<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/NCT04477902</url>
  </required_header>
  <id_info>
    <org_study_id>altcovid-192020</org_study_id>
    <nct_id>NCT04477902</nct_id>
  </id_info>
  <brief_title>Long-Term Experience and Health Effects of COVID-19</brief_title>
  <official_title>A Longitudinal, Long-Term, Observational Study of COVID-19 Experience and Health Effects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Altura</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Altura</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 purpose of this study is to gain on-going COVID-19 feedback/data to drive timely action&#xD;
      locally and nationally in order to mitigate transmission. Data will be deidentified and&#xD;
      consolidated to create a large national longitudinal database.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ths is a longitudinal, observational, descriptive study to gather data needed to support a&#xD;
      better understanding of COVID-19 from the perspective of a diverse national population.&#xD;
&#xD;
      This multi-phase study will use an action research approach to identify specific ways that&#xD;
      physician groups, federally qualified health centers (FQHCs), public health departments, and&#xD;
      other health and social services systems in the United States can address healthcare needs&#xD;
      and mitigate the transmission of COVID-19. Email surveys will be used to assess the&#xD;
      historical and current status of participants by medical condition, geography, and&#xD;
      demographic characteristics, as well as their history of symptoms (e.g. recent cough, fever,&#xD;
      loss of sense of taste or smell, etc.) and their current psychosocial needs.&#xD;
&#xD;
      The study will provide the structure for an iterative exploration of trends over time (up to&#xD;
      24 months). The opt-in survey will be posted and available to individuals 18 and older who&#xD;
      choose to participate. Survey frequency will be every two weeks.&#xD;
&#xD;
      To analyze broader trends, all survey responses will be de-identified and aggregated. Overall&#xD;
      general findings will not be linked to individuals or physician groups when reporting and&#xD;
      publishing study results.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">June 22, 2021</completion_date>
  <primary_completion_date type="Actual">June 22, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Longitudinal survey</measure>
    <time_frame>2 years</time_frame>
    <description>To gain on-going COVID-19 feedback/data to drive timely action locally and nationally in order to mitigate transmission.</description>
  </primary_outcome>
  <enrollment type="Actual">64</enrollment>
  <condition>Covid19</condition>
  <condition>Corona Virus Infection</condition>
  <condition>Quality of Life</condition>
  <condition>Risk Reduction</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>none - observational</intervention_name>
    <description>online survey</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Anyone in the USA can participate in this study that meets inclusion criteria. To ensure&#xD;
        diversity urban, suburban and rural areas of the country will be included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Any gender specification&#xD;
&#xD;
          -  Has consented to proceed with survey&#xD;
&#xD;
          -  Is able to complete the survey via email on a regular basis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pete Fronte, MBA</last_name>
    <role>Study Chair</role>
    <affiliation>Altura</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Altura</name>
      <address>
        <city>Mission Viejo</city>
        <state>California</state>
        <zip>92691</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://alturastudies.com/covid-19-studyregistration/</url>
    <description>Study Registration Page</description>
  </link>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>June 22, 2021</last_update_submitted>
  <last_update_submitted_qc>June 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>covid-19</keyword>
  <keyword>corona virus</keyword>
  <keyword>covid19</keyword>
  <keyword>coronavirus</keyword>
  <keyword>SARS-CoV-2</keyword>
  <keyword>infection</keyword>
  <keyword>household</keyword>
  <keyword>transmission</keyword>
  <keyword>vaccine</keyword>
  <keyword>clinical trials</keyword>
  <keyword>online</keyword>
  <keyword>Altura</keyword>
  <keyword>outpatient</keyword>
  <keyword>telemedicine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT04477902
org study id: altcovid-192020
nct id: NCT04477902
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to gain on-going COVID-19 feedback/data to drive timely action
      locally and nationally in order to mitigate transmission. Data will be deidentified and
      consolidated to create a large national longitudinal database.
Ths is a longitudinal, observational, descriptive study to gather data needed to support a
      better understanding of COVID-19 from the perspective of a diverse national population.

      This multi-phase study will use an action research approach to identify specific ways that
      physician groups, federally qualified health centers (FQHCs), public health departments, and
      other health and social services systems in the United States can address healthcare needs
      and mitigate the transmission of COVID-19. Email surveys will be used to assess the
      historical and current status of participants by medical condition, geography, and
      demographic characteristics, as well as their history of symptoms (e.g. recent cough, fever,
      loss of sense of taste or smell, etc.) and their current psychosocial needs.

      The study will provide the structure for an iterative exploration of trends over time (up to
      24 months). The opt-in survey will be posted and available to individuals 18 and older who
      choose to participate. Survey frequency will be every two weeks.

      To analyze broader trends, all survey responses will be de-identified and aggregated. Overall
      general findings will not be linked to individuals or physician groups when reporting and
      publishing study results.
observational model: Ecologic or Community
time perspective: Prospective
measure: Longitudinal survey
time frame: 2 years
description: To gain on-going COVID-19 feedback/data to drive timely action locally and nationally in order to mitigate transmission.
intervention type: Other
intervention name: none - observational
description: online survey
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pete Fronte, MBA
role: Study Chair
affiliation: Altura
facility: 
country: United States
url: https://alturastudies.com/covid-19-studyregistration/
description: Study Registration Page
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Coronavirus Infections
sharing ipd: Undecided