<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/NCT03749499</url>
  </required_header>
  <id_info>
    <org_study_id>2017-0118</org_study_id>
    <secondary_id>1R61HL139454-01A1</secondary_id>
    <nct_id>NCT03749499</nct_id>
  </id_info>
  <brief_title>Targeting of UnControlled Hypertension in Emergency Department</brief_title>
  <acronym>TOUCHED</acronym>
  <official_title>Targeting of UnControlled Hypertension in Emergency Department (TOUCHED)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Illinois at Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Illinois at Chicago</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>
      The proposed project underscores the following: 1) The prevalence of uncontrolled/undiagnosed&#xD;
      hypertension (HTN) in underrepresented groups presenting to the ED is alarmingly high, and 2)&#xD;
      ED engagement and early risk assessment/stratification is a cost-effective, feasible&#xD;
      innovation to help close health disparity gaps in HTN. This proposal involves a two-arm&#xD;
      randomized controlled trial of up to 770 patients from the Emergency Department at University&#xD;
      of Illinois Hospital with elevated blood pressure (BP). The primary objective is to determine&#xD;
      the effectiveness of an emergency department-initiated Educational and Empowerment (E2)&#xD;
      intervention with a Post Acute Care Hypertension Consultation (PACHT-c) intervention (arm 2)&#xD;
      on the primary outcome of mean systolic blood pressure (SBP) differences between the two&#xD;
      trial arms at 6-months post intervention. Secondary objectives include evaluating the&#xD;
      effectiveness of this ED education and empowerment intervention on mean SBP and diastolic&#xD;
      blood pressure (DBP) differences at 3-months, and mean DBP differences at 6-months.&#xD;
      Additionally improvement in cardiovascular risk score (as measured by the Atherosclerotic&#xD;
      Cardiovascular Disease (ASCVD) Risk Score), medication adherence (as measured by the Modified&#xD;
      Morisky Scale), primary care engagement (measured by compliance with outpatient follow-up&#xD;
      appointments), and HTN knowledge improvement (as measured by a validated HTN knowledge&#xD;
      survey).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a single-site randomized controlled trial (RCT) focused on a high-risk ED&#xD;
      population with evidence of moderately elevated BP (≥140/90 mmHg) at discharge. ED patients&#xD;
      will be recruited and randomized into two arms: 1) usual care (preprinted discharge&#xD;
      instructions and 48-72 hour referral to a federally qualified health center (FQHC) or&#xD;
      assigned provider as appropriate); 2) ED-initiated E2 intervention program followed by 48-72&#xD;
      hour referral to a FQHC (or assigned health center). Based on the ED population demographics&#xD;
      (70% ethnic minorities), the majority of participants will be underrepresented minorities&#xD;
      (NHB and Hispanic) and low-income individuals. The investigators propose the following&#xD;
      specific aims and hypotheses:&#xD;
&#xD;
      Aim 1: Evaluate the effectiveness of an ED-based E2 + PACHT-c intervention (arm 2) on the&#xD;
      primary outcome of mean SBP difference at 6-months post-intervention compared to usual care&#xD;
      (arm 1).&#xD;
&#xD;
      H1: The mean SBP difference (from baseline) will be significantly greater in the E2+ PACHT-c&#xD;
      group (arm 2) compared to the usual care group (arm 1) at 6- months post-randomization, i.e.,&#xD;
      SBP change in arm 2 &gt; arm 1 at 6-months post-randomization.&#xD;
&#xD;
      Aim 2: Evaluate the effectiveness of an ED-based E2 intervention with PACHT-c on the&#xD;
      secondary outcome of mean SBP and DBP differences at 3-months, and mean DBP differences at 6&#xD;
      months post-intervention compared to usual care.&#xD;
&#xD;
      H2: The mean SBP and DBP differences from baseline to 3- months post-intervention and mean&#xD;
      DBP at 6-months post intervention will be significantly greater in the ED-based E2&#xD;
      intervention compared to the usual care group, i.e., SBP and DBP change in arm 2 &gt; arm 1 at 3&#xD;
      -months post-intervention and DBP change in arm 2 &gt; arm 1 at 6 -months post-intervention.&#xD;
&#xD;
      Aim 3: Examine if the E2 intervention reduces racial disparities. Specifically, if the&#xD;
      intervention is as effective in racial minorities as non-minorities. This will be an&#xD;
      exploratory analysis and will primarily focus on changes in cardiovascular risk&#xD;
      score/profile. Also included will be an assessment of intervention mediators: primary care&#xD;
      engagement, medication adherence, and HTN knowledge in these same patients at 3 and 6-months&#xD;
      post randomization-intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 19, 2019</start_date>
