The Multicenter Randomized HYpertension and VALUEs (HYVALUE) Trial

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Using Values Affirmation to Reduce the Effects of Stereotype Threat on Hypertension Disparities: The Multicenter Randomized HYpertension and VALUEs (HYVALUE) Trial

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: Intervention Values Affirmation
* Behavioral: Control Values Affirmation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Values Affirmation<br>The task first asks patients to reflect on a list of 11 personal values or self-defining skills. | Behavioral: Intervention Values Affirmation<br>* 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.<br>|
| Active Comparator: Control Values Affirmation<br>The task first asks patients to reflect on a list of 11 personal values or self-defining skills. | Behavioral: Control Values Affirmation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Antihypertensive Medication Adherence using Pharmacy Records | 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. | Baseline, 3 and 6 months | 
| Change in Antihypertensive Medication Adherence using Self-Reported Adherence | 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. | Baseline, 3 and 6 months | 
| Change in Antihypertensive Medication Adherence using Pill Counts | 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]. | Baseline, 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic Blood Pressure | Systolic blood pressure over time | Baseline, 3 and 6 months | 
| Proportion of Time Blood Pressure is Under Control | Defined as the proportion of time over the 6-months of follow-up with a BP ≤ 140/90 mmHg. | 6 months | 
| Average Treatment Intensification | 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Medication Adherence, Values Affirmation, African Americans