Habit Formation for Adherence to Statin Use and LDL Reduction

Medication Adherence Clinical Trial

Official title:

Testing Behavioral Economic Interventions to Improve Statin Use and Reduce CVD Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01798784
• Other study ID #: 1R01AG043844-01
• Secondary ID: 5R01AG043844
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: September 2017

Study information

• Verified date: May 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 805
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Medication Adherence

Intervention

Behavioral:
• Sweepstake Incentive 1
Daily sweepstake conditional on daily medication adherence
• Sweepstake Incentive 2
Daily sweepstake conditional on daily medication adherence
• Sweepstake Incentive 3
Daily sweepstake conditional on daily medication adherence

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
University of Pennsylvania	Carnegie Mellon University, National Institute on Aging (NIA), Rutgers University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in LDL from baseline to 12 months		12 months
Secondary	Statin Adherence 6 months after active phase of intervention		6 months