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

Study Description
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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 Not Applicable

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
Actual Study Start Date : July 2013
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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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
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Information from the National Library of Medicine

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


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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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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