<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/NCT04414982</url>
  </required_header>
  <id_info>
    <org_study_id>15-1711</org_study_id>
    <nct_id>NCT04414982</nct_id>
  </id_info>
  <brief_title>An Intervention to Increase Engagement With Hypertension Care for American Indian Patients</brief_title>
  <official_title>An Intervention to Increase Engagement With Hypertension Care for American Indian Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Heart Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Colorado Centers for American Indian and Alaska Native Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Denver Health and Hospital Authority</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Denver Indian Health and Family Services</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;
      American Indian/Alaska Native 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 with a control exercise in AI/AN&#xD;
           patients with hypertension.&#xD;
&#xD;
        2. Compare the effects of the values-affirmation exercise in AI/AN patients with its&#xD;
           effects in white patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      American Indians and Alaska Natives (AI/ANs) in the U.S. bear a disproportionate burden of&#xD;
      cardiovascular disease. They have a higher prevalence of conditions that predispose to&#xD;
      cardiovascular disease and poorer outcomes after developing cardiovascular disease than white&#xD;
      Americans. The causes of these differences are complex and multiple, but there are widespread&#xD;
      concerns that racial bias contributes to the problem. As concluded over a decade ago in the&#xD;
      2003 Institute of Medicine report, Unequal Treatment, &quot;Racial/ethnic disparities in health&#xD;
      care occur in the context of broader historic and contemporary social and economic inequality&#xD;
      and evidence of persistent racial and ethnic discrimination… Bias, stereotyping and prejudice&#xD;
      on the part of healthcare providers may contribute to racial and ethnic disparities in health&#xD;
      care.&quot; These concerns persist. Minority group members are well aware of negative stereotypes&#xD;
      targeted at them as a group and of the possibility of bias directed at them as individuals.&#xD;
      Given the reality of prejudice and their previous experiences with it, it is understandable&#xD;
      that minority group members would be apprehensive about the possibility of being judged in&#xD;
      light of the stereotype, both outside and inside the healthcare system. Critically, this&#xD;
      apprehension may occur in the absence of actual bias. This raises the possibility that&#xD;
      interventions directed at patients' perception of discrimination may have an independent and&#xD;
      additive effect beyond the effects of interventions directed at provider bias.&#xD;
&#xD;
      Investigators propose to evaluate a novel intervention that reduces the detrimental effects&#xD;
      of negative stereotypes on minority patients by reducing stereotype threat through values-&#xD;
      affirmation. Stereotype threat is a stressful psychological state that occurs when a person&#xD;
      fears being judged in light of negative stereotypes. The stress of this situation and the&#xD;
      pressure to avoid confirming negative stereotypes can result in impaired performance and&#xD;
      worse outcomes - something of a self-fulfilling prophecy. For example, an American Indian&#xD;
      patient fearful of confirming the stereotype of being unintelligent may fail to ask for&#xD;
      clarification of changes in antihypertensive medications and, based on misconceptions,&#xD;
      persist in taking an old regimen that is ineffective. Values-affirmation is a process in&#xD;
      which global sense of personal worth is strengthened in the face of a threat, making&#xD;
      individuals better able to cope with psychological threats.&#xD;
&#xD;
      The intervention proposed in this application is based on one found to be effective in&#xD;
      alleviating stereotype threat in other contexts such as education and in alleviating more&#xD;
      general threats to the self in a health context as well as in a prior study investigators&#xD;
      performed with African American patients. Investigators will randomly assign AI/AN patients&#xD;
      with hypertension to complete an affirmation exercise or a control exercise prior to a visit&#xD;
      with their providers. The affirmation exercise is performed immediately before a clinic&#xD;
      visit. It asks patients to reflect on values or self-defining skills that they find&#xD;
      important, and to write a few sentences about why one of them is important. The project is&#xD;
      innovative in that it is directed against a mechanism, stereotype threat, not generally&#xD;
      recognized as important in healthcare settings. Since the intervention is brief and easily&#xD;
      applied across a wide range of health conditions, it directly addresses the need for&#xD;
      interventions to be generalizable and sustainable.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2015</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</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 ≤ 160/90 mmHg</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">339</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Intervention Values Affirmation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Compare the effects of the values-affirmation exercise with a control exercise in AI/AN patients with hypertension.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Values Affirmation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Compare the effects of the values-affirmation exercise in AI/AN patients with its effects in white patients.</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;160 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 American Indian/Alaska Native, self-reported race&#xD;
&#xD;
          -  Upcoming primary care visit&#xD;
&#xD;
          -  Ability to read and write English&#xD;
&#xD;
          -  History of hypertension defined as having an outpatient visit in the past year with a&#xD;
             primary or secondary ICD-9 code diagnosis of hypertension, with the diagnosis of&#xD;
             hypertension confirmed by review of the patient's medical record before enrollment.&#xD;
&#xD;
          -  Additional inclusion criteria are age &gt;18 years&#xD;
&#xD;
          -  Use of Denver Indian Health and Family Services (DIHFS) or Denver Health (DH) as their&#xD;
             usual source of care.&#xD;
&#xD;
          -  American Indian/Alaska Native as defined by DIHFS uses to define eligibility for&#xD;
             no-cost services.&#xD;
&#xD;
          -  To define the comparator group at DH we will use self-described race/ethnicity of&#xD;
             white/non- Latino.&#xD;
&#xD;
          -  All eligible patients must have the ability to provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy-related hypertension&#xD;
&#xD;
          -  Dialysis-dependent end-stage renal disease&#xD;
&#xD;
          -  Patients who cannot speak or write English&#xD;
&#xD;
          -  Unable to provide consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ed Havranek, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorad, 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>Denver Indian Health and Family Services</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>August 28, 2020</last_update_submitted>
  <last_update_submitted_qc>August 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2020</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>American Indian/Alaska Native</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <!-- 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/NCT04414982
org study id: 15-1711
nct id: NCT04414982
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
      American Indian/Alaska Native 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 with a control exercise in AI/AN
           patients with hypertension.

