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.
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.
