<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/NCT03288142</url>
  </required_header>
  <id_info>
    <org_study_id>STU00205025</org_study_id>
    <nct_id>NCT03288142</nct_id>
  </id_info>
  <brief_title>The Smart Hypertension Control Study</brief_title>
  <acronym>iSmartHyp</acronym>
  <official_title>Improving Hypertension Using a Smartphone-Enabled Personal Control Program: The Smart Hypertension Control Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Omron Healthcare Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Northwestern University</source>
  <oversight_info>
    <has_dmc>Yes</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 at Northwestern University will partner with Omron Healthcare Co., Ltd.&#xD;
      (hereinafter referred to as &quot;Omron&quot;) to conduct a randomized controlled trial of a&#xD;
      hypertension personal control program (HPCP), known as Lark HTN Pro with a home blood&#xD;
      pressure monitoring device (HBMD) compared to a HBMD alone. The overarching goal of this&#xD;
      study is to investigate the effects of the HPCP on blood pressure, blood pressure&#xD;
      self-management behaviors, and healthy lifestyle behaviors among adults with hypertension.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study team used structured language queries of electronic health record data from the&#xD;
      Northwestern Medicine Enterprise Data Warehouse (NMEDW) to identify potentially-eligible&#xD;
      participants with elevated blood pressure and exclude patients with clinical exclusion&#xD;
      criteria from Northwestern Medical Group outpatient practices. During the on-site visit&#xD;
      individuals were asked to provide written informed consent and have blood pressure measured&#xD;
      in a standardized fashion to see if this inclusion criteria is met.&#xD;
&#xD;
      We conducted a non-blinded randomized controlled trial among hypertensive adults in NMG&#xD;
      outpatient clinics. We randomized participants in a 1:1 fashion to the intervention group&#xD;
      (HPCP + HBMD) or the comparator group (HBMD alone). Randomization was performed using a&#xD;
      centralized computer-generated assignment sequence uploaded a priori to Northwestern&#xD;
      University's REDCap (Research Electronic Data Capture) application. Randomization was&#xD;
      stratified by: age (&lt;65 or ≥65 years of age) and baseline systolic blood pressure (&lt;145 or&#xD;
      ≥145 mmHg) to optimize the likelihood of obtaining similar populations in each treatment&#xD;
      group.&#xD;
&#xD;
      We recruited adults with elevated blood pressure as assessed by in-person standardized&#xD;
      examination at baseline. We measured change in blood pressure by in-person examination at 6&#xD;
      months. We recruited between 350 to 400 participants in order to have 333 participants with&#xD;
      analyzable data at the time of study completion. If changes were deemed necessary, a revision&#xD;
      to the study protocol was submitted to the IRB for review and approval prior to implementing&#xD;
      these changes.&#xD;
&#xD;
      Control group participants were provided with a home blood pressure monitoring device (HBMD)&#xD;
      (Omron BP761N Bluetooth Smart Automatic Upper Arm Blood Pressure Monitor) and will be&#xD;
      instructed in its use at the baseline study visit. Participant also received an information&#xD;
      sheet describing home blood pressure monitoring that gives advice for how to respond to&#xD;
      different home readings. At the baseline visit, participants were instructed to install an&#xD;
      Omron application to their smart phone device (to monitor use of the HBMD). Participants&#xD;
      continued to receive all routine care, including anti-hypertensive medications as prescribed&#xD;
      by their regular clinicians.&#xD;
&#xD;
      The intervention group received all the interventions provided to the control group.&#xD;
      Intervention group participants were sent a hyperlink to install the hypertension personal&#xD;
      control program (HPCP) (&quot;Lark HTN Pro&quot;), which is a smartphone application installed on their&#xD;
      iOS device during their initial office visit (screening/baseline) and successfully took a&#xD;
      reading from their HBMD. The HPCP has blood pressure, medication, and weight monitoring,&#xD;
      including periodic reminders for the user to measure blood pressure, measure weight, and take&#xD;
      their medication(s). The HPCP provides real-time feedback based on user input, such as&#xD;
      out-of-range measurements and has additional features designed to encourage behavior change&#xD;
      in areas such as dietary intake, physical activity, sleep, and stress reduction.&#xD;
&#xD;
      Study participants were required to return for a 6-month study visit (within 2 weeks before&#xD;
      to 4 weeks after). During the 6-month visit, subjects had their height/weight and blood&#xD;
      pressure measured again. Participants also repeated questionnaires related to their current&#xD;
      cardiovascular medications. They also completed questionnaires measuring: medication&#xD;
      adherence, self-efficacy, diet, physical activity, and sleep duration. An exit survey was&#xD;
      provided to participants at the end of the 6-month follow up visit to obtain feedback on Lark&#xD;
      and Omron apps usability.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 21, 2017</start_date>
  <completion_date type="Actual">December 1, 2019</completion_date>
  <primary_completion_date type="Actual">April 28, 2019</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>
    <intervention_model_description>Randomized controlled trial with randomization stratified by age and baseline systolic blood pressure.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood Pressure at 6 Months</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood Pressure &lt;140/90mmHg</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Antihypertensive Agents Used</measure>
    <time_frame>6 months</time_frame>
    <description>Number of self reported antihypertensive medication drug classes taken</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antihypertensive Medication Intensification, No. of Additions, Dose Increases, or Substitutions</measure>
    <time_frame>6 months</time_frame>
    <description>Number of antihypertensive drug classes that were increased, added or substituted for another drug class</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Health System Contacts (Telephone, Office, or Mychart Encounters)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Home Blood Pressure Measurements Per Month</measure>
    <time_frame>6 months</time_frame>
    <description>Frequency of home blood pressure measurements per month derived from home blood pressure monitor for months when home monitoring occurred</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Months When a Home Blood Pressure Reading is Obtained, No.</measure>
    <time_frame>6 months</time_frame>
    <description>Number of months out of the 6 month study period when at least one home blood pressure reading was obtained</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy: Confidence in Controlling High Blood Pressure</measure>
    <time_frame>6 months</time_frame>
    <description>Self reported response to :How confident are you that you will be able to get your blood pressure controlled and keep it there during the next few months? Reponses were on a 5-point scale ranging from (1) not at all confident to (5) extremely confident.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMI</measure>
    <time_frame>6 months</time_frame>
    <description>Body mass index is calculated as the weight in kilograms divided by height in meters squared.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diet Quality Score (as Assessed by Dietary Approaches to Stop Hypertension Questionnaire, DASH-Q</measure>
    <time_frame>6 months</time_frame>
    <description>Sum of responses represents intake of foods associated with the Dietary Approaches to Stop Hypertension diet. Range is from 0 to 77 with a higher score indicating better diet. Scores 32 and below indicate a low-quality diet, scores 33 to 51 indicate a medium-quality diet, and scores greater than or equal to 52 indicate a high-quality diet.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minutes Per Week of Self-reported Physical Activity</measure>
