34 Chapter 2 2 Method Study design This study employed a user-centred, participatory design approach, during which people with asthma, as the end-users, had an important role in the design process. The approach consisted of four phases: define, ideate, prototype, and evaluate. The define phase (phase 1) was used to gain a deep understanding of the users’ needs, lived experiences and reasons for non-adherence and to identify design requirements. Design requirements were translated into several design directions in the ideation phase (phase 2). In two iterations, a prototype was developed (phase 3) and evaluated with end-users to gather user-feedback and improve the prototype (phase 4). Multiple stakeholder groups were included and consulted throughout the project. Healthcare professionals (i.e., general practitioner, practice nurse) provided input on medical content and feasibility for practice. Smart inhaler developers (i.e., representatives from pharmaceutical and medical device companies involved in the development and manufacturing of smart inhalers) provided input on technical and commercial feasibility. A visual representation of the study design and phases, including the core study activities and stakeholders involved, is presented in Figure 1. Design context The study was conducted between February 2019 and August 2019 in the area of Zuid-Holland, the Netherlands. Participants and recruitment procedures Participants People with asthma were eligible for study participation if they reported the following: 18 years and older, self-reported diagnosis of asthma, use of an inhaled corticosteroids (ICS) inhaler, difficulties being medication adherent, adequate oral fluency in Dutch or English. Participants were sampled purposively to represent diversity in age, gender, frequency of inhaler use and educational level. Recruitment procedure Multifaceted strategies were utilized including advertising on social media and university websites, and posters placed in sporting clubs and on university noticeboards. The recruitment poster included an illustration of three people representing different reasons to be non-adherent, with the question “do you recognize yourself? Participate in our study”. Upon expression of interest in participation a patient information sheet was sent by e-mail. The sheet contained information about the purpose of the study, the description of the study activity, that participation is voluntary, that audio is recorded, that data is treated confidentially and anonymously and that responses are reported pseudonymised. The information sheet was adapted per study activity (i.e., interview, survey, user test 1, user test 2, and online survey).
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