Tailored Approaches to Improve Medication Adherence

NYU Langone Health

Status: Completed

Conditions: Hypertension

Treatments: Other: Attention Control; Behavioral: Adherence Intervention

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01643473

s14-00414

Details and patient eligibility

About

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.

Full 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 Black and 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 tablet delivered patient education session 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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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42 participants in 2 patient groups

Attention Control

Active Comparator group

Description:

Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes

Treatment:

Other: Attention Control

Tailored Adherence Intervention

Experimental group

Description:

Tablet-based tailored adherence intervention matched to patients' most salient adherence barriers

Treatment:

Behavioral: Adherence Intervention