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OpenTrials
Completed

NCT Number: NCT01798784

Habit Formation for Adherence to Statin Use and LDL Reduction

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).

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Key information

Conditions

Medication Adherence Behavior Health Behavior Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sweepstake Incentive 1

Behavioral

Daily sweepstake conditional on daily medication adherence

Sweepstake Incentive 2

Behavioral

Daily sweepstake conditional on daily medication adherence

Sweepstake Incentive 3

Behavioral

Daily sweepstake conditional on daily medication adherence

Primary outcomes

  1. Change in LDL from baseline to 12 months

    Time frame: 12 months

Secondary outcomes

  1. Statin Adherence 6 months after active phase of intervention

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Carnegie Mellon University
  • National Institute on Aging (NIA)
  • Rutgers University

Registry information

Official study title

Testing Behavioral Economic Interventions to Improve Statin Use and Reduce CVD Risk

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Feb 26, 2013
Registry last updated
May 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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