Human-centered Design for a Chronic Disease Management System: An Explorative Case for Cystic Fibrosis

Background: Consistent self-management can improve symptoms and increase the quality of life of persons with cystic fibrosis (CF) who require daily care through following complex, time-consuming, and frequently changing self-management routines. However, it is challenging for many persons with CF to adhere to their self-management routines. Mobile health (mHealth) applications can support patients following and documenting daily treatment routines and medical history. Objective: This research aims to exploratively use the human-centered design approach (HCD) to identify needs and requirements to design an mHealth software concept for the disease management of persons with CF that includes secure data storage and communication with health care providers (HCP). Methods: The HCD process, as defined in ISO 9241–210, was used. Semi-structured interviews and a focus group interview were conducted with three adult persons living with CF, and two experienced CF nurses to explore the needs, challenges, and requirements for daily CF routines, nursing, and therapies. The interview transcripts were qualitatively assessed by thematic analysis, and the results were validated against previously published studies. The identified requirements were then used to design a technical software concept. Results: Participants expressed a need for patient-centered documentation that supports treatment adherence, enhances communication with their healthcare provider team, supports recalling their medical history, and overall enhances patient empowerment. The proposed features of the concept rely on daily documentation between clinic appointments, reminders and adherence checklists, a secure and direct communication channel with the healthcare provider team, medical summary reports, and customizing the application to individual user needs. This input made it possible to describe a user workflow and software functionalities using low-fidelity mockups. Based on the user workflow, a secure software architecture was developed. Prominent features are an in-person authentication process to define a trusted, secure, and direct communication channel between the self-management and HCP system. Furthermore, a clear separation of data storage and access is proposed, where the patient has full sovereignty to decide which data should be shared. Conclusion: We found that the HCD approach, particularly the use of stakeholder interviews, represents a feasible way to support the design of an mHealth software architecture in the context of CF. Further research in this domain is encouraged.