Status:
COMPLETED
Habit Formation for Adherence to Statin Use and LDL Reduction
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Carnegie Mellon University
Rutgers University
Conditions:
Medication Adherence
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In a 4-arm, Randomized Control Trial among members of CVS Caremark or Penn Medicine Patients with suboptimal cholesterol control who are at high risk for CVD, the study investigators propose to test t...
Eligibility Criteria
Inclusion
- Individuals at high risk of a cardiac event, specifically one of the following:
- Individuals with clinical CVD (defined as diagnosis with myocardial infarction, stroke, or peripheral vascular disease) with an LDL greater than or equal to 100 mg/dl ;
- Individuals with Diabetes (between the ages of 40-75) with an LDL greater than or equal to 100 mg/dl;
- Individuals without clinical CVD or diabetes with LDL greater than or equal to 100 mg/dl and estimated 10-year CVD risk 7.5%;
- Individuals without clinical CVD or diabetes with LDL cholesterol greater than or equal to 190 mg/dl A prescription filled for a statin medication within the last 12 months (derived from pharmacy records);
- Medication Possession Ratio (MPR) less than or equal to 80%
- Low medication adherence on self-report completed during enrollment
Exclusion
- Less than 18 years old
- Contraindication to further statin use or have suffered side effects from statins, such as myopathy
- Will not or cannot give consent
- History of active or progressive liver disease or abnormal liver function tests on baseline screening when applicable
- Currently participating in another clinical trial with related aims
- Co-morbidities likely to lead to death within a short-period
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
805 Patients enrolled
Trial Details
Trial ID
NCT01798784
Start Date
July 1 2013
End Date
September 1 2017
Last Update
May 20 2020
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104