<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/NCT02217059</url>
  </required_header>
  <id_info>
    <org_study_id>UEMF0000</org_study_id>
    <nct_id>NCT02217059</nct_id>
  </id_info>
  <brief_title>Emergency Department Home Blood Pressure Monitoring and BpTRU Study</brief_title>
  <official_title>Congruence of Emergency Department Attendings' Predictions of Hypertension With Results of Home Blood Pressure Monitoring</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rhode Island Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rhode Island Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the Congruence of Emergency Department (ED)&#xD;
      Attendings' Predictions of Hypertension with Results of Home Blood Pressure Monitoring.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Evaluate the Congruence of Emergency Department (ED) Attendings' Predictions of Hypertension&#xD;
      with Results of Home Blood Pressure Monitoring &amp; evaluate reliability of ED measured elevated&#xD;
      blood pressure compared to the BpTRU&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</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>The percentage of emergency department attendings that accurately predict which patients meet criteria for hypertension in two week follow-up using home blood pressure monitoring.</measure>
    <time_frame>18 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The predictive value of the emergency department measured blood pressure by the standard ED blood pressure device, BpTRU device, and home blood pressure device for hypertension in follow-up</measure>
    <time_frame>18 months</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">105</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Prehypertension</arm_group_label>
    <description>Using the JNC7 definition</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage I Hypertension</arm_group_label>
    <description>Using the JNC7 definition</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage II Hypertension</arm_group_label>
    <description>Using the JNC7 definition</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Emergency Department&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  One elevated blood pressure greater than 120 systolic and/or 80 diastolic&#xD;
&#xD;
          -  BpTRU device blood pressure greater than 120 systolic and/or 80 diastolic while in ED&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior history of hypertension&#xD;
&#xD;
          -  Currently on antihypertensives or receiving prescription on discharge&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  History of atrial fibrillation&#xD;
&#xD;
          -  Dialysis patient&#xD;
&#xD;
          -  Nursing home or rehabilitation center resident&#xD;
&#xD;
          -  Admitted&#xD;
&#xD;
          -  Moving out of the area in next 30 days&#xD;
&#xD;
          -  Substance abuse&#xD;
&#xD;
          -  Prisoner&#xD;
&#xD;
          -  Presenting for psychiatric complaint requiring constant observation&#xD;
&#xD;
          -  Inability to give informed consent (intoxicated, altered, non-English speaking)&#xD;
&#xD;
          -  Presenting with symptoms of hypertensive emergency&#xD;
&#xD;
          -  Inability to demonstrate adequate use of the home blood pressure device in the ED&#xD;
&#xD;
          -  Arm circumference less than 9 inches or greater than 17 inches&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Rhode Island Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>November 27, 2017</last_update_submitted>
  <last_update_submitted_qc>November 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Emergency Medical Services</keyword>
  <keyword>Emergency Care</keyword>
  <keyword>Hypertension</keyword>
  <keyword>BpTRU</keyword>
  <keyword>Blood pressure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Emergencies</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/NCT02217059
org study id: UEMF0000
nct id: NCT02217059
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the Congruence of Emergency Department (ED)
      Attendings' Predictions of Hypertension with Results of Home Blood Pressure Monitoring.
Evaluate the Congruence of Emergency Department (ED) Attendings' Predictions of Hypertension
      with Results of Home Blood Pressure Monitoring & evaluate reliability of ED measured elevated
      blood pressure compared to the BpTRU
observational model: Cohort
time perspective: Prospective
measure: The percentage of emergency department attendings that accurately predict which patients meet criteria for hypertension in two week follow-up using home blood pressure monitoring.
time frame: 18 months
measure: The predictive value of the emergency department measured blood pressure by the standard ED blood pressure device, BpTRU device, and home blood pressure device for hypertension in follow-up
time frame: 18 months
arm group label: Prehypertension
description: Using the JNC7 definition
arm group label: Stage I Hypertension
description: Using the JNC7 definition
arm group label: Stage II Hypertension
description: Using the JNC7 definition
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Emergencies
sharing ipd: No