Habit Formation for Adherence to Statin Use and LDL Reduction

• Sponsor: University of Pennsylvania
• Collaborators: Carnegie Mellon University; Rutgers University; National Institute on Aging (NIA)
• Information provided by (Responsible Party): University of Pennsylvania

Study Description

Brief 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).

Condition or disease	Intervention/treatment	Phase
Medication Adherence	Behavioral: Sweepstake Incentive 1; Behavioral: Sweepstake Incentive 2; Behavioral: Sweepstake Incentive 3	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	805 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Testing Behavioral Economic Interventions to Improve Statin Use and Reduce CVD Risk
Study Start Date :	July 2013
Actual Primary Completion Date :	September 2017
Actual Study Completion Date :	September 2017

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Control Arm; Arm 1 will be the Control arm, in which participants receive an electronic pill container and are provided with daily reminders to take their medication but are not enrolled in the sweepstakes.
Experimental: Sweepstakes Incentive 1; Arm 2 will be a sweepstakes incentive arm where participants receive an electronic pill container and daily reminders to take their medication. In addition, this group is enrolled in a sweepstakes, in which participants may win money if they remember to take their medication.	Behavioral: Sweepstake Incentive 1; Daily sweepstake conditional on daily medication adherence
Experimental: Sweepstake Incentive 2; Arm 3 will be a sweepstake incentive arm where participants receive an electronic pill container and daily reminders to take their medication. In addition, this group is enrolled in a sweepstakes, in which monetary prizes may be awarded if participants take their medication prior to receiving a reminder.	Behavioral: Sweepstake Incentive 2; Daily sweepstake conditional on daily medication adherence
Experimental: Sweepstake Incentive 3; Arm 4 will be a sweepstake incentive arm where participants receive an electronic pill container and daily reminders to take their medication. In addition, this group is enrolled in a sweepstakes, in which each participant maintains an account that will accumulate money based on their medication adherence throughout the study.	Behavioral: Sweepstake Incentive 3; Daily sweepstake conditional on daily medication adherence

Outcome Measures

Primary Outcome Measures :

1. Change in LDL from baseline to 12 months [ Time Frame: 12 months ]

Secondary Outcome Measures :

1. Statin Adherence 6 months after active phase of intervention [ Time Frame: 6 months ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Locations

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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

University of Pennsylvania

Carnegie Mellon University

Rutgers University

National Institute on Aging (NIA)

Investigators

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Principal Investigator:	Kevin Volpp, MD, PhD	University of Pennsylvania
Principal Investigator:	Iwan Barankay, PhD	University of Pennsylvania
Principal Investigator:	Peter Reese, MD, MSCE	University of Pennsylvania

More Information

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Responsible Party:	University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT01798784 History of Changes
Other Study ID Numbers:	1R01AG043844-01 ( U.S. NIH Grant/Contract ); 5R01AG043844 ( U.S. NIH Grant/Contract )
First Posted:	February 26, 2013
Last Update Posted:	October 16, 2018
Last Verified:	October 2018