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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL133343-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| University of Colorado, Boulder | OTHER |
| Kaiser Permanente | OTHER |
| Denver Health and Hospital Authority |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Values Affirmation | Experimental | The task first asks patients to reflect on a list of 11 personal values or self-defining skills. |
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| Control Values Affirmation | Active Comparator | The task first asks patients to reflect on a list of 11 personal values or self-defining skills. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure | Systolic blood pressure over time | Baseline, 3 and 6 months |
| Proportion of Time Blood Pressure is Under Control | Defined as the proportion of time over the 6-months of follow-up with a BP ≤ 140/90 mmHg. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stacie L Daugherty, MD, MSPH | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denver Health and Hospital Authority | Denver | Colorado | 80204 | United States | ||
| Kaiser Permanente of Colorado |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38322707 | Derived | 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. | |
| 36992865 | 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. |
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No plan to share IPD at this time.
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
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| OTHER |
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| 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. |
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| 6 months |
| Average Treatment Intensification | 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. | 6 months |
| Denver |
| Colorado |
| 80205 |
| United States |
| Kaiser Permanente Mid Atlantic States | Rockville | Maryland | 20852 | United States |
| 35418247 | 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. |
| 34913976 | 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. |
| 30907744 | 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. |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |