Habit Formation for Adherence to Statin Use and LDL Reduction
NCT ID: NCT01798784
Last Updated: 2020-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
805 participants
INTERVENTIONAL
2013-07-31
2017-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
No interventions assigned to this group
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.
Sweepstake Incentive 1
Daily sweepstake conditional on daily medication adherence
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.
Sweepstake Incentive 2
Daily sweepstake conditional on daily medication adherence
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.
Sweepstake Incentive 3
Daily sweepstake conditional on daily medication adherence
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Carnegie Mellon University
OTHER
Rutgers University
OTHER
National Institute on Aging (NIA)
NIH
University of Pennsylvania
OTHER
Responsible Party
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Principal Investigators
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Kevin Volpp, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Iwan Barankay, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Peter Reese, MD, MSCE
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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References
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Barankay I, Reese PP, Putt ME, Russell LB, Phillips C, Pagnotti D, Chadha S, Oyekanmi KO, Yan J, Zhu J, Volpp KG, Clapp JT. Qualitative Exploration of Barriers to Statin Adherence and Lipid Control: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2021 May 3;4(5):e219211. doi: 10.1001/jamanetworkopen.2021.9211.
Russell LB, Norton LA, Pagnotti D, Sevinc C, Anderson S, Finnerty Bigelow D, Iannotte LG, Josephs M, McGilloway R, Barankay I, Putt ME, Reese PP, Asch DA, Goldberg LR, Mehta SJ, Tanna MS, Troxel AB, Volpp KG. Using Clinical Trial Data to Estimate the Costs of Behavioral Interventions for Potential Adopters: A Guide for Trialists. Med Decis Making. 2021 Jan;41(1):9-20. doi: 10.1177/0272989X20973160. Epub 2020 Nov 20.
Barankay I, Reese PP, Putt ME, Russell LB, Loewenstein G, Pagnotti D, Yan J, Zhu J, McGilloway R, Brennan T, Finnerty D, Hoffer K, Chadha S, Volpp KG. Effect of Patient Financial Incentives on Statin Adherence and Lipid Control: A Randomized Clinical Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2019429. doi: 10.1001/jamanetworkopen.2020.19429.
Putt ME, Reese PP, Volpp KG, Russell LB, Loewenstein G, Yan J, Pagnotti D, McGilloway R, Brennen T, Finnerty D, Hoffer K, Chadha S, Barankay I. The Habit Formation trial of behavioral economic interventions to improve statin use and reduce the risk of cardiovascular disease: Rationale, design and methodologies. Clin Trials. 2019 Aug;16(4):399-409. doi: 10.1177/1740774519846852. Epub 2019 May 31.
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