POWER: Physical activity Outcome in hemophilia A patients Without inhibitors Evaluated in a Real-world setting

POWER is a multicenter, noninterventional, prospective study which aimed at evaluating the relationship between physical activity levels and bleeding in a target population of approximately 150 individuals aged between 12 and 50 years with severe/moderate hemophilia A without inhibitors against Factor VIII, also through the collection of patient-reported outcome measures (PROMs) via a mobile app.

Principal investigator: Francesco Petracca (CeRGAS) 

Team UB/Cergas: Oriana Ciani, Maria Cucciniello, Rosanna Tarricone (CeRGAS) 

Sponsor: Roche 

Duration: 2018-2019 

Abstract:

Background - There is limited evidence on the level and intensity of physical activity in individuals with hemophilia A. Mobile technologies 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 is often attributed to the insufficient consideration of stakeholder inputs in the development process of mobile apps. This study aimed at designing and validating an electronic patient-reported outcome mobile app that requires sustained active input by individuals during the observational study POWER. 

We adopted a user-centered design and engaged several stakeholders in the development and usability testing of this mobile app. The findings from the thematic analysis of the need-assessment focus group revealed that there was a demand for sense making, simplification of app functionalities, maximized integration, and minimization of the feeling of external control. Participants involved in the later stages of the design refinement contributed to improving the design further and rated the app highly during the quantitative assessment, with high average scores in the mobile health app usability questionnaire (MAUQ) recorded in the 2 iterative usability testing cycles.  

The adoption of a thorough user-centered design process using several types of focus groups is expected to maximize the likelihood of sustained retention of the users. The continuous use of the app and the actual level of engagement will be evaluated during the actual POWER trial. 

Material produced and publications:  

Petracca F, Tempre R, Cucciniello M, et al. An Electronic Patient-Reported Outcome Mobile App for Data Collection in Type A Hemophilia: Design and Usability Study. JMIR Form Res. 2021;5(12):e25071. Published 2021 Dec 1.