跳至主要内容
临床试验/NCT03028597
NCT03028597已完成不适用

Using Values Affirmation to Reduce the Effects of Stereotype Threat on Hypertension Disparities: The Multicenter Randomized HYpertension and VALUEs (HYVALUE) Trial

University of Colorado, Denver6 个研究点 分布在 1 个国家目标入组 960 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
960
试验地点
6
主要终点
Change in Antihypertensive Medication Adherence using Pharmacy Records

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Investigator)

入排标准

年龄范围
21 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Change in Antihypertensive Medication Adherence using Pharmacy Records

时间窗: 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

时间窗: 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

时间窗: 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- \[(x-y)/z\].

次要结局

  • Systolic Blood Pressure(Baseline, 3 and 6 months)
  • Proportion of Time Blood Pressure is Under Control(6 months)
  • Average Treatment Intensification(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

Loading locations...

相似试验