Digital Assistant Supported Medication Adherence and Medical Monitoring Syst

描述（由申请人提供）：创意行动有限责任公司，总部设在阿克伦，俄亥俄州，计划把市场的个人数字助理为基础的健康数据收集和报告系统。有兴趣研究药物对老年人影响的研究人员将是我们产品的最初市场。我们将我们的药物依从性和数据收集系统称为iRxReminder”系统。该软件是专门设计的，并将测试老年人使用。该软件是专门设计的，并将测试老年人使用。该系统将最先进的药物提醒和实时现场数据收集和报告软件集成在一个完全便携的包中。在第二阶段，我们将与商业合作伙伴一起将iRxReminder系统与现有的电子病历系统集成。我们的硬件包括一个理想的个人数字助理和集成的药丸载体，以确保个人将随身携带的系统。Pillbox保护套已获得一项实用专利（美国专利号7337899）、九项外观设计专利（美国专利号D501303-D501309、D509055 Pillbox）和一项正在申请的专利。第一阶段将包括开发软件和完成可行性研究。在地区医院接受急性治疗的合格缺血性卒中和短暂性脑缺血发作（TIA）患者将获得知情同意，然后随机分配至干预组或对照组。在随机化时，对照组患者将接受卒中后教育和医学信息日记，以帮助他们进行出院后自我管理。干预组的患者将收到一个带有预先编程了药物治疗方案的iRxReminder软件的个人数字助理，以及一个带有集成药盒的病例。患者将在家庭访视时接受个人数字助理所有功能的使用培训，包括练习对iRxReminder服药和调查提示的响应。第一阶段的目标是证明老年人有兴趣和能力中风后充分使用现有的功能，并通过全面的掌握测试和60天的使用证明成功的使用培训后。在60天结束时，将使用统计检验确定老年人是否通过稳定使用支持1）药物提醒、2）医学和态度调查以及3）展示与卒中相关的教育材料的软件，利用该器械改善卒中后护理的自我管理;与对照组（使用既往卒中后护理研究中使用的印刷小册子）进行比较。可行性研究将提供必要的现场经验，以确定招募率、参与率和可行的现场试验数据收集程序，用于II期完全有效的健康结局研究。公共卫生相关性：与药物有关的问题对美国经济来说是一个巨大的成本。估计的数额从760亿美元（约翰逊和布特曼，1995年）到1 770亿美元（恩斯特和格里兹，2001年）不等。缺乏依从性会导致不必要的疾病进展、疾病并发症、功能降低、生活质量降低，甚至过早死亡。我们之前的实验室（Sunday和Mayhorn，2006）和扩展的实地研究（Sunday，2005）有44名老年人（M = 72岁）。使用智能手机与所附药盒盒的组合提供了以下证据：1）改善药物依从性; 2）充当给个体用药的专家之间的联系;以及3）向医疗保健专业人员提供反馈以更好地指导药物方案。拟议的研究将在第一阶段证明该系统对老年人的可行性，并在第二阶段证明为医生和老年患者提供的信息的实用性。随着时间的推移，我们相信该产品可以发展成为老年人的认知假体，这将降低整体治疗成本，延长独立性并提高成功衰老。

DESCRIPTION (provided by applicant): Creative Action LLC, based in Akron, Ohio, plans to bring to market a personal digital assistant-based health data gathering and reporting system. Researchers interested in studying the effects of medications on older adults will be the initial market for our product. We call our medication adherence and data gathering system the iRxReminder" System. The software is specifically designed and will be tested for use by older adults. The software is specifically designed and will be tested for use by older adults. The system brings together state-of- the-art medication reminding and real-time field data collection and reporting software in a completely portable package. With our commercial partners we will integrate the iRxReminder System with existing electronic medical record systems in Phase II. Our hardware includes a desirable personal digital assistant and integrated pill carrier that ensures an individual will 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 pending. Phase I will include development of the software and completion of a feasibility study. Eligible ischemic stroke and transient ischemic attack (TIA) patients undergoing acute treatment at a regional hospital will be approached for consent and then randomized into either the intervention or control group. At the time of randomization, patients in the control group will receive a post-stroke education and medical information diary to assist them in post-discharge self-management. Patients in the intervention group will receive a personal digital assistant with the iRxReminder software preprogrammed with their medication regimen, and a case with the integrated pillbox. Patients will receive training in use of the all the features of the personal digital assistant at a home visit, including practice responding to the iRxReminder medication-taking and survey prompts. The objectives of Phase I are to demonstrate that older adults have an interest in and capacity post-stoke to sufficiently use the features available and to demonstrate successful usage following training, both through a comprehensive mastery test and through 60 days of usage. At the end of 60 days statistical test will be used to determine if older adults utilize the device in improving self-management of care following a stroke through steady use of software that supports 1) medication reminding, 2) medical and attitudinal surveying, and 3) presentation of educational materials related to stroke; compared to a control group using a printed booklet used in a previous post-stroke care study. The feasibility study will provide the field experience necessary to determine recruitment rates, participation rates, and workable field test data collection procedures for a fully powered health outcomes study in Phase II. PUBLIC HEALTH RELEVANCE: Medication-related problems represent a huge cost to the United States economy. Estimates range from $76 billion dollars (Johnson & Bootman, 1995) to $177 billion (Ernst and Grizzle, 2001). Lack of adherence leads to unnecessary disease progression, disease complications, reduced functional abilities, lower quality of life, and even premature death. Our previous lab (Sterns and Mayhorn, 2006) and extended field research (Sterns, 2005) with 44 older adults (M = 72 yrs.) using a Smartphone in combination with an attached pillbox case provided evidence of 1) improving medication adherence; 2) serving as a link between specialists medicating the individual; and 3) providing feedback to healthcare professionals to better direct medication regimens. The proposed research will demonstrate the feasibility of the system for older adults in Phase I, and demonstrate the utility of the information provided for physicians and for older adult patients in Phase II. Over time, we believe the product can evolve to serve as a cognitive prosthesis for older adults that will reduce overall treatment costs and extend independence and enhance successful aging.