    <time_frame>6 months</time_frame>
    <description>Self-reported physical activity in minutes per week of at least moderate exercise</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported Sleep Duration</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">333</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Intervention: Hypertension Coaching Application and Home Monitor:</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention group will receive all the interventions provided to the control group. In addition, intervention group participants will install on their mobile phone the hypertension personal control program (HPCP) (&quot;Lark HTN Pro&quot;), which is a smartphone application. The intervention group will have the HPCP installed on their iOS device during their initial office visit (screening/baseline) and will successfully take a reading from their HBMD. The HPCP has blood pressure, medication, and weight monitoring, including periodic reminders for the user to measure blood pressure, measure weight, and take their medication(s). The HPCP provides real-time feedback based on user input, such as out-of-range measurements and has additional features designed to encourage behavior change in areas such as dietary intake, physical activity, sleep, and stress reduction. Users can set goals and receive guidance and feedback through the app.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control:Tracking Application and Home Monitor:</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control group participants will be provided with a home blood pressure monitoring device (HBMD) (Omron BP761N Bluetooth Smart Automatic Upper Arm Blood Pressure Monitor) and will be instructed in its use at the baseline study visit. Participants will also receive an information sheet describing home blood pressure monitoring that gives advice for how to respond to different home readings. At the baseline visit, participants will be instructed to install an Omron application to their smart phone device (to monitor use of the HBMD). Participants will continue to receive all routine care, including anti-hypertensive medications as prescribed by their regular clinicians.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hypertension Coaching Application and Home Monitor</intervention_name>
    <description>The intervention group will have the HPCP installed on their iOS device during their initial office visit (screening/baseline) and will successfully take a reading from their HBMD</description>
    <arm_group_label>Intervention: Hypertension Coaching Application and Home Monitor:</arm_group_label>
    <other_name>Lark HTN Pro</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control: Tracking Application and Home Monitor</intervention_name>
    <description>Control group participants will be provided with a home blood pressure monitoring device (HBMD) (Omron BP761N Bluetooth Smart Automatic Upper Arm Blood Pressure Monitor) and will be instructed in its use at the baseline study visit. Participants will also receive an information sheet describing home blood pressure monitoring that gives advice for how to respond to different home readings. At the baseline visit, participants will be instructed to install an Omron application to their smart phone device (to monitor use of the HBMD). Participants will continue to receive all routine care, including anti-hypertensive medications as prescribed by their regular clinicians.</description>
    <arm_group_label>Control:Tracking Application and Home Monitor:</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults aged 18 years to &lt;85 years at the time of screening&#xD;
&#xD;
          -  Standardized mean blood pressure measurement ≥135 to &lt;180 mmHg systolic or ≥85 to &lt;110&#xD;
             mmHg diastolic&#xD;
&#xD;
          -  Have and use an iOS device(s) (iPhone generation 5s or newer)&#xD;
&#xD;
          -  Able to provide written informed consent prior to participation in the study&#xD;
&#xD;
          -  Receive their primary care from a Northwestern Medicine clinic site&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current user of the HCPC (Lark HTN Pro)&#xD;
&#xD;
          -  Standardized mean blood pressure measurement ≥180 mmHg systolic or ≥110 mmHg diastolic&#xD;
&#xD;
          -  Persistent atrial fibrillation as indicated in the electronic health record (EHR)&#xD;
&#xD;
          -  Pregnant or planning to become pregnant during the study period&#xD;
&#xD;
          -  Severe kidney disease, defined as estimated glomerular filtration rate &lt;30 per 1.73 m2&#xD;
             or currently on renal replacement therapy (i.e. hemodialysis or peritoneal dialysis)&#xD;
&#xD;
          -  Hearing impaired and unable to respond to phone calls&#xD;
&#xD;
          -  Lack of fluency in English&#xD;
&#xD;
          -  History of a cardiovascular event (stroke, transient ischemic attack, myocardial&#xD;
             infarction, coronary artery bypass grafting) in the past 3 months&#xD;
&#xD;
          -  Diagnosis of dementia as indicated in the electronic health record&#xD;
&#xD;
          -  Diagnosis of psychosis as indicated in the electronic health record&#xD;
&#xD;
          -  Terminal cancer diagnosis or NYHA III or IV heart failure&#xD;
&#xD;
          -  Deemed unsuitable for study by primary care provider&#xD;
&#xD;
          -  Individuals requiring BP monitor cuff size larger than 17 inches or 42cm&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephen D Persell, MD/MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwestern Medical Group</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <results_first_submitted>October 6, 2020</results_first_submitted>
  <results_first_submitted_qc>April 14, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">April 15, 2022</results_first_posted>
  <last_update_submitted>April 14, 2022</last_update_submitted>
  <last_update_submitted_qc>April 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Stephen Persell, MD, MPH</investigator_full_name>
    <investigator_title>Associate 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>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>January 25, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT03288142/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Hypertension Coaching Application and Home Monitor</title>
          <description>The intervention group will receive all the interventions provided to the control group. In addition, intervention group participants will install on their mobile phone the hypertension personal control program (HPCP) (&quot;Lark HTN Pro&quot;), which is a smartphone application. The intervention group will have the HPCP installed on their iOS device during their initial office visit (screening/baseline) and will successfully take a reading from their HBMD. The HPCP has blood pressure, medication, and weight monitoring, including periodic reminders for the user to measure blood pressure, measure weight, and take their medication(s). The HPCP provides real-time feedback based on user input, such as out-of-range measurements and has additional features designed to encourage behavior change in areas such as dietary intake, physical activity, sleep, and stress reduction. Users can set goals and receive guidance and feedback through the app.</description>
        </group>
        <group group_id="P2">
          <title>Tracking Application and Home Monitor</title>
          <description>Control group participants will be provided with a home blood pressure monitoring device (HBMD) (Omron BP761N Bluetooth Smart Automatic Upper Arm Blood Pressure Monitor) and will be instructed in its use at the baseline study visit. Participants will also receive an information sheet describing home blood pressure monitoring that gives advice for how to respond to different home readings. At the baseline visit, participants will be instructed to install an Omron application to their smart phone device (to monitor use of the HBMD). Participants will continue to receive all routine care, including anti-hypertensive medications as prescribed by their regular clinicians.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="166"/>
                <participants group_id="P2" count="167"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="144"/>
