Habit Formation for Adherence to Statin Use and LDL Reduction

Not Applicable

Completed

• Conditions: Medication Adherence
• Interventions: Behavioral: Sweepstake Incentive 3; Behavioral: Sweepstake Incentive 1; Behavioral: Sweepstake Incentive 2

• Registration Number: NCT01798784
• Lead Sponsor: University of Pennsylvania

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-02-21
• Study First Submitted QC: 2013-02-21
• Study First Posted: 2013-02-26
• Study Start: 2013-07
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-18
• Last Update Posted: 2020-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 805

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sweepstake Incentive 3	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.
Sweepstakes Incentive 1	Sweepstake 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.
Sweepstake Incentive 2	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Statin Adherence 6 months after active phase of intervention	6 months

Trial Locations

Locations (1)

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