<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/NCT03796689</url>
  </required_header>
  <id_info>
    <org_study_id>18-254-53</org_study_id>
    <nct_id>NCT03796689</nct_id>
  </id_info>
  <brief_title>The PCORnet Blood Pressure Home Monitoring Study</brief_title>
  <acronym>BP Home</acronym>
  <official_title>The PCORnet Blood Pressure Home Monitoring Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The PCORnet Blood Pressure Home Monitoring (BP HOME) Study is a patient-level randomized&#xD;
      controlled trial that will compare the effectiveness of home blood pressure monitoring (HPBM)&#xD;
      with versus without a linked Smartphone application (&quot;app&quot;) for helping patients with&#xD;
      uncontrolled hypertension achieve a reduction in systolic blood pressure. The trial will be&#xD;
      conducted within the National Patient-Centered Clinical Research Network (PCORnet), which&#xD;
      supports a research network that enables distributed querying of EHR data in a common data&#xD;
      model. It will also use the Eureka Research Platform, an online research platform hosted by&#xD;
      UCSF that supports eConsent, online surveys, and data collection from devices such as HBPMs.&#xD;
      Data from these two data sources will be used together to accomplish the study aims. Given&#xD;
      that HBPM is the guideline-recommended standard of care (without specification of Smartphone&#xD;
      linkage), the HPBM devices and the app are all commercially available and currently in use,&#xD;
      and that clinicians, with input from patients, will maintain full control of how BP is&#xD;
      clinically managed, we believe participation in the project poses minimal risk to&#xD;
      participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We have designed a patient-level randomized controlled trial that will compare the&#xD;
      effectiveness of Smartphone-linked versus standard HBPM for helping patients with&#xD;
      uncontrolled hypertension achieve a reduction in their Systolic Blood Pressure (SBP), and&#xD;
      patient satisfaction with the device. Our original plan was to recruit 2000 patients who&#xD;
      would be randomized in a 1:1 ratio to receive a Smartphone-linked or standard HBPM. However,&#xD;
      to recruit higher diversity with more African Americans and LatinX patients, we extended the&#xD;
      recruitment period.* We will use data from the electronic health record (EHR), an online&#xD;
      patient portal, and the home BP monitor (in the Smartphone-linked arm) to collect outcome&#xD;
      data for a period of at least 6 months (for the primary outcome), and up to 18 months (for&#xD;
      secondary outcomes, depending on enrollment date). The primary BP control outcome will be&#xD;
      reduction in SBP, by clinic measurements, at 6 months. The primary patient satisfaction&#xD;
      outcome will be the Net Promoter Score derived from self-reported likelihood of recommending&#xD;
      the device to a friend, at 6 months.&#xD;
&#xD;
      *edited after completing recruitment&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 15, 2019</start_date>
  <completion_date type="Actual">October 23, 2021</completion_date>
  <primary_completion_date type="Actual">October 23, 2021</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Systolic Blood Pressure (SBP)</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Change is defined by the absolute difference between the SBP measured at the most recent outpatient clinical encounter at the time of enrollment, and the SBP measured at the most recent outpatient clinical encounter 6 months after enrollment. If more than 1 measurement is recorded during a single clinical encounter, the lower/lowest will be used.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Net Promoter Score</measure>
    <time_frame>6 months</time_frame>
    <description>This score is assessed by asking a single question about likelihood of recommending the device to a friend, with options from 1-10 (10 being extremely likely). As per published methods, persons indicating 9 or 10 are considered &quot;Promoters&quot;; persons indicating 7 or 8 are &quot;Passives&quot;; and persons indicating 1-6 are &quot;Detractors&quot;. The score is calculated by taking the percent of Promoters and subtracting the percent of Detractors, yielding a score for each group ranging from -100 to 100, with higher scores indicating a better outcome.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2238</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Smartphone-linked</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Smartphone-linked HBPM and associated app</intervention_name>
    <description>Participants in the Smartphone-linked arm of the study will receive an Omron 786N Home Blood Pressure Monitor (HBPM) that can be linked to the Omron Connect app via Bluetooth. They will also receive instructions about how to use their device and download the app and will be provided with publicly available guidelines for HBPM. Participants will be instructed to use their device and app to take readings which they can track over time and share with their provider using the app.</description>
    <arm_group_label>Smartphone-linked</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard HBPM</intervention_name>
    <description>Participants in the Standard arm of the study will receive an Omron 785N Home Blood Pressure Monitor (HBPM), instructions about how to use their device and publicly available guidelines for HBPM. They will be instructed to use their device to take readings which they can track over time and share with their provider.</description>
    <arm_group_label>Standard</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  At least one ambulatory visit in one of the participating study sites during the past&#xD;
             year&#xD;
&#xD;
          -  SBP &gt; 145 mmHg at most recent clinic visit (may be treated with BP meds already or&#xD;
