<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/NCT04402801</url>
  </required_header>
  <id_info>
    <org_study_id>22327</org_study_id>
    <nct_id>NCT04402801</nct_id>
  </id_info>
  <brief_title>Patient Outcomes of Clinic Transition From Face to Face Encounter to Telemedicine in Cystic Fibrosis</brief_title>
  <official_title>Impact on Patient Outcomes of Clinic Transition From Face to Face Encounters to Telemedicine in the Cystic Fibrosis (CF) Adult Population at UVA</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Virginia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Virginia</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>
      Adult patients with Cystic Fibrosis who are seen at the specialty CF clinic at University of&#xD;
      Virginia will be given an option to utilize telemedicine instead of in-person visits for&#xD;
      standard clinic visits. Health information from standard of care visits including FEV1,&#xD;
      exacerbations, leading to oral or intravenous antibiotics, laboratory results,&#xD;
      hospitalization records, and responses to health questionnaires will be recorded for research&#xD;
      purposes. Data collected for the research study will be compared to baseline and previous&#xD;
      years to determine if there are any deleterious effects for those who transition to&#xD;
      telemedicine clinic visits.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">May 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>FEV1 stability</measure>
    <time_frame>12 months</time_frame>
    <description>A change of 10% or more in FEV1 percent predicted will be considered significant; FEV1 pre and pos covid telemedicine implementation will be compared</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Exacerbation rate</measure>
    <time_frame>12 months</time_frame>
    <description>Exacerbation rate pre and pos covid telemedicine implementation will be compared</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Cystic Fibrosis</condition>
  <arm_group>
    <arm_group_label>Standard of Care Telemedicine Cohort</arm_group_label>
    <description>This cohort will have telemedicine visits in lieu of in-person clinic visits</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care In-Person Cohort</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adult CF patients 18 yo and older.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (18-year-old and older) with CF seen in the UVA adult CF clinic who&#xD;
             agree to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who cannot consent to the research study. In addition, prisoners will not be&#xD;
             included.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Dana Albon, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Virginia Health System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Virginia Health System</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>June 8, 2020</last_update_submitted>
  <last_update_submitted_qc>June 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Virginia</investigator_affiliation>
    <investigator_full_name>Dana Albon, MD</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystic Fibrosis</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <!-- 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/NCT04402801
org study id: 22327
nct id: NCT04402801
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Adult patients with Cystic Fibrosis who are seen at the specialty CF clinic at University of
      Virginia will be given an option to utilize telemedicine instead of in-person visits for
      standard clinic visits. Health information from standard of care visits including FEV1,
      exacerbations, leading to oral or intravenous antibiotics, laboratory results,
      hospitalization records, and responses to health questionnaires will be recorded for research
      purposes. Data collected for the research study will be compared to baseline and previous
      years to determine if there are any deleterious effects for those who transition to
      telemedicine clinic visits.
observational model: Cohort
time perspective: Prospective
measure: FEV1 stability
time frame: 12 months
description: A change of 10% or more in FEV1 percent predicted will be considered significant; FEV1 pre and pos covid telemedicine implementation will be compared
measure: Exacerbation rate
time frame: 12 months
description: Exacerbation rate pre and pos covid telemedicine implementation will be compared
arm group label: Standard of Care Telemedicine Cohort
description: This cohort will have telemedicine visits in lieu of in-person clinic visits
arm group label: Standard of Care In-Person Cohort
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
last name: Dana Albon, MD
role: Principal Investigator
affiliation: University of Virginia Health System
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Virginia
investigator full name: Dana Albon, MD
investigator title: Assistant Professor
mesh term: Cystic Fibrosis
mesh term: Fibrosis