Process Versus Outcomes Incentives for Lipid Management

Not Applicable

Completed

• Conditions: Diabetes; Cardiovascular Disease
• Interventions: Behavioral: Outcome Incentive; Behavioral: Process Incentive

• Registration Number: NCT02246959
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-18
• Study First Submitted QC: 2014-09-18
• Study First Posted: 2014-09-23
• Study Start: 2015-02
• Primary Completion: 2018-05
• Study Completion: 2018-10
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-25
• Last Update Posted: 2019-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 764

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Outcome Arm	Outcome Incentive	Arm 3 will be an Outcome incentive arm where participants receive electronic pill bottles for their statin medication. In addition, this group may receive incentives if they lower their LDL.
Process Plus Outcome Arm	Process Incentive	Arm 4 will be a process plus outcome incentive arm where participants receive electronic pill bottles for their statin medication. In addition, this group is enrolled in a sweepstakes, in which participants may win money if they remember to take their medication and receive additional incentives for lowering their LDL cholesterol.
Process Plus Outcome Arm	Outcome Incentive	Arm 4 will be a process plus outcome incentive arm where participants receive electronic pill bottles for their statin medication. In addition, this group is enrolled in a sweepstakes, in which participants may win money if they remember to take their medication and receive additional incentives for lowering their LDL cholesterol.
Process Arm	Process Incentive	Arm 2 will be a Process incentive arm where participants receive electronic pill bottles for their statin medication. In addition, this group is enrolled in a sweepstakes, in which participants may win money if they remember to take their medication.

Primary Outcome Measures

Name	Time	Method
Change in LDL cholesterol from baseline to 12 months	12 months

Secondary Outcome Measures

Name	Time	Method
Statin Adherence	18 months

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States