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Completed

NCT Number: NCT03028597

The Multicenter Randomized HYpertension and VALUEs (HYVALUE) Trial

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

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Key information

Age range

21 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Denver Health and Hospital Authority, Denver, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention Values Affirmation

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

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.

Primary outcomes

  1. Change in Antihypertensive Medication Adherence using Pharmacy Records

    Time frame: Baseline, 3 and 6 months

    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.

  2. Change in Antihypertensive Medication Adherence using Self-Reported Adherence

    Time frame: Baseline, 3 and 6 months

    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.

  3. Change in Antihypertensive Medication Adherence using Pill Counts

    Time frame: Baseline, 3 and 6 months

    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].

Secondary outcomes

  1. Systolic Blood Pressure

    Time frame: Baseline, 3 and 6 months

    Systolic blood pressure over time

  2. Proportion of Time Blood Pressure is Under Control

    Time frame: 6 months

    Defined as the proportion of time over the 6-months of follow-up with a BP ≤ 140/90 mmHg.

  3. Average Treatment Intensification

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

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

Registry information

Official study title

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

Acronym: HYVALUE

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jan 23, 2017
Registry last updated
Jan 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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