Medication Adherence
Conditions
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 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).
Interventions
BEHAVIORALSweepstake Incentive 1
Daily sweepstake conditional on daily medication adherence
BEHAVIORALSweepstake Incentive 2
Daily sweepstake conditional on daily medication adherence
BEHAVIORALSweepstake Incentive 3
Daily sweepstake conditional on daily medication adherence
Sponsors
Carnegie Mellon University
Rutgers University
National Institute on Aging (NIA)
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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% * Low medication adherence on self-report 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 when applicable * Currently participating in another clinical trial with related aims * Co-morbidities likely to lead to death within a short-period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in LDL from baseline to 12 months | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Statin Adherence 6 months after active phase of intervention | 6 months |
Countries
United States
Outcome results
None listed