Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03028597
Recruitment Status : Recruiting
First Posted : January 23, 2017
Last Update Posted : September 27, 2019
Sponsor:
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

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.


Layout table for study information
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 : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


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.




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03028597


Contacts
Layout table for location contacts
Contact: Stacie L Daugherty, MD, MSPH 303-724-2088 stacie.daugherty@cuanschutz.edu
Contact: Julie A Maertens, PhD 303-724-7319 julie.maertens@cuanschutz.edu

Locations
Layout table for location information
United States, Colorado
Denver Health and Hospital Authority Recruiting
Denver, Colorado, United States, 80204
Contact: Edward Havranek, MD    303-436-6000    ed.havranek@dhha.org   
Kaiser Permanente of Colorado Recruiting
Denver, Colorado, United States, 80205
Contact: John F Steiner, MD, MPH    303-493-8333    John.F.Steiner@kp.org   
United States, Maryland
Kaiser Permanente Mid Atlantic States Recruiting
Rockville, Maryland, United States, 20852
Contact: Suma Vupputuri, PhD, MPH    301-816-6134    suma.vupputuri@kp.org   
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
Layout table for investigator information
Principal Investigator: Stacie L Daugherty, MD, MSPH University of Colorado, Denver

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03028597     History of Changes
Other Study ID Numbers: 16-0510
1R01HL133343-01 ( U.S. NIH Grant/Contract )
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
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:
Layout table for MeSH terms
Hypertension
Vascular Diseases
Cardiovascular Diseases