Tailored Approaches to Improve Medication Adherence

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by New York University School of Medicine
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01643473
First received: July 16, 2012
Last updated: December 22, 2015
Last verified: December 2015
  Purpose
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 Intervention Phase
Hypertension
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: Tailored Approaches 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: 40
Study Start Date: April 2013
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: July 2017 (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:
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  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 ClinicalTrials.gov identifier: NCT01643473

Contacts
Contact: Antoinette Schoenthaler, EdD 212-263-4205 antoinette.schoenthaler@nyumc.org

Locations
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
Investigators
Principal Investigator: Antoinette Schoenthaler, EdD New York University School of Medicine
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01643473     History of Changes
Other Study ID Numbers: s14-00414 
Study First Received: July 16, 2012
Last Updated: December 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:
Hypertension
Latinos
Medication Adherence
Blood Pressure Control
Patient-centered
Black

ClinicalTrials.gov processed this record on May 03, 2016