Background Involving chronically ill patients in the management of their health is widely recognized as a vital component of high-quality health care. However, to assume the role of informed participants, patients need both access to their health information and assistance in interpreting such data. Smartphone technology with SMS text messaging functionality offers a convenient and minimally demanding mechanism for providing such dual capabilities to patients. To date, a number of similar digital tools have been developed for use in various chronic and progressive disease conditions, including rheumatoid arthritis. Objective This paper aims to describe the development of a research protocol that applies a human-centered design (HCD) approach to develop a mobile health (mHealth) intervention to support symptom management and treatment adherence for rheumatoid arthritis. Methods To guide the development of the mHealth intervention for use within a commercial biotechnology context, we selected and applied an HCD framework consisting of three phases: understanding, ideation, and implementation. Results Leveraging the framework, we mapped the key objectives and research questions to each phase and identified the HCD techniques and methods most suitable for addressing them. In addition, we identified the need to include a fourth phase, one that referred to postimplementation assessment, which would enable evaluation of patient engagement and intervention impact on symptom self-management. Conclusions This paper presents a research protocol that applied an HCD framework to guide the development of an mHealth intervention within a commercial biotechnology context. This type of guidance is salient because commercial entities are becoming one of the leading producers of this type of intervention. However, the methodologies used and challenges faced from a research and development perspective are not well-represented in the published research literature to date. Our application of the HCD framework yielded important findings. Each phase of the HCD framework provided important guidance for increasing the likelihood that the final product would be understandable, acceptable, feasible, and engaging to use. Consistent with other researchers in the field of mHealth interventions, we identified the need to add a fourth phase to the HCD framework, one that focused on a postimplementation assessment to guide further improvements to support adoption in real-world settings. International Registered Report Identifier (IRRID) RR1-10.2196/16430
BACKGROUND Involving chronically ill patients in the management of their health is widely recognized as a vital component of high-quality healthcare. In order to assume the role of informed participants, however, patients need both access to their health information as well as assistance in interpreting such data. Smart phone technology with text messaging (SMS) functionality offers a convenient and minimally demanding mechanism for providing such a dual capability to patients. To date, numerous such digital tools have been developed for use in various chronic and progressive disease conditions, including for rheumatoid arthritis. OBJECTIVE To describe the application of a human centered design (HCD) approach to inform the development of a framework for a digital health intervention to support symptom management and treatment adherence in rheumatoid arthritis. METHODS We reviewed the HCD approach which consists of three phases: understanding, ideation, and implementation. To develop our framework, methods were mapped to the objectives of each phase. RESULTS We developed a four-phase framework that was informed by an HCD approach. The first three phases in the framework, which consisted of understanding, ideation, and implementation, were consistent with the HCD approach. In addition, we added a fourth phase, post-implementation assessment, to enable evaluation of patient engagement and intervention impact on symptom self-management. CONCLUSIONS Applying HCD-based methods demands commitment to an iterative approach to intervention design. Each phase of our framework yields critical findings for ensuring that the final product is understandable, acceptable, and feasible, and provides value to the patient such that the intervention is both engaging and positively impacts patient outcomes. CLINICALTRIAL N/A
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