             not)&#xD;
&#xD;
          -  A self-reported commitment to &quot;work on lowering your blood pressure by 10 points or&#xD;
             more to reduce your risk of heart attack and stroke&quot;&#xD;
&#xD;
          -  Owns a Smartphone (Android or iOS)&#xD;
&#xD;
          -  Willing to receive text messages from the study&#xD;
&#xD;
          -  Can read/write English well enough to use English-based Smartphone apps and fill out&#xD;
             online surveys in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has an arm circumference &lt;22 cm or &gt;42 cm&#xD;
&#xD;
          -  Owns a functioning HPBM and has used it in the last 3 months&#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>Mark Pletcher, MD MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida Health</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Adler NE, Epel ES, Castellazzo G, Ickovics JR. Relationship of subjective and objective social status with psychological and physiological functioning: preliminary data in healthy white women. Health Psychol. 2000 Nov;19(6):586-92. doi: 10.1037//0278-6133.19.6.586.</citation>
    <PMID>11129362</PMID>
  </reference>
  <reference>
    <citation>Hamilton DF, Lane JV, Gaston P, Patton JT, Macdonald DJ, Simpson AH, Howie CR. Assessing treatment outcomes using a single question: the net promoter score. Bone Joint J. 2014 May;96-B(5):622-8. doi: 10.1302/0301-620X.96B5.32434.</citation>
    <PMID>24788496</PMID>
  </reference>
  <reference>
    <citation>Krol MW, de Boer D, Delnoij DM, Rademakers JJ. The Net Promoter Score--an asset to patient experience surveys? Health Expect. 2015 Dec;18(6):3099-109. doi: 10.1111/hex.12297. Epub 2014 Oct 27.</citation>
    <PMID>25345554</PMID>
  </reference>
  <results_reference>
    <citation>Pletcher MJ, Fontil V, Modrow MF, Carton T, Chamberlain AM, Todd J, O'Brien EC, Sheer A, Vittinghoff E, Park S, Orozco J, Lin F, Maeztu C, Wozniak G, Rakotz M, Shay CM, Cooper-DeHoff RM. Effectiveness of Standard vs Enhanced Self-measurement of Blood Pressure Paired With a Connected Smartphone Application: A Randomized Clinical Trial. JAMA Intern Med. 2022 Oct 1;182(10):1025-1034. doi: 10.1001/jamainternmed.2022.3355. Erratum In: JAMA Intern Med. 2023 Mar 1;183(3):278.</citation>
    <PMID>35969408</PMID>
  </results_reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <results_first_submitted>September 12, 2022</results_first_submitted>
  <results_first_submitted_qc>October 24, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">November 16, 2022</results_first_posted>
  <last_update_submitted>October 24, 2022</last_update_submitted>
  <last_update_submitted_qc>October 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 28, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/89/NCT03796689/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Patients meeting screening criteria were invited to participate by mail, email, phone, patient portal message or in person, and directed to the online study portal for eligibility assessment. The first participant was enrolled on August 15, 2019 and the last participant was enrolled on December 31, 2020.</recruitment_details>
      <pre_assignment_details>137 participants who withdrew consent prior to randomization or did not complete their baseline surveys were excluded.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Smartphone-linked</title>
          <description>Smartphone-linked HBPM and associated app: Participants in the Smartphone-linked arm of the study will receive an Omron 786N Home Blood Pressure Monitor (HBPM) that can be linked to the Omron Connect app via Bluetooth. They will also receive instructions about how to use their device and download the app and will be provided with publicly available guidelines for HBPM. Participants will be instructed to use their device and app to take readings which they can track over time and share with their provider using the app.</description>
        </group>
        <group group_id="P2">
          <title>Standard</title>
          <description>Standard HBPM: Participants in the Standard arm of the study will receive an Omron 785N Home Blood Pressure Monitor (HBPM), instructions about how to use their device and publicly available guidelines for HBPM. They will be instructed to use their device to take readings which they can track over time and share with their provider.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1051"/>
                <participants group_id="P2" count="1050"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1051"/>
                <participants group_id="P2" count="1050"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Smartphone-linked</title>
          <description>Smartphone-linked HBPM and associated app: Participants in the Smartphone-linked arm of the study will receive an Omron 786N Home Blood Pressure Monitor (HBPM) that can be linked to the Omron Connect app via Bluetooth. They will also receive instructions about how to use their device and download the app and will be provided with publicly available guidelines for HBPM. Participants will be instructed to use their device and app to take readings which they can track over time and share with their provider using the app.</description>
        </group>
        <group group_id="B2">
          <title>Standard</title>
          <description>Standard HBPM: Participants in the Standard arm of the study will receive an Omron 785N Home Blood Pressure Monitor (HBPM), instructions about how to use their device and publicly available guidelines for HBPM. They will be instructed to use their device to take readings which they can track over time and share with their provider.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1051"/>
            <count group_id="B2" value="1050"/>
            <count group_id="B3" value="2101"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59" spread="13"/>
