<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/NCT03028597</url>
  </required_header>
  <id_info>
    <org_study_id>16-0510</org_study_id>
    <secondary_id>1R01HL133343-01</secondary_id>
    <nct_id>NCT03028597</nct_id>
  </id_info>
  <brief_title>The Multicenter Randomized HYpertension and VALUEs (HYVALUE) Trial</brief_title>
  <acronym>HYVALUE</acronym>
  <official_title>Using Values Affirmation to Reduce the Effects of Stereotype Threat on Hypertension Disparities: The Multicenter Randomized HYpertension and VALUEs (HYVALUE) Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Colorado, Boulder</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kaiser Permanente</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Denver Health and Hospital Authority</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</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 objective of this study is to reduce the effects of stereotype threat on the adherence of&#xD;
      African American patients with hypertension.&#xD;
&#xD;
      The specific aims of this study, which employs a values affirmation intervention, are to:&#xD;
&#xD;
        1. Compare the effects of the values-affirmation exercise to a control condition on&#xD;
           antihypertensive medication adherence in African American patients with uncontrolled&#xD;
           hypertension across three clinical settings,&#xD;
&#xD;
        2. Compare the effects of the values-affirmation exercise on antihypertensive medication&#xD;
           adherence in African American patients and white patients with uncontrolled hypertension&#xD;
           and similar socioeconomic characteristics, and&#xD;
&#xD;
        3. Evaluate the intervention for widespread dissemination using the RE-AIM (reach,&#xD;
           effectiveness, adoption, implementation and maintenance) framework&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      One in 3 US adults has hypertension and African Americans are disproportionately affected;&#xD;
      almost 40% of non-Hispanic blacks have hypertension. Although the rates of uncontrolled&#xD;
      hypertension have been decreasing in all groups, African Americans continue to have higher&#xD;
      rates of uncontrolled hypertension compared to white Americans. The Institute of Medicine,&#xD;
      World Health Organization and others have identified poor adherence to medications as the&#xD;
      most significant, modifiable contributor to uncontrolled hypertension.&#xD;
&#xD;
      Stereotype threat may contribute to low adherence. Stereotype threat occurs when cues in the&#xD;
      environment (such as visiting a doctor's office) trigger the threat of confirming, as&#xD;
      self-characteristic, a negative stereotype about one's group. Although any individual may&#xD;
      experience stereotype threat, African Americans are at greater risk due to widespread racism&#xD;
      and past experiences of discrimination.&#xD;
&#xD;
      Values affirmation interventions reduce stereotype threat and decrease racial disparities in&#xD;
      various outcomes. Values affirmation exercises typically ask participants to write a few&#xD;
      sentences about their core values. By focusing on values that are important to them, values&#xD;
      affirmation bolsters a person's self-concept by helping them view themselves as adequate,&#xD;
      effective, and able to control important outcomes in spite of a possible threat.&#xD;
&#xD;
      Based on the evidence supporting the effectiveness of values affirmation in educational and&#xD;
      other settings, the investigators hypothesize that values affirmation can similarly reduce&#xD;
      racial disparities in medication adherence and subsequent health outcomes. By asking&#xD;
      participating intervention patients to engage in a values affirmation exercise at an initial&#xD;
      appointment with a primary care provider, the investigators hope to improve hypertensive&#xD;
      medication adherence, systolic blood pressure, time under blood pressure control, and&#xD;
      treatment intensification, and to reduce racial disparities in these outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">May 2021</completion_date>
  <primary_completion_date type="Actual">May 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Antihypertensive Medication Adherence using Pharmacy Records</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>This antihypertensive medication adherence outcome will be a summary measure of adherence which assesses the proportion of days covered (PDC) over the period of observation for which a patient obtains antihypertensive medications. Adherence will be calculated for each antihypertensive drug in the regimen and combined across drugs into a summary measure of adherence for the entire drug regimen.