Testing Behavioral Economic Interventions to Improve Statin Use and Reduce CVD Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 805
- 试验地点
- 1
- 主要终点
- Change in LDL from baseline to 12 months
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
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.
干预措施: Sweepstake Incentive 1 (Behavioral)
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.
干预措施: Sweepstake Incentive 2 (Behavioral)
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.
干预措施: Sweepstake Incentive 3 (Behavioral)
结局指标
主要结局
Change in LDL from baseline to 12 months
时间窗: 12 months
次要结局
- Statin Adherence 6 months after active phase of intervention(6 months)