A Randomized Controlled Trial of Outreach Approaches to Increase Enrollment in the Habit Formation for Adherence to Statin Use and LDL Reduction Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Enrollment into the Habit Formation study
研究概览
简要总结
This study aims to determine the effectiveness of 4 different recruitment techniques for enrollment into a cholesterol study. 2,000 people that meet initial eligibility criteria for the study will be randomized into one of 4 groups and will all receive the same recruitment letter inviting them to participate in the study by enrolling on an online platform. Group 1 will receive the recruitment letter in a normal sized envelope, Group 2 will receive the recruitment letter in an 8.5 x 11 inch envelope, Group 3 will receive a recruitment letter shipped via USPS priority mail and a Group 4 will receive a recruitment letter with the image of an Amazon gift card and told they will receive a $25 gift card if they enroll in the study. All other groups are told that they will receive a $25 check upon enrollment in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes and or history of CVD
- •LDL > or = 130 mg/dl - measured during screening
- •A prescription filled for statin medication within the last 12 months
- •Medication Possession Ratio (MPR) <80%
- •CVS Caremark Beneficiary
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
- •Currently participating in another clinical trial with related aims
- •Co-morbidities likely to lead to death within a short-period
结局指标
主要结局
Enrollment into the Habit Formation study
时间窗: 3 months
次要结局
未报告次要终点