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Antihypertensive Medication Adherence using Self-Reported Adherence</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>This antihypertensive medication adherence outcome will be a summary measure of self-reported adherence using the validated Voils instrument, which has 3 questions that address adherence over the previous 7 days.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Antihypertensive Medication Adherence using Pill Counts</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>This antihypertensive medication adherence outcome will be a summary outcome measure of adherence where if x is the number of pills in the bottle, y is the number of pills that would have been in the bottle had all pills been taken since the bottle was filled, and z is the number of pills that should have been taken since the last fill, and adherence is calculated as 1- [(x-y)/z].</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Systolic Blood Pressure</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>Systolic blood pressure over time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Time Blood Pressure is Under Control</measure>
    <time_frame>6 months</time_frame>
    <description>Defined as the proportion of time over the 6-months of follow-up with a BP ≤ 140/90 mmHg.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Treatment Intensification</measure>
    <time_frame>6 months</time_frame>
    <description>Calculated by subtracting the number of expected intensifications (number of visits after enrollment with a BP ≥140/90 mm Hg) from the number of observed intensifications (either an increase in dose or addition of a new medication class), and then dividing this difference by the number of office visits over the observation period.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">960</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Intervention Values Affirmation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The task first asks patients to reflect on a list of 11 personal values or self-defining skills.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Values Affirmation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The task first asks patients to reflect on a list of 11 personal values or self-defining skills.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intervention Values Affirmation</intervention_name>
    <description>Participants are asked to circle the two or three values that are MOST important to them. Next, participants are asked to think about times when the values chosen might be important to THEMSELVES and then write a few sentences to describe when and why they might be important.</description>
    <arm_group_label>Intervention Values Affirmation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control Values Affirmation</intervention_name>
    <description>Participants are asked to circle the two or three items that are LEAST important to them. Next, participants are asked to think about times when the values chosen might be important to SOMEONE ELSE and then write a few sentences to describe when and why they might be important.</description>
    <arm_group_label>Control Values Affirmation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hypertension diagnosis: primary or secondary ICD-10 code diagnosis in last 24 mo&#xD;
&#xD;
          -  SBP &gt;140 mm Hg or DBP &gt;90 mm Hg in last 12 months&#xD;
&#xD;
          -  Currently taking antihypertensive medications&#xD;
&#xD;
          -  Medications filled within health system's pharmacy&#xD;
&#xD;
          -  White or African American, self-reported race&#xD;
&#xD;
          -  Upcoming primary care visit&#xD;
&#xD;
          -  Ability to read and write English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy-related hypertension&#xD;
&#xD;
          -  Dialysis-dependent end-stage renal disease&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Unable to provide consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stacie L Daugherty, MD, MSPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Denver Health and Hospital Authority</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente of Colorado</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Mid Atlantic States</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20852</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>November 15, 2022</last_update_submitted>
  <last_update_submitted_qc>November 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hypertension</keyword>
  <keyword>Medication Adherence</keyword>
  <keyword>Values Affirmation</keyword>
  <keyword>African Americans</keyword>
  <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>
    <ipd_description>No plan to share IPD at this time.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03028597
org study id: 16-0510
secondary id: 1R01HL133343-01
nct id: NCT03028597
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to reduce the effects of stereotype threat on the adherence of
      African American patients with hypertension.

