Helping Hypertensive Latinos to Improve Medication Adherence (ALMA)

This study is ongoing, but not recruiting participants.
American Heart Association
Information provided by (Responsible Party):
Antoinette Schoenthaler, New York University School of Medicine Identifier:
First received: July 16, 2012
Last updated: October 22, 2015
Last verified: October 2015
The purpose of this study is to determine the effect of a clinic-based culturally tailored intervention, delivered by bilingual Health Coaches, on medication-taking behaviors and blood pressure in Latino patients with high blood pressure.

Condition Intervention Phase
Behavioral: Adherence Intervention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ayudando Latinos Hipertensos Para Mejorar Adherencia a Los Medicamentos (ALMA)/Helping Hypertensive Latinos to Improve Medication Adherence

Resource links provided by NLM:

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Medication adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Medication adherence will be assessed with an electronic monitoring device (EMD). Adherence is defined as the scheduling adherence metric, which is the proportion of days in which a patient takes their medication correctly divided by the total number of days that s/he is expected to take them in that period.

Secondary Outcome Measures:
  • Blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Within-patient change in blood pressure is the difference between the baseline and systolic and diastolic BP readings at 6 months

Estimated Enrollment: 148
Study Start Date: April 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual Care
Standard care as provided by primary care physician.
Experimental: Adherence Intervention
9 adherence counseling sessions with a health coach
Behavioral: Adherence Intervention
Patients randomized to the AI group will participate in 9 sessions with bilingual Health Coaches who will utilize a culturally tailored adherence checklist to identify patient's specific medication adherence barriers. Based on the patient's responses, the Health Coach will then engage in targeted patient-centered counseling to assist patients in developing individualized self-monitoring strategies to overcome these barriers and improve adherence behaviors.

Detailed Description:
Poorly controlled hypertension (HTN) remains a significant public health problem in the US. Though the age-adjusted prevalence of HTN is similar for Latinos and whites, blood pressure (BP) is much less likely to be controlled in Latinos who receive treatment than in both blacks and whites. Inadequate BP control due to poor medication adherence may explain the worse outcomes seen in Latinos. Despite a wealth of research dedicated to developing interventions to improve medication adherence in hypertensive patients, practice-based randomized trials in Latinos are limited. To address this gap, this proposal will evaluate the effect of a practice-based adherence intervention (AI) vs. usual care (UC) on medication adherence in 148 high-risk Latino patients with uncontrolled HTN. Feedback from patient interviews and a Community Academic Advisory Board will be used to culturally adapt the AI. To facilitate translation into routine practice, the AI will be integrated into the clinic electronic medical record system, and delivered by bilingual Health Coaches. To provide a more targeted intervention, a 1-month screening phase with an electronic monitoring device (EMD) will be used to determine patient's adherence status. Only patients who are non-adherent to their antihypertensive medications (taking < 80%) at the 1-month visit will be randomly assigned to either the AI or UC group. We hypothesize that a higher proportion of patients in the AI group will be adherent to their medications, and exhibit a greater reduction in systolic and diastolic BP at 6-months. All patients will meet with Health Coaches for medication reconciliation, appointment-setting, and follow-up. Those in the UC group will receive standard HTN care as determined by their physician. Patients in the AI group will also complete a tailored adherence checklist with the Health Coach and receive individualized counseling to develop self-monitoring strategies to improve medication adherence. Sessions for the AI group will be held biweekly for the first 3 months followed by monthly sessions for the remaining 3 months (9 sessions total).The primary outcome is the proportion of adherent patients 1 month after the final intervention session, assessed with EMD. The secondary outcome is reduction in systolic and diastolic BP at 6 months assessed with a validated BP monitor. Regardless of group assignment, all outcomes will be assessed at baseline, 3, and 6 months with well-validated procedures and measures.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts 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) and 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; and
  • Be > 18 years of age

Exclusion Criteria:

  • Refuse or are unable to provide informed consent;
  • Currently participate in another hypertension study; or
  • Have significant psychiatric comorbidity
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01643473

United States, New York
Union Health Center
New York, New York, United States, 10001
Sponsors and Collaborators
New York University School of Medicine
American Heart Association
Principal Investigator: Antoinette Schoenthaler, EdD New York University School of Medicine
  More Information

No publications provided by New York University School of Medicine

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Antoinette Schoenthaler, Assistant Professor of Medicine, New York University School of Medicine Identifier: NCT01643473     History of Changes
Other Study ID Numbers: 12GRNT11670001
Study First Received: July 16, 2012
Last Updated: October 22, 2015
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
Medication Adherence
Blood Pressure Control
Patient-centered processed this record on November 30, 2015