The Multicenter Randomized HYpertension and VALUEs (HYVALUE) Trial
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      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
    

Detailed description: 
      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.
    

Intervention name(s): Intervention Values Affirmation; Control Values Affirmation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: Hypertension; Medication Adherence; Values Affirmation; African Americans