Mobile Technology & Online Tools to Track Adherence in Chronic Illness Patients

描述（由申请人提供）：提高患者对治疗方案的依从性的需求是巨大的，既可以改善个体患者的结局，也可以提高科学治疗知识。过去为提高依从性而采取的干预措施结果好坏参半，其中最成功的是那些非常复杂和昂贵的干预措施。需要方便的、具有成本效益的工具来提高临床医生/研究人员对依从性的认识，同时使患者负担最小化。自我监测（SM）越来越多地用于不同的医疗领域，作为一种临床工具和研究方法，从患者那里收集关键的依从性数据。与传统的数据收集方法相比，SM具有许多优点，包括更低的回忆偏差，更高的概括性和更低的患者负担。然而，传统的纸笔SM方法过于复杂和劳动密集，患者无法轻松完成，导致依从性差，数据不准确，质量低。为了在真实的时间和自然环境中对患者的行为和体验进行最佳采样，用于移动的设备的计算机化SM技术（C-SM）具有巨大的前景，患者报告它们更方便、耗时更少、更易于使用并且更有动力完成。然而，尽管C-SM提供了巨大的潜力，但由于开发个性化软件对时间、资金和训练有素的技术人员的高要求，在医学治疗和研究中的大规模传播和使用尚未显示出可行性。此外，目前可用的C-SM技术对于特定目的是高度专业化的，几乎没有能力将用于一个患者组的C-SM的技术适应于另一个患者组。第一阶段项目的目标是开发和测试技术基础设施，以支持移动的设备的C-SM的创建和大规模部署。所提出的用于健康监测的移动的应用系统（MAS-HM）将允许临床医生和医学研究人员：（a）创建C-SM评估、协议和提示，专门用于部署到移动的设备（智能手机应用、移动的web或SMS文本消息），（B）监测和跟踪患者的SM进展，以及（c）进行同步数据分析以确定患者依从性水平。最重要的是，MAS-HM将利用一个无处不在的技术平台，消除采用C-SM方法的关键障碍，并使C-SM的移动的部署可用于任何医疗干预或研究。该第一阶段提案将实现三个具体目标：1）设计MAS-HM原型; 2）与临床医生，医学研究人员以及患有慢性疾病的青少年和年轻人进行可行性小组; 3）使用可行性小组编制和分析的数据建立最终原型规格。这些质量标准将用于指导疗效试验前的II期开发。最终的MAS-HM产品将利用移动的设备的普遍性及其强大的网络和计算能力，显著提高C-SM的准确性、及时性和易用性。更多地获得和使用C-SM应转化为改善患者依从性和治疗有效性。 公共卫生相关性：医疗不依从性已被确定为一个主要的公共卫生问题，对现代医疗保健系统造成了相当大的经济负担[1-5]。由于测量依从性的复杂性，无法进行一般性估计，但预计30-50%的患者依从性较差，无论疾病、预后或环境如何[2，3，6-8]。据估计，在美国，这种负担每年花费1000亿美元[4]，包括10%的住院费用[2，3]。为了保持足够的分析统计效力，并最大限度地减少模糊结果的可能性，依从性对临床研究结果的完整性也至关重要。事实上，随着临床医生越来越依赖于基于临床试验证据的治疗方案，在研究领域解决依从性也至关重要[9-14]。拟议的MAS-HM将消除依从性监测的障碍，并提供显着的优势，方便，成本效益和实用性超过现有的临床工具和研究工具。

DESCRIPTION (provided by applicant): The need to improve patient adherence to treatment protocol is immense, both for improved individual patient outcomes and advancement of scientific treatment knowledge. Past interventions to improve adherence have had mixed results, with the most success stemming from those that were very complex and costly. Convenient, cost effective tools to increase clinician/researcher awareness of adherence while creating minimal patient burden are needed. Self-monitoring (SM) is increasingly used across diverse medical fields as both a clinical tool and research method to gather critical adherence data from patients. SM presents myriad advantages over traditional data collection methods including lower recall bias, increased generalizability, and lower patient burden. However, traditional paper-and-pencil methods of SM are too complex and labor intensive for patients to complete easily, resulting in poor compliance and inaccurate, low quality data. In order to best sample patients' behaviors and experiences in real time and in natural environments, computerized SM technologies (C-SM) for mobile devices hold tremendous promise, with patients reporting them to be more convenient, less time consuming, easier to use, and more motivating to complete. Yet, despite the vast potential offered by C- SM, broad scale dissemination and use in medical treatment and research has not yet shown viability due to prohibitively high demands for time, finances, and trained technical staff to develop individualized software. Furthermore, currently available C-SM technologies are highly specialized for a specific purpose with little ability to adapt technology used for C-SM with one patient group to another. The goal of this Phase I project is to develop and test a technology infrastructure to support creation and broad scale deployment of C-SM for mobile devices. The proposed Mobile Application System for Health Monitoring (MAS-HM) would allow clinicians and medical researchers to: (a) create C-SM assessments, protocols, and prompts specifically for deployment to mobile devices (smartphone app, mobile web, or SMS text messaging), (b) monitor and track patients' SM progress, and (c) conduct synchronous data analysis to determine patient adherence level. Most importantly, the MAS-HM will utilize a ubiquitous technology platform that would remove key barriers to adopting C-SM methods and make mobile deployment of C-SM accessible for any medical intervention or research study. This Phase I proposal will accomplish three specific aims: 1) Design the MAS-HM prototype; 2) Conduct feasibility groups with clinicians, medical researchers, and adolescents and young adults with chronic illness; and 3) Establish final prototype specifications using data compiled and analyzed from the feasibility groups. These specifications will be used to guide Phase II development prior to efficacy testing. The final MAS-HM product will leverage the ubiquity of mobile devices combined with their powerful networking and computational capabilities to significantly increase C-SM accuracy, timeliness, and ease of use. Greater access to and use of C-SM should translate into improved patient adherence and treatment effectiveness. PUBLIC HEALTH RELEVANCE: Medical non-adherence has been identified as a major public health problem that imposes a considerable financial burden upon modern health care systems [1-5]. Because of the complexities in measuring adherence, no estimate can be generalized, but poor adherence is to be expected in 30-50% of all patients, irrespective of disease, prognosis, or setting [2, 3, 6-8]. This burden has been estimated to cost $100 billion each year in the US [4], including 10% of hospital admissions [2, 3]. Adherence is also critical to the integrity of clinical research findings in order to preserve sufficient statistical power for analysis and to minimize the potential for obscured findings. Indeed, as clinician's increasingly rely on treatment protocols that are based on clinical trial evidence, it is critical to address adherence in the realm of research as well [9-14]. The proposed MAS-HM would remove barriers to adherence monitoring and provide significant advantages in convenience, cost effectiveness, and utility over existing clinical tools and research instruments.