                <participants group_id="P2" count="152"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>166 participants contributed data for the hypertension coaching application arm of the study. 167 participants from the tracking application arm contributed data to the study. Overall number of participants is 333. 22 participants from intervention arm were excluded from analyses for various reasons leaving 144 participants for analyses.1 missing data and 14 participants were lost to follow up and were excluded from analyses in the control arm which leaves us with 153 participants for analyses.</population>
      <group_list>
        <group group_id="B1">
          <title>Hypertension Coaching Application and Home Monitor</title>
          <description>Arm assigned hypertension coaching application and home monitor</description>
        </group>
        <group group_id="B2">
          <title>Tracking Application and Home Monitor</title>
          <description>Arm assigned tracking application and home monitor</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="144"/>
            <count group_id="B2" value="152"/>
            <count group_id="B3" value="296"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>22 participants from intervention arm were excluded from analyses for various reasons.14 participants were lost to follow up and were excluded from analyses in the control arm.</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59.6" spread="12.4"/>
                    <measurement group_id="B2" value="58.3" spread="13.2"/>
                    <measurement group_id="B3" value="58.9" spread="12.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="91"/>
                    <measurement group_id="B2" value="91"/>
                    <measurement group_id="B3" value="182"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <population>22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="134"/>
                    <measurement group_id="B2" value="139"/>
                    <measurement group_id="B3" value="273"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <population>22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="103"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                    <measurement group_id="B2" value="79"/>
                    <measurement group_id="B3" value="152"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education</title>
          <population>22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Less thank HS graduate</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 12 or GED</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>College 1-3y</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="55"/>
                  </measurement_list>
                </category>
                <category>
                  <title>College≥4</title>
                  <measurement_list>
                    <measurement group_id="B1" value="103"/>
                    <measurement group_id="B2" value="106"/>
                    <measurement group_id="B3" value="209"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Primary Language</title>
          <population>22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and participants were excluded from analyses in the control arm.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>English</title>
                  <measurement_list>
                    <measurement group_id="B1" value="141"/>
                    <measurement group_id="B2" value="143"/>
                    <measurement group_id="B3" value="284"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Refused</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>No. of antihypertensive agents used</title>
          <population>22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>0</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="87"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1</title>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="105"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="75"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥3</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body mass index</title>
          <description>weight in kilograms divided by height in meters squared.</description>
          <population>22 participants from intervention arm were excluded from analyses for various reasons. 14 participants were lost to follow up and were excluded from analyses in the control arm.</population>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.9" spread="8.3"/>
                    <measurement group_id="B2" value="31.7" spread="7.8"/>
                    <measurement group_id="B3" value="31.8" spread="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Blood Pressure at 6 Months</title>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Control group participants will be provided with a home blood pressure monitoring device (HBMD) (Omron BP761N Bluetooth Smart Automatic Upper Arm Blood Pressure Monitor) and will be instructed in its use at the baseline study visit. Participants will also receive an information sheet describing home blood pressure monitoring that gives advice for how to respond to different home readings. At the baseline visit, participants will be instructed to install an Omron application to their smart phone device (to monitor use of the HBMD). Participants will continue to receive all routine care, including anti-hypertensive medications as prescribed by their regular clinicians.</description>
          </group>
          <group group_id="O2">
            <title>Intervention</title>
            <description>The intervention group will receive all the interventions provided to the control group. In addition, intervention group participants will install on their mobile phone the hypertension personal control program (HPCP) (&quot;Lark HTN Pro&quot;), which is a smartphone application. The intervention group will have the HPCP installed on their iOS device during their initial office visit (screening/baseline) and will successfully take a reading from their HBMD. The HPCP has blood pressure, medication, and weight monitoring, including periodic reminders for the user to measure blood pressure, measure weight, and take their medication(s). The HPCP provides real-time feedback based on user input, such as out-of-range measurements and has additional features designed to encourage behavior change in areas such as dietary intake, physical activity, sleep, and stress reduction. Users can set goals and receive guidance and feedback through the app.&#xD;
Lark HTN Pro: The intervention group will have the HPCP</description>
          </group>
        </group_list>
        <measure>
          <title>Blood Pressure at 6 Months</title>
          <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="144"/>
                <count group_id="O2" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Systolic BP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="135.0" spread="13.9"/>
                    <measurement group_id="O2" value="132.3" spread="15.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic BP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.6" spread="9.8"/>
                    <measurement group_id="O2" value="85.1" spread="9.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Blood Pressure &lt;140/90mmHg</title>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Control group participants will be provided with a home blood pressure monitoring device (HBMD) (Omron BP761N Bluetooth Smart Automatic Upper Arm Blood Pressure Monitor) and will be instructed in its use at the baseline study visit. Participants will also receive an information sheet describing home blood pressure monitoring that gives advice for how to respond to different home readings. At the baseline visit, participants will be instructed to install an Omron application to their smart phone device (to monitor use of the HBMD). Participants will continue to receive all routine care, including anti-hypertensive medications as prescribed by their regular clinicians.</description>
          </group>
          <group group_id="O2">
            <title>Intervention</title>
