Clinical trial NCT03560596: Helping Hypertensive Latinos to Improve Medication Adherence
Official title: Helping Hypertensive Latinos to Improve Medication Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Latino
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-06-18
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Medication Adherence assessed with electronic drug monitoring devices (EMD)
timeFrame: 6 Months
Secondary outcomes:
measure: Self-reported medication adherence
timeFrame: 6 Months
measure: Blood pressure reduction
timeFrame: 6 Months
measure: Blood pressure control
timeFrame: 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Antoinette Schoenthaler
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schoenthaler A, de la Calle F, Pitaro M, Lum A, Chaplin W, Mogavero J, Rosal MC. A Systems-Level Approach to Improving Medication Adherence in Hypertensive Latinos: a Randomized Control Trial. J Gen Intern Med. 2020 Jan;35(1):182-189. doi: 10.1007/s11606-019-05419-3. Epub 2019 Oct 17.