Helping Hypertensive Latinos to Improve Medication Adherence

Hypertension Clinical Trial

Official title:

Helping Hypertensive Latinos to Improve Medication Adherence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03560596
• Other study ID #: 12-02974
• Status: Completed
• Phase: N/A
• Start date: April 4, 2013
• Est. completion date: August 1, 2017

Study information

• Verified date: July 2018
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: August 1, 2017
• Est. primary completion date: June 4, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• Adherence Intervention
9 sessions with bilingual health coaches who will utilize a culturally tailored adherence checklist to identify patients specific medication adherence barriers.
• Usual Care
standard hypertension treatment recommendations as determined by PCP

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Blood pressure reduction	Difference between the baseline and systolic and diastolic BP readings at 6 months.	6 Months
Secondary	Blood pressure control	Rate of blood pressure control at 6 months	6 months