            <description>The intervention group will receive all the interventions provided to the control group. In addition, intervention group participants will install on their mobile phone the hypertension personal control program (HPCP) (&quot;Lark HTN Pro&quot;), which is a smartphone application. The intervention group will have the HPCP installed on their iOS device during their initial office visit (screening/baseline) and will successfully take a reading from their HBMD. The HPCP has blood pressure, medication, and weight monitoring, including periodic reminders for the user to measure blood pressure, measure weight, and take their medication(s). The HPCP provides real-time feedback based on user input, such as out-of-range measurements and has additional features designed to encourage behavior change in areas such as dietary intake, physical activity, sleep, and stress reduction. Users can set goals and receive guidance and feedback through the app.&#xD;
Lark HTN Pro: The intervention group will have the HPCP</description>
          </group>
        </group_list>
        <measure>
          <title>Blood Pressure &lt;140/90mmHg</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="144"/>
                <count group_id="O2" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72"/>
                    <measurement group_id="O2" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Antihypertensive Agents Used</title>
        <description>Number of self reported antihypertensive medication drug classes taken</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>The intervention group will receive all the interventions provided to the control group. In addition, intervention group participants will install on their mobile phone the hypertension personal control program (HPCP) (&quot;Lark HTN Pro&quot;), which is a smartphone application. The intervention group will have the HPCP installed on their iOS device during their initial office visit (screening/baseline) and will successfully take a reading from their HBMD. The HPCP has blood pressure, medication, and weight monitoring, including periodic reminders for the user to measure blood pressure, measure weight, and take their medication(s). The HPCP provides real-time feedback based on user input, such as out-of-range measurements and has additional features designed to encourage behavior change in areas such as dietary intake, physical activity, sleep, and stress reduction. Users can set goals and receive guidance and feedback through the app.&#xD;
Lark HTN Pro: The intervention group will have the HPCP</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Control group participants will be provided with a home blood pressure monitoring device (HBMD) (Omron BP761N Bluetooth Smart Automatic Upper Arm Blood Pressure Monitor) and will be instructed in its use at the baseline study visit. Participants will also receive an information sheet describing home blood pressure monitoring that gives advice for how to respond to different home readings. At the baseline visit, participants will be instructed to install an Omron application to their smart phone device (to monitor use of the HBMD). Participants will continue to receive all routine care, including anti-hypertensive medications as prescribed by their regular clinicians.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Antihypertensive Agents Used</title>
          <description>Number of self reported antihypertensive medication drug classes taken</description>
          <units>Antihypertensives</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="144"/>
                <count group_id="O2" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" spread="1.0"/>
                    <measurement group_id="O2" value="1.3" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Antihypertensive Medication Intensification, No. of Additions, Dose Increases, or Substitutions</title>
        <description>Number of antihypertensive drug classes that were increased, added or substituted for another drug class</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>The intervention group will receive all the interventions provided to the control group. In addition, intervention group participants will install on their mobile phone the hypertension personal control program (HPCP) (&quot;Lark HTN Pro&quot;), which is a smartphone application. The intervention group will have the HPCP installed on their iOS device during their initial office visit (screening/baseline) and will successfully take a reading from their HBMD. The HPCP has blood pressure, medication, and weight monitoring, including periodic reminders for the user to measure blood pressure, measure weight, and take their medication(s). The HPCP provides real-time feedback based on user input, such as out-of-range measurements and has additional features designed to encourage behavior change in areas such as dietary intake, physical activity, sleep, and stress reduction. Users can set goals and receive guidance and feedback through the app.&#xD;
Lark HTN Pro: The intervention group will have the HPCP</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Control group participants will be provided with a home blood pressure monitoring device (HBMD) (Omron BP761N Bluetooth Smart Automatic Upper Arm Blood Pressure Monitor) and will be instructed in its use at the baseline study visit. Participants will also receive an information sheet describing home blood pressure monitoring that gives advice for how to respond to different home readings. At the baseline visit, participants will be instructed to install an Omron application to their smart phone device (to monitor use of the HBMD). Participants will continue to receive all routine care, including anti-hypertensive medications as prescribed by their regular clinicians.</description>
          </group>
        </group_list>
        <measure>
          <title>Antihypertensive Medication Intensification, No. of Additions, Dose Increases, or Substitutions</title>
          <description>Number of antihypertensive drug classes that were increased, added or substituted for another drug class</description>
          <units>Antihypertensives</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="144"/>
                <count group_id="O2" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="0.6"/>
                    <measurement group_id="O2" value="0.4" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Health System Contacts (Telephone, Office, or Mychart Encounters)</title>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>The intervention group will receive all the interventions provided to the control group. In addition, intervention group participants will install on their mobile phone the hypertension personal control program (HPCP) (&quot;Lark HTN Pro&quot;), which is a smartphone application. The intervention group will have the HPCP installed on their iOS device during their initial office visit (screening/baseline) and will successfully take a reading from their HBMD. The HPCP has blood pressure, medication, and weight monitoring, including periodic reminders for the user to measure blood pressure, measure weight, and take their medication(s). The HPCP provides real-time feedback based on user input, such as out-of-range measurements and has additional features designed to encourage behavior change in areas such as dietary intake, physical activity, sleep, and stress reduction. Users can set goals and receive guidance and feedback through the app.&#xD;
Lark HTN Pro: The intervention group will have the HPCP</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Control group participants will be provided with a home blood pressure monitoring device (HBMD) (Omron BP761N Bluetooth Smart Automatic Upper Arm Blood Pressure Monitor) and will be instructed in its use at the baseline study visit. Participants will also receive an information sheet describing home blood pressure monitoring that gives advice for how to respond to different home readings. At the baseline visit, participants will be instructed to install an Omron application to their smart phone device (to monitor use of the HBMD). Participants will continue to receive all routine care, including anti-hypertensive medications as prescribed by their regular clinicians.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Health System Contacts (Telephone, Office, or Mychart Encounters)</title>
          <units>calls</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="144"/>
                <count group_id="O2" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.0" spread="11.5"/>
                    <measurement group_id="O2" value="6.7" spread="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Home Blood Pressure Measurements Per Month</title>
