Process Versus Outcomes Incentives for Lipid Management

Diabetes Clinical Trial

Official title:

Comparative Effectiveness of Process and Outcomes Incentives for Lipid Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02246959
• Other study ID #: 1R01HL118195-01A1
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: October 2018

Study information

• Verified date: February 2019
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 764
• Est. completion date: October 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes

Intervention

Behavioral:
• Process Incentive
Daily sweepstake conditional on daily medication adherence
• Outcome Incentive
Incentives conditional on LDL cholesterol reduction

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (5)

Lead Sponsor	Collaborator
University of Pennsylvania	Carnegie Mellon University, Lancaster General Hospital, Rutgers University, University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in LDL cholesterol from baseline to 12 months		12 months
Secondary	Statin Adherence		18 months