        2. Compare the effects of the values-affirmation exercise in AI/AN patients with its
           effects in white patients.
American Indians and Alaska Natives (AI/ANs) in the U.S. bear a disproportionate burden of
      cardiovascular disease. They have a higher prevalence of conditions that predispose to
      cardiovascular disease and poorer outcomes after developing cardiovascular disease than white
      Americans. The causes of these differences are complex and multiple, but there are widespread
      concerns that racial bias contributes to the problem. As concluded over a decade ago in the
      2003 Institute of Medicine report, Unequal Treatment, "Racial/ethnic disparities in health
      care occur in the context of broader historic and contemporary social and economic inequality
      and evidence of persistent racial and ethnic discrimination… Bias, stereotyping and prejudice
      on the part of healthcare providers may contribute to racial and ethnic disparities in health
      care." These concerns persist. Minority group members are well aware of negative stereotypes
      targeted at them as a group and of the possibility of bias directed at them as individuals.
      Given the reality of prejudice and their previous experiences with it, it is understandable
      that minority group members would be apprehensive about the possibility of being judged in
      light of the stereotype, both outside and inside the healthcare system. Critically, this
      apprehension may occur in the absence of actual bias. This raises the possibility that
      interventions directed at patients' perception of discrimination may have an independent and
      additive effect beyond the effects of interventions directed at provider bias.

      Investigators propose to evaluate a novel intervention that reduces the detrimental effects
      of negative stereotypes on minority patients by reducing stereotype threat through values-
      affirmation. Stereotype threat is a stressful psychological state that occurs when a person
      fears being judged in light of negative stereotypes. The stress of this situation and the
      pressure to avoid confirming negative stereotypes can result in impaired performance and
      worse outcomes - something of a self-fulfilling prophecy. For example, an American Indian
      patient fearful of confirming the stereotype of being unintelligent may fail to ask for
      clarification of changes in antihypertensive medications and, based on misconceptions,
      persist in taking an old regimen that is ineffective. Values-affirmation is a process in
      which global sense of personal worth is strengthened in the face of a threat, making
      individuals better able to cope with psychological threats.

      The intervention proposed in this application is based on one found to be effective in
      alleviating stereotype threat in other contexts such as education and in alleviating more
      general threats to the self in a health context as well as in a prior study investigators
      performed with African American patients. Investigators will randomly assign AI/AN patients
      with hypertension to complete an affirmation exercise or a control exercise prior to a visit
      with their providers. The affirmation exercise is performed immediately before a clinic
      visit. It asks patients to reflect on values or self-defining skills that they find
      important, and to write a few sentences about why one of them is important. The project is
      innovative in that it is directed against a mechanism, stereotype threat, not generally
      recognized as important in healthcare settings. Since the intervention is brief and easily
      applied across a wide range of health conditions, it directly addresses the need for
      interventions to be generalizable and sustainable.
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 ≤ 160/90 mmHg
arm group label: Intervention Values Affirmation
arm group type: Experimental
description: Compare the effects of the values-affirmation exercise with a control exercise in AI/AN patients with hypertension.
arm group label: Control Values Affirmation
arm group type: Active Comparator
description: Compare the effects of the values-affirmation exercise in AI/AN patients with its effects in white patients.
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: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Ed Havranek, MD
role: Principal Investigator
affiliation: University of Colorad, Denver
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hypertension