36 Chapter 2 2 Ethical Considerations The study was cleared for ethics by the Medical Ethical Review Committee of the Leiden University Medical Centre (No P18.158). The study was conducted in accordance with the Helsinki declaration. Written informed consent was obtained from all participants prior to all study activities. Study procedures The research was conducted in multiple phases using a mixed-methods approach. Throughout the phases, design methods such as personas, creative assignments, and prototyping were used to gain an in-depth understanding of user needs and preferences, identify opportunities for design and facilitate engagement of the participants with the research activities. Phase 1: Define To gain an in-depth understanding of people’s inhaler use, reasons for nonadherence and their needs, semi-structured interviews (n = 6) were held. The number of participants were deemed sufficient in light of the specific study activity purpose (i.e., to identify design directions). Interviews were guided by a topic list including questions about inhaler usage, beliefs about medication and challenges in everyday life dealing with inhaler use and their asthma. Interviews were – in agreement with the participant – held at the participants’ house or at another place which offered sufficient privacy (e.g., university). The duration of the interviews was approximately 30 to 60 minutes. Interviews were audio recorded and transcribed. A 5-minute online survey was administered among people with asthma (n = 20), containing items on efficacy and attitude from the Knowledge Attitude Self Efficacy Questionnaire (KASE-Q)34 and Beliefs about Medication Questionnaire – Specific (BMQ-specific) used to measure beliefs about asthma medication (34,35). Both questionnaires were available in Dutch and used in previous studies (36-39). The online survey was distributed via social media. Descriptive statistics were obtained using SPSS. Interview transcripts were analysed and triangulated with results from an online survey. Results were discussed with four primary care healthcare professionals to facilitate contextual understanding. Also, current strategies on how healthcare professionals motivate people to adhere to their maintenance medication were discussed to identify potentially useful behaviour change strategies. Themes were identified and mapped onto The Transtheoretical Model (TTM) for Behaviour Change to identify behaviour change strategies and place these within the five stages of behaviour change (i.e., pre-contemplation; contemplation; preparation; action and maintenance). The TTM helped to structure behavioural change strategies, without losing the complex interactions between individual and environmental factors that can impact behaviour out of sight.
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