Tailored Approaches to Improve Medication Adherence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01643473
Recruitment Status : Recruiting
First Posted : July 18, 2012
Last Update Posted : January 29, 2018
American Heart Association
Information provided by (Responsible Party):
New York University School of Medicine

Brief Summary:
The purpose of this study is to to culturally tailor a technology-based individualized adherence intervention for Black and Latino patients with uncontrolled HTN or T2DM, who are non-adherent to their medications, and determine its acceptability.

Condition or disease Intervention/treatment Phase
Hypertension Behavioral: Adherence Intervention Not Applicable

Detailed Description:
Using a randomized controlled trial design, this study will compare the efficacy of a tailored adherence intervention (TAI) to a single patient education (PE) session, on medication adherence among 40 high-risk Latino patients with uncontrolled hypertension (HTN) who are non-adherent to their prescribed antihypertensive medications. Patients randomized to the PE group will receive a single patient education session on HTN and medication management by a trained research assistant (RA) at the baseline visit. Patients randomized to the TAI group will complete a tailoring survey at the baseline visit to identify the most salient adherence barriers to the individual, which will be used to create an individualized adherence profile. Following completion of the tailoring survey, patients will collaborate with the RA to identify the most suitable mix of intervention strategies for improving medication adherence (i.e., reminder aids, motivational interviewing, case management) that are matched to the barriers outlined on patients' individualized adherence profiles.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tailored Approaches to Improve Medication Adherence
Study Start Date : April 2013
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Medication adherence [ Time Frame: 6 months ]
    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 :
  1. Blood pressure [ Time Frame: 6 months ]
    Within-patient change in blood pressure is the difference between the baseline and systolic and diastolic BP readings at 6 months

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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);
  • Have been prescribed at least one antihypertensive or oral anti-diabetic medication;
  • Self-identify as Latino or African American/Black
  • Be > 18 years of age

Exclusion Criteria:

  • Refuse or are unable to provide informed consent;
  • Currently participate in another hypertension study; or 2 diabetes study
  • Have significant psychiatric comorbidity
  • Plan to discontinue care at the clinic within the next 3 months

Vulnerable populations including adults unable to provide informed consent, pregnant women, and prisoners will be excluded from this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01643473

Contact: Antoinette Schoenthaler, EdD 212-263-4205

United States, New York
Union Health Center Recruiting
New York, New York, United States, 10001
Contact: Maria Pitaro, MD    212-924-2510      
Principal Investigator: Maria Pitaro, MD         
Sponsors and Collaborators
New York University School of Medicine
American Heart Association
Principal Investigator: Antoinette Schoenthaler, EdD New York University School of Medicine

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: New York University School of Medicine Identifier: NCT01643473     History of Changes
Other Study ID Numbers: s14-00414
First Posted: July 18, 2012    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by New York University School of Medicine:
Medication Adherence
Blood Pressure Control

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases