<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/NCT04480411</url>
  </required_header>
  <id_info>
    <org_study_id>56472</org_study_id>
    <nct_id>NCT04480411</nct_id>
  </id_info>
  <brief_title>Use of Technology and Telemedicine to Improve Quality of Care in COVID 19 Patients</brief_title>
  <official_title>Use of Technology and Telemedicine to Improve Quality of Care in COVID 19 Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the use of technology including remote vital sign&#xD;
      monitoring in improving quality of patient care, decreasing hospital admissions and&#xD;
      re-admissions, decreasing hospital length of stay and decreasing use of personal protective&#xD;
      equipment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Unavailable IT resources&#xD;
  </why_stopped>
  <start_date type="Anticipated">January 2022</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient provider experience survey score</measure>
    <time_frame>Once after completion of device use (up to 15 minutes to complete the survey)</time_frame>
    <description>Five questions related to satisfaction with experience using home pulse oximetry, each on a scale of 1 (poor) to 5 (excellent) summed and averaged for an overall range of 1 to 5 (higher scores = better experience).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Provider experience survey score</measure>
    <time_frame>Once after completion of device use (up to 15 minutes to complete the survey)</time_frame>
    <description>Four questions related to satisfaction with experience using home pulse oximetry, each on a scale of 1 (poor) to 5 (excellent) summed and averaged for an overall range of 1 to 4 (higher scores = better experience).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Use of personal protective improvement</measure>
    <time_frame>6 months</time_frame>
    <description>Level of personal protective improvement in an in-patient setting.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of in-patient encounters with COVID patients as a measure of provider exposure to high risk illness</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Diagnoses Disease</condition>
  <condition>Covid19</condition>
  <arm_group>
    <arm_group_label>COVID-19 Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients that are admitted to the hospital with COVID 19.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Doctorgram Patient Kit</intervention_name>
    <description>Participants will use the Doctorgram Patient Kit for remote monitoring and remote use stethoscope.</description>
    <arm_group_label>COVID-19 Patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hospitalized patient with COVID 19 or outpatient under investigation for or diagnosed&#xD;
             with COVID 19&#xD;
&#xD;
          -  Clinically stable (on 4L O2 or less, non ICU)&#xD;
&#xD;
          -  Demonstrates ability to be trained in use of digital stethoscope technology&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Delirium&#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>Ritu Parikh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Julieta M Gabiola, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nicholas Scoulios, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lisa Shieh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>January 14, 2022</last_update_submitted>
  <last_update_submitted_qc>January 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Telemedicine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04480411
org study id: 56472
nct id: NCT04480411
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this study is to assess the use of technology including remote vital sign
      monitoring in improving quality of patient care, decreasing hospital admissions and
      re-admissions, decreasing hospital length of stay and decreasing use of personal protective
      equipment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Patient provider experience survey score
time frame: Once after completion of device use (up to 15 minutes to complete the survey)
description: Five questions related to satisfaction with experience using home pulse oximetry, each on a scale of 1 (poor) to 5 (excellent) summed and averaged for an overall range of 1 to 5 (higher scores = better experience).
measure: Provider experience survey score
time frame: Once after completion of device use (up to 15 minutes to complete the survey)
description: Four questions related to satisfaction with experience using home pulse oximetry, each on a scale of 1 (poor) to 5 (excellent) summed and averaged for an overall range of 1 to 4 (higher scores = better experience).
measure: Use of personal protective improvement
time frame: 6 months
description: Level of personal protective improvement in an in-patient setting.
measure: Number of in-patient encounters with COVID patients as a measure of provider exposure to high risk illness
time frame: 6 months
arm group label: COVID-19 Patients
arm group type: Experimental
description: Patients that are admitted to the hospital with COVID 19.
intervention type: Behavioral
intervention name: Doctorgram Patient Kit
description: Participants will use the Doctorgram Patient Kit for remote monitoring and remote use stethoscope.
arm group label: COVID-19 Patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ritu Parikh, MD
role: Principal Investigator
affiliation: Stanford University
last name: Julieta M Gabiola, MD
role: Principal Investigator
affiliation: Stanford University
last name: Nicholas Scoulios, MD
role: Principal Investigator
affiliation: Stanford University
last name: Lisa Shieh, MD
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No