The Multicenter Randomized HYpertension and VALUEs (HYVALUE) Trial

NCT03028597 | Completed DMC

• 2 other identifiers: 16-05101R01HL133343-01
• Study Type: interventional
• Target: 960
• Locations: 1 country
• Sites: 3

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. 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. 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. 3.Evaluate the intervention for widespread dissemination using the RE-AIM (reach, effectiveness, adoption, implementation and maintenance) framework

Conditions

Hypertension

Keywords

Hypertension; Medication Adherence; Values Affirmation; African Americans

Outcome Measures

Primary Outcomes (3)

• Change in Antihypertensive Medication Adherence using Pharmacy Records

  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.

  Baseline, 3 and 6 months

• Change in Antihypertensive Medication Adherence using Self-Reported Adherence

  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.

  Baseline, 3 and 6 months

• Change in Antihypertensive Medication Adherence using Pill Counts

  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- \[(x-y)/z\].

  Baseline, 3 and 6 months

Secondary Outcomes (3)

• Systolic Blood Pressure

  Baseline, 3 and 6 months

• Proportion of Time Blood Pressure is Under Control

  6 months

• Average Treatment Intensification

  6 months

Study Arms (2)

Intervention Values Affirmation

EXPERIMENTAL

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

Behavioral: Intervention Values Affirmation

Control Values Affirmation

ACTIVE COMPARATOR

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

Behavioral: Control Values Affirmation

Interventions

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.

Intervention Values Affirmation

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.

Control Values Affirmation

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy-related hypertension
• Dialysis-dependent end-stage renal disease
• Prisoners
• Unable to provide consent

Sponsors & Collaborators

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

Study Sites (3)

Denver Health and Hospital Authority

Denver, Colorado, 80204, United States

Location

Kaiser Permanente of Colorado

Denver, Colorado, 80205, United States

Location

Kaiser Permanente Mid Atlantic States

Rockville, Maryland, 20852, United States

Location

Related Publications (5)

• Gust CJ, Bryan AD, Havranek EP, Vupputuri S, Steiner JF, Blair IV, Hanratty R, Daugherty SL. Health Behavior Theory and Hypertension Management: Comparisons Among Black, White, and American Indian and Alaska Native Patients. Race Soc Probl. 2022 Dec;14(4):369-382. doi: 10.1007/s12552-022-09359-2. Epub 2022 Feb 25.

  PMID: 38322707 DERIVED

• Genelin MP, Helmkamp LJ, Steiner JF, Maertens JA, Hanratty R, Vupputuri S, Havranek EP, Dickinson LM, Blair IV, Daugherty SL. Patient Pill Organization Strategies and Adherence Measured in a Cross-Sectional Study of Hypertension. Patient Prefer Adherence. 2023 Mar 23;17:817-826. doi: 10.2147/PPA.S399693. eCollection 2023.

  PMID: 36992865 DERIVED

• 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.

  PMID: 35418247 DERIVED

• 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.

  PMID: 34913976 DERIVED

• 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.

  PMID: 30907744 DERIVED

MeSH Terms

Conditions

Hypertension; Medication Adherence

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Stacie L Daugherty, MD, MSPH

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: January 23, 2017
• Study Start: January 1, 2017
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: January 27, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)