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/NCT06018350</url>
    </required_header>
    <id_info>
      <org_study_id>Pro00108618</org_study_id>
      <nct_id>NCT06018350</nct_id>
    </id_info>
    <brief_title>Medication Adherence in Rheumatic Diseases</brief_title>
    <official_title>Improving Medication Adherence in Chronic Rheumatic Diseases</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Duke University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Duke University</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>
        The investigators will pilot test a clinician-led intervention to improve medication&#xD;
        adherence in general rheumatology clinic across a spectrum of rheumatic diseases. The study&#xD;
        will assess feasibility, acceptability, and fidelity, and explore signal for improved&#xD;
        medication adherence.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">December 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>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Intervention Feasibility</measure>
      <time_frame>4 weeks</time_frame>
      <description>Percent of providers agreeing to participate</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intervention Feasibility</measure>
      <time_frame>4 weeks</time_frame>
      <description>Provider survey based on the Feasibility of Intervention Measure, scores range from 1-5, 5 is most feasible</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intervention Feasibility</measure>
      <time_frame>4 weeks</time_frame>
      <description>Percent of visits with EMR documentation of providers reviewing refills</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Acceptability</measure>
      <time_frame>4 weeks</time_frame>
      <description>Provider survey based on the Acceptability of Intervention Measure, scores range from 1-5, 5 is most acceptable</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acceptability, as measured by the percentage of patients who report a positive feeling after having an adherence conversation with their providers</measure>
      <time_frame>4 weeks</time_frame>
      <description>Patient survey will be administered after their provider visit</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fidelity</measure>
      <time_frame>4 weeks</time_frame>
      <description>Provider survey about the frequency of conducting the intervention components of reviewing pharmacy refills and using effective communication strategies</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fidelity</measure>
      <time_frame>4 weeks</time_frame>
      <description>Frequency of EMR documentation of completing the intervention components of reviewing pharmacy refills and using effective communication strategies</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in medication adherence</measure>
      <time_frame>baseline, 3 months</time_frame>
      <description>90-day medication possession ratio at 3 months after the intervention visit compared to baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in medication adherence</measure>
      <time_frame>baseline, 6 months</time_frame>
      <description>90-day medication possession ratio at 6 months after the intervention visit compared to baseline</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">12</enrollment>
    <condition>Chronic Rheumatic Diseases</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Clinicians in this arm will be trained to conduct the adherence intervention in general rheumatology clinic with all follow up patients with a chronic rheumatic disease.&#xD;
  Patients seen by these clinicians will contribute to the outcome data collection.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Clinician-led adherence intervention</intervention_name>
      <description>The clinician will review real time pharmacy refill data during clinic and use effective communication techniques to discuss adherence with the patient</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  all providers at Southpoint Rheumatology All patients with a rheumatic disease&#xD;
               diagnosis currently prescribed at least one rheumatic medication will be included in&#xD;
               the analysis&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  new patients, those who are not prescribed any rheumatic disease medications, or do&#xD;
               not have available pharmacy refill data&#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>Kai Sun, MD, MS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Duke Health</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kai Sun, MD, MS</last_name>
      <phone>919 681 7405</phone>
      <email>kai.sun@duke.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Duke University</name>
        <address>
          <city>Durham</city>
          <state>North Carolina</state>
          <zip>27710</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 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Rheumatic Diseases</mesh_term>
      <mesh_term>Collagen Diseases</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/NCT06018350
  org study id: Pro00108618
  nct id: NCT06018350
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The investigators will pilot test a clinician-led intervention to improve medication
        adherence in general rheumatology clinic across a spectrum of rheumatic diseases. The study
        will assess feasibility, acceptability, and fidelity, and explore signal for improved
        medication adherence.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Intervention Feasibility
  time frame: 4 weeks
  description: Percent of providers agreeing to participate
  measure: Intervention Feasibility
  time frame: 4 weeks
  description: Provider survey based on the Feasibility of Intervention Measure, scores range from 1-5, 5 is most feasible
  measure: Intervention Feasibility
  time frame: 4 weeks
  description: Percent of visits with EMR documentation of providers reviewing refills
  measure: Acceptability
  time frame: 4 weeks
  description: Provider survey based on the Acceptability of Intervention Measure, scores range from 1-5, 5 is most acceptable
  measure: Acceptability, as measured by the percentage of patients who report a positive feeling after having an adherence conversation with their providers
  time frame: 4 weeks
  description: Patient survey will be administered after their provider visit
  measure: Fidelity
  time frame: 4 weeks
  description: Provider survey about the frequency of conducting the intervention components of reviewing pharmacy refills and using effective communication strategies
  measure: Fidelity
  time frame: 4 weeks
  description: Frequency of EMR documentation of completing the intervention components of reviewing pharmacy refills and using effective communication strategies
  measure: Change in medication adherence
  time frame: baseline, 3 months
  description: 90-day medication possession ratio at 3 months after the intervention visit compared to baseline
  measure: Change in medication adherence
  time frame: baseline, 6 months
  description: 90-day medication possession ratio at 6 months after the intervention visit compared to baseline
  arm group label: Intervention
  arm group type: Experimental
  description: Clinicians in this arm will be trained to conduct the adherence intervention in general rheumatology clinic with all follow up patients with a chronic rheumatic disease.
  Patients seen by these clinicians will contribute to the outcome data collection.
  intervention type: Behavioral
  intervention name: Clinician-led adherence intervention
  description: The clinician will review real time pharmacy refill data during clinic and use effective communication techniques to discuss adherence with the patient
  arm group label: Intervention
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Kai Sun, MD, MS
  role: Principal Investigator
  affiliation: Duke Health
  last name: Kai Sun, MD, MS
  phone: 919 681 7405
  email: kai.sun@duke.edu
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Rheumatic Diseases
  mesh term: Collagen Diseases
  sharing ipd: No