  <completion_date type="Anticipated">February 2023</completion_date>
  <primary_completion_date type="Anticipated">February 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Research Assistants are blinded to study arm assignment of participant when assessing outcomes measures.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Mean systolic blood pressure (SBP) difference at 6 months post-intervention compared to usual care.</measure>
    <time_frame>Baseline, 6 months after baseline</time_frame>
    <description>Blood pressure will be collected at two time points (baseline and 6 months). ED-pharmacists and trained research assistants will perform BP measurements using standardized procedures.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) differences at 3 months post-intervention compared to usual care.</measure>
    <time_frame>Baseline, 3 months after baseline</time_frame>
    <description>Blood pressure will be collected at two time points (baseline and 3 months). ED-pharmacists and trained research assistants will perform BP measurements using standardized procedures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic blood pressure (DBP) difference at 6 months post-intervention compared to usual care.</measure>
    <time_frame>Baseline, 6 months after baseline</time_frame>
    <description>Blood pressure will be collected at two time points (baseline and 6 months). ED-pharmacists and trained research assistants will perform BP measurements using standardized procedures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cardiovascular risk score/profile.</measure>
    <time_frame>Baseline, 3 months and 6 months after baseline</time_frame>
    <description>As measured by the Atherosclerotic Cardiovascular Disease (ASCVD) Risk Estimator Plus at baseline, 3 months, and then at 6 months.&#xD;
Atherosclerotic Cardiovascular Disease Risk Estimator Plus provides a patient's 10-year risk and a lifetime of developing atherosclerotic cardiovascular disease. The 10-year calculated ASCVD risk a quantitative estimation of absolute risk based upon data from representative population samples. The lifetime calculated ASCVD risk represents a quantitative estimation of absolute risk for a 50 year old man or woman with the same risk profile.&#xD;
The estimator provides risk as a percentage, ranging from 0-100%. A higher percentage is considered a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in medication adherence.</measure>
    <time_frame>Baseline, 3 months and 6 months after baseline</time_frame>
    <description>As measured by the Morisky Medication Adherence Scale at baseline, 3 months, and then at 6 months.&#xD;
The 4-item Morisky Medication Adherence Scale (MMAS-4) is a validated instrument to assess self-reported patient adherence related to antihypertensive medication. The modified Morisky scale provides a total score with a range of 0 to 4, with higher scores indicating lower adherence to medication. The scores of the modified Morisky scale can be classified as low compliers (3-4), medium compliers (1-2) and high compliers (0) based on its criterion validity with BP control. A higher score on the scale is a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Primary care engagement.</measure>
    <time_frame>1 month after baseline</time_frame>
    <description>Measured by compliance with outpatient follow-up appointment at 1 month after baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in hypertension knowledge.</measure>
    <time_frame>Baseline and 6 months after baseline</time_frame>
    <description>As measured by a validated HTN knowledge survey at baseline and then at 6 months.&#xD;
The hypertension knowledge survey is a 10-item, validated tool developed to assess hypertension knowledge in low literacy patient populations. The scale assesses respondents' knowledge in defining hypertension, lifestyle, and behaviors that may affect BP levels, and the long-term consequences of HTN. The survey has been validated in an urban population that included a high proportion of black and Latino patients. Scores are categorized into tertiles that indicate low (≤7), medium (8), or high (9-10) levels of HTN knowledge. The tool comes from: Shane S, Muntner P, Kawasaki L, Hyre A, DeSalvo K. Hypertension Knowledge Among Patients from an Urban Clinic. Ethnicity &amp; Disease. 2008; 18: 42-47.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">570</enrollment>
  <condition>Hypertension</condition>
  <condition>Cardiovascular Diseases</condition>
  <condition>Vascular Diseases</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants randomized to usual care will receive preprinted discharge instructions on HTN and a 48-72-hour referral to our FQHC (or other community health center if pre-assigned though Illinois Medicaid) to schedule their follow-up appointment (current standard of care)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Educational and Empowerment Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants receive:&#xD;
