Helping Hypertensive Latinos to Improve Medication Adherence

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Adherence Intervention; Behavioral: Usual Care

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.

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Risk Latino Patients Adherence Intervention; 74 high risk Latinos with uncontrolled hypertension	Behavioral: Adherence Intervention; 9 sessions with bilingual health coaches who will utilize a culturally tailored adherence checklist to identify patients specific medication adherence barriers.
Active Comparator: High Risk Latinos Usual Care; 74 high risk Latinos with uncontrolled hypertension	Behavioral: Usual Care; standard hypertension treatment recommendations as determined by PCP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Medication Adherence assessed with electronic drug monitoring devices (EMD)	Adherence 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.	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported medication adherence	Self-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	6 Months
Blood pressure reduction	Difference between the baseline and systolic and diastolic BP readings at 6 months.	6 Months
Blood pressure control	Rate of blood pressure control at 6 months	6 months

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Antoinette Schoenthaler, NYU Langone Health

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2013
• Primary Completion (Actual): June 4, 2016
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: June 6, 2018
• First Submitted That Met QC Criteria: June 6, 2018
• First Posted (Actual): June 18, 2018

Study Record Updates

• Last Update Posted (Actual): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 24, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Latino
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 12-02974

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No