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，这既是为了改善患者的个体结果，也是为了促进科学治疗知识的进步。过去改善遵守情况的干预措施效果喜忧参半，其中最成功的是那些非常复杂和代价高昂的干预措施。需要方便、经济高效的工具来提高临床医生/研究人员对依从性的认识，同时将患者负担降至最低。自我监测(SM)作为一种临床工具和研究方法被越来越多地应用于不同的医学领域，以收集患者的关键依从性数据。与传统的数据收集方法相比，SM具有许多优点，包括较低的回忆偏差、更高的概括性和更低的患者负担。然而，传统的纸笔检查方法过于复杂，劳动强度大，患者不容易完成，导致依从性差，数据不准确，质量不高。为了更好地实时和在自然环境中采样患者的行为和体验，适用于移动设备的计算机化SM技术(C-SM)具有巨大的前景，患者报告说，它们更方便、更省时、更容易使用，更有动力完成。然而，尽管C-SM提供了巨大的潜力，但由于对开发个性化软件的时间、资金和训练有素的技术人员的高要求，在医疗和研究中的广泛传播和使用尚未显示出可行性。此外，目前可用的C-SM技术是针对特定目的高度专业化的，几乎没有能力将用于C-SM的技术与一个患者组相适应。该第一阶段项目的目标是开发和测试技术基础设施，以支持移动设备C-SM的创建和广泛部署。拟议的健康监测移动应用系统(MAS-HM)将允许临床医生和医学研究人员：(A)创建专门用于部署到移动设备(智能手机应用程序、移动网络或短信)的C-SM评估、协议和提示，(B)监控和跟踪患者的SM进展，以及(C)进行同步数据分析，以确定患者的依从性水平。最重要的是，MAS-HM将利用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的移动部署可用于任何医疗干预或研究。这个第一阶段的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病的青少年和年轻人建立可行性小组；以及3)使用从可行性小组汇编和分析的数据建立最终的原型规范。这些规范将用于指导第二阶段的开发，然后再进行有效性测试。最终的MAS-HM产品将利用移动设备的无处不在以及它们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。更多地接触和使用C-SM应该会转化为患者依从性和治疗有效性的提高。 公共卫生相关性：医疗不遵守已被确定为一个主要的公共卫生问题，给现代卫生保健系统带来相当大的财政负担[1-5]。由于依从性测量的复杂性，没有任何估计可以一概而论，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，这一负担在美国每年花费1000亿美元[4]，其中包括10%的入院费用[2，3]。坚持对临床研究结果的完整性也是至关重要的，以保持足够的统计分析能力，并将模糊发现的可能性降至最低。事实上，随着临床医生越来越依赖基于临床试验证据的治疗方案，解决研究领域的坚持问题也是至关重要的[9-14]。拟议的MAS-HM将消除依从性监测的障碍，并在便利性、成本效益和实用性方面提供比现有临床工具和研究工具更大的优势。

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.