HTN Educational Video about high BP, how it is diagnosed, and importance of treatment to prevent secondary complications.&#xD;
Visual Echocardiogram Image Clips of age/gender-matched echocardiograms will be used to educate and motivate patients to change behavior and improve their BP.&#xD;
Mobile Health and Remote BP monitoring- participants receive an FDA-approved home blood pressure monitoring (HBPM) kit that includes the Nokia wireless BPM+ monitor and Health Mate mobile app. The app automatically launches when the patient slips on the cuff. Synced data are automatically uploaded from the mobile app to the iCardia server of our study.&#xD;
A Post-Acute Care HTN Transition consultation (PACHT-c) with a clinical pharmacist or advanced practice nurse (APN).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>HTN Educational Video</intervention_name>
    <description>The video will educate participants in arm 2 about high BP, how it is diagnosed, and the importance of treating it to prevent secondary complications.</description>
    <arm_group_label>Educational and Empowerment Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Visual Echocardiogram Image Clips</intervention_name>
    <description>Visual clips of age/gender-matched echocardiograms will be used to educate and motivate patients to change their behavior and improve their BP. We have found that real time visualization of cardiac ultrasound images with active discussion of findings is a significant patient motivator and empowerment tool, and was a significant factor in the success of our previous pilot study.</description>
    <arm_group_label>Educational and Empowerment Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mobile Health and Remote BP monitoring</intervention_name>
    <description>All participants randomized to the intervention group will receive an FDA-approved HBPM kit that includes the Nokia wireless (self-inflating) BPM+ monitor and Health Mate mobile app. The app automatically launches when the patient slips on the cuff and turns on the monitor to measure his/her BP. Synced data are automatically uploaded from the mobile app to the iCardia server of our study.</description>
    <arm_group_label>Educational and Empowerment Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Post-Acute Care HTN Transition consultation (PACHT-c)</intervention_name>
    <description>All participants randomized to the E2 intervention will have a focused consultation with either a clinical pharmacist or an APN. During this consultation, the pharmacist/APN repeats the BP measurement; reviews the screening assessments; and reviews general principles of BP control including nutrition, exercise, and smoking cessation. BP will be managed according to the current published guidelines available at the time of funding regarding initiation of first-line antihypertensive medications. Patients with BP ≥160/100 mmHg may be started on antihypertensive medications by the provider during the consultation if appropriate.</description>
    <arm_group_label>Educational and Empowerment Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BP&gt;=140/90 and &lt;=180/110 mm Hg at time of discharge from ED&#xD;
&#xD;
          -  Verbal fluency in English or Spanish&#xD;
&#xD;
          -  Age 18-75 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to verbalize comprehension of study, impaired decision-making or documented&#xD;
             dementia&#xD;
&#xD;
          -  Plans to move from Chicago area within the next year&#xD;
&#xD;
          -  Pregnant or trying to get pregnant&#xD;
&#xD;
          -  COVID-19 positive within the past 14 days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Heather Prendergast, MD, MPH, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Illinois at Chicago</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Heather Prendergast, MD, MPH, MS</last_name>
    <phone>312-413-1214</phone>
    <email>hprender@uic.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Prutha Patel</last_name>
    <phone>312-996-0508</phone>
    <email>ppate97@uic.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Illinois at Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Heather Prendergast, MD</last_name>
      <email>hprender@uic.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>November 29, 2021</last_update_submitted>
  <last_update_submitted_qc>November 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Illinois at Chicago</investigator_affiliation>
    <investigator_full_name>Heather Prendergast</investigator_full_name>
    <investigator_title>Professor (CT), Associate Head for Academic Affairs, Resident Research Director, Emergency Medicine</investigator_title>
  </responsible_party>
  <keyword>Emergency Department</keyword>
  <keyword>Minorities</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Vascular Diseases</mesh_term>
