Improving Adherence to Statins Among Minority Populations

NCT02037685 | Completed

• 2 other identifiers: 1KG114KB13
• Study Type: interventional
• Target: 779
• Locations: 1 country
• Sites: 1

Brief Summary

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%.

Conditions

Dyslipidemia

Keywords

Statins; Cholesterol lowering medications; Adherence; Motivational interviewing; Minority populations

Outcome Measures

Primary Outcomes (1)

• Medication possession ratio (MPR)

  The primary outcome will be MPR for statin medication equal or above .80. MPR is a continuous multiple interval measure of medication availability. The medication possession ratio is defined as the sum of the days' supply of medication divided by the number of days between the enrollment and the last day of follow up. The binary dependent variable is: MPR equal to or above .80 (adequate adherence or drug availability during 80% or more of the therapy time) and MPR below .80 (non adherence or drug availability during less than 80% of the therapy time).

  12 months after the statin prescription

Secondary Outcomes (1)

• Self-reported adherence score (Morisky Medication Adherence Scale-8)

  At baseline and 12 months after statin prescription

Other Outcomes (1)

• Smoking status

  At baseline and at 12 months

Study Arms (2)

Usual care

ACTIVE COMPARATOR

Subjects randomized to usual care will receive a brochure once a year on the importance and impact of controlling cardiovascular risk factors, tips to improve statin adherence and smoking cessation strategies and public services. Subjects will also receive a letter every 6 months to remind about study participation along with educational material.

Other: Usual Care

Motivational Interviewing (MINT)

EXPERIMENTAL

The MINT intervention will consist of 6 to 9 telephone encounters between a counselor trained in Motivational interviewing. All subjects in the MINT arm will be contacted every 3 months; however subjects who are not filling medication appropriately will receive additional calls. Each telephone encounter will last from 20 to 30 minutes and have a patient centered approach having the following basic structure and goals: * Establishing a connection and reinforcing autonomy: . * Empathizing with ambivalence and rolling with resistance. * Coach the subject towards expressions of commitment.

Behavioral: Motivational Interviewing (MINT)

Interventions

Motivational Interviewing (MINT) BEHAVIORAL

MINT has the following basic structure and goals: * Establishing a connection and reinforcing autonomy: open ended questions regarding the health status or well being of the participant to establish an empathetic connection with the subject via reflective listening. * Empathizing with ambivalence and rolling with resistance. The counselor will help the subject express the ambivalence they may have regarding taking their statins. * Coach the subject towards expressions of commitment. Commitment is predictive of change. Speaking commitment out loud to an "other" enhances the likelihood that the commitment will be acted upon

Motivational Interviewing (MINT)

Usual Care OTHER

We selected American Heart Association brochures on a variety of risk factors, including dyslipidemia and mailed them to subjects in the usual care.

Usual care

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients over age 35 years
• 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.
• Self report of being Latino or AA.

You may not qualify if:

• Enrollment in any other CVD intervention program

Sponsors & Collaborators

• University of Miami: lead
• Humana Inc.: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Dyslipidemias

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Ana Palacio

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 14, 2014
• First Posted: January 16, 2014
• Study Start: June 1, 2010
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 25, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)