Improving Adherence to Statins Among Minority Populations



Status:Completed
Conditions:High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:35 - 85
Updated:4/21/2016
Start Date:June 2010
End Date:December 2015

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Improving Adherence to Cholesterol Lowering Medications Among Minority Populations in Florida: A Randomized Trial

Statins are cholesterol lowering medications that reduce the risk of cardiovascular events.
However adherence to these medications has been found to be lower among minorities, a group
particularly vulnerable for heart disease.

The purpose of this study is to compare the efficacy of a phone based behavioral
intervention to mailed educational materials regarding how to control cholesterol and other
risk factors. We hypothesized that the behavioral intervention will improve adherence to
statins by 15%.

Cardiovascular disease (CVD) disproportionately affects members of certain racial/ethnic
minority groups.Further in spite of a reduction in rates of cardiovascular events,the gap
between certain minority groups and non-minority groups has not diminished. Cholesterol
lowering medications are a medically proven intervention that dramatically reduces the risk
of primary and secondary cardiovascular outcomes.However, the literature shows that at one
year only half of the patients prescribed this medication continue to take a statin. One
well known risk factor shown to be a predictor for non adherence is belonging to a racial/
ethnic minority group.

The focus of the proposed study is to examine a non-traditional care-management approach
delivered by a large commercial health benefit carrier in the prevention of cardiovascular
disease among minority populations who have cardiovascular risk factors and who have been
started in cholesterol lowering therapy. In particular, we seek to determine if a culturally
tailored phone based intervention (Motivational Interviewing) delivered to Latino and
African American enrollees living in predominantly minority neighborhoods in Florida, is
effective at improving adherence to Statins.

Specific Aims

1. To prospectively identify 1200 Latino or African American residing in Florida who have
received a new prescription for statin therapy, evaluate their adherence to the statin
and determine if the reasons for non-adherence are similar or different from other
studies of adherence to cardiovascular medications.

2. Conduct a randomized control trial to compare the effectiveness of a motivational
interviewing telephonic intervention to usual care on the primary outcome of statin
adherence among minority subjects living in Florida.

In addition, among the tobacco users at baseline we will evaluate the impact of our phone
based MINT intervention on tobacco cessation in this minority populations.

Update: The sponsor and the IRB approved a reduction in the target number of participants to
800. The reason was that we experienced a recruitment delay to ensure HIPAA compliant
procedures between the University and the Health Benefits company when the Humana research
group moved out of the University campus. Data that became available from another study
showed 800 subjects will yield enough power for the analyses planned originally.

Inclusion Criteria:

1. Adult patients over age 35 years

2. Recent new prescription for a Statin (GPI code 39.40.xx ) which will be the index
prescription. We will define new as no GPI code present for any statin over a 6 month
period before the index prescription.

3. Self report of being Latino or AA.

Exclusion Criteria:

- Enrollment in any other CVD intervention program
We found this trial at
1
site
Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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mi
from
Miami, FL
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