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Helping Hypertensive Latinos to Improve Medication Adherence

Helping Hypertensive Latinos to Improve Medication Adherence

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03560596
Enrollment
119
Registered
2018-06-18
Start date
2013-04-04
Completion date
2017-08-01
Last updated
2018-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Latino

Brief summary

Poor medication adherence is a major contributor to inadequate BP control, and is associated with 125,000 deaths annually. Translation of adherence interventions to community-based primary care practices where majority of Latino patients receive care is non-existent. Thus, the development of tailored interventions targeted at improving medication adherence in the Latino population is needed in order to address the racial disparities in BP control between Latinos and whites. This proposal provides a unique opportunity to address this gap in the literature. Using a randomized control design (RCT), the study will evaluate the effect of a culturally tailored, practice-based intervention on medication adherence in 148 high-risk Latino patients with uncontrolled HTN. To facilitate translation into routine practices, the intervention will be integrated into the clinic's electronic medical record (EMR) system, and will be delivered by trained, bilingual Health Coaches.

Detailed description

Latinos are the fastest growing ethnic group of the U.S. with a growth rate of 43% compared to 23% among whites over the past decade. This increase is four times the nation's 9.7% growth rate, and accounts for more than half of the total U.S. population increase of 27.3 million during this period. This growth is accompanied by a significant increase in cardiovascular disease (CVD)-related morbidity and mortality. Despite increasing trends in the awareness and treatment of hypertension (HTN) among all groups, Latinos have the lowest blood pressure (BP) control rates in the U.S. Although barriers to optimal HTN control such as poor access, and low awareness have been used to explain the disparities in BP control between Latinos and whites, BP control rates remain lower among Latinos who receive treatment compared to whites. This enigma may be explained by the disproportionately poorer adherence to prescribed antihypertensive medications among Latinos compared to whites. Poor medication adherence is a major contributor to inadequate BP control, and is associated with 125,000 deaths annually. Despite over 30 years of research dedicated to understanding adherence behaviors in hypertensive patients, data in Latino patients is scant. More importantly, translation of adherence interventions to community-based primary care practices where majority of Latino patients receive care is non-existent.

Interventions

9 sessions with bilingual health coaches who will utilize a culturally tailored adherence checklist to identify patients specific medication adherence barriers.

BEHAVIORALUsual Care

standard hypertension treatment recommendations as determined by PCP

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Have uncontrolled hypertension defined as BP\>140/90 mmHg on at least two consecutive visits in the past year (or BP\>130/80 mmHg for those with diabetes or kidney disease) * Framingham Risk Scores (FRS) \>20% (or at least one CVD risk factor including hyperlipidemia or diabetes) * Be taking at least one antihypertensive medication; * Self-identify as Latino

Exclusion criteria

* Refuse or are unable to provide informed consent; * Currently participate in another hypertension study; * Have significant psychiatric comorbidity

Design outcomes

Primary

MeasureTime frameDescription
Rate of Medication Adherence assessed with electronic drug monitoring devices (EMD)6 MonthsAdherence will be defined as the number of times the EMD records an opening of the pill bottle cap for each day the patient was in the study.

Secondary

MeasureTime frameDescription
Self-reported medication adherence6 MonthsSelf-reported adherence will be measured with a validated tool. Adherence will be defined as the percent adherence between baseline and 6 months B. Blood pressure control
Blood pressure reduction6 MonthsDifference between the baseline and systolic and diastolic BP readings at 6 months.
Blood pressure control6 monthsRate of blood pressure control at 6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026