      The specific aims of this study, which employs a values affirmation intervention, are to:

        1. Compare the effects of the values-affirmation exercise to a control condition on
           antihypertensive medication adherence in African American patients with uncontrolled
           hypertension across three clinical settings,

        2. Compare the effects of the values-affirmation exercise on antihypertensive medication
           adherence in African American patients and white patients with uncontrolled hypertension
           and similar socioeconomic characteristics, and

        3. Evaluate the intervention for widespread dissemination using the RE-AIM (reach,
           effectiveness, adoption, implementation and maintenance) framework
One in 3 US adults has hypertension and African Americans are disproportionately affected;
      almost 40% of non-Hispanic blacks have hypertension. Although the rates of uncontrolled
      hypertension have been decreasing in all groups, African Americans continue to have higher
      rates of uncontrolled hypertension compared to white Americans. The Institute of Medicine,
      World Health Organization and others have identified poor adherence to medications as the
      most significant, modifiable contributor to uncontrolled hypertension.

      Stereotype threat may contribute to low adherence. Stereotype threat occurs when cues in the
      environment (such as visiting a doctor's office) trigger the threat of confirming, as
      self-characteristic, a negative stereotype about one's group. Although any individual may
      experience stereotype threat, African Americans are at greater risk due to widespread racism
      and past experiences of discrimination.

      Values affirmation interventions reduce stereotype threat and decrease racial disparities in
      various outcomes. Values affirmation exercises typically ask participants to write a few
      sentences about their core values. By focusing on values that are important to them, values
      affirmation bolsters a person's self-concept by helping them view themselves as adequate,
      effective, and able to control important outcomes in spite of a possible threat.

      Based on the evidence supporting the effectiveness of values affirmation in educational and
      other settings, the investigators hypothesize that values affirmation can similarly reduce
      racial disparities in medication adherence and subsequent health outcomes. By asking
      participating intervention patients to engage in a values affirmation exercise at an initial
      appointment with a primary care provider, the investigators hope to improve hypertensive
      medication adherence, systolic blood pressure, time under blood pressure control, and
      treatment intensification, and to reduce racial disparities in these outcomes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Participant, Investigator)
measure: Change in Antihypertensive Medication Adherence using Pharmacy Records
time frame: Baseline, 3 and 6 months
description: This antihypertensive medication adherence outcome will be a summary measure of adherence which assesses the proportion of days covered (PDC) over the period of observation for which a patient obtains antihypertensive medications. Adherence will be calculated for each antihypertensive drug in the regimen and combined across drugs into a summary measure of adherence for the entire drug regimen.
measure: Change in Antihypertensive Medication Adherence using Self-Reported Adherence
time frame: Baseline, 3 and 6 months
description: This antihypertensive medication adherence outcome will be a summary measure of self-reported adherence using the validated Voils instrument, which has 3 questions that address adherence over the previous 7 days.
measure: Change in Antihypertensive Medication Adherence using Pill Counts
time frame: Baseline, 3 and 6 months
description: This antihypertensive medication adherence outcome will be a summary outcome measure of adherence where if x is the number of pills in the bottle, y is the number of pills that would have been in the bottle had all pills been taken since the bottle was filled, and z is the number of pills that should have been taken since the last fill, and adherence is calculated as 1- [(x-y)/z].
measure: Systolic Blood Pressure
time frame: Baseline, 3 and 6 months
description: Systolic blood pressure over time
measure: Proportion of Time Blood Pressure is Under Control
time frame: 6 months
description: Defined as the proportion of time over the 6-months of follow-up with a BP ≤ 140/90 mmHg.
measure: Average Treatment Intensification
time frame: 6 months
description: Calculated by subtracting the number of expected intensifications (number of visits after enrollment with a BP ≥140/90 mm Hg) from the number of observed intensifications (either an increase in dose or addition of a new medication class), and then dividing this difference by the number of office visits over the observation period.
arm group label: Intervention Values Affirmation
arm group type: Experimental
description: The task first asks patients to reflect on a list of 11 personal values or self-defining skills.
arm group label: Control Values Affirmation
arm group type: Active Comparator
description: The task first asks patients to reflect on a list of 11 personal values or self-defining skills.
intervention type: Behavioral
intervention name: Intervention Values Affirmation
description: Participants are asked to circle the two or three values that are MOST important to them. Next, participants are asked to think about times when the values chosen might be important to THEMSELVES and then write a few sentences to describe when and why they might be important.
arm group label: Intervention Values Affirmation
intervention type: Behavioral
intervention name: Control Values Affirmation
description: Participants are asked to circle the two or three items that are LEAST important to them. Next, participants are asked to think about times when the values chosen might be important to SOMEONE ELSE and then write a few sentences to describe when and why they might be important.
arm group label: Control Values Affirmation
criteria: 
gender: All
minimum age: 21 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Stacie L Daugherty, MD, MSPH
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hypertension
sharing ipd: No
ipd description: No plan to share IPD at this time.