Habit Formation for Adherence to Statin Use and LDL Reduction
This trial is active, not recruiting.
|Treatments||sweepstake incentive 1, sweepstake incentive 2, sweepstake incentive 3|
|Sponsor||University of Pennsylvania|
|Collaborator||Carnegie Mellon University|
|Start date||July 2013|
|End date||May 2017|
|Trial size||800 participants|
|Trial identifier||NCT01798784, 1R01AG043844-01, 5R01AG043844|
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 the effectiveness of different behavioral economic techniques in inducing habit formation for adherence to statin use and sustained reductions in LDL cholesterol after financial incentives are discontinued. Primary outcome is changes in LDL from enrollment to 12 months (6 months after cessation of financial incentives).
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Change in LDL from baseline to 12 months
time frame: 12 months
Statin Adherence 6 months after active phase of intervention
time frame: 6 months
Male or female participants at least 18 years old.
Inclusion Criteria: - 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% - A score 0 on the 8-item Morisky Medication Adherence Questionnaire completed during enrollment Exclusion Criteria: - 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 - Currently participating in another clinical trial with related aims - Co-morbidities likely to lead to death within a short-period
|Official title||Testing Behavioral Economic Interventions to Improve Statin Use and Reduce CVD Risk|
|Principal investigator||Kevin Volpp, MD, PhD|
Call for more information