Comparative Effectiveness of Process and Outcomes Incentives for Lipid Management

University of Pennsylvania1 site in 1 country764 target enrollmentFebruary 2015

ConditionsDiabetes Cardiovascular Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetes
Sponsor: University of Pennsylvania
Enrollment: 764
Locations: 1
Primary Endpoint: Change in LDL cholesterol from baseline to 12 months
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2015

End Date

October 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Pennsylvania

Responsible Party

Sponsor

Eligibility Criteria

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)