The Multicenter Randomized HYpertension and VALUEs (HYVALUE) Trial
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About
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:
- 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,
- 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
- Evaluate the intervention for widespread dissemination using the RE-AIM (reach, effectiveness, adoption, implementation and maintenance) framework
Full 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.
Enrollment
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Inclusion criteria
- Hypertension diagnosis: primary or secondary ICD-10 code diagnosis in last 24 mo
- SBP >140 mm Hg or DBP >90 mm Hg in last 12 months
- Currently taking antihypertensive medications
- Medications filled within health system's pharmacy
- White or African American, self-reported race
- Upcoming primary care visit
- Ability to read and write English
Exclusion criteria
- Pregnancy-related hypertension
- Dialysis-dependent end-stage renal disease
- Prisoners
- Unable to provide consent
Trial design
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Interventional model
Masking
960 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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