        <description>Frequency of home blood pressure measurements per month derived from home blood pressure monitor for months when home monitoring occurred</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>The intervention group will receive all the interventions provided to the control group. In addition, intervention group participants will install on their mobile phone the hypertension personal control program (HPCP) (&quot;Lark HTN Pro&quot;), which is a smartphone application. The intervention group will have the HPCP installed on their iOS device during their initial office visit (screening/baseline) and will successfully take a reading from their HBMD. The HPCP has blood pressure, medication, and weight monitoring, including periodic reminders for the user to measure blood pressure, measure weight, and take their medication(s). The HPCP provides real-time feedback based on user input, such as out-of-range measurements and has additional features designed to encourage behavior change in areas such as dietary intake, physical activity, sleep, and stress reduction. Users can set goals and receive guidance and feedback through the app.&#xD;
Lark HTN Pro: The intervention group will have the HPCP</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Control group participants will be provided with a home blood pressure monitoring device (HBMD) (Omron BP761N Bluetooth Smart Automatic Upper Arm Blood Pressure Monitor) and will be instructed in its use at the baseline study visit. Participants will also receive an information sheet describing home blood pressure monitoring that gives advice for how to respond to different home readings. At the baseline visit, participants will be instructed to install an Omron application to their smart phone device (to monitor use of the HBMD). Participants will continue to receive all routine care, including anti-hypertensive medications as prescribed by their regular clinicians.</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Home Blood Pressure Measurements Per Month</title>
          <description>Frequency of home blood pressure measurements per month derived from home blood pressure monitor for months when home monitoring occurred</description>
          <units>measurements per month</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="144"/>
                <count group_id="O2" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16" lower_limit="8.5" upper_limit="29"/>
                    <measurement group_id="O2" value="17" lower_limit="9" upper_limit="32.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Months When a Home Blood Pressure Reading is Obtained, No.</title>
        <description>Number of months out of the 6 month study period when at least one home blood pressure reading was obtained</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>The intervention group will receive all the interventions provided to the control group. In addition, intervention group participants will install on their mobile phone the hypertension personal control program (HPCP) (&quot;Lark HTN Pro&quot;), which is a smartphone application. The intervention group will have the HPCP installed on their iOS device during their initial office visit (screening/baseline) and will successfully take a reading from their HBMD. The HPCP has blood pressure, medication, and weight monitoring, including periodic reminders for the user to measure blood pressure, measure weight, and take their medication(s). The HPCP provides real-time feedback based on user input, such as out-of-range measurements and has additional features designed to encourage behavior change in areas such as dietary intake, physical activity, sleep, and stress reduction. Users can set goals and receive guidance and feedback through the app.&#xD;
Lark HTN Pro: The intervention group will have the HPCP</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Control group participants will be provided with a home blood pressure monitoring device (HBMD) (Omron BP761N Bluetooth Smart Automatic Upper Arm Blood Pressure Monitor) and will be instructed in its use at the baseline study visit. Participants will also receive an information sheet describing home blood pressure monitoring that gives advice for how to respond to different home readings. At the baseline visit, participants will be instructed to install an Omron application to their smart phone device (to monitor use of the HBMD). Participants will continue to receive all routine care, including anti-hypertensive medications as prescribed by their regular clinicians.</description>
          </group>
        </group_list>
        <measure>
          <title>Months When a Home Blood Pressure Reading is Obtained, No.</title>
          <description>Number of months out of the 6 month study period when at least one home blood pressure reading was obtained</description>
          <units>Months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="144"/>
                <count group_id="O2" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9" spread="1.8"/>
                    <measurement group_id="O2" value="5.0" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Self-efficacy: Confidence in Controlling High Blood Pressure</title>
        <description>Self reported response to :How confident are you that you will be able to get your blood pressure controlled and keep it there during the next few months? Reponses were on a 5-point scale ranging from (1) not at all confident to (5) extremely confident.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>The intervention group will receive all the interventions provided to the control group. In addition, intervention group participants will install on their mobile phone the hypertension personal control program (HPCP) (&quot;Lark HTN Pro&quot;), which is a smartphone application. The intervention group will have the HPCP installed on their iOS device during their initial office visit (screening/baseline) and will successfully take a reading from their HBMD. The HPCP has blood pressure, medication, and weight monitoring, including periodic reminders for the user to measure blood pressure, measure weight, and take their medication(s). The HPCP provides real-time feedback based on user input, such as out-of-range measurements and has additional features designed to encourage behavior change in areas such as dietary intake, physical activity, sleep, and stress reduction. Users can set goals and receive guidance and feedback through the app.&#xD;
Lark HTN Pro: The intervention group will have the HPCP</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Control group participants will be provided with a home blood pressure monitoring device (HBMD) (Omron BP761N Bluetooth Smart Automatic Upper Arm Blood Pressure Monitor) and will be instructed in its use at the baseline study visit. Participants will also receive an information sheet describing home blood pressure monitoring that gives advice for how to respond to different home readings. At the baseline visit, participants will be instructed to install an Omron application to their smart phone device (to monitor use of the HBMD). Participants will continue to receive all routine care, including anti-hypertensive medications as prescribed by their regular clinicians.</description>
          </group>
        </group_list>
        <measure>
          <title>Self-efficacy: Confidence in Controlling High Blood Pressure</title>
          <description>Self reported response to :How confident are you that you will be able to get your blood pressure controlled and keep it there during the next few months? Reponses were on a 5-point scale ranging from (1) not at all confident to (5) extremely confident.</description>
          <units>units 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="144"/>
                <count group_id="O2" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Confidence in controlling blood pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4" spread="0.8"/>
                    <measurement group_id="O2" value="4.1" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Confidence in using home monitor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" spread="0.6"/>
                    <measurement group_id="O2" value="4.7" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Confidence in judging when medication change needed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" spread="1.3"/>
