<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/NCT02982629</url>
  </required_header>
  <id_info>
    <org_study_id>410005727</org_study_id>
    <nct_id>NCT02982629</nct_id>
  </id_info>
  <brief_title>Improving Access to Eye Care in Glaucoma Patients</brief_title>
  <official_title>Improving Access to Eye Care in Glaucoma Patients a Prospective, Controlled, Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wills Eye</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Thomas Jefferson University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Wills Eye</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. To design and develop a prospective, randomized pilot study utilizing information from&#xD;
           electronic medical records to address follow-up adherence and reduce the gap between&#xD;
           recommended and actual follow-up adherence in patients with glaucoma.&#xD;
&#xD;
        2. To evaluate the impact of a telephone-based intervention on follow-up adherence in&#xD;
           patients with glaucoma using a randomly assigned comparison with usual care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Wills Eye Health System (WEHS) proposes to conduct a pilot study to evaluate the&#xD;
      feasibility and effectiveness of a telephone-based intervention to improve rates of follow-up&#xD;
      exams in patients with glaucoma. The prospective, randomized, controlled trial entitled&#xD;
      &quot;Improving Access to Eye Care in Patients with Glaucoma&quot; will utilize cohort data from 2013&#xD;
      electronic medical record information to reduce the gap between recommended and actual&#xD;
      follow-up utilization of eye care services in glaucoma patients. Patients with glaucoma will&#xD;
      be recruited from the Wills Eye Glaucoma clinic who were seen between 3/1/13 and 10/31/13. A&#xD;
      recall list will be generated for patients who have scheduled follow-up appointments from&#xD;
      9/1/13 to 11/30/13. These patients will be randomly assigned to the &quot;Usual Care&quot; group or&#xD;
      &quot;Intervention&quot; group. The primary outcome will be successful attendance at a follow-up&#xD;
      appointment within an appropriate time frame. This intervention is based on a CDC funded&#xD;
      project at Wills to improve access to eye care in patients with diabetes. Thus, this pilot&#xD;
      study will test the efficacy of a telephone-based intervention to improve follow-up adherence&#xD;
      in patients with glaucoma by improving access to eye care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adherence to Follow-Up</measure>
    <time_frame>28 weeks</time_frame>
    <description>Whether patients adhere to follow-up appointments at 28 weeks.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">250</enrollment>
  <condition>Glaucoma</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients in this group do not receive any letters or phone calls after missing follow-up appointment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reminder Letter Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this group receive letters and phone calls after missing follow-up appointment to reschedule the appointment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Reminder letter Intervention</intervention_name>
    <description>Patients in this group receive letters and phone calls to reschedule missed follow-up appointments.</description>
    <arm_group_label>Reminder Letter Intervention</arm_group_label>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Attended Wills Eye Glaucoma Clinic from 9/1/12 and 10/31/13&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any medical condition that would preclude the subject from providing reliable and&#xD;
             valid data.&#xD;
&#xD;
          -  Recommended to f/u in less than 1 month time period.&#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>
  <reference>
    <citation>Hark LA, Johnson DM, Berardi G, Patel NS, Zeng L, Dai Y, Mayro EL, Waisbourd M, Katz LJ. A randomized, controlled trial to test the effectiveness of a glaucoma patient navigator to improve appointment adherence. Patient Prefer Adherence. 2016 Sep 8;10:1739-48. doi: 10.2147/PPA.S108391. eCollection 2016.</citation>
    <PMID>27660423</PMID>
  </reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>August 6, 2015</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>November 30, 2016</last_update_submitted>
  <last_update_submitted_qc>November 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wills Eye</investigator_affiliation>
    <investigator_full_name>L. Jay Katz MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Glaucoma</keyword>
  <keyword>Eye Care</keyword>
  <keyword>Community Outreach</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>A total of 8 papers have been published. Results will be uploaded by 2016.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT02982629
org study id: 410005727
nct id: NCT02982629
lead sponsor: 
collaborator: 
has dmc: No
1. To design and develop a prospective, randomized pilot study utilizing information from
           electronic medical records to address follow-up adherence and reduce the gap between
           recommended and actual follow-up adherence in patients with glaucoma.

        2. To evaluate the impact of a telephone-based intervention on follow-up adherence in
           patients with glaucoma using a randomly assigned comparison with usual care.
The Wills Eye Health System (WEHS) proposes to conduct a pilot study to evaluate the
      feasibility and effectiveness of a telephone-based intervention to improve rates of follow-up
      exams in patients with glaucoma. The prospective, randomized, controlled trial entitled
      "Improving Access to Eye Care in Patients with Glaucoma" will utilize cohort data from 2013
      electronic medical record information to reduce the gap between recommended and actual
      follow-up utilization of eye care services in glaucoma patients. Patients with glaucoma will
      be recruited from the Wills Eye Glaucoma clinic who were seen between 3/1/13 and 10/31/13. A
      recall list will be generated for patients who have scheduled follow-up appointments from
      9/1/13 to 11/30/13. These patients will be randomly assigned to the "Usual Care" group or
      "Intervention" group. The primary outcome will be successful attendance at a follow-up
      appointment within an appropriate time frame. This intervention is based on a CDC funded
      project at Wills to improve access to eye care in patients with diabetes. Thus, this pilot
      study will test the efficacy of a telephone-based intervention to improve follow-up adherence
      in patients with glaucoma by improving access to eye care.
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: Adherence to Follow-Up
time frame: 28 weeks
description: Whether patients adhere to follow-up appointments at 28 weeks.
arm group label: Usual Care
arm group type: Placebo Comparator
description: Patients in this group do not receive any letters or phone calls after missing follow-up appointment.
arm group label: Reminder Letter Intervention
arm group type: Active Comparator
description: Patients in this group receive letters and phone calls after missing follow-up appointment to reschedule the appointment.
intervention type: Behavioral
intervention name: Reminder letter Intervention
description: Patients in this group receive letters and phone calls to reschedule missed follow-up appointments.
arm group label: Reminder Letter Intervention
arm group label: Usual Care
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
citation: Hark LA, Johnson DM, Berardi G, Patel NS, Zeng L, Dai Y, Mayro EL, Waisbourd M, Katz LJ. A randomized, controlled trial to test the effectiveness of a glaucoma patient navigator to improve appointment adherence. Patient Prefer Adherence. 2016 Sep 8;10:1739-48. doi: 10.2147/PPA.S108391. eCollection 2016.
PMID: 27660423
responsible party type: Principal Investigator
investigator affiliation: Wills Eye
investigator full name: L. Jay Katz MD
investigator title: Principal Investigator
mesh term: Glaucoma
sharing ipd: Yes
ipd description: A total of 8 papers have been published. Results will be uploaded by 2016.