Corrie Lipids Program: Optimizing LDL-Cholesterol by Improving Awareness, Access, and Achievement
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Percentage of participants achieving guideline-based LDL-C goals
研究概览
简要总结
The overall objective is to evaluate the effectiveness and implementation of the Corrie Lipids Program, a comprehensive digital health initiative designed to address critical gaps in lipid-lowering as a component of ASCVD treatment by delivering an intervention that combines a patient-facing smartphone app, clinician education and coaching, and seamless incorporation into clinical workflows.
Researchers plan to assess this multicenter digital health initiative in approximately 1,000 adults with uncontrolled LDL-C and elevated ASCVD risk using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. The study will examine whether the program improves LDL-C goal attainment, app engagement, prescribing patterns, and LDL-C monitoring, while also identifying barriers and facilitators to implementation across sites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Age ≥18 years
- •Uncontrolled LDL-C per AHA/ACC guidelines
- •At least 1 major cardiovascular risk factor, including: high risk for ASCVD (individuals who meet criteria for Lipid-Lowering Therapy (LLT) based on ASCVD risk assessment using the most up-to-date guidelines), known ASCVD or subclinical ASCVD based on imaging, clinically diagnosed familial hypercholesterolemia or LDL-C ≥190 mg/dL, diabetes mellitus, history of statin-associated side effects
- •Has a primary care physician and/or cardiologist who can prescribe lipid therapy
- •Owns a smartphone and agrees to the End User License Agreement to use the digital health app
- •Provided informed consent before initiation of study-specific activities
排除标准
- •Motor, cognitive, auditory, or visual impairment limiting technology use
- •Does not speak English
- •Malignancy (except nonmelanoma skin cancers or cervical or breast ductal carcinoma in situ within the previous 5 years)
- •Pregnancy (positive pregnancy test, highly sensitive urine or serum), plan to become pregnant or donate eggs, breastfeeding or plan to breastfeed
- •Likely to not be available to comply with all required study procedures to the best of the patient's and investigator's knowledge
- •History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion
研究组 & 干预措施
Corrie Lipids Program
Multicomponent digital health lipid management and education program
干预措施: Corrie Lipids Digital Health Program (Device)
结局指标
主要结局
Percentage of participants achieving guideline-based LDL-C goals
时间窗: 6 months, 12 months
LDL-C Goal Achievement assessed 6 months after enrollment in the Corrie Lipids program
Percentage of participants who download and engage with the Corrie app
时间窗: 6 months
Patient Engagement With the App defined as downloading and completing an educational article or video among those who were offered the app.
次要结局
- Percentage of patients prescribed statin and non-statin therapies(12 months)
- Percentage of patients ordered an LDL-C test(12 months)
- Percentage of clinicians utilizing the program for patients(12 months)
- Percentage of patients utilizing the app(12 months)