                    <measurement group_id="O2" value="4.0" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Confidence in doing nonmedication behaviors to control blood pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4" spread="0.9"/>
                    <measurement group_id="O2" value="4.4" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>BMI</title>
        <description>Body mass index is calculated as the weight in kilograms divided by height in meters squared.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>The intervention group will receive all the interventions provided to the control group. In addition, intervention group participants will install on their mobile phone the hypertension personal control program (HPCP) (&quot;Lark HTN Pro&quot;), which is a smartphone application. The intervention group will have the HPCP installed on their iOS device during their initial office visit (screening/baseline) and will successfully take a reading from their HBMD. The HPCP has blood pressure, medication, and weight monitoring, including periodic reminders for the user to measure blood pressure, measure weight, and take their medication(s). The HPCP provides real-time feedback based on user input, such as out-of-range measurements and has additional features designed to encourage behavior change in areas such as dietary intake, physical activity, sleep, and stress reduction. Users can set goals and receive guidance and feedback through the app.&#xD;
Lark HTN Pro: The intervention group will have the HPCP</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Control group participants will be provided with a home blood pressure monitoring device (HBMD) (Omron BP761N Bluetooth Smart Automatic Upper Arm Blood Pressure Monitor) and will be instructed in its use at the baseline study visit. Participants will also receive an information sheet describing home blood pressure monitoring that gives advice for how to respond to different home readings. At the baseline visit, participants will be instructed to install an Omron application to their smart phone device (to monitor use of the HBMD). Participants will continue to receive all routine care, including anti-hypertensive medications as prescribed by their regular clinicians.</description>
          </group>
        </group_list>
        <measure>
          <title>BMI</title>
          <description>Body mass index is calculated as the weight in kilograms divided by height in meters squared.</description>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="144"/>
                <count group_id="O2" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.0" spread="8.2"/>
                    <measurement group_id="O2" value="31.9" spread="7.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Diet Quality Score (as Assessed by Dietary Approaches to Stop Hypertension Questionnaire, DASH-Q</title>
        <description>Sum of responses represents intake of foods associated with the Dietary Approaches to Stop Hypertension diet. Range is from 0 to 77 with a higher score indicating better diet. Scores 32 and below indicate a low-quality diet, scores 33 to 51 indicate a medium-quality diet, and scores greater than or equal to 52 indicate a high-quality diet.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>The intervention group will receive all the interventions provided to the control group. In addition, intervention group participants will install on their mobile phone the hypertension personal control program (HPCP) (&quot;Lark HTN Pro&quot;), which is a smartphone application. The intervention group will have the HPCP installed on their iOS device during their initial office visit (screening/baseline) and will successfully take a reading from their HBMD. The HPCP has blood pressure, medication, and weight monitoring, including periodic reminders for the user to measure blood pressure, measure weight, and take their medication(s). The HPCP provides real-time feedback based on user input, such as out-of-range measurements and has additional features designed to encourage behavior change in areas such as dietary intake, physical activity, sleep, and stress reduction. Users can set goals and receive guidance and feedback through the app.&#xD;
Lark HTN Pro: The intervention group will have the HPCP</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Control group participants will be provided with a home blood pressure monitoring device (HBMD) (Omron BP761N Bluetooth Smart Automatic Upper Arm Blood Pressure Monitor) and will be instructed in its use at the baseline study visit. Participants will also receive an information sheet describing home blood pressure monitoring that gives advice for how to respond to different home readings. At the baseline visit, participants will be instructed to install an Omron application to their smart phone device (to monitor use of the HBMD). Participants will continue to receive all routine care, including anti-hypertensive medications as prescribed by their regular clinicians.</description>
          </group>
        </group_list>
        <measure>
          <title>Diet Quality Score (as Assessed by Dietary Approaches to Stop Hypertension Questionnaire, DASH-Q</title>
          <description>Sum of responses represents intake of foods associated with the Dietary Approaches to Stop Hypertension diet. Range is from 0 to 77 with a higher score indicating better diet. Scores 32 and below indicate a low-quality diet, scores 33 to 51 indicate a medium-quality diet, and scores greater than or equal to 52 indicate a high-quality diet.</description>
          <units>scores 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="144"/>
                <count group_id="O2" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Dietary Approaches to Stop Hypertension-Questionnaire score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.7" spread="12.1"/>
                    <measurement group_id="O2" value="39.3" spread="11.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Consumption of processed meats, d/wk</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" spread="1.6"/>
                    <measurement group_id="O2" value="1.5" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Consumption of fried foods, d/wk</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="1.3"/>
                    <measurement group_id="O2" value="1.1" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Consumption of sugar-sweetened beverages, d/wk</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="2.5"/>
                    <measurement group_id="O2" value="1.7" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Consumption of candy, baked goods, or ice cream, d/wk</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" spread="2.3"/>
                    <measurement group_id="O2" value="2.9" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Minutes Per Week of Self-reported Physical Activity</title>
        <description>Self-reported physical activity in minutes per week of at least moderate exercise</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>The intervention group will receive all the interventions provided to the control group. In addition, intervention group participants will install on their mobile phone the hypertension personal control program (HPCP) (&quot;Lark HTN Pro&quot;), which is a smartphone application. The intervention group will have the HPCP installed on their iOS device during their initial office visit (screening/baseline) and will successfully take a reading from their HBMD. The HPCP has blood pressure, medication, and weight monitoring, including periodic reminders for the user to measure blood pressure, measure weight, and take their medication(s). The HPCP provides real-time feedback based on user input, such as out-of-range measurements and has additional features designed to encourage behavior change in areas such as dietary intake, physical activity, sleep, and stress reduction. Users can set goals and receive guidance and feedback through the app.&#xD;
