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

Tracking Information
First Submitted Date  ICMJE January 17, 2017
First Posted Date  ICMJE January 23, 2017
Last Update Posted Date September 27, 2019
Study Start Date  ICMJE January 2017
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2018)
  • 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.
  • 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.
  • 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].
Original Primary Outcome Measures  ICMJE
 (submitted: January 19, 2017)
  • Change in Antihypertensive Medication Adherence using Pharmacy Records [ Time Frame: 12 months prior to baseline and 6 months after baseline ]
    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.
  • Change in Antihypertensive Medication Adherence using Self-Reported Adherence [ Time Frame: Baseline and 6 months after baseline ]
    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.
  • Change in Antihypertensive Medication Adherence using Pill Counts [ Time Frame: Baseline and 6 months after baseline ]
    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].
Change History Complete list of historical versions of study NCT03028597 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2018)
  • Systolic Blood Pressure [ Time Frame: Baseline, 3 and 6 months ]
    Systolic blood pressure over time
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2017)
  • Change in Systolic Blood Pressure [ Time Frame: Baseline and 6 months after baseline ]
    Change in baseline systolic blood pressure compared with 6 months after baseline
  • Proportion of Time Blood Pressure is Under Control [ Time Frame: 12 months ]
    Defined as the proportion of time over the 12-months of follow-up with a BP ≤ 140/90 mmHg.
  • Average Treatment Intensification [ Time Frame: 12 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 12 months.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Multicenter Randomized HYpertension and VALUEs (HYVALUE) Trial
Official Title  ICMJE Using Values Affirmation to Reduce the Effects of Stereotype Threat on Hypertension Disparities: The Multicenter Randomized HYpertension and VALUEs (HYVALUE) Trial
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Condition  ICMJE Hypertension
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Intervention Values Affirmation
    The task first asks patients to reflect on a list of 11 personal values or self-defining skills.
    Intervention: Behavioral: Intervention Values Affirmation
  • Active Comparator: Control Values Affirmation
    The task first asks patients to reflect on a list of 11 personal values or self-defining skills.
    Intervention: Behavioral: Control Values Affirmation
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 1, 2018)
1130
Original Estimated Enrollment  ICMJE
 (submitted: January 19, 2017)
1330
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
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
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03028597
Other Study ID Numbers  ICMJE 16-0510
1R01HL133343-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No plan to share IPD at this time.
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE
  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of Colorado, Boulder
  • Kaiser Permanente
  • Denver Health and Hospital Authority
Investigators  ICMJE
Principal Investigator: Stacie L Daugherty, MD, MSPH University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP