The Multicenter Randomized HYpertension and VALUEs (HYVALUE) Trial (NCT03028597) | Clinical Trial Compass
CompletedNot Applicable
The Multicenter Randomized HYpertension and VALUEs (HYVALUE) Trial
United States960 participantsStarted 2017-01
Plain-language 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
Who can participate
Age range
21 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Antihypertensive Medication Adherence using Pharmacy Records
Timeframe: Baseline, 3 and 6 months
2
Change in Antihypertensive Medication Adherence using Self-Reported Adherence
Timeframe: Baseline, 3 and 6 months
3
Change in Antihypertensive Medication Adherence using Pill Counts