                    <measurement group_id="B2" value="58" spread="13"/>
                    <measurement group_id="B3" value="58" spread="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Sex, male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="462"/>
                    <measurement group_id="B2" value="448"/>
                    <measurement group_id="B3" value="910"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sex, female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="589"/>
                    <measurement group_id="B2" value="602"/>
                    <measurement group_id="B3" value="1191"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race/Ethnicity</title>
              <category_list>
                <category>
                  <title>Non-Hispanic Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-Hispanic Black</title>
                  <measurement_list>
                    <measurement group_id="B1" value="239"/>
                    <measurement group_id="B2" value="226"/>
                    <measurement group_id="B3" value="465"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-Hispanic White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="676"/>
                    <measurement group_id="B2" value="666"/>
                    <measurement group_id="B3" value="1342"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic/LatinX, any race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="79"/>
                    <measurement group_id="B2" value="101"/>
                    <measurement group_id="B3" value="180"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-Hispanic, other/multiple races</title>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Subjective Social Status</title>
          <description>MacArthur Subjective Social Scale, 1-10 scale (10 = Best off; 1 = Worst off)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.2" spread="2.2"/>
                    <measurement group_id="B2" value="6.2" spread="2.2"/>
                    <measurement group_id="B3" value="6.2" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Eligibility systolic BP</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="157" spread="11"/>
                    <measurement group_id="B2" value="158" spread="12"/>
                    <measurement group_id="B3" value="157" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Eligibility diastolic BP</title>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="88" spread="11"/>
                    <measurement group_id="B2" value="88" spread="12"/>
                    <measurement group_id="B3" value="88" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Satisfaction with BP management</title>
          <description>1-5 scale (1 = Very Unsatisfied; 5 = Very Satisfied)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Overall</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.8" spread="1.1"/>
                    <measurement group_id="B2" value="3.7" spread="1.2"/>
                    <measurement group_id="B3" value="3.8" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Your healthcare provider</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.3" spread="1.1"/>
                    <measurement group_id="B2" value="4.3" spread="1.0"/>
                    <measurement group_id="B3" value="4.3" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Your BP medications</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.7" spread="1.2"/>
                    <measurement group_id="B2" value="3.7" spread="1.2"/>
                    <measurement group_id="B3" value="3.7" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Comfort using technology like a computer or smartphone</title>
          <description>1-5 scale (1 = Not at all comfortable; 5 = Very comfortable)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.1" spread="1.1"/>
                    <measurement group_id="B2" value="4.1" spread="1.1"/>
                    <measurement group_id="B3" value="4.1" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Systolic Blood Pressure (SBP)</title>
        <description>Change is defined by the absolute difference between the SBP measured at the most recent outpatient clinical encounter at the time of enrollment, and the SBP measured at the most recent outpatient clinical encounter 6 months after enrollment. If more than 1 measurement is recorded during a single clinical encounter, the lower/lowest will be used.</description>
        <time_frame>Baseline and 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Smartphone-linked</title>
            <description>Smartphone-linked HBPM and associated app: Participants in the Smartphone-linked arm of the study will receive an Omron 786N Home Blood Pressure Monitor (HBPM) that can be linked to the Omron Connect app via Bluetooth. They will also receive instructions about how to use their device and download the app and will be provided with publicly available guidelines for HBPM. Participants will be instructed to use their device and app to take readings which they can track over time and share with their provider using the app.</description>
          </group>
          <group group_id="O2">
            <title>Standard</title>
            <description>Standard HBPM: Participants in the Standard arm of the study will receive an Omron 785N Home Blood Pressure Monitor (HBPM), instructions about how to use their device and publicly available guidelines for HBPM. They will be instructed to use their device to take readings which they can track over time and share with their provider.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Systolic Blood Pressure (SBP)</title>
          <description>Change is defined by the absolute difference between the SBP measured at the most recent outpatient clinical encounter at the time of enrollment, and the SBP measured at the most recent outpatient clinical encounter 6 months after enrollment. If more than 1 measurement is recorded during a single clinical encounter, the lower/lowest will be used.</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1051"/>
                <count group_id="O2" value="1050"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.8" spread="18"/>
                    <measurement group_id="O2" value="10.6" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Net Promoter Score</title>
        <description>This score is assessed by asking a single question about likelihood of recommending the device to a friend, with options from 1-10 (10 being extremely likely). As per published methods, persons indicating 9 or 10 are considered &quot;Promoters&quot;; persons indicating 7 or 8 are &quot;Passives&quot;; and persons indicating 1-6 are &quot;Detractors&quot;. The score is calculated by taking the percent of Promoters and subtracting the percent of Detractors, yielding a score for each group ranging from -100 to 100, with higher scores indicating a better outcome.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Smartphone-linked</title>
            <description>Smartphone-linked HBPM and associated app: Participants in the Smartphone-linked arm of the study will receive an Omron 786N Home Blood Pressure Monitor (HBPM) that can be linked to the Omron Connect app via Bluetooth. They will also receive instructions about how to use their device and download the app and will be provided with publicly available guidelines for HBPM. Participants will be instructed to use their device and app to take readings which they can track over time and share with their provider using the app.</description>
          </group>
          <group group_id="O2">
            <title>Standard</title>
            <description>Standard HBPM: Participants in the Standard arm of the study will receive an Omron 785N Home Blood Pressure Monitor (HBPM), instructions about how to use their device and publicly available guidelines for HBPM. They will be instructed to use their device to take readings which they can track over time and share with their provider.</description>
          </group>
        </group_list>
        <measure>
          <title>Net Promoter Score</title>
          <description>This score is assessed by asking a single question about likelihood of recommending the device to a friend, with options from 1-10 (10 being extremely likely). As per published methods, persons indicating 9 or 10 are considered &quot;Promoters&quot;; persons indicating 7 or 8 are &quot;Passives&quot;; and persons indicating 1-6 are &quot;Detractors&quot;. The score is calculated by taking the percent of Promoters and subtracting the percent of Detractors, yielding a score for each group ranging from -100 to 100, with higher scores indicating a better outcome.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1051"/>
                <count group_id="O2" value="1050"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59" spread="2.81"/>
                    <measurement group_id="O2" value="57" spread="4.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Not applicable: adverse events were not collected.</time_frame>
      <desc>Adverse events were not collected.</desc>
      <group_list>
        <group group_id="E1">
          <title>Smartphone-linked</title>
          <description>Smartphone-linked HBPM and associated app: Participants in the Smartphone-linked arm of the study will receive an Omron 786N Home Blood Pressure Monitor (HBPM) that can be linked to the Omron Connect app via Bluetooth. They will also receive instructions about how to use their device and download the app and will be provided with publicly available guidelines for HBPM. Participants will be instructed to use their device and app to take readings which they can track over time and share with their provider using the app.</description>
        </group>
        <group group_id="E2">
          <title>Standard</title>
          <description>Standard HBPM: Participants in the Standard arm of the study will receive an Omron 785N Home Blood Pressure Monitor (HBPM), instructions about how to use their device and publicly available guidelines for HBPM. They will be instructed to use their device to take readings which they can track over time and share with their provider.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Mark Pletcher, Professor</name_or_title>
      <organization>University of California, San Fransico</organization>
      <phone>415-514-8008</phone>
      <email>mark.pletcher@ucsf.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03796689
org study id: 18-254-53
nct id: NCT03796689
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
The PCORnet Blood Pressure Home Monitoring (BP HOME) Study is a patient-level randomized
      controlled trial that will compare the effectiveness of home blood pressure monitoring (HPBM)
      with versus without a linked Smartphone application ("app") for helping patients with
      uncontrolled hypertension achieve a reduction in systolic blood pressure. The trial will be
      conducted within the National Patient-Centered Clinical Research Network (PCORnet), which
      supports a research network that enables distributed querying of EHR data in a common data
      model. It will also use the Eureka Research Platform, an online research platform hosted by
      UCSF that supports eConsent, online surveys, and data collection from devices such as HBPMs.
      Data from these two data sources will be used together to accomplish the study aims. Given
      that HBPM is the guideline-recommended standard of care (without specification of Smartphone
      linkage), the HPBM devices and the app are all commercially available and currently in use,
      and that clinicians, with input from patients, will maintain full control of how BP is
      clinically managed, we believe participation in the project poses minimal risk to
      participants.
