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The Multicenter Randomized HYpertension and VALUEs (HYVALUE) Trial

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03028597
Acronym
HYVALUE
Enrollment
960
Registered
2017-01-23
Start date
2017-01-31
Completion date
2021-05-31
Last updated
2023-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Hypertension, Medication Adherence, Values Affirmation, African Americans

Brief 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.

Interventions

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.

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
University of Colorado, Boulder
CollaboratorOTHER
Kaiser Permanente
CollaboratorOTHER
Denver Health and Hospital Authority
CollaboratorOTHER
University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
21 Years to 100 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Antihypertensive Medication Adherence using Pharmacy RecordsBaseline, 3 and 6 monthsThis 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.
Change in Antihypertensive Medication Adherence using Self-Reported AdherenceBaseline, 3 and 6 monthsThis 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.
Change in Antihypertensive Medication Adherence using Pill CountsBaseline, 3 and 6 monthsThis 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- \[(x-y)/z\].

Secondary

MeasureTime frameDescription
Systolic Blood PressureBaseline, 3 and 6 monthsSystolic blood pressure over time
Proportion of Time Blood Pressure is Under Control6 monthsDefined as the proportion of time over the 6-months of follow-up with a BP ≤ 140/90 mmHg.
Average Treatment Intensification6 monthsCalculated 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026