Lark HTN Pro: The intervention group will have the HPCP</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Control group participants will be provided with a home blood pressure monitoring device (HBMD) (Omron BP761N Bluetooth Smart Automatic Upper Arm Blood Pressure Monitor) and will be instructed in its use at the baseline study visit. Participants will also receive an information sheet describing home blood pressure monitoring that gives advice for how to respond to different home readings. At the baseline visit, participants will be instructed to install an Omron application to their smart phone device (to monitor use of the HBMD). Participants will continue to receive all routine care, including anti-hypertensive medications as prescribed by their regular clinicians.</description>
          </group>
        </group_list>
        <measure>
          <title>Minutes Per Week of Self-reported Physical Activity</title>
          <description>Self-reported physical activity in minutes per week of at least moderate exercise</description>
          <units>minutes/week</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="144"/>
                <count group_id="O2" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="177.6" spread="169.2"/>
                    <measurement group_id="O2" value="143.1" spread="156.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Self-reported Sleep Duration</title>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>The intervention group will receive all the interventions provided to the control group. In addition, intervention group participants will install on their mobile phone the hypertension personal control program (HPCP) (&quot;Lark HTN Pro&quot;), which is a smartphone application. The intervention group will have the HPCP installed on their iOS device during their initial office visit (screening/baseline) and will successfully take a reading from their HBMD. The HPCP has blood pressure, medication, and weight monitoring, including periodic reminders for the user to measure blood pressure, measure weight, and take their medication(s). The HPCP provides real-time feedback based on user input, such as out-of-range measurements and has additional features designed to encourage behavior change in areas such as dietary intake, physical activity, sleep, and stress reduction. Users can set goals and receive guidance and feedback through the app.&#xD;
Lark HTN Pro: The intervention group will have the HPCP</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Control group participants will be provided with a home blood pressure monitoring device (HBMD) (Omron BP761N Bluetooth Smart Automatic Upper Arm Blood Pressure Monitor) and will be instructed in its use at the baseline study visit. Participants will also receive an information sheet describing home blood pressure monitoring that gives advice for how to respond to different home readings. At the baseline visit, participants will be instructed to install an Omron application to their smart phone device (to monitor use of the HBMD). Participants will continue to receive all routine care, including anti-hypertensive medications as prescribed by their regular clinicians.</description>
          </group>
        </group_list>
        <measure>
          <title>Self-reported Sleep Duration</title>
          <units>sleep hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="144"/>
                <count group_id="O2" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.6" spread="1.4"/>
                    <measurement group_id="O2" value="6.5" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <desc>We assessed adverse events for the duration of the duration of the study. We are not aware of any serious adverse events or deaths and had no events reported to study personnel during the study period. Because no adverse events were reported, we noted this in the required section but want readers to be aware that adverse events were not retorted by any participant to study team.</desc>
      <group_list>
        <group group_id="E1">
          <title>Intervention</title>
          <description>The intervention group will receive all the interventions provided to the control group. In addition, intervention group participants will install on their mobile phone the hypertension personal control program (HPCP) (&quot;Lark HTN Pro&quot;), which is a smartphone application. The intervention group will have the HPCP installed on their iOS device during their initial office visit (screening/baseline) and will successfully take a reading from their HBMD. The HPCP has blood pressure, medication, and weight monitoring, including periodic reminders for the user to measure blood pressure, measure weight, and take their medication(s). The HPCP provides real-time feedback based on user input, such as out-of-range measurements and has additional features designed to encourage behavior change in areas such as dietary intake, physical activity, sleep, and stress reduction. Users can set goals and receive guidance and feedback through the app.</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>Control group participants will be provided with a home blood pressure monitoring device (HBMD) (Omron BP761N Bluetooth Smart Automatic Upper Arm Blood Pressure Monitor) and will be instructed in its use at the baseline study visit. Participants will also receive an information sheet describing home blood pressure monitoring that gives advice for how to respond to different home readings. At the baseline visit, participants will be instructed to install an Omron application to their smart phone device (to monitor use of the HBMD). Participants will continue to receive all routine care, including anti-hypertensive medications as prescribed by their regular clinicians.</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="166"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="167"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="166"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="167"/>
              </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="166"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="167"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Stephen D. Persell, MD, MPH, FACP</name_or_title>
      <organization>Northwestern University Feinberg School of Medicine</organization>
      <phone>312-503-6464</phone>
      <email>spersell@nm.org</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/NCT03288142
org study id: STU00205025
nct id: NCT03288142
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Investigators at Northwestern University will partner with Omron Healthcare Co., Ltd.
      (hereinafter referred to as "Omron") to conduct a randomized controlled trial of a
      hypertension personal control program (HPCP), known as Lark HTN Pro with a home blood
      pressure monitoring device (HBMD) compared to a HBMD alone. The overarching goal of this
      study is to investigate the effects of the HPCP on blood pressure, blood pressure
      self-management behaviors, and healthy lifestyle behaviors among adults with hypertension.
The study team used structured language queries of electronic health record data from the
      Northwestern Medicine Enterprise Data Warehouse (NMEDW) to identify potentially-eligible
      participants with elevated blood pressure and exclude patients with clinical exclusion
      criteria from Northwestern Medical Group outpatient practices. During the on-site visit
      individuals were asked to provide written informed consent and have blood pressure measured
      in a standardized fashion to see if this inclusion criteria is met.

      We conducted a non-blinded randomized controlled trial among hypertensive adults in NMG
      outpatient clinics. We randomized participants in a 1:1 fashion to the intervention group
      (HPCP + HBMD) or the comparator group (HBMD alone). Randomization was performed using a
      centralized computer-generated assignment sequence uploaded a priori to Northwestern
      University's REDCap (Research Electronic Data Capture) application. Randomization was
      stratified by: age (<65 or ≥65 years of age) and baseline systolic blood pressure (<145 or
      ≥145 mmHg) to optimize the likelihood of obtaining similar populations in each treatment
      group.

      We recruited adults with elevated blood pressure as assessed by in-person standardized
      examination at baseline. We measured change in blood pressure by in-person examination at 6
      months. We recruited between 350 to 400 participants in order to have 333 participants with
      analyzable data at the time of study completion. If changes were deemed necessary, a revision
      to the study protocol was submitted to the IRB for review and approval prior to implementing
      these changes.

