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Habit Formation for Adherence to Statin Use and LDL Reduction

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University of Pennsylvania

Status

Completed

Conditions

Medication Adherence

Treatments

Behavioral: Sweepstake Incentive 3
Behavioral: Sweepstake Incentive 2
Behavioral: Sweepstake Incentive 1

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01798784
1R01AG043844-01
5R01AG043844 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Enrollment

805 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

805 participants in 4 patient groups

Control Arm
No Intervention group
Description:
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.
Sweepstakes Incentive 1
Experimental group
Description:
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.
Treatment:
Behavioral: Sweepstake Incentive 1
Sweepstake Incentive 2
Experimental group
Description:
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.
Treatment:
Behavioral: Sweepstake Incentive 2
Sweepstake Incentive 3
Experimental group
Description:
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.
Treatment:
Behavioral: Sweepstake Incentive 3

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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