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/NCT05992415</url>
    </required_header>
    <id_info>
      <org_study_id>AAAU8104</org_study_id>
      <nct_id>NCT05992415</nct_id>
    </id_info>
    <brief_title>New York City Eye Study (NYCES)</brief_title>
    <acronym>NYCES</acronym>
    <official_title>New York City Eye Study (NYCES)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Columbia University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Columbia University</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Dr. Lisa A. Hark (PI and Study Chair) and an interdisciplinary team have designed the New&#xD;
        York City Eye Study (NYCES) to promote eye and vision health equity and address eye health&#xD;
        disparities in adults age 21+ (PAR-23-009/NOT-EY-22-004).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The proposed innovative clinical trial will be a hybrid 1, masked, 2:1 cluster-randomized&#xD;
        design (by housing development) comprised of adults age 21+ of diverse race/ethnicity&#xD;
        (primarily African American and Hispanic/Latino) with high rates of inadequate eye&#xD;
        care.(Curran 2012) A total of 14 NYCHA developments confirm access to 43,273 residents living&#xD;
        at or below the NYC.gov poverty measure.(NYC Mayor Clinical measures (visual acuity,&#xD;
        intraocular pressure, and fundus images), quality-of-life, and falls risk will be assessed.&#xD;
        To ensure that all community members receive the basic level of service, all participants who&#xD;
        fail the eye health screening will be seen the same day by the study optometrist and eye&#xD;
        glasses will be provided at no charge. All participant referred to ophthalmology will be&#xD;
        assisted with scheduling their initial in-office eye exam appointment. Participants referred&#xD;
        in the 9 developments randomized to the Intervention Arm will receive ongoing support from a&#xD;
        patient navigator to assist with follow-up eye care; those referred in the 5 developments&#xD;
        randomized to the Usual Care Arm will not receive support from patient navigators.&#xD;
        Participants referred to ophthalmology will be followed prospectively for 2 years to evaluate&#xD;
        the effectiveness of the intervention on adherence to in-office follow-up eye care (primary&#xD;
        outcome), presenting visual acuity and vision-related quality-of-life (secondary outcomes).&#xD;
        We will also assess implementation outcomes including acceptability, fidelity, barriers and&#xD;
        facilitators with the eye health screenings and optometrist eye exams. The aims of the study&#xD;
        are:&#xD;
  &#xD;
        Aim 1) Evaluate the effectiveness of a community-based intervention that begins with eye&#xD;
        health screenings conducted in NYCHA affordable housing developments, followed by a hybrid 1&#xD;
        masked, cluster-randomized clinical trial using patient navigators to improve adherence to&#xD;
        follow-up eye care.&#xD;
  &#xD;
        Aim 2) Assess implementation outcomes of the intervention including reach, adoption,&#xD;
        implementation, maintenance, and health equity (RE-AIM) using mixed methodology for those&#xD;
        screened and referred to ophthalmology.&#xD;
  &#xD;
        Aim 3) To determine the costs of the eye health screening and intervention and its cost&#xD;
        effectiveness as cost per case detected and cost per participant achieving adherence as well&#xD;
        as the intervention's health and social benefits to a densely urban community.&#xD;
  &#xD;
        Impact: This community-based intervention provides basic level of services to everyone and is&#xD;
        specifically addressing a structural issue of access to healthcare by partnering with NYCHA.&#xD;
        The study will address vision and eye health disparities by testing the effectiveness of&#xD;
        patient navigators to improve follow-up adherence in those who need follow-up eye care.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 1, 2024</start_date>
    <completion_date type="Anticipated">June 30, 2029</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2029</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>
      <intervention_model_description>The proposed innovative clinical trial will be a hybrid 1, masked, 2:1 cluster-randomized design (by housing development) comprised of adults age 21+ of diverse race/ethnicity (primarily African American and Hispanic/Latino) with high rates of inadequate eye care.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Masking will be conducted by the study biostatistician and is &quot;cluster&quot; randomization by housing development. Using a random number generator, the 5 (masked) developments were chosen for the usual care arm, and the 9 (masked) developments for the intervention.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Adherence to Follow-up Eye Care</measure>
      <time_frame>1-year</time_frame>
      <description>The Outcome Measure is ADHERENCE TO FOLLOW-UP EYE EXAM APPOINTMENT, and will be measured by appointment attendance at the initial eye exam appointment. The unit of measure is the eye exam appointment, which will be scheduled within 6-months of the referral at either Harkness Eye Institute or Harlem Hospital. The measure will assess the rate of adherence at the initial appointment. Comparison will be made between the 9 developments randomized to the Intervention Arm compared to 5 developments randomized to the Usual Care Arm.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">10000</enrollment>
    <condition>Glaucoma</condition>
    <condition>Vision Impairment and Blindness</condition>
    <condition>Cataract</condition>
