Clinical trial NCT01643473: Tailored Approaches to Improve Medication Adherence
Official title: Tailored Approaches to Improve Medication Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Latinos
Medication Adherence
Blood Pressure Control
Patient-centered
Black
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2012-07-18
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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.

Eligibility 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.

Primary outcomes:
measure: Feasibility of Retaining Study Participants Through the 3 Month Trial
timeFrame: 3 months
Secondary outcomes:
measure: Change From Baseline in Mean Systolic and Diastolic Blood Pressure at 3 Months
timeFrame: baseline and 3 months
measure: Change From Baseline in HbA1c at 3 Months
timeFrame: baseline and 3 months
measure: Change From Baseline in Self-reported Medication Adherence at 3 Months
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Union Health Center
state: New York
Study officials:
affiliation: NYU Langone Health
name: Antoinette Schoenthaler, EdD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schoenthaler A, Leon M, Butler M, Steinhaeuser K, Wardzinski W. Development and Evaluation of a Tailored Mobile Health Intervention to Improve Medication Adherence in Black Patients With Uncontrolled Hypertension and Type 2 Diabetes: Pilot Randomized Feasibility Trial. JMIR Mhealth Uhealth. 2020 Sep 23;8(9):e17135. doi: 10.2196/17135.
citation: Schoenthaler A, De La Calle F, Barrios-Barrios M, Garcia A, Pitaro M, Lum A, Rosal M. A practice-based randomized controlled trial to improve medication adherence among Latinos with hypertension: study protocol for a randomized controlled trial. Trials. 2015 Jul 2;16:290. doi: 10.1186/s13063-015-0815-x.