      Control group participants were provided with a home blood pressure monitoring device (HBMD)
      (Omron BP761N Bluetooth Smart Automatic Upper Arm Blood Pressure Monitor) and will be
      instructed in its use at the baseline study visit. Participant also received an information
      sheet describing home blood pressure monitoring that gives advice for how to respond to
      different home readings. At the baseline visit, participants were instructed to install an
      Omron application to their smart phone device (to monitor use of the HBMD). Participants
      continued to receive all routine care, including anti-hypertensive medications as prescribed
      by their regular clinicians.

      The intervention group received all the interventions provided to the control group.
      Intervention group participants were sent a hyperlink to install the hypertension personal
      control program (HPCP) ("Lark HTN Pro"), which is a smartphone application installed on their
      iOS device during their initial office visit (screening/baseline) and successfully took a
      reading from their HBMD. The HPCP has blood pressure, medication, and weight monitoring,
      including periodic reminders for the user to measure blood pressure, measure weight, and take
      their medication(s). The HPCP provides real-time feedback based on user input, such as
      out-of-range measurements and has additional features designed to encourage behavior change
      in areas such as dietary intake, physical activity, sleep, and stress reduction.

      Study participants were required to return for a 6-month study visit (within 2 weeks before
      to 4 weeks after). During the 6-month visit, subjects had their height/weight and blood
      pressure measured again. Participants also repeated questionnaires related to their current
      cardiovascular medications. They also completed questionnaires measuring: medication
      adherence, self-efficacy, diet, physical activity, and sleep duration. An exit survey was
      provided to participants at the end of the 6-month follow up visit to obtain feedback on Lark
      and Omron apps usability.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled trial with randomization stratified by age and baseline systolic blood pressure.
primary purpose: Other
masking: None (Open Label)
measure: Blood Pressure at 6 Months
time frame: 6 months
measure: Blood Pressure <140/90mmHg
time frame: 6 months
measure: Number of Antihypertensive Agents Used
time frame: 6 months
description: Number of self reported antihypertensive medication drug classes taken
measure: Antihypertensive Medication Intensification, No. of Additions, Dose Increases, or Substitutions
time frame: 6 months
description: Number of antihypertensive drug classes that were increased, added or substituted for another drug class
measure: Number of Health System Contacts (Telephone, Office, or Mychart Encounters)
time frame: 6 months
measure: Frequency of Home Blood Pressure Measurements Per Month
time frame: 6 months
description: Frequency of home blood pressure measurements per month derived from home blood pressure monitor for months when home monitoring occurred
measure: Months When a Home Blood Pressure Reading is Obtained, No.
time frame: 6 months
description: Number of months out of the 6 month study period when at least one home blood pressure reading was obtained
measure: Self-efficacy: Confidence in Controlling High Blood Pressure
time frame: 6 months
description: Self reported response to :How confident are you that you will be able to get your blood pressure controlled and keep it there during the next few months? Reponses were on a 5-point scale ranging from (1) not at all confident to (5) extremely confident.
measure: BMI
time frame: 6 months
description: Body mass index is calculated as the weight in kilograms divided by height in meters squared.
measure: Diet Quality Score (as Assessed by Dietary Approaches to Stop Hypertension Questionnaire, DASH-Q
time frame: 6 months
description: Sum of responses represents intake of foods associated with the Dietary Approaches to Stop Hypertension diet. Range is from 0 to 77 with a higher score indicating better diet. Scores 32 and below indicate a low-quality diet, scores 33 to 51 indicate a medium-quality diet, and scores greater than or equal to 52 indicate a high-quality diet.
measure: Minutes Per Week of Self-reported Physical Activity
time frame: 6 months
description: Self-reported physical activity in minutes per week of at least moderate exercise
measure: Self-reported Sleep Duration
time frame: 6 months
arm group label: Intervention: Hypertension Coaching Application and Home Monitor:
arm group type: Experimental
description: The intervention group will receive all the interventions provided to the control group. In addition, intervention group participants will install on their mobile phone the hypertension personal control program (HPCP) ("Lark HTN Pro"), which is a smartphone application. The intervention group will have the HPCP installed on their iOS device during their initial office visit (screening/baseline) and will successfully take a reading from their HBMD. The HPCP has blood pressure, medication, and weight monitoring, including periodic reminders for the user to measure blood pressure, measure weight, and take their medication(s). The HPCP provides real-time feedback based on user input, such as out-of-range measurements and has additional features designed to encourage behavior change in areas such as dietary intake, physical activity, sleep, and stress reduction. Users can set goals and receive guidance and feedback through the app.
arm group label: Control:Tracking Application and Home Monitor:
arm group type: Active Comparator
description: Control group participants will be provided with a home blood pressure monitoring device (HBMD) (Omron BP761N Bluetooth Smart Automatic Upper Arm Blood Pressure Monitor) and will be instructed in its use at the baseline study visit. Participants will also receive an information sheet describing home blood pressure monitoring that gives advice for how to respond to different home readings. At the baseline visit, participants will be instructed to install an Omron application to their smart phone device (to monitor use of the HBMD). Participants will continue to receive all routine care, including anti-hypertensive medications as prescribed by their regular clinicians.
intervention type: Other
intervention name: Hypertension Coaching Application and Home Monitor
description: The intervention group will have the HPCP installed on their iOS device during their initial office visit (screening/baseline) and will successfully take a reading from their HBMD
arm group label: Intervention: Hypertension Coaching Application and Home Monitor:
other name: Lark HTN Pro
intervention type: Other
intervention name: Control: Tracking Application and Home Monitor
description: Control group participants will be provided with a home blood pressure monitoring device (HBMD) (Omron BP761N Bluetooth Smart Automatic Upper Arm Blood Pressure Monitor) and will be instructed in its use at the baseline study visit. Participants will also receive an information sheet describing home blood pressure monitoring that gives advice for how to respond to different home readings. At the baseline visit, participants will be instructed to install an Omron application to their smart phone device (to monitor use of the HBMD). Participants will continue to receive all routine care, including anti-hypertensive medications as prescribed by their regular clinicians.
arm group label: Control:Tracking Application and Home Monitor:
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Stephen D Persell, MD/MPH
role: Principal Investigator
affiliation: Northwestern Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Stephen Persell, MD, MPH
investigator title: Associate Professor of Medicine
mesh term: Hypertension
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 