We have designed a patient-level randomized controlled trial that will compare the
      effectiveness of Smartphone-linked versus standard HBPM for helping patients with
      uncontrolled hypertension achieve a reduction in their Systolic Blood Pressure (SBP), and
      patient satisfaction with the device. Our original plan was to recruit 2000 patients who
      would be randomized in a 1:1 ratio to receive a Smartphone-linked or standard HBPM. However,
      to recruit higher diversity with more African Americans and LatinX patients, we extended the
      recruitment period.* We will use data from the electronic health record (EHR), an online
      patient portal, and the home BP monitor (in the Smartphone-linked arm) to collect outcome
      data for a period of at least 6 months (for the primary outcome), and up to 18 months (for
      secondary outcomes, depending on enrollment date). The primary BP control outcome will be
      reduction in SBP, by clinic measurements, at 6 months. The primary patient satisfaction
      outcome will be the Net Promoter Score derived from self-reported likelihood of recommending
      the device to a friend, at 6 months.

      *edited after completing recruitment
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Systolic Blood Pressure (SBP)
time frame: Baseline and 6 months
description: Change is defined by the absolute difference between the SBP measured at the most recent outpatient clinical encounter at the time of enrollment, and the SBP measured at the most recent outpatient clinical encounter 6 months after enrollment. If more than 1 measurement is recorded during a single clinical encounter, the lower/lowest will be used.
measure: Net Promoter Score
time frame: 6 months
description: This score is assessed by asking a single question about likelihood of recommending the device to a friend, with options from 1-10 (10 being extremely likely). As per published methods, persons indicating 9 or 10 are considered "Promoters"; persons indicating 7 or 8 are "Passives"; and persons indicating 1-6 are "Detractors". The score is calculated by taking the percent of Promoters and subtracting the percent of Detractors, yielding a score for each group ranging from -100 to 100, with higher scores indicating a better outcome.
arm group label: Smartphone-linked
arm group type: Experimental
arm group label: Standard
arm group type: Active Comparator
intervention type: Device
intervention name: Smartphone-linked HBPM and associated app
description: Participants in the Smartphone-linked arm of the study will receive an Omron 786N Home Blood Pressure Monitor (HBPM) that can be linked to the Omron Connect app via Bluetooth. They will also receive instructions about how to use their device and download the app and will be provided with publicly available guidelines for HBPM. Participants will be instructed to use their device and app to take readings which they can track over time and share with their provider using the app.
arm group label: Smartphone-linked
intervention type: Device
intervention name: Standard HBPM
description: Participants in the Standard arm of the study will receive an Omron 785N Home Blood Pressure Monitor (HBPM), instructions about how to use their device and publicly available guidelines for HBPM. They will be instructed to use their device to take readings which they can track over time and share with their provider.
arm group label: Standard
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mark Pletcher, MD MPH
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Adler NE, Epel ES, Castellazzo G, Ickovics JR. Relationship of subjective and objective social status with psychological and physiological functioning: preliminary data in healthy white women. Health Psychol. 2000 Nov;19(6):586-92. doi: 10.1037//0278-6133.19.6.586.
PMID: 11129362
citation: Hamilton DF, Lane JV, Gaston P, Patton JT, Macdonald DJ, Simpson AH, Howie CR. Assessing treatment outcomes using a single question: the net promoter score. Bone Joint J. 2014 May;96-B(5):622-8. doi: 10.1302/0301-620X.96B5.32434.
PMID: 24788496
citation: Krol MW, de Boer D, Delnoij DM, Rademakers JJ. The Net Promoter Score--an asset to patient experience surveys? Health Expect. 2015 Dec;18(6):3099-109. doi: 10.1111/hex.12297. Epub 2014 Oct 27.
PMID: 25345554
citation: Pletcher MJ, Fontil V, Modrow MF, Carton T, Chamberlain AM, Todd J, O'Brien EC, Sheer A, Vittinghoff E, Park S, Orozco J, Lin F, Maeztu C, Wozniak G, Rakotz M, Shay CM, Cooper-DeHoff RM. Effectiveness of Standard vs Enhanced Self-measurement of Blood Pressure Paired With a Connected Smartphone Application: A Randomized Clinical Trial. JAMA Intern Med. 2022 Oct 1;182(10):1025-1034. doi: 10.1001/jamainternmed.2022.3355. Erratum In: JAMA Intern Med. 2023 Mar 1;183(3):278.
PMID: 35969408
responsible party type: Sponsor
mesh term: Hypertension
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 