Habit Formation for Adherence to Statin Use and LDL Reduction
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01798784 |
Recruitment Status :
Completed
First Posted : February 26, 2013
Last Update Posted : May 20, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Medication Adherence | Behavioral: Sweepstake Incentive 1 Behavioral: Sweepstake Incentive 2 Behavioral: Sweepstake Incentive 3 | Not Applicable |
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 |
Actual Study Start Date : | July 2013 |
Actual Primary Completion Date : | September 2017 |
Actual Study Completion Date : | September 2017 |

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 |
- Change in LDL from baseline to 12 months [ Time Frame: 12 months ]
- Statin Adherence 6 months after active phase of intervention [ Time Frame: 6 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01798784
United States, Pennsylvania | |
University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 |
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 |
Responsible Party: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT01798784 |
Other Study ID Numbers: |
1R01AG043844-01 ( U.S. NIH Grant/Contract ) 5R01AG043844 ( U.S. NIH Grant/Contract ) |
First Posted: | February 26, 2013 Key Record Dates |
Last Update Posted: | May 20, 2020 |
Last Verified: | May 2020 |