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The TOUCHED data sets will be submitted to the NHLBI Data repository, and will include the following:&#xD;
Data Information collected and recorded from study participants, including baseline, interim visit, ancillary data, outcome data, laboratory measurements not otherwise summarized, blood pressure measurements; quantitative results from survey assessments; clinical event surveillance and follow-up contacts.&#xD;
Study documentation: Descriptive information regarding the conduct of the study and collection of Data, including study protocol, manual of operations/procedures, annotated data collection forms, codebooks /data dictionary, and descriptions of data derived from procedures.&#xD;
In the preparation and delivery of the Data to the NHLBI Data Repository, all personal identifiers will be eliminated. A summary of all proposed modifications and deletions to be made to a data set will be submitted to and approved by the NHLBI Data Repository representative prior to their implementation.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>The TOUCHED data set will be submitted to the NHLBI Program Officer, no later than 3 years after the end of the clinical activity (final patient follow-up, etc.) or 2 years after the main paper of the trial has been published, whichever comes first.</ipd_time_frame>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03749499
org study id: 2017-0118
secondary id: 1R61HL139454-01A1
nct id: NCT03749499
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The proposed project underscores the following: 1) The prevalence of uncontrolled/undiagnosed
      hypertension (HTN) in underrepresented groups presenting to the ED is alarmingly high, and 2)
      ED engagement and early risk assessment/stratification is a cost-effective, feasible
      innovation to help close health disparity gaps in HTN. This proposal involves a two-arm
      randomized controlled trial of up to 770 patients from the Emergency Department at University
      of Illinois Hospital with elevated blood pressure (BP). The primary objective is to determine
      the effectiveness of an emergency department-initiated Educational and Empowerment (E2)
      intervention with a Post Acute Care Hypertension Consultation (PACHT-c) intervention (arm 2)
      on the primary outcome of mean systolic blood pressure (SBP) differences between the two
      trial arms at 6-months post intervention. Secondary objectives include evaluating the
      effectiveness of this ED education and empowerment intervention on mean SBP and diastolic
      blood pressure (DBP) differences at 3-months, and mean DBP differences at 6-months.
      Additionally improvement in cardiovascular risk score (as measured by the Atherosclerotic
      Cardiovascular Disease (ASCVD) Risk Score), medication adherence (as measured by the Modified
      Morisky Scale), primary care engagement (measured by compliance with outpatient follow-up
      appointments), and HTN knowledge improvement (as measured by a validated HTN knowledge
      survey).
The study is a single-site randomized controlled trial (RCT) focused on a high-risk ED
      population with evidence of moderately elevated BP (≥140/90 mmHg) at discharge. ED patients
      will be recruited and randomized into two arms: 1) usual care (preprinted discharge
      instructions and 48-72 hour referral to a federally qualified health center (FQHC) or
      assigned provider as appropriate); 2) ED-initiated E2 intervention program followed by 48-72
      hour referral to a FQHC (or assigned health center). Based on the ED population demographics
      (70% ethnic minorities), the majority of participants will be underrepresented minorities
      (NHB and Hispanic) and low-income individuals. The investigators propose the following
      specific aims and hypotheses:

      Aim 1: Evaluate the effectiveness of an ED-based E2 + PACHT-c intervention (arm 2) on the
      primary outcome of mean SBP difference at 6-months post-intervention compared to usual care
      (arm 1).

      H1: The mean SBP difference (from baseline) will be significantly greater in the E2+ PACHT-c
      group (arm 2) compared to the usual care group (arm 1) at 6- months post-randomization, i.e.,
      SBP change in arm 2 > arm 1 at 6-months post-randomization.

      Aim 2: Evaluate the effectiveness of an ED-based E2 intervention with PACHT-c on the
      secondary outcome of mean SBP and DBP differences at 3-months, and mean DBP differences at 6
      months post-intervention compared to usual care.

      H2: The mean SBP and DBP differences from baseline to 3- months post-intervention and mean
      DBP at 6-months post intervention will be significantly greater in the ED-based E2
      intervention compared to the usual care group, i.e., SBP and DBP change in arm 2 > arm 1 at 3
      -months post-intervention and DBP change in arm 2 > arm 1 at 6 -months post-intervention.

