The Interactive Cholesterol Advisory Tool (ICAT)

互动胆固醇咨询工具 (ICAT)

• 批准号: 8136701
• 负责人: Charles Scott Rigby
• 金额: $ 43.06万
• 依托单位: SELF-DETERMINED HEALTH, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-15 至 2013-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8136701
• 关键词: Achievement; Adherence; Behavioral Sciences; Cardiovascular system; Caring; Cessation of life; Cholesterol; Clinical; Clinical Trials; Competence; Coronary; Coronary heart disease; Development; Environment; Event; Guidelines; Health; Health Care Costs; Health Personnel; Health behavior; Healthcare Market; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Informal Social Control; Intervention; LDL Cholesterol Lipoproteins; Length; Life Style; Maintenance; Measures; Medical; Modeling; Monitor; Motivation; Multimedia; Myocardial Infarction; Participant; Patients; Perception; Pharmaceutical Preparations; Phase; Play; Population; Quality of life; Randomized Clinical Trials; Regimen; Research; Risk; Role; Self Determination; Solutions; Stroke; System; Technology; Testing; base; behavior change; design; high risk; innovation; medication compliance; primary outcome; prototype; response; theories; therapeutic lifestyle change; tool; usability; virtual

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.

描述(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，建议改变生活方式并服用HMG-CoA-Reductase抑制剂(即他汀类药物)的患者中，只有不到一半的人继续遵循规定的方案。这种不遵守会导致更多的心血管事件，缩短生活时间和生活质量，并每年增加数百万美元的医疗费用。实际的挑战是，在不增加对已经不堪重负的卫生保健提供者和系统的要求的情况下，制定遵守干预措施。拟议的项目将把经过验证的行为科学与互动技术相结合，开发一种高度可扩展的解决方案--互动胆固醇咨询工具(ICAT)，旨在通过提高冠心病风险患者的自主自我调节能力和感知能力，提高他们对药物依从性的启动和维持，并改变治疗生活方式。为了实现这一目标，ICAT将使用高度吸引人的和个性化的多媒体技术，利用经过科学验证的、自我决定理论(SDT)的健康行为模型(SDT；Deci和Ryan，1985,2000；Patrick，Williams等人，2008)。具体地说，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做出有意义的回应，并帮助根据临床指南制定有效的护理计划。因此，ICAT在将经过验证的行为改变模型整合为高度可扩展、有效和高效的技术工具方面具有重大创新意义，可在广大人群中维持冠状动脉健康。在拟议项目的第一阶段，将开发ICAT的原型，以提供SDT干预内容，并根据用户的输入定制答复。可用性测试将在开发过程中的两个不同点进行，以评估(1)ICAT的准确技术功能和(2)用户对ICAT的易用性和总体感知。随着第一阶段里程碑的成功实现，在拟议项目的第二阶段期间，ICAT将得到全面开发，以提供完整的基于SDT的干预措施，用于随机临床试验。100名在10年内发生心血管事件的中风险或高风险参与者将比较处方者加ICAT组(n=50)和处方者标准护理组(n=50)在(A)降低低密度脂蛋白-C水平(主要结果)和(B)增加他汀类药物的启动和长期依从性方面的效果，这是通过医疗事件监测系统CAPS(或Memscape(Tm))来衡量的。然后将在两个主要依赖指标上进行比较：(1)低密度脂蛋白-C的改善和(2)服药依从性。基本的假设是，处方者加ICAT组将(1)在低密度脂蛋白-C方面有更大的改善，(2)表现出更大的用药依从性。在临床试验中证明ICAT的疗效后，鉴于该产品能够有效和高效地接触到大量人群，该产品将在医疗保健市场的许多细分市场具有商业价值。