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Accepted for/Published in: JMIR Formative Research

Date Submitted: Oct 16, 2020
Open Peer Review Period: Oct 16, 2020 - Dec 11, 2020
Date Accepted: Sep 16, 2021
Date Submitted to PubMed: Dec 2, 2021
(closed for review but you can still tweet)

The final, peer-reviewed published version of this preprint can be found here:

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

Petracca F, Tempre R, Cucciniello M, Ciani O, Pompeo E, Sannino L, Lovato V, Castaman G, Ghirardini A, Tarricone R

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

DOI: 10.2196/25071

PMID: 34855619

PMCID: 8686465

Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.

The POWER app: design and usability testing of a mobile app for the collection of patient-reported outcome data in type A haemophilia

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

ABSTRACT

Background:

Mobile technologies can offer a high potential solution to increase the rigorousness and reliability of data collected within clinical studies. However, the development process of mHealth apps is often inadequate and not sufficiently participatory, affecting the potential to meet intended purposes.

Objective:

The aim of this study was to design and validate a mHealth app for physical activities and electronic patient-reported outcomes (ePRO) collection in the POWER observational study currently enrolling patients with haemophilia A.

Methods:

We adopted a user-design process grounded in design science engaging several stakeholders in the development and usability testing of this mobile application, measured through the mHealth app usability questionnaire (MAUQ). During an initial need-assessment focus group we elicited the specific design requirements of the end-users. We then conducted 2 Exploratory Focus Groups to seek additional inputs for improvement and 2 Confirmatory Focus Groups to validate the proposed artifact and test its usability in the field.

Results:

Findings from thematic analysis of the need-assessment FG revealed a demand for sense making, simplification of app functionalities, maximized integration, and minimized feeling of external control. Participants involved in the later stages of the design refinement contributed to improve the design further by refining the app layout and adding aspects such as a chatbot function and a visual feedback on the number of hours the wearable device has been worn, to make sure the minimum is reached and observed data are actually registered. The end-users rated the app highly during the quantitative assessment, with an average MAUQ score of 5.32 (range 4.44-6.23) and 6.20 (5.72-6.88) out of seven in the two iterative usability testing cycles.

Conclusions:

The results of the usability test indicated high and growing satisfaction with the app. The adoption of a thorough user-centered design process can maximize the likelihood of sustained retention of the POWER mHealth app and make it fit for data collection of relevant outcomes in the observational study. Findings from our work support the use of different types of focus groups in the design process of a mHealth app. Continuous use of this tool and the actual level of engagement will be properly evaluated during the on-going study.


 Citation

Please cite as:

Petracca F, Tempre R, Cucciniello M, Ciani O, Pompeo E, Sannino L, Lovato V, Castaman G, Ghirardini A, Tarricone R

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

DOI: 10.2196/25071

PMID: 34855619

PMCID: 8686465

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