      Aim 3: Examine if the E2 intervention reduces racial disparities. Specifically, if the
      intervention is as effective in racial minorities as non-minorities. This will be an
      exploratory analysis and will primarily focus on changes in cardiovascular risk
      score/profile. Also included will be an assessment of intervention mediators: primary care
      engagement, medication adherence, and HTN knowledge in these same patients at 3 and 6-months
      post randomization-intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Single (Outcomes Assessor)
masking description: Research Assistants are blinded to study arm assignment of participant when assessing outcomes measures.
measure: Mean systolic blood pressure (SBP) difference at 6 months post-intervention compared to usual care.
time frame: Baseline, 6 months after baseline
description: Blood pressure will be collected at two time points (baseline and 6 months). ED-pharmacists and trained research assistants will perform BP measurements using standardized procedures.
measure: Mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) differences at 3 months post-intervention compared to usual care.
time frame: Baseline, 3 months after baseline
description: Blood pressure will be collected at two time points (baseline and 3 months). ED-pharmacists and trained research assistants will perform BP measurements using standardized procedures.
measure: Diastolic blood pressure (DBP) difference at 6 months post-intervention compared to usual care.
time frame: Baseline, 6 months after baseline
description: Blood pressure will be collected at two time points (baseline and 6 months). ED-pharmacists and trained research assistants will perform BP measurements using standardized procedures.
measure: Change in cardiovascular risk score/profile.
time frame: Baseline, 3 months and 6 months after baseline
description: As measured by the Atherosclerotic Cardiovascular Disease (ASCVD) Risk Estimator Plus at baseline, 3 months, and then at 6 months.
Atherosclerotic Cardiovascular Disease Risk Estimator Plus provides a patient's 10-year risk and a lifetime of developing atherosclerotic cardiovascular disease. The 10-year calculated ASCVD risk a quantitative estimation of absolute risk based upon data from representative population samples. The lifetime calculated ASCVD risk represents a quantitative estimation of absolute risk for a 50 year old man or woman with the same risk profile.
The estimator provides risk as a percentage, ranging from 0-100%. A higher percentage is considered a worse outcome.
measure: Change in medication adherence.
time frame: Baseline, 3 months and 6 months after baseline
description: As measured by the Morisky Medication Adherence Scale at baseline, 3 months, and then at 6 months.
The 4-item Morisky Medication Adherence Scale (MMAS-4) is a validated instrument to assess self-reported patient adherence related to antihypertensive medication. The modified Morisky scale provides a total score with a range of 0 to 4, with higher scores indicating lower adherence to medication. The scores of the modified Morisky scale can be classified as low compliers (3-4), medium compliers (1-2) and high compliers (0) based on its criterion validity with BP control. A higher score on the scale is a worse outcome.
measure: Primary care engagement.
time frame: 1 month after baseline
description: Measured by compliance with outpatient follow-up appointment at 1 month after baseline.
measure: Change in hypertension knowledge.
time frame: Baseline and 6 months after baseline
description: As measured by a validated HTN knowledge survey at baseline and then at 6 months.
The hypertension knowledge survey is a 10-item, validated tool developed to assess hypertension knowledge in low literacy patient populations. The scale assesses respondents' knowledge in defining hypertension, lifestyle, and behaviors that may affect BP levels, and the long-term consequences of HTN. The survey has been validated in an urban population that included a high proportion of black and Latino patients. Scores are categorized into tertiles that indicate low (≤7), medium (8), or high (9-10) levels of HTN knowledge. The tool comes from: Shane S, Muntner P, Kawasaki L, Hyre A, DeSalvo K. Hypertension Knowledge Among Patients from an Urban Clinic. Ethnicity & Disease. 2008; 18: 42-47.
arm group label: Usual Care
arm group type: No Intervention
description: Participants randomized to usual care will receive preprinted discharge instructions on HTN and a 48-72-hour referral to our FQHC (or other community health center if pre-assigned though Illinois Medicaid) to schedule their follow-up appointment (current standard of care)
arm group label: Educational and Empowerment Intervention
arm group type: Active Comparator
description: Participants receive:
HTN Educational Video about high BP, how it is diagnosed, and importance of treatment to prevent secondary complications.
