Smartphone Delivered Comprehensive Heart Failure Self-management System

描述(由申请者提供)：Creative Action LLC计划推出一种全面的心力衰竭自我管理系统。该系统允许使用基于网络的管理软件的智能手机进行数据收集和监控。大学研究中心将是我们产品的初始市场。这一全面的自我管理系统被称为iRxRminder系统，专门为支持老年人使用而设计。该系统将最先进的药物提醒、可定制的调查、教育和实时现场数据报告模块整合在一个完全便携的包中。在一项试点研究中成功地对中风后患者进行了可行性和使用测试，iRxRminder系统将在第二阶段与合作伙伴的现有电子病历(EMR)系统集成。我们的硬件包括理想的智能手机和鼓励个人随身携带该系统的集成药丸载体。该地堡案已获得实用新型专利(美国专利号7337899)、九项外观设计专利(美国专利号：D501303-D501309、D509055柱体)，还有一项专利正在申请中。试点结果成功地表明，老年人有兴趣和能力充分使用智能手机功能，以实现服药依从性，完成互动调查，从提供的多媒体教育材料中学习，并向研究人员提供每周体重等数据。第一阶段的结果旨在确定第二阶段全面健康结果研究的招募率、参与率和可行的现场测试数据收集程序。心力衰竭导致认知能力低下，原因是心力衰竭的病理生理学(如脑血流减少)以及疲劳和压力。心力衰竭导致的认知功能恶化部分解释了为什么在这一人群中加强自我管理的干预措施收效甚微。这项建议的目的是开发和测试一个全面的自我管理系统，该系统将适合在更大的随机对照试验中使用。社会认知理论表明，基于智能手机的慢性病自我管理系统将提高患者的依从性，并将提供适当的认知支持，以克服认知障碍对服药依从性、日常体重和钠限制的影响。第一阶段旨在证明心力衰竭患者是否会在短期内(28天)接受和使用该综合系统，然后在第二阶段为期12个月的研究中进行。 公共卫生相关性：慢性病每年花费1.95万亿美元。慢性病影响了近一半的美国人，消耗了所有医疗保健支出的85%。为了最大限度地提高健康和生活质量，二级预防与慢性病相关的并发症是必不可少的。慢性护理文献表明，对于许多慢性病，跨学科循证护理管理方法是预防继发性并发症的最有效方法。心力衰竭(HF)造成的公共健康负担令人震惊，超过500万美国人受到影响，每年的成本超过430亿美元。与心力衰竭相关的大部分费用可归因于患者未能管理复杂的治疗方案而导致的再次住院。成功的自我管理源于坚持治疗方案和有效的决策，以及在心力衰竭症状恶化时采取纠正行动。对改善服药依从性的干预措施的荟萃分析显示，这些努力的有效性令人失望，强调需要更好的干预措施来改善患者的自我管理。作为全面护理管理的替代方案，越来越多的研究表明，包括教育、遵守支持(例如提醒)和监测在内的技术支持的自我管理对一般人，特别是老年人来说，可能同样有效、更容易获得，并且更具成本效益。

DESCRIPTION (provided by applicant): Creative Action LLC plans to market a comprehensive heart failure self-management system. The system enables data gathering and monitoring using of a smartphone with web-based management software. University research centers will be the initial market for our product. Called the iRxReminder" System, this comprehensive self-management system is specifically designed to support use by older adults. The system brings together state-of-the-art medication reminding, customizable surveying, education, and real-time field data reporting modules in a completely portable package. Successfully tested for feasibility and use with post-stroke patients in a pilot study, the iRxReminder System will be integrated with existing electronic medical record (EMR) systems of collaborating partners in Phase II Our hardware includes a desirable smartphone and integrated pill carrier that encourages an individual to carry the system with them. The pillbox case has been awarded a utility patent (US Patent No. 7337899), nine design patents (US Patent No. D501303-D501309, D509055 Pillbox), and one patent is pending. Pilot results successfully demonstrate older adults have an interest in and capacity to sufficiently use the smartphone features available for medication adherence, completing interactive surveys, learning from the multimedia educational materials presented, and providing data such as weekly weight to researchers. Phase I results are intended to determine recruitment rates, participation rates, and workable field test data collection procedures for a fully powered health outcomes study in Phase II. Heart failure contributes to low cognitive capacity due to the pathophysiology of heart failure (e.g. reduced cerebral blood flow), as well as fatigue and stress. Worsening cognitive function as a result of heart failure explain in part why interventions to enhance self-management in this population have had limited success. The purpose of this proposal is to develop and test a comprehensive self-management system that would be appropriate for use in a larger randomized controlled trial. Social Cognitive theory indicates that a smartphone-based chronic disease self-management system will improve adherence and will provide appropriate cognitive supports to overcome the effects of cognitive impairment on medication adherence, daily weighing, and sodium restriction. Phase I is intended to demonstrate if heart failure patients will accept and use the comprehensive system in the short-term (28-days), and later in a 12-month study in Phase II. PUBLIC HEALTH RELEVANCE: Chronic illnesses costs $1.95 trillion annually. Chronic conditions affect nearly half of all Americans and consume 85% of all health care spending. Secondary prevention of the complications associated with chronic conditions is essential in order to maximize health and quality of life. The chronic care literature indicates that for many chronic illnesses, an interdisciplinary evidence-based care management approach is the most effective way to prevent secondary complications. The public health burden of heart failure (HF) is staggering, as over 5 million Americans are affected and the annual costs exceed $43 billion. Much of the costs associated with HF are attributable to re-hospitalization that is a result from the failure of the patient to manage the complex treatment regimen. Successful self-management results from adherence to the treatment regimen and effective decision making with action regarding corrective action when HF symptoms are exacerbated. Meta- analyses of interventions to improve medication adherence reveal disappointing effectiveness of these efforts, underscoring the need for better interventions to improve patient self-management. As an alternative to comprehensive care management, there is a growing body of research indicating technology supported self-management that includes education, adherence support (e.g. reminding) and monitoring may be as effective, more accessible, and more cost effective for everyone in general, and older adults in particular.