The Multicenter Randomized HYpertension and VALUEs (HYVALUE) Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

960 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2021-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

An Intervention to Improve Communication Between Physicians and Minority Patients With Hypertension

NCT01037920

Hypertension

COMPLETED NA

A Randomized Trial of Changing Medication Adherence In Hypertensive African-American Patients

NCT00248872

Hypertension

COMPLETED NA

An Intervention to Increase Engagement With Hypertension Care for American Indian Patients

NCT04414982

Hypertension

COMPLETED NA

Patient-Provider Communication and Medication Adherence

NCT01428011

Hypertension

COMPLETED

Patient Centered Health Technology Medication Adherence Program for African American Hypertensives

NCT03454308

Hypertension Medication Non-Adherence

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention Values Affirmation

The task first asks patients to reflect on a list of 11 personal values or self-defining skills.

Group Type EXPERIMENTAL

Intervention Values Affirmation

Intervention Type BEHAVIORAL

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.

Control Values Affirmation

The task first asks patients to reflect on a list of 11 personal values or self-defining skills.

Group Type ACTIVE_COMPARATOR

Control Values Affirmation

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intervention Values Affirmation

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.

Intervention Type BEHAVIORAL

Control Values Affirmation

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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