Cardiovascular Disease, Diabetes
Conditions
Brief summary
In a 4-arm, randomized controlled trial, we will evaluate the relative effectiveness and cost-effectiveness of improving cholesterol levels among participants who are at high risk of CVD and who have elevated LDL cholesterol levels by testing process versus outcomes financial incentives. Participants will use electronic pill bottles that continuously monitor statin adherence. The primary outcome will be change in LDL cholesterol over 12 months.
Interventions
BEHAVIORALProcess Incentive
Daily sweepstake conditional on daily medication adherence
BEHAVIORALOutcome Incentive
Incentives conditional on LDL cholesterol reduction
Sponsors
Rutgers University
University of California, San Francisco
Carnegie Mellon University
Lancaster General Hospital
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
In a 4-arm, randomized controlled trial, we propose to evaluate the relative effectiveness and cost-effectiveness of improving cholesterol levels among participants who are at high risk of CVD and who have elevated LDL cholesterol levels by testing process versus outcomes financial incentives. Participants will use electronic pill bottles that continuously monitor statin adherence.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Individuals at high risk of a cardiac event, specifically one of the following: * Individuals with clinical ASCVD (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 ASCVD or diabetes with LDLC with an LDL greater than or equal to 100 mg/dl and estimated 10-year ASCVD risk 7.5%; * Individuals without clinical ASCVD or diabetes with LDL cholesterol 190 mg/dl * A prescription filled for a statin medication within the last 12 months (derived from pharmacy records); * Low medication adherence on self-report completed during enrollment
Exclusion criteria
* Under 18 years old * A contraindication to further statin use or have suffered statin side effects, such as myopathy * Will not or cannot give consent * A history of active or progressive liver disease * Participating in another clinical trial with related aims * Co-morbidities likely to lead to death within a short period (e.g. metastatic cancer)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in LDL cholesterol from baseline to 12 months | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Statin Adherence | 18 months |
Countries
United States
Outcome results
None listed