<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/NCT04409535</url>
  </required_header>
  <id_info>
    <org_study_id>20-266</org_study_id>
    <nct_id>NCT04409535</nct_id>
  </id_info>
  <brief_title>Effects of the COVID-19 Health Emergency on Biopsychosocial Health</brief_title>
  <official_title>Effects of the COVID-19 Health Emergency on the Biopsychosocial Health of Rural Residents of New Mexico Using Mixed Methods Research</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of New Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of New Mexico</source>
  <oversight_info>
    <has_dmc>Yes</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>
      There is a critical need to determine the impact of the COVID-19 emergency on the&#xD;
      comprehensive well-being of people as they are living through the emergency and sequelae of&#xD;
      the emergency period. The research team is requesting National Institutes of Health funding&#xD;
      with the goal to investigate rural vs. urban living people's response to the crisis and its&#xD;
      impact using mixed methods research.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The state of New Mexico and the entire nation have entered an unprecedented health emergency&#xD;
      created by the COVID-19 virus; affecting the lives of all people, many of whom were&#xD;
      significantly unprepared for the disruptions the emergency created in daily life. Rural&#xD;
      residents are at increased risk from effects of the emergency due to numerous disadvantages&#xD;
      as compared to urban living people (i.e. critical care access, food insecurity, social&#xD;
      isolation). Very little is known about how people are living through a national emergency&#xD;
      event affecting all people of the nation. Therefore, a significant gap in knowledge exists:&#xD;
      1. How are rural-living vs. urban-living people responding physically and mentally to the&#xD;
      crisis? 2. What strategies of resilience are employed by people living in rural vs. urban&#xD;
      counties? 3. What are perceptions of access to critical supplies and services in urban vs.&#xD;
      rural counties; 4. How is the availability and use of technology used for news, reliable&#xD;
      information, and communication? and 5. Use of time: what alterations in daily life self-care,&#xD;
      care of others, commerce, and valued routines in urban vs. rural counties are occurring?&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">May 7, 2020</start_date>
  <completion_date type="Anticipated">March 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">February 25, 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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>World Health Organization Quality of Life-Brief Scale</measure>
    <time_frame>From enrollment until post-event (Feb. 2021)</time_frame>
    <description>participant responses about quality of life during COVID-19 emergency</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Open-ended Interview</measure>
    <time_frame>From enrollment until post-event (Feb. 2021)</time_frame>
    <description>Participants responses to open-ended interview questions regarding alteration in daily life routines</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Activities</condition>
  <condition>Mental Health Issue</condition>
  <condition>Life Style</condition>
  <arm_group>
    <arm_group_label>Rural Living Community Member</arm_group_label>
    <description>Adult residents of a New Mexico rural county (as federally designated)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Urban/Suburban Living Community Member</arm_group_label>
    <description>Comparison group: adult resident of a New Mexico urban/suburban city or town (as federally designated)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>WHOQOL-BREF survey</intervention_name>
    <description>Participants will be surveyed and interviewed about their perceptions regarding COVID-19 health emergency</description>
    <arm_group_label>Rural Living Community Member</arm_group_label>
    <arm_group_label>Urban/Suburban Living Community Member</arm_group_label>
    <other_name>Personal Interview</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Urban or rural living residents of New Mexico currently living under the &quot;stay at home&quot;&#xD;
        emergency secondary to COVID-19&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Urban and rural living residents of New Mexico, any gender, gender identity, any&#xD;
             ethnic origin, any health status (healthy, chronic, disabled), and adult age from&#xD;
             18-85&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-New Mexico residents, adults unable to give consent due to cognition or&#xD;
             incarceration status&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carla Wilhite, DOT</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of New Mexico</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of New Mexico Department of Pediatrics</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 11, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>May 28, 2020</last_update_submitted>
  <last_update_submitted_qc>May 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of New Mexico</investigator_affiliation>
    <investigator_full_name>Carla S. Wilhite</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Quality of Life</keyword>
  <keyword>Rural Community</keyword>
  <keyword>COVID-19</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified, aggregated data will be available</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>March 2021 (tentative) and will be available for three years</ipd_time_frame>
    <ipd_access_criteria>Written request from other academic research university</ipd_access_criteria>
  </patient_data>
  <pending_results>
    <submitted>June 27, 2023</submitted>
  </pending_results>
  <!-- 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/NCT04409535
org study id: 20-266
nct id: NCT04409535
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
There is a critical need to determine the impact of the COVID-19 emergency on the
      comprehensive well-being of people as they are living through the emergency and sequelae of
      the emergency period. The research team is requesting National Institutes of Health funding
      with the goal to investigate rural vs. urban living people's response to the crisis and its
      impact using mixed methods research.
The state of New Mexico and the entire nation have entered an unprecedented health emergency
      created by the COVID-19 virus; affecting the lives of all people, many of whom were
      significantly unprepared for the disruptions the emergency created in daily life. Rural
      residents are at increased risk from effects of the emergency due to numerous disadvantages
      as compared to urban living people (i.e. critical care access, food insecurity, social
      isolation). Very little is known about how people are living through a national emergency
      event affecting all people of the nation. Therefore, a significant gap in knowledge exists:
      1. How are rural-living vs. urban-living people responding physically and mentally to the
      crisis? 2. What strategies of resilience are employed by people living in rural vs. urban
      counties? 3. What are perceptions of access to critical supplies and services in urban vs.
      rural counties; 4. How is the availability and use of technology used for news, reliable
      information, and communication? and 5. Use of time: what alterations in daily life self-care,
      care of others, commerce, and valued routines in urban vs. rural counties are occurring?
observational model: Ecologic or Community
time perspective: Other
measure: World Health Organization Quality of Life-Brief Scale
time frame: From enrollment until post-event (Feb. 2021)
description: participant responses about quality of life during COVID-19 emergency
measure: Open-ended Interview
time frame: From enrollment until post-event (Feb. 2021)
description: Participants responses to open-ended interview questions regarding alteration in daily life routines
arm group label: Rural Living Community Member
description: Adult residents of a New Mexico rural county (as federally designated)
arm group label: Urban/Suburban Living Community Member
description: Comparison group: adult resident of a New Mexico urban/suburban city or town (as federally designated)
intervention type: Other
intervention name: WHOQOL-BREF survey
description: Participants will be surveyed and interviewed about their perceptions regarding COVID-19 health emergency
arm group label: Rural Living Community Member
arm group label: Urban/Suburban Living Community Member
other name: Personal Interview
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Carla Wilhite, DOT
role: Principal Investigator
affiliation: University of New Mexico
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of New Mexico
investigator full name: Carla S. Wilhite
investigator title: Assistant Professor
mesh term: COVID-19
mesh term: Emergencies
sharing ipd: Yes
ipd description: De-identified, aggregated data will be available
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: March 2021 (tentative) and will be available for three years
ipd access criteria: Written request from other academic research university
submitted: June 27, 2023