An Electronic Patient-Reported Outcome Mobile App for Data Collection in Type A Hemophilia: Design and Usability Study

Francesco Petracca, Rosaria Tempre, Maria Cucciniello, Oriana Ciani, Elena Pompeo, Luigi Sannino, Valeria Lovato, Giancarlo Castaman, Alessandra Ghirardini, Rosanna Tarricone, Francesco Petracca, Rosaria Tempre, Maria Cucciniello, Oriana Ciani, Elena Pompeo, Luigi Sannino, Valeria Lovato, Giancarlo Castaman, Alessandra Ghirardini, Rosanna Tarricone

Abstract

Background: There is currently limited evidence on the level and intensity of physical activity in individuals with hemophilia A. Mobile technologies can offer a rigorous and reliable alternative to support data collection processes but they are often associated with poor user retention. The lack of longitudinal continuity in their use can be partly attributed to the insufficient consideration of stakeholder inputs in the development process of mobile apps. Several user-centered models have been proposed to guarantee that a thorough knowledge of the end user needs is considered in the development process of mobile apps.

Objective: The aim of this study is to design and validate an electronic patient-reported outcome mobile app that requires sustained active input by individuals during POWER, an observational study that aims at evaluating the relationship between physical activity levels and bleeding in patients with hemophilia A.

Methods: We adopted a user-centered design and engaged several stakeholders in the development and usability testing of this mobile app. During the concept generation and ideation phase, we organized a need-assessment focus group (FG) with patient representatives to elicit specific design requirements for the end users. We then conducted 2 exploratory FGs to seek additional inputs for the app's improvement and 2 confirmatory FGs to validate the app and test its usability in the field through the mobile health app usability questionnaire.

Results: The findings from the thematic analysis of the need-assessment FG revealed that there was a demand for sense making, for simplification of app functionalities, for maximizing integration, and for minimizing the feeling of external control. Participants involved in the later stages of the design refinement contributed to improving the design further by upgrading the app's layout and making the experience with the app more efficient through functions such as chatbots and visual feedback on the number of hours a wearable device had been worn, to ensure that the observed data were actually registered. The end users rated the app highly during the quantitative assessment, with an average mobile health app usability questionnaire score of 5.32 (SD 0.66; range 4.44-6.23) and 6.20 (SD 0.43; range 5.72-6.88) out of 7 in the 2 iterative usability testing cycles.

Conclusions: The results of the usability test indicated a high, growing satisfaction with the electronic patient-reported outcome app. The adoption of a thorough user-centered design process using several types of FGs helped maximize the likelihood of sustained retention of the app's users and made it fit for data collection of relevant outcomes in the observational POWER study. The continuous use of the app and the actual level of engagement will be evaluated during the ongoing trial.

Trial registration: ClinicalTrials.gov NCT04165135; https://ichgcp.net/clinical-trials-registry/NCT04165135.

Keywords: design science; hemophilia A; mHealth; mobile apps; mobile phone; rare diseases; usability; user-centered design.

Conflict of interest statement

Conflicts of Interest: FP, MC, OC and RT all reported grants from the European Union’s Horizon 2020 Research and Innovation Program under grant agreement 779306. FP, MC, OC, and RT are also involved in a randomized controlled trial to evaluate a mobile supportive care app for patients with metastatic lung cancer. RT, EP, LS, VL, and AG are employees of Roche SpA. GC is on the advisory boards or is a speaker in company-sponsored symposia for Alexion, Bayer, Sanofi, Roche, Biomarin, Takeda, Novo Nordisk, Werfen, Grifols, Kedrion, LFB, Uniqure, and SOBI.

©Francesco Petracca, Rosaria Tempre, Maria Cucciniello, Oriana Ciani, Elena Pompeo, Luigi Sannino, Valeria Lovato, Giancarlo Castaman, Alessandra Ghirardini, Rosanna Tarricone. Originally published in JMIR Formative Research (https://formative.jmir.org), 01.12.2021.

Figures

Figure 1
Figure 1
Design process of the electronic patient-reported outcome app.
Figure 2
Figure 2
Screenshots of the electronic patient-reported outcome app final prototype.

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