<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/NCT03291535</url>
  </required_header>
  <id_info>
    <org_study_id>12397</org_study_id>
    <nct_id>NCT03291535</nct_id>
  </id_info>
  <brief_title>Virtual Hypertension Management Pilot</brief_title>
  <official_title>Virtual Hypertension Management Pilot: Randomized Evaluation of Electronic Health Record-connected Blood Pressure Cuffs in a Clinical Pharmacist Panel.</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigators are examining the quality improvement impact of providing patients with a an&#xD;
      electronic health record-connected blood pressure cuff. Investigators will give half of&#xD;
      patients already eligible for hypertension management within a clinical pharmacist panel, the&#xD;
      ability to upload their blood pressure data into Stanford's electronic health record.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 26, 2017</start_date>
  <completion_date type="Actual">March 1, 2022</completion_date>
  <primary_completion_date type="Actual">March 1, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in blood pressure over time in control group vs. the intervention group</measure>
    <time_frame>From enrollment to 6 months later</time_frame>
    <description>Difference in the change in blood pressure between the control group and intervention group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient visits</measure>
    <time_frame>From enrollment to 6 months later</time_frame>
    <description>Measurement of the number of in-person visits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient remote interactions</measure>
    <time_frame>From enrollment to 6 months later</time_frame>
    <description>Measurement of the number of patient phone calls plus patient-portal messages to the clinical pharmacist</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication changes</measure>
    <time_frame>From enrollment to 6 months later</time_frame>
    <description>Number of changes in medication or medication dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure control</measure>
    <time_frame>From enrollment to 6 months later</time_frame>
    <description>Time to reach target blood pressure control (Adults 18-59 years of age &lt;140/90 mm Hg, Adults 60-85 years of age, without a diagnosis of diabetes, &lt;150/90 mm Hg, Adults 60-85 years of age, with a diagnosis of diabetes, &lt;140/90 mm Hg)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Hypertension</condition>
  <condition>Electronic Health Record</condition>
  <condition>Digital Health</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>This arm will consist of the usual care of management of hypertension by a clinical pharmacist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm will consistent of usual care plus the addition of a blood pressure cuff that will allow patients to upload data to the electronic health record via a secure portal.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Connected-device</intervention_name>
    <description>This intervention will allow patients to upload blood pressure data automatically from a blood pressure cuff into the electronic health record.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <description>This intervention will consist of usual clinical care as determined by the clinical pharmacist.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hypertension as defined by clinical pharmacist usual care panel (2 or more readings of&#xD;
             blood pressure &gt;140/90)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Chronic kidney disease III or IV&#xD;
&#xD;
          -  Systolic heart failure with ejection fraction &lt;35%&#xD;
&#xD;
          -  Current use of 3 or more anti-hypertension drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Stanford Primary Care</name>
      <address>
        <city>Portola Valley</city>
        <state>California</state>
        <zip>94028</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford Primary Care Clinic</name>
      <address>
        <city>Santa Clara</city>
        <state>California</state>
        <zip>95054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>August 18, 2022</last_update_submitted>
  <last_update_submitted_qc>August 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>N. Lance Downing, MD</investigator_full_name>
    <investigator_title>Clinical Assistant Professor of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Undecided, this is a quality improvement project.</ipd_description>
  </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/NCT03291535
org study id: 12397
nct id: NCT03291535
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Investigators are examining the quality improvement impact of providing patients with a an
      electronic health record-connected blood pressure cuff. Investigators will give half of
      patients already eligible for hypertension management within a clinical pharmacist panel, the
      ability to upload their blood pressure data into Stanford's electronic health record.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Change in blood pressure over time in control group vs. the intervention group
time frame: From enrollment to 6 months later
description: Difference in the change in blood pressure between the control group and intervention group.
measure: Patient visits
time frame: From enrollment to 6 months later
description: Measurement of the number of in-person visits
measure: Patient remote interactions
time frame: From enrollment to 6 months later
description: Measurement of the number of patient phone calls plus patient-portal messages to the clinical pharmacist
measure: Medication changes
time frame: From enrollment to 6 months later
description: Number of changes in medication or medication dose
measure: Blood pressure control
time frame: From enrollment to 6 months later
description: Time to reach target blood pressure control (Adults 18-59 years of age <140/90 mm Hg, Adults 60-85 years of age, without a diagnosis of diabetes, <150/90 mm Hg, Adults 60-85 years of age, with a diagnosis of diabetes, <140/90 mm Hg)
arm group label: Control
arm group type: Placebo Comparator
description: This arm will consist of the usual care of management of hypertension by a clinical pharmacist.
arm group label: Intervention
arm group type: Active Comparator
description: This arm will consistent of usual care plus the addition of a blood pressure cuff that will allow patients to upload data to the electronic health record via a secure portal.
intervention type: Other
intervention name: Connected-device
description: This intervention will allow patients to upload blood pressure data automatically from a blood pressure cuff into the electronic health record.
arm group label: Intervention
intervention type: Other
intervention name: Usual care
description: This intervention will consist of usual clinical care as determined by the clinical pharmacist.
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: N. Lance Downing, MD
investigator title: Clinical Assistant Professor of Medicine
mesh term: Hypertension
sharing ipd: Undecided
ipd description: Undecided, this is a quality improvement project.