The Interactive Cholesterol Advisory Tool (ICAT)

描述（由申请人提供）：研究表明，在所有低密度脂蛋白胆固醇（LDL-C）升高的患者中，只有不到一半的人被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，降低寿命和生活质量，每年增加数百万美元的医疗保健费用。实际的挑战是制定依从性干预措施，而不增加对已经负担过重的卫生保健提供者和系统的要求。拟议的项目将整合验证的行为科学与互动技术，以开发一个高度可扩展的解决方案-互动胆固醇咨询工具（ICAT）-旨在增加冠心病（CHD）风险患者的药物依从性和治疗生活方式的改变的启动和维持，通过增加他们的自主自我调节和感知能力。为了实现这一目标，ICAT将使用高度吸引人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;帕特里克，威廉姆斯等人，2008年）。具体而言，ICAT将是一个虚拟环境，其中患者将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输入做出有意义的响应，并帮助基于临床指南制定有效的护理计划。因此，ICAT代表了将经验证的行为改变模型整合到高度可扩展、有效和高效的技术工具中以维持广泛人群的冠状动脉健康的重大创新。在拟议项目的第一阶段，将开发一个ICAT原型，以提供特殊和差别待遇干预内容，并根据用户的投入定制答复。在开发过程中，将在两个不同的时间点进行可用性测试，以评估（1）ICAT的准确技术功能和（2）用户对ICAT的易用性和一般感知。在成功实现I期里程碑之后，在拟议项目的II期期间，ICAT将得到充分开发，以提供一个完整的基于SDT的干预措施，用于随机临床试验。10年内CV事件中度或高度风险的100例受试者将比较处方药加ICAT组（n = 50）与处方药标准治疗组（n = 50）对（a）降低LDL-C水平的影响（主要结果），和（B）增加对他汀类药物的起始和长期依从性，如使用医疗事件监测系统CAPS（或MemscapsTM）测量的。然后将在两个主要依赖性指标上对各组进行比较：（1）LDL-C的改善和（2）药物依从性。基本假设是，处方药加ICAT组将（1）LDL-C改善更大，（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，鉴于其有效和高效地接触大量人群的能力，该产品将具有商业价值的医疗保健市场的许多部分。公共卫生相关性：在所有被建议改变生活方式并服用他汀类药物的低密度脂蛋白-胆固醇（或“坏”胆固醇：LDL-C）升高患者中，只有不到一半的人继续遵循处方。 这导致更多的心脏病发作、中风和死亡，并增加了医疗保健费用。该项目将开发一种创新的互动技术，称为互动胆固醇咨询工具（ICAT），旨在提高患者改变生活方式和为高危人群服药的积极性。这一工具的价值在于，它可以接触到处于风险中的广大人群，并在维持他们的健康和生活质量方面发挥作用。

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. PUBLIC HEALTH RELEVANCE: Fewer than half of all patients with elevated low density lipoprotein-Cholesterol (or "bad" cholesterol: LDL-C) who are advised to make life style changes and to take statin medications continue to follow the prescribed regimen, resulting in more heart attacks, strokes and deaths and increased health care costs. This project will develop an innovative interactive technology, called the Interactive Cholesterol Advisory Tool (ICAT), which is designed to enhance patients' motivation regarding lifestyle change and taking medications for those who are at risk. The value of this tool is that it can reach a broad population of people who are at risk and play a role in sustaining their health and their quality of life.