Visual Echocardiogram Image Clips of age/gender-matched echocardiograms will be used to educate and motivate patients to change behavior and improve their BP.
Mobile Health and Remote BP monitoring- participants receive an FDA-approved home blood pressure monitoring (HBPM) kit that includes the Nokia wireless BPM+ monitor and Health Mate mobile app. The app automatically launches when the patient slips on the cuff. Synced data are automatically uploaded from the mobile app to the iCardia server of our study.
A Post-Acute Care HTN Transition consultation (PACHT-c) with a clinical pharmacist or advanced practice nurse (APN).
intervention type: Other
intervention name: HTN Educational Video
description: The video will educate participants in arm 2 about high BP, how it is diagnosed, and the importance of treating it to prevent secondary complications.
arm group label: Educational and Empowerment Intervention
intervention type: Other
intervention name: Visual Echocardiogram Image Clips
description: Visual clips of age/gender-matched echocardiograms will be used to educate and motivate patients to change their behavior and improve their BP. We have found that real time visualization of cardiac ultrasound images with active discussion of findings is a significant patient motivator and empowerment tool, and was a significant factor in the success of our previous pilot study.
arm group label: Educational and Empowerment Intervention
intervention type: Other
intervention name: Mobile Health and Remote BP monitoring
description: All participants randomized to the intervention group will receive an FDA-approved HBPM kit that includes the Nokia wireless (self-inflating) BPM+ monitor and Health Mate mobile app. The app automatically launches when the patient slips on the cuff and turns on the monitor to measure his/her BP. Synced data are automatically uploaded from the mobile app to the iCardia server of our study.
arm group label: Educational and Empowerment Intervention
intervention type: Other
intervention name: Post-Acute Care HTN Transition consultation (PACHT-c)
description: All participants randomized to the E2 intervention will have a focused consultation with either a clinical pharmacist or an APN. During this consultation, the pharmacist/APN repeats the BP measurement; reviews the screening assessments; and reviews general principles of BP control including nutrition, exercise, and smoking cessation. BP will be managed according to the current published guidelines available at the time of funding regarding initiation of first-line antihypertensive medications. Patients with BP ≥160/100 mmHg may be started on antihypertensive medications by the provider during the consultation if appropriate.
arm group label: Educational and Empowerment Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Heather Prendergast, MD, MPH, MS
role: Principal Investigator
affiliation: University of Illinois at Chicago
last name: Heather Prendergast, MD, MPH, MS
phone: 312-413-1214
email: hprender@uic.edu
last name: Prutha Patel
phone: 312-996-0508
email: ppate97@uic.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Illinois at Chicago
investigator full name: Heather Prendergast
investigator title: Professor (CT), Associate Head for Academic Affairs, Resident Research Director, Emergency Medicine
mesh term: Hypertension
mesh term: Cardiovascular Diseases
mesh term: Vascular Diseases
mesh term: Emergencies
sharing ipd: Yes
ipd description: The TOUCHED data sets will be submitted to the NHLBI Data repository, and will include the following:
Data Information collected and recorded from study participants, including baseline, interim visit, ancillary data, outcome data, laboratory measurements not otherwise summarized, blood pressure measurements; quantitative results from survey assessments; clinical event surveillance and follow-up contacts.
Study documentation: Descriptive information regarding the conduct of the study and collection of Data, including study protocol, manual of operations/procedures, annotated data collection forms, codebooks /data dictionary, and descriptions of data derived from procedures.
In the preparation and delivery of the Data to the NHLBI Data Repository, all personal identifiers will be eliminated. A summary of all proposed modifications and deletions to be made to a data set will be submitted to and approved by the NHLBI Data Repository representative prior to their implementation.
ipd info type: Study Protocol
ipd info type: Analytic Code
ipd time frame: The TOUCHED data set will be submitted to the NHLBI Program Officer, no later than 3 years after the end of the clinical activity (final patient follow-up, etc.) or 2 years after the main paper of the trial has been published, whichever comes first.