Comparative Effectiveness of Process and Outcomes Incentives for Lipid Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 764
- 试验地点
- 1
- 主要终点
- Change in LDL cholesterol from baseline to 12 months
研究概览
简要总结
In a 4-arm, randomized controlled trial, we will evaluate the relative effectiveness and cost-effectiveness of improving cholesterol levels among participants who are at high risk of CVD and who have elevated LDL cholesterol levels by testing process versus outcomes financial incentives. Participants will use electronic pill bottles that continuously monitor statin adherence. The primary outcome will be change in LDL cholesterol over 12 months.
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 90 Years（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 ASCVD (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 ASCVD or diabetes with LDLC with an LDL greater than or equal to 100 mg/dl and estimated 10-year ASCVD risk 7.5%;
- •Individuals without clinical ASCVD or diabetes with LDL cholesterol 190 mg/dl
- •A prescription filled for a statin medication within the last 12 months (derived from pharmacy records);
- •Low medication adherence on self-report completed during enrollment
排除标准
- •Under 18 years old
- •A contraindication to further statin use or have suffered statin side effects, such as myopathy
- •Will not or cannot give consent
- •A history of active or progressive liver disease
- •Participating in another clinical trial with related aims
- •Co-morbidities likely to lead to death within a short period (e.g. metastatic cancer)
研究组 & 干预措施
Control Arm
Arm 1 will be the Control arm, in which participants receive electronic pill bottles for their statin medication but are not enrolled in the sweepstakes.
Process Arm
Arm 2 will be a Process incentive arm where participants receive electronic pill bottles for their statin 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: Process Incentive (Behavioral)
Outcome Arm
Arm 3 will be an Outcome incentive arm where participants receive electronic pill bottles for their statin medication. In addition, this group may receive incentives if they lower their LDL.
干预措施: Outcome Incentive (Behavioral)
Process Plus Outcome Arm
Arm 4 will be a process plus outcome incentive arm where participants receive electronic pill bottles for their statin medication. In addition, this group is enrolled in a sweepstakes, in which participants may win money if they remember to take their medication and receive additional incentives for lowering their LDL cholesterol.
干预措施: Process Incentive (Behavioral)
Process Plus Outcome Arm
Arm 4 will be a process plus outcome incentive arm where participants receive electronic pill bottles for their statin medication. In addition, this group is enrolled in a sweepstakes, in which participants may win money if they remember to take their medication and receive additional incentives for lowering their LDL cholesterol.
干预措施: Outcome Incentive (Behavioral)
结局指标
主要结局
Change in LDL cholesterol from baseline to 12 months
时间窗: 12 months
次要结局
- Statin Adherence(18 months)