The Interactive Cholesterol Advisory Tool (ICAT)

描述（由申请人提供）：研究表明，只有不到一半的低密度脂蛋白-胆固醇（LDL-C）升高的患者建议改变生活方式并服用hmg - coa -还原酶抑制剂（即他汀类药物）继续遵循规定的方案。这种不依从性导致更多的心血管事件，寿命和生活质量下降，每年增加数百万美元的医疗保健费用。实际的挑战是在不增加对已经负担过重的卫生保健提供者和系统的需求的情况下制定依从性干预措施。拟议的项目将整合经过验证的行为科学与互动技术，以开发一种高度可扩展的解决方案——交互式胆固醇咨询工具（ICAT）——旨在通过提高冠心病（CHD）风险患者的自主自我调节和感知能力，增加药物依从性和治疗生活方式改变的启动和维持。为了实现这一目标，ICAT将使用高度参与和个性化的多媒体技术，利用科学验证的自我决定理论（SDT）健康行为模型（SDT； Deci和Ryan， 1985,2000; Patrick， Williams等人，2008）。具体来说，ICAT将是一个虚拟环境，患者将在其中与虚拟医疗保健提供者（“ICAT化身”）进行“对话”，该虚拟医疗保健提供者将对患者的输入作出有意义的回应，并协助制定基于临床指南的有效护理计划。因此，ICAT代表了一项重大创新，它将一种经过验证的行为改变模型整合为一种高度可扩展、有效和高效的技术工具，用于维持广大人群的冠状动脉健康。在拟议项目的第一阶段，我们将开发一个ICAT的原型，以提供sdt干预内容，并根据用户输入定制响应。可用性测试将在开发期间的两个不同阶段进行，以评估(1)ICAT的准确技术功能和(2)ICAT的易用性和用户对ICAT的一般看法。在成功实现I期里程碑之后，在拟议项目的II期期间，ICAT将被充分开发，以提供一个完整的基于sdt的干预措施，用于随机临床试验。100名10年内心血管事件中度或高风险的参与者将比较处方加icat组（n = 50）和处方标准护理组（n = 50）在以下方面的效果：(a)降低LDL-C水平（主要结局），(b)增加他汀类药物的起始和长期依从性，使用医疗事件监测系统CAPS（或Memscaps(tm)）进行测量。然后对两组进行比较：(1)LDL-C的改善和(2)药物依从性。潜在的假设是，处方加icat组将(1)在LDL-C方面有更大的改善，(2)表现出更大的药物依从性。在临床试验中证明ICAT的功效后，鉴于ICAT能够有效和高效地覆盖大量人口，该产品将在医疗保健市场的许多细分市场具有商业价值。

DESCRIPTION (provided by applicant): Research indicates that fewer than half of all patients with elevated low density lipoprotein-Cholesterol (LDL-C) advised to make life style changes and to take HMG-CoA-Reductase inhibitors (i.e. statins) continue to follow the prescribed regimens. This non-adherence results in more cardiovascular events, decreased length and quality of life, and millions of dollars more in health care costs each year. The practical challenge is to develop adherence interventions without increasing demands on already overburdened health care providers and systems. The proposed project will integrate validated behavioral science with interactive technology to develop a highly-scalable solution-The Interactive Cholesterol Advisory Tool (ICAT)-designed to increase the initiation and maintenance of medication adherence and therapeutic lifestyle change in patients at risk for coronary heart disease (CHD) by increasing their autonomous self-regulation and perceived competence. To achieve this, the ICAT will use highly engaging and personalized multimedia technology, capitalizing on the scientifically validated, self-determination-theory (SDT) health behavior model (SDT; Deci and Ryan, 1985, 2000; Patrick, Williams et al., 2008). Specifically, the ICAT will be a virtual environment in which the patient will have a "conversation" with a virtual health care provider (the "ICAT avatar") that will respond meaningfully to patient input and assist in developing an effective care plan based upon clinical guidelines. The ICAT therefore represents significant innovation in integrating a validated model for behavior change into a highly scalable, effective, and efficient technology tool for sustaining coronary health in a broad population. During Phase I of the proposed project, a prototype of the ICAT will be developed to deliver SDTintervention content and to customize responses based upon user input. Usability testing will be conducted at two different points during development to assess both (1) the accurate technical functioning of the ICAT and (2) the ease of use and general perception of the ICAT by users. Following successful achievement of Phase I milestones, during Phase II of the proposed project the ICAT will be fully developed to deliver a complete SDT-based intervention for use in a randomized clinical trial. One hundred (100) participants at moderate or high risk for a CV event within 10 years will compare the effects of a prescriber-plus-ICAT group (n = 50) to a prescriber-standard-care group (n = 50) on (a) reducing levels of LDL-C (primary outcome), and (b) increasing initiation and long-term adherence to statin medications, as measured using Medical Events Monitoring System CAPS (or Memscaps(tm)). Groups will then be compared on two primary dependent measures: (1) improvement in LDL-C and (2) medication adherence. The underlying hypothesis is that the prescriber-plus-ICAT group will (1) have greater improvement in LDL-C and (2) demonstrate greater medication adherence. Upon demonstration of the ICAT's efficacy in a clinical trial, there are numerous segments of the health care market for which the product will have commercial value, given its ability to reach large populations effectively and efficiently.