The investigators further hypothesize that the award opportunity incentive&#xD;
        will increase the enrollment rate of CCRMC patients into the APT Webstudy more than a certain&#xD;
        financial incentive with the same expected value.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">March 2026</completion_date>
    <primary_completion_date type="Anticipated">March 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Enrollment status into the APT Webstudy</measure>
      <time_frame>2-weeks</time_frame>
      <description>APT Webstudy enrollment rate based on completion of at least one of the two APT Webstudy cognitive assessments (Cognitive Function Instrument [CFI] and/or Cogstate Brief Battery).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cost per enrollee</measure>
      <time_frame>annual</time_frame>
      <description>Cost to acquire an enrollment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Completion of cognitive assessments within the APT Webstudy</measure>
      <time_frame>2-weeks</time_frame>
      <description>Completion of both APT Webstudy cognitive assessments (Cognitive Function Instrument [CFI] and/or Cogstate Brief Battery).</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">48000</enrollment>
    <condition>Alzheimer Disease</condition>
    <condition>Dementia</condition>
    <condition>Preclinical Alzheimer's Disease</condition>
    <condition>Prodromal Alzheimer's Disease</condition>
    <arm_group>
      <arm_group_label>Messaging Only</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>16,000 participants will be randomized to Arm 1 where no monetary incentive is offered.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Small Incentive</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>16,000 participants will be randomized to Arm 2 where a small one-time monetary incentive is offered.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Prize Incentive</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>16,000 participants will be randomized to Arm 3 where an opportunity based incentive (or a drawing with a prize) with a single winner will be offered.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Financial Incentives</intervention_name>
      <description>Small financial incentive or prize incentive</description>
      <arm_group_label>Prize Incentive</arm_group_label>
      <arm_group_label>Small Incentive</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Message</intervention_name>
      <description>Message inviting participant to enroll</description>
      <arm_group_label>Messaging Only</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          To be eligible to participate in this study, an individual must meet all of the following&#xD;
          criteria:&#xD;
  &#xD;
            -  Patients empaneled at Contra Costa Regional Medical Center (CCRMC), the county public&#xD;
               hospital and its affiliated health centers.&#xD;
  &#xD;
            -  Age 50 or older&#xD;
  &#xD;
            -  Literate in either English or Spanish&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Below age 50&#xD;
  &#xD;
            -  Documentation of prior dementia diagnosis&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <link>
      <url>https://www.aptwebstudy.org/</url>
      <description>APT Webstudy</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Southern California</investigator_affiliation>
      <investigator_full_name>Mireille Jacobson</investigator_full_name>
      <investigator_title>Associate Professor of Gerontology</investigator_title>
    </responsible_party>
    <keyword>Alzheimer's</keyword>
    <keyword>Prevention</keyword>
    <keyword>Observational</keyword>
    <keyword>Trial-Ready Cohort</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Alzheimer Disease</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The health system will not allow sharing of individual data on a public site. However, we will share data on request from investigators.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>Data will be made available within 6 months of publication.</ipd_time_frame>
      <ipd_access_criteria>Individual data shared upon request.</ipd_access_criteria>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>September 6, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/66/NCT06033066/Prot_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT06033066
  org study id: UP-22-01037
  nct id: NCT06033066
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This single-blind, three-arm, randomized, controlled trial will assess the impact of messages
        and financial incentives on the enrollment of demographically diverse individuals to the
        Alzheimer Prevention Trials (APT) Webstudy. The APT Webstudy is a novel, online registry that
        employs quarterly cognitive testing using validated platforms. The APT Webstudy implements
        fully remote assessments, coordinated by the Alzheimer's Therapeutic Research Institute
        (ATRI) under USC IRB #HS-17-00746. The purpose of the current study is to test whether we can
        increase enrollment of diverse individuals into the registry. To do this, we will work with
        Contra Costa Regional Medical Center (CCRMC), the county public hospital and its affiliated
        health centers in Contra Costa County, California, to test whether sending messages with and
        without financial incentives to patients who receive primary care with the health system can
        increase enrollment to the APT Webstudy. The investigators hypothesize that 1) a certain
        small financial incentive and an award opportunity based incentive (or a drawing with a
        prize) will increase enrollment rates of CCHS members into the APT Webstudy relative to the
        control group. The investigators further hypothesize that the award opportunity incentive
        will increase the enrollment rate of CCRMC patients into the APT Webstudy more than a certain
        financial incentive with the same expected value.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Enrollment status into the APT Webstudy
  time frame: 2-weeks
  description: APT Webstudy enrollment rate based on completion of at least one of the two APT Webstudy cognitive assessments (Cognitive Function Instrument [CFI] and/or Cogstate Brief Battery).
  measure: Cost per enrollee
  time frame: annual
  description: Cost to acquire an enrollment
  measure: Completion of cognitive assessments within the APT Webstudy
  time frame: 2-weeks
  description: Completion of both APT Webstudy cognitive assessments (Cognitive Function Instrument [CFI] and/or Cogstate Brief Battery).
  arm group label: Messaging Only
  arm group type: Active Comparator
  description: 16,000 participants will be randomized to Arm 1 where no monetary incentive is offered.
  arm group label: Small Incentive
  arm group type: Experimental
  description: 16,000 participants will be randomized to Arm 2 where a small one-time monetary incentive is offered.
  arm group label: Prize Incentive
  arm group type: Experimental
  description: 16,000 participants will be randomized to Arm 3 where an opportunity based incentive (or a drawing with a prize) with a single winner will be offered.
  intervention type: Behavioral
  intervention name: Financial Incentives
  description: Small financial incentive or prize incentive
  arm group label: Prize Incentive
  arm group label: Small Incentive
  intervention type: Behavioral
  intervention name: Message
  description: Message inviting participant to enroll
  arm group label: Messaging Only
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  url: https://www.aptwebstudy.org/
  description: APT Webstudy
  responsible party type: Principal Investigator
  investigator affiliation: University of Southern California
  investigator full name: Mireille Jacobson
  investigator title: Associate Professor of Gerontology
  mesh term: Alzheimer Disease
  sharing ipd: Yes
  ipd description: The health system will not allow sharing of individual data on a public site. However, we will share data on request from investigators.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Analytic Code
  ipd time frame: Data will be made available within 6 months of publication.
  ipd access criteria: Individual data shared upon request.
  provided document: 