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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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:
- 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,
- 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
- 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 |
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 : | 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 |
| 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. |
- 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].
- 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.
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.
| Ages Eligible for Study: | 21 Years to 100 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
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
| 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 |
| 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 | |
| Principal Investigator: | Stacie L Daugherty, MD, MSPH | University of Colorado, Denver |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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. |
|
Hypertension Medication Adherence Values Affirmation African Americans |
|
Hypertension Vascular Diseases Cardiovascular Diseases |