    <condition>Diabetic Retinopathy</condition>
    <arm_group>
      <arm_group_label>Arm 1: Intervention Using Patient Navigators</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Consented participants referred to ophthalmology from the 9 developments randomized to the Intervention Arm will receive ongoing support from patient navigators to assist with all aspects of follow-up eye care and ocular surgery at either Harkness Eye Institute or Harlem Hospital, specifically eye exam appointment scheduling and arranging transportation over a 1-year period.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm 2: Usual Care Without Patient Navigators</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Consented participants referred from the 5 developments randomized to the Usual Care Arm 2 who are referred to an ophthalmologist for a follow-up eye exam will only be scheduled for their initial appointment at either Harkness Eye Institute or Harlem Hospital. They will not receive enhanced support. Scheduling this initial appointment will allow tracking of adherence. Arm 2 represents a realistic choice available for participants following screening over a 1-year period.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Intervention Using Patient Navigators</intervention_name>
      <description>Consented participants referred to ophthalmology from the 9 developments randomized to the Intervention Arm will receive ongoing support from patient navigators to assist with all aspects of follow-up eye care and ocular surgery at either Harkness Eye Institute or Harlem Hospital, specifically eye exam appointment scheduling and arranging transportation over a 1-year period.</description>
      <arm_group_label>Arm 1: Intervention Using Patient Navigators</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Usual Care Without Patient Navigators</intervention_name>
      <description>Consented participants referred from the 5 developments randomized to the Usual Care Arm 2 who are referred to an ophthalmologist for a follow-up eye exam will only be scheduled for their initial appointment at either Harkness Eye Institute or Harlem Hospital. They will not receive enhanced support. Scheduling this initial appointment will allow tracking of adherence. Arm 2 represents a realistic choice available for participants following screening over a 1-year period.</description>
      <arm_group_label>Arm 2: Usual Care Without Patient Navigators</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Individuals age 21 and older.&#xD;
  &#xD;
            -  Living independently in an affordable housing development and surrounding&#xD;
               neighborhoods.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Self-reported terminal illness with life expectancy less than 1 year.&#xD;
  &#xD;
            -  Inability to provide informed consent due to dementia or other reasons.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Lisa A. Hark</last_name>
      <role>Principal Investigator</role>
      <affiliation>Columbia University Department of Ophthalmology</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lisa A. Hark, PhD, MBA</last_name>
      <phone>212-342-4586</phone>
      <email>lah112@cumc.columbia.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Columbia University Irving Medical Center - 622 W. 168th St. Floor 18</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10032</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>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Columbia University</investigator_affiliation>
      <investigator_full_name>Lisa Hark, PhD, MBA</investigator_full_name>
      <investigator_title>Professor of Ophthalmology</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Blindness</mesh_term>
      <mesh_term>Cataract</mesh_term>
      <mesh_term>Diabetic Retinopathy</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05992415
  org study id: AAAU8104
  nct id: NCT05992415
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Dr. Lisa A. Hark (PI and Study Chair) and an interdisciplinary team have designed the New
        York City Eye Study (NYCES) to promote eye and vision health equity and address eye health
        disparities in adults age 21+ (PAR-23-009/NOT-EY-22-004).
  The proposed innovative clinical trial will be a hybrid 1, masked, 2:1 cluster-randomized
        design (by housing development) comprised of adults age 21+ of diverse race/ethnicity
        (primarily African American and Hispanic/Latino) with high rates of inadequate eye
        care.(Curran 2012) A total of 14 NYCHA developments confirm access to 43,273 residents living
        at or below the NYC.gov poverty measure.(NYC Mayor Clinical measures (visual acuity,
        intraocular pressure, and fundus images), quality-of-life, and falls risk will be assessed.
        To ensure that all community members receive the basic level of service, all participants who
        fail the eye health screening will be seen the same day by the study optometrist and eye
        glasses will be provided at no charge. All participant referred to ophthalmology will be
        assisted with scheduling their initial in-office eye exam appointment. Participants referred
        in the 9 developments randomized to the Intervention Arm will receive ongoing support from a
        patient navigator to assist with follow-up eye care; those referred in the 5 developments
        randomized to the Usual Care Arm will not receive support from patient navigators.
        Participants referred to ophthalmology will be followed prospectively for 2 years to evaluate
        the effectiveness of the intervention on adherence to in-office follow-up eye care (primary
        outcome), presenting visual acuity and vision-related quality-of-life (secondary outcomes).
        We will also assess implementation outcomes including acceptability, fidelity, barriers and
        facilitators with the eye health screenings and optometrist eye exams. The aims of the study
        are:
  
        Aim 1) Evaluate the effectiveness of a community-based intervention that begins with eye
        health screenings conducted in NYCHA affordable housing developments, followed by a hybrid 1
        masked, cluster-randomized clinical trial using patient navigators to improve adherence to
        follow-up eye care.
  
        Aim 2) Assess implementation outcomes of the intervention including reach, adoption,
        implementation, maintenance, and health equity (RE-AIM) using mixed methodology for those
        screened and referred to ophthalmology.
  
        Aim 3) To determine the costs of the eye health screening and intervention and its cost
        effectiveness as cost per case detected and cost per participant achieving adherence as well
        as the intervention's health and social benefits to a densely urban community.
  
        Impact: This community-based intervention provides basic level of services to everyone and is
        specifically addressing a structural issue of access to healthcare by partnering with NYCHA.
        The study will address vision and eye health disparities by testing the effectiveness of
        patient navigators to improve follow-up adherence in those who need follow-up eye care.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The proposed innovative clinical trial will be a hybrid 1, masked, 2:1 cluster-randomized design (by housing development) comprised of adults age 21+ of diverse race/ethnicity (primarily African American and Hispanic/Latino) with high rates of inadequate eye care.
  primary purpose: Other
  masking: Single (Participant)
  masking description: Masking will be conducted by the study biostatistician and is "cluster" randomization by housing development. Using a random number generator, the 5 (masked) developments were chosen for the usual care arm, and the 9 (masked) developments for the intervention.
  measure: Adherence to Follow-up Eye Care
  time frame: 1-year
  description: The Outcome Measure is ADHERENCE TO FOLLOW-UP EYE EXAM APPOINTMENT, and will be measured by appointment attendance at the initial eye exam appointment. The unit of measure is the eye exam appointment, which will be scheduled within 6-months of the referral at either Harkness Eye Institute or Harlem Hospital. The measure will assess the rate of adherence at the initial appointment. Comparison will be made between the 9 developments randomized to the Intervention Arm compared to 5 developments randomized to the Usual Care Arm.
  arm group label: Arm 1: Intervention Using Patient Navigators
  arm group type: Active Comparator
  description: Consented participants referred to ophthalmology from the 9 developments randomized to the Intervention Arm will receive ongoing support from patient navigators to assist with all aspects of follow-up eye care and ocular surgery at either Harkness Eye Institute or Harlem Hospital, specifically eye exam appointment scheduling and arranging transportation over a 1-year period.
  arm group label: Arm 2: Usual Care Without Patient Navigators
  arm group type: Placebo Comparator
  description: Consented participants referred from the 5 developments randomized to the Usual Care Arm 2 who are referred to an ophthalmologist for a follow-up eye exam will only be scheduled for their initial appointment at either Harkness Eye Institute or Harlem Hospital. They will not receive enhanced support. Scheduling this initial appointment will allow tracking of adherence. Arm 2 represents a realistic choice available for participants following screening over a 1-year period.
  intervention type: Other
  intervention name: Intervention Using Patient Navigators
  description: Consented participants referred to ophthalmology from the 9 developments randomized to the Intervention Arm will receive ongoing support from patient navigators to assist with all aspects of follow-up eye care and ocular surgery at either Harkness Eye Institute or Harlem Hospital, specifically eye exam appointment scheduling and arranging transportation over a 1-year period.
  arm group label: Arm 1: Intervention Using Patient Navigators
  intervention type: Other
  intervention name: Usual Care Without Patient Navigators
  description: Consented participants referred from the 5 developments randomized to the Usual Care Arm 2 who are referred to an ophthalmologist for a follow-up eye exam will only be scheduled for their initial appointment at either Harkness Eye Institute or Harlem Hospital. They will not receive enhanced support. Scheduling this initial appointment will allow tracking of adherence. Arm 2 represents a realistic choice available for participants following screening over a 1-year period.
  arm group label: Arm 2: Usual Care Without Patient Navigators
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Lisa A. Hark
  role: Principal Investigator
  affiliation: Columbia University Department of Ophthalmology
  last name: Lisa A. Hark, PhD, MBA
  phone: 212-342-4586
  email: lah112@cumc.columbia.edu
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Columbia University
  investigator full name: Lisa Hark, PhD, MBA
  investigator title: Professor of Ophthalmology
  mesh term: Blindness
  mesh term: Cataract
  mesh term: Diabetic Retinopathy
  sharing ipd: No