Clinical trial NCT03028597: The Multicenter Randomized HYpertension and VALUEs (HYVALUE) Trial
Official title: Using Values Affirmation to Reduce the Effects of Stereotype Threat on Hypertension Disparities: The Multicenter Randomized HYpertension and VALUEs (HYVALUE) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Medication Adherence
Values Affirmation
African Americans
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: University of Colorado, Boulder
name: Kaiser Permanente
name: Denver Health and Hospital Authority
First posted: 2017-01-23
Enrollment: 960
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Antihypertensive Medication Adherence using Pharmacy Records
timeFrame: Baseline, 3 and 6 months
measure: Change in Antihypertensive Medication Adherence using Self-Reported Adherence
timeFrame: Baseline, 3 and 6 months
measure: Change in Antihypertensive Medication Adherence using Pill Counts
timeFrame: Baseline, 3 and 6 months
Secondary outcomes:
measure: Systolic Blood Pressure
timeFrame: Baseline, 3 and 6 months
measure: Proportion of Time Blood Pressure is Under Control
timeFrame: 6 months
measure: Average Treatment Intensification
timeFrame: 6 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health and Hospital Authority
state: Colorado
city: Denver
country: United States
facility: Kaiser Permanente of Colorado
state: Colorado
city: Rockville
country: United States
facility: Kaiser Permanente Mid Atlantic States
state: Maryland
Study officials:
affiliation: University of Colorado, Denver
name: Stacie L Daugherty, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Henderson KH, Helmkamp LJ, Steiner JF, Havranek EP, Vupputuri SX, Hanratty R, Blair IV, Maertens JA, Dickinson M, Daugherty SL. Relationship Between Social Vulnerability Indicators and Trial Participant Attrition: Findings From the HYVALUE Trial. Circ Cardiovasc Qual Outcomes. 2022 May;15(5):e007709. doi: 10.1161/CIRCOUTCOMES.120.007709. Epub 2022 Apr 14.
citation: Daugherty SL, Helmkamp L, Vupputuri S, Hanratty R, Steiner JF, Blair IV, Dickinson LM, Maertens JA, Havranek EP. Effect of Values Affirmation on Reducing Racial Differences in Adherence to Hypertension Medication: The HYVALUE Randomized Clinical Trial. JAMA Netw Open. 2021 Dec 1;4(12):e2139533. doi: 10.1001/jamanetworkopen.2021.39533.
citation: Daugherty SL, Vupputuri S, Hanratty R, Steiner JF, Maertens JA, Blair IV, Dickinson LM, Helmkamp L, Havranek EP. Using Values Affirmation to Reduce the Effects of Stereotype Threat on Hypertension Disparities: Protocol for the Multicenter Randomized Hypertension and Values (HYVALUE) Trial. JMIR Res Protoc. 2019 Mar 25;8(3):e12498. doi: 10.2196/12498.