Tailored Approaches to Improve Medication Adherence

Study Overview
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Brief Summary
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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
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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.

Official Title
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Tailored Approaches to Improve Medication Adherence

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: Adherence Intervention
* Other: Attention Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Attention Control<br>Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes | Other: Attention Control<br>* Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes<br>|
| Experimental: Tailored Adherence Intervention<br>Tablet-based tailored adherence intervention matched to patients' most salient adherence barriers | Behavioral: Adherence Intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Retaining Study Participants Through the 3 Month Trial | Feasibility is assessed as the absolute number of patients that are retained in the study once they are consented and enrolled at baseline. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean Systolic and Diastolic Blood Pressure at 3 Months | Change in mean systolic and diastolic blood pressure readings from baseline to 3 months. Systolic and diastolic blood pressure are measured in mmHg using a validated automated blood pressure monitor. The average of three readings was used as the blood pressure measurements for the baseline and 3 month study visit. | baseline and 3 months | 
| Change From Baseline in HbA1c at 3 Months | Change in HbA1c from baseline to 3 months using a validated point-of-care device (Afinion AS100 Analyzer) at baseline and 3 months. | baseline and 3 months | 
| Change From Baseline in Self-reported Medication Adherence at 3 Months | Medication adherence will be assessed by self-report using the validated 8-item Morisky Medication Adherence Scale. Scores range from 0-8, with higher scores indicative of better medication adherence. | Baseline and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Latinos, Medication Adherence, Blood Pressure Control, Patient-centered, Black