The Multicenter Randomized HYpertension and VALUEs (HYVALUE) Trial (HYVALUE)

• ClinicalTrials.gov Identifier: NCT03028597
• Recruitment Status: Active, not recruiting
• First Posted: January 23, 2017
• Last Update Posted: December 29, 2020
• Sponsor: University of Colorado, Denver
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); University of Colorado, Boulder; Kaiser Permanente; Denver Health and Hospital Authority
• Information provided by (Responsible Party): University of Colorado, Denver

Study Description

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

Condition or disease	Intervention/treatment	Phase
Hypertension	Behavioral: Intervention Values Affirmation; Behavioral: Control Values Affirmation	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1130 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Health Services Research
• Official Title: Using Values Affirmation to Reduce the Effects of Stereotype Threat on Hypertension Disparities: The Multicenter Randomized HYpertension and VALUEs (HYVALUE) Trial
• Study Start Date: January 2017
• Estimated Primary Completion Date: May 2021
• Estimated Study Completion Date: May 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention Values Affirmation; The task first asks patients to reflect on a list of 11 personal values or self-defining skills.	Behavioral: 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.
Active Comparator: Control Values Affirmation; The task first asks patients to reflect on a list of 11 personal values or self-defining skills.	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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Colorado

Denver Health and Hospital Authority

Denver, Colorado, United States, 80204

Kaiser Permanente of Colorado

Denver, Colorado, United States, 80205

United States, Maryland

Kaiser Permanente Mid Atlantic States

Rockville, Maryland, United States, 20852

Sponsors and Collaborators

University of Colorado, Denver

National Heart, Lung, and Blood Institute (NHLBI)

University of Colorado, Boulder

Kaiser Permanente

Denver Health and Hospital Authority

Investigators

• Principal Investigator: Stacie L Daugherty, MD, MSPH; University of Colorado, Denver

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT03028597
• Other Study ID Numbers: 16-0510; 1R01HL133343-01 ( U.S. NIH Grant/Contract )
• First Posted: January 23, 2017
• Last Update Posted: December 29, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: No plan to share IPD at this time.

Keywords provided by University of Colorado, Denver:

Hypertension; Medication Adherence; Values Affirmation; African Americans

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases