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OpenTrials
Completed

NCT Number: NCT03560596

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adherence intervention

Behavioral

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

Usual Care

Behavioral

standard hypertension treatment recommendations as determined by PCP

Primary outcomes

  1. Rate of Medication Adherence assessed with electronic drug monitoring devices (EMD)

    Time frame: 6 Months

    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.

Secondary outcomes

  1. Self-reported medication adherence

    Time frame: 6 Months

    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

  2. Blood pressure reduction

    Time frame: 6 Months

    Difference between the baseline and systolic and diastolic BP readings at 6 months.

  3. Blood pressure control

    Time frame: 6 months

    Rate of blood pressure control at 6 months

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Jun 18, 2018
Registry last updated
Jul 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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