<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/NCT04461158</url>
  </required_header>
  <id_info>
    <org_study_id>00095036</org_study_id>
    <secondary_id>3P30AR072582-03S1</secondary_id>
    <nct_id>NCT04461158</nct_id>
  </id_info>
  <brief_title>CCCR Lupus Patient Navigator Program</brief_title>
  <official_title>Utilizing a Lupus Patient Navigator Program (LPNP) to Address Barriers to Care Related to Access to Preventive and Specialty Healthcare, Medication Adherence and Health Literacy in Systemic Lupus Erythematosus (SLE) for Minority Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University of South Carolina</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To address the health disparities in SLE outcomes for minorities, targeted intervention will&#xD;
      be used to address the common barriers to care among patients; a comprehensive patient&#xD;
      navigator approach will be utilized based on evidence from prior studies is the purpose of&#xD;
      this research. The navigator services most commonly provided include facilitation and&#xD;
      coordination of care, practical support, including scheduling transportation and referrals to&#xD;
      financial assistance programs, appointment scheduling and reminders, education and&#xD;
      psycho-social support. The most effective patient navigators address both health system and&#xD;
      patient barriers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 3, 2020</start_date>
  <completion_date type="Actual">March 30, 2023</completion_date>
  <primary_completion_date type="Actual">March 30, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in Medication Adherence</measure>
    <time_frame>12 months - from baseline to 12 month visit</time_frame>
    <description>Adherence with prescribed medical therapies will be defined as the ratio between the number of therapy-days supplied to the number of days until the prescription was refilled and compared between LPNP participants and usual care patients. Medication adherence rates will be estimated by charts review and comparing these medications to pharmacy records on dates and quantities filled. Included medication classifications will include antihypertensives, immunosuppressants, Plaquenil (hydroxychloroquine), and glucocorticoids. Additionally, overall pill burden will be compared between LPNP participants and usual care patients. LPNP participants' medication diaries will be reviewed to determine self-reported adherence.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement in patient-reported lupus-specific disease status</measure>
    <time_frame>12 months - from baseline to 12 month visit</time_frame>
    <description>Changes in patient-reported lupus-specific disease status (measured by the LupusPRO v1.7) over time, from Baseline, 3, 6, 9, and 12 months, compared between interventional and usual care groups will be completed at the start and end of participation. The LupusPRO is a validated, comprehensive patient reported quality of life questionnaire specific for patients with lupus. Domain areas include: lupus symptoms, cognition, physical health, pain vitality, procreation, emotional health, body image, desires-goals, social support, coping, and satisfaction with care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in Adherence with medical providers and services</measure>
    <time_frame>12 months - from baseline to 12 month visit</time_frame>
    <description>Adherence with medical providers and services will be the ratio of number of visits scheduled to the number of visits kept. Rates will be compared between LPNP participants and usual care patients.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Systemic Lupus Erythematosus (SLE)</condition>
  <arm_group>
    <arm_group_label>Interventional Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Patient Navigator Services</intervention_name>
    <description>The navigator services most commonly provided include facilitation and coordination of care, practical support, including transportation and financial assistance, appointment scheduling and reminders, education and psychosocial support</description>
    <arm_group_label>Interventional Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Self-identified Minority.&#xD;
&#xD;
          2. Patients ≥ 18 years of age as documented in the electronic medical record.&#xD;
&#xD;
          3. Meeting either American College of Rheumatology or SLICC Classification Criteria for&#xD;
             SLE as documented in the electronic medical record.&#xD;
&#xD;
          4. Ability to speak and understand English by self-report.&#xD;
&#xD;
          5. In the past six months having ≥ 1 missed clinic or diagnostic study/laboratory visit&#xD;
             as documented in the electronic medical record, or self-reported failure to adhere&#xD;
             with prescribed medical therapy for SLE.&#xD;
&#xD;
          6. In the past six months having been prescribed at least one immunosuppressive&#xD;
             medication for SLE activity as documented in the electronic medical record regardless&#xD;
             of whether taking the medication.&#xD;
&#xD;
          7. Currently enrolled into the Core Center for Clinical Research (CCCR; Pro 00021985)&#xD;
             with properly executed Informed Consent Document and HIPAA Authorization.&#xD;
&#xD;
          8. Have telephone access.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unwilling or unable to give informed consent.&#xD;
&#xD;
          2. Being a prisoner or institutionalized individual.&#xD;
&#xD;
          3. Without telephone access.&#xD;
&#xD;
          4. Do not meet all of the inclusion criteria listed above.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jim C. Oates, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of South Carolina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>June 2, 2023</last_update_submitted>
  <last_update_submitted_qc>June 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of South Carolina</investigator_affiliation>
    <investigator_full_name>Jim C. Oates</investigator_full_name>
    <investigator_title>Professor and Director, Division of Rheumatology &amp; Immunology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lupus Erythematosus, Systemic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 28, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/58/NCT04461158/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04461158
org study id: 00095036
secondary id: 3P30AR072582-03S1
nct id: NCT04461158
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
To address the health disparities in SLE outcomes for minorities, targeted intervention will
      be used to address the common barriers to care among patients; a comprehensive patient
      navigator approach will be utilized based on evidence from prior studies is the purpose of
      this research. The navigator services most commonly provided include facilitation and
      coordination of care, practical support, including scheduling transportation and referrals to
      financial assistance programs, appointment scheduling and reminders, education and
      psycho-social support. The most effective patient navigators address both health system and
      patient barriers.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Improvement in Medication Adherence
time frame: 12 months - from baseline to 12 month visit
description: Adherence with prescribed medical therapies will be defined as the ratio between the number of therapy-days supplied to the number of days until the prescription was refilled and compared between LPNP participants and usual care patients. Medication adherence rates will be estimated by charts review and comparing these medications to pharmacy records on dates and quantities filled. Included medication classifications will include antihypertensives, immunosuppressants, Plaquenil (hydroxychloroquine), and glucocorticoids. Additionally, overall pill burden will be compared between LPNP participants and usual care patients. LPNP participants' medication diaries will be reviewed to determine self-reported adherence.
measure: Improvement in patient-reported lupus-specific disease status
time frame: 12 months - from baseline to 12 month visit
description: Changes in patient-reported lupus-specific disease status (measured by the LupusPRO v1.7) over time, from Baseline, 3, 6, 9, and 12 months, compared between interventional and usual care groups will be completed at the start and end of participation. The LupusPRO is a validated, comprehensive patient reported quality of life questionnaire specific for patients with lupus. Domain areas include: lupus symptoms, cognition, physical health, pain vitality, procreation, emotional health, body image, desires-goals, social support, coping, and satisfaction with care.
measure: Improvement in Adherence with medical providers and services
time frame: 12 months - from baseline to 12 month visit
description: Adherence with medical providers and services will be the ratio of number of visits scheduled to the number of visits kept. Rates will be compared between LPNP participants and usual care patients.
arm group label: Interventional Group
arm group type: Experimental
intervention type: Behavioral
intervention name: Patient Navigator Services
description: The navigator services most commonly provided include facilitation and coordination of care, practical support, including transportation and financial assistance, appointment scheduling and reminders, education and psychosocial support
arm group label: Interventional Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jim C. Oates, MD
role: Principal Investigator
affiliation: Medical University of South Carolina
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Medical University of South Carolina
investigator full name: Jim C. Oates
investigator title: Professor and Director, Division of Rheumatology & Immunology
mesh term: Lupus Erythematosus, Systemic
sharing ipd: No
provided document: 