<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/NCT03800628</url>
  </required_header>
  <id_info>
    <org_study_id>09-06-2018-0576535</org_study_id>
    <nct_id>NCT03800628</nct_id>
  </id_info>
  <brief_title>Resource Availability Following Critical Illness</brief_title>
  <official_title>Perception of Quality of Life and Resource Availability After Surviving Critical Illness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Walden University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Walden 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 purpose of this qualitative study is to explore the vital issues in recovery of QOL from&#xD;
      the perspective of survivors of critical illness and understand these patients' views on&#xD;
      rehabilitative services in the United States (U.S.). The theoretical framework for this study&#xD;
      is Max Weber's Rational Choice Theory (RCT). The research questions will focus on&#xD;
      understanding post-ICU QOL and the patients' experience with rehabilitative services&#xD;
      following critical illness. A phenomenological study design is being employed, using&#xD;
      semi-structured individual interviews with critical illness survivors. Data from the&#xD;
      interviews will be coded for thematic analysis. The implications for social change include&#xD;
      defining the meaning of QOL for an ICU survivor and improving healthcare policies for the&#xD;
      therapies necessary to return survivors to a life worth living.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this qualitative study is to understand the patient perception of QOL after&#xD;
      surviving critical illness and how survivors can help illuminate gaps in current health&#xD;
      policies to provide better recovery resources for this growing population.&#xD;
&#xD;
      The central research questions are:&#xD;
&#xD;
      RQ1: What are the issues important to preserve quality of life from the perspective of&#xD;
      critical illness survivors? RQ2: How do survivors of critical illness describe rehabilitative&#xD;
      services after discharge?&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 7, 2018</start_date>
  <completion_date type="Anticipated">August 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>RQ1: What are the issues important to preserve quality of life from the perspective of critical illness survivors?</measure>
    <time_frame>6 months</time_frame>
    <description>semi-structured, open-ended qualitative interview</description>
  </primary_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Quality of Life</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>qualitative study</intervention_name>
    <description>semi-structured interviews</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        critical illness survivors&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  critical illness survivors within 18 months of ICU discharge&#xD;
&#xD;
          -  minimum 48 hours of mechanical ventilation&#xD;
&#xD;
          -  ability to read and understand English&#xD;
&#xD;
          -  over the age of 18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  emotional or psychological inability to participate in a 30-min interview&#xD;
&#xD;
          -  not meeting inclusion criteria&#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_contact>
    <last_name>Michelle M McMoon</last_name>
    <phone>410-300-2786</phone>
    <email>michelle.mcmoon@waldenu.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Wake Forest Baptist Health</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rita Bakhru, MD</last_name>
      <email>rbakhru@wakehealth.edu</email>
    </contact>
    <contact_backup>
      <last_name>Mary LaRose, RN</last_name>
      <phone>336-716-4155</phone>
      <email>mlarose@wakehealth.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>January 10, 2019</last_update_submitted>
  <last_update_submitted_qc>January 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Walden University</investigator_affiliation>
    <investigator_full_name>Michelle McMoon</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>survivor</keyword>
  <keyword>QOL</keyword>
  <keyword>resources</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</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/NCT03800628
org study id: 09-06-2018-0576535
nct id: NCT03800628
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this qualitative study is to explore the vital issues in recovery of QOL from
      the perspective of survivors of critical illness and understand these patients' views on
      rehabilitative services in the United States (U.S.). The theoretical framework for this study
      is Max Weber's Rational Choice Theory (RCT). The research questions will focus on
      understanding post-ICU QOL and the patients' experience with rehabilitative services
      following critical illness. A phenomenological study design is being employed, using
      semi-structured individual interviews with critical illness survivors. Data from the
      interviews will be coded for thematic analysis. The implications for social change include
      defining the meaning of QOL for an ICU survivor and improving healthcare policies for the
      therapies necessary to return survivors to a life worth living.
The purpose of this qualitative study is to understand the patient perception of QOL after
      surviving critical illness and how survivors can help illuminate gaps in current health
      policies to provide better recovery resources for this growing population.

      The central research questions are:

      RQ1: What are the issues important to preserve quality of life from the perspective of
      critical illness survivors? RQ2: How do survivors of critical illness describe rehabilitative
      services after discharge?
observational model: Other
time perspective: Other
measure: RQ1: What are the issues important to preserve quality of life from the perspective of critical illness survivors?
time frame: 6 months
description: semi-structured, open-ended qualitative interview
intervention type: Other
intervention name: qualitative study
description: semi-structured interviews
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michelle M McMoon
phone: 410-300-2786
email: michelle.mcmoon@waldenu.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Walden University
investigator full name: Michelle McMoon
investigator title: Principle Investigator
mesh term: Critical Illness
sharing ipd: Undecided