Helping Hypertensive Latinos to Improve Medication Adherence (ALMA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by New York University School of Medicine
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Antoinette Schoenthaler, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01643473
First received: July 16, 2012
Last updated: September 23, 2014
Last verified: September 2014

July 16, 2012
September 23, 2014
April 2013
March 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01643473 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Helping Hypertensive Latinos to Improve Medication Adherence
Ayudando Latinos Hipertensos Para Mejorar Adherencia a Los Medicamentos (ALMA)/Helping Hypertensive Latinos to Improve Medication Adherence

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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Hypertension
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.
  • No Intervention: Usual Care
    Standard care as provided by primary care physician.
  • Experimental: Adherence Intervention
    9 adherence counseling sessions with a health coach
    Intervention: Behavioral: Adherence Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
148
August 2015
March 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Antoinette Schoenthaler, EdD 212-263-4205 antoinette.schoenthaler@nyumc.org
United States
 
NCT01643473
12GRNT11670001
Yes
Antoinette Schoenthaler, New York University School of Medicine
New York University School of Medicine
American Heart Association
Principal Investigator: Antoinette Schoenthaler, EdD New York University School of Medicine
New York University School of Medicine
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP