The Design of a Persuasive Game to Motivate People with Asthma in Adherence to Their Maintenance Medication.

Objective: This study aimed to design a persuasive game, using objective adherence data, to motivate people with asthma to adhere to their medication regimen. Methods: A participatory user-centered design approach was employed, involving end-users and other stakeholders throughout the study. The approach consisted of four phases. Semi-structured interviews and a survey were conducted to understand user needs and reasons for poor adherence (Phase 1: define). Key themes were identified, leading to the formulation of behavior change strategies and design and game requirements. Several design directions were ideated, resulting in a concept for a serious game (Phase 2: ideate). Two rounds of user-tests were performed to evaluate a prototype of the serious game in terms of usability, perceived impact on medication adherence and motivation (Phase 3: prototype and Phase 4: evaluate). Results: Findings from semi-structured interviews (n = 6) and the online survey (n = 20) revealed that people's non-adherence was often attributed to the perception of asthma as an episodic condition, the delayed experienced effect of maintenance inhalers, and lack of knowledge regarding difference of effect between maintenance and reliever inhalers. The study used behavior change strategies to translate these insights into design requirements for the development of the narrative-based persuasive game Ademgenoot. This six-week challenge-based game combines various behavior change strategies, including personal goal setting and continuous visual feedback, as well as persuasive game design elements, such as a narrative and rewards, with the aim of enhancing motivation to adhere to their medication regimen. User-testing (n = 8; round 1 and 2) showed that Ademgenoot is feasible in clinical practice and has the potential to support people with mild asthma in adherence to their maintenance medication. Discussion: Future efforts should be directed towards a larger evaluation to assess the impact on motivation and inhaler use behaviour.

Translation, cultural adaptation and validity assessment of the Dutch version of the eHealth Literacy Questionnaire: a mixed-method approach.

BACKGROUND: The digitalization of healthcare requires users to have sufficient competence in using digital health technologies. In the Netherlands, as well as in other countries, there is a need for a comprehensive, person-centered assessment of eHealth literacy to understand and address eHealth literacy related needs, to improve equitable uptake and use of digital health technologies. OBJECTIVE: We aimed to translate and culturally adapt the original eHealth Literacy Questionnaire (eHLQ) to Dutch and to collect initial validity evidence. METHODS: The eHLQ was translated using a systematic approach with forward translation, an item intent matrix, back translation, and consensus meetings with the developer. A validity-driven and multi-study approach was used to collect validity evidence on 1) test content, 2) response processes and 3) internal structure. Cognitive interviews (n = 14) were held to assess test content and response processes (Study 1). A pre-final eHLQ version was completed by 1650 people participating in an eHealth study (Study 2). A seven-factor Confirmatory Factor Analysis (CFA) model was fitted to the data to assess the internal structure of the eHLQ. Invariance testing was performed across gender, age, education and current diagnosis. RESULTS: Cognitive interviews showed some problems in wording, phrasing and resonance with individual's world views. CFA demonstrated an equivalent internal structure to the hypothesized (original) eHLQ with acceptable fit indices. All items loaded substantially on their corresponding latent factors (range 0.51-0.81). The model was partially metric invariant across all subgroups. Comparison of scores between groups showed that people who were younger, higher educated and who had a current diagnosis generally scored higher across domains, however effect sizes were small. Data from both studies were triangulated, resulting in minor refinements to eight items and recommendations on use, score interpretation and reporting. CONCLUSION: The Dutch version of the eHLQ showed strong properties for assessing eHealth literacy in the Dutch context. While ongoing collection of validity evidence is recommended, the evidence presented indicate that the eHLQ can be used by researchers, eHealth developers and policy makers to identify eHealth literacy needs and inform the development of eHealth interventions to ensure that people with limited digital access and skills are not left behind.

Anticipated barriers and facilitators for implementing smart inhalers in asthma medication adherence management.

Smart inhalers are electronic monitoring devices which are promising in increasing medication adherence and maintaining asthma control. A multi-stakeholder capacity and needs assessment is recommended prior to implementation in healthcare systems. This study aimed to explore perceptions of stakeholders and to identify anticipated facilitators and barriers associated with the implementation of smart digital inhalers in the Dutch healthcare system. Data were collected through focus group discussions with female patients with asthma (n = 9) and healthcare professionals (n = 7) and through individual semi-structured interviews with policy makers (n = 4) and smart inhaler developers (n = 4). Data were analysed using the Framework method. Five themes were identified: (i) perceived benefits, (ii) usability, (iii) feasibility, (iv) payment and reimbursement, and (v) data safety and ownership. In total, 14 barriers and 32 facilitators were found among all stakeholders. The results of this study could contribute to the design of a tailored implementation strategy for smart inhalers in daily practice.

Developing a Digital Medication Adherence Intervention for and With Patients With Asthma and Low Health Literacy: Protocol for a Participatory Design Approach.

BACKGROUND: Current eHealth interventions are poorly adopted by people with low health literacy (LHL) as they often fail to meet their needs, skills, and preferences. A major reason for this poor adoption is the generic, one-size-fits-all approach taken by designers of these interventions, without addressing the needs, skills, and preferences of disadvantaged groups. Participatory design approaches are effective for developing interventions that fit the needs of specific target groups; yet, very little is known about the practical implications of executing a participatory design project for and with people with LHL. OBJECTIVE: This study aimed to demonstrate the application of participatory design activities specifically selected to fit the needs and skills of people with LHL and how these were manifested within an overarching eHealth design process. In addition, the study aims to present reflections and implications of these activities that could support future designers to engage people with LHL in their design processes. METHODS: We used the design process of a smart asthma inhaler for people with asthma and LHL to demonstrate participatory design activities. The study was framed under 5 stages of design thinking: empathize, define, ideate, prototype, and test within 2 major iteration cycles. We integrated 3 participatory design activities deemed specifically appropriate for people with LHL: co-constructing stories, experience prototype exhibition, and video prototype evaluation. RESULTS: Co-constructing stories was found to deepen the understanding of the participant's motivation to use or not to use maintenance medication. This understanding informed and facilitated the subsequent development of diverse preliminary prototypes of possible interventions. Discussing these prototypes in the experience prototype exhibition helped provoke reactions, thoughts, and feelings about the interventions, and potential scenarios of use. Through the video prototype evaluation, we were able to clearly communicate the goal and functionality of the final version of our intervention and gather appropriate responses from our participants. CONCLUSIONS: This study demonstrates a participatory design approach for and with patients with asthma and LHL. We demonstrated that careful consideration and selection of activities can result in participants that are engaged and feel understood. This paper provides insight into the practical implications of participatory activities with people with LHL and supports and inspires future designers to engage with this disadvantaged target group.

How to use participatory design to develop an eHealth intervention to reduce preprocedural stress and anxiety among children visiting the hospital: The Hospital Hero app multi-study and pilot report.

Background: Medical procedures can cause considerable stress and anxiety among children. Current interventions mainly diminish stress and anxiety during procedures, while stress and anxiety often build up at home. Moreover, interventions often focus on either distraction or preparation. eHealth can combine multiple strategies and provide a low-cost solution that can be used outside the hospital. Objective: To develop an eHealth solution to diminish preprocedural stress and anxiety, and to evaluate the app on use, usability and user experience in practice. We also aimed to gain in-depth insights in children's and caregivers' opinions and experiences to inform future improvements. Methods: This is a multi-study report on the development (Study 1) and evaluation (Study 2) of a first version of the developed app. In study 1 we adopted a participatory design approach in which children's experiences were central to the design process. We performed an experience journey session with stakeholders (n = 13) to map the child's outpatient journey, identify pains and gains, and formulate the desired experience journey. Iterative development and testing with children (n = 8) and caregivers (n = 6) resulted in a working prototype. The prototype was tested with children, resulting in a first version of the Hospital Hero app. The app was evaluated on use, user-experience and usability during an eight-week pilot study in practice (Study 2). We triangulated data from online interviews with children and caregivers (n = 21) and online questionnaires (n = 46). Results: Multiple stress and anxiety experience touchpoints were identified. The Hospital Hero app supports children in their hospital journey by facilitating preparation at home and providing distraction at the hospital. The pilot study showed that the app was evaluated positively on usability and user-experience and is considered feasible. Qualitative data showed five themes: (1) user-friendliness, (2) coherence and power of storytelling, (3) motivation and reward, (4) fit with real hospital journey, (5) procedural comfort. Discussion: Using participatory design, we developed a child-centered solution that supports children in the entire hospital journey and may diminish preprocedural stress and anxiety. Future efforts should create a more tailored journey, define an optimal engagement window and formulate implementation strategies.

Effectiveness, usability and acceptability of a smart inhaler programme in patients with asthma: protocol of the multicentre, pragmatic, open-label, cluster randomised controlled ACCEPTANCE trial.

INTRODUCTION: Suboptimal asthma control is associated with incorrect inhaler use and poor medication adherence, which could lead to unfavourable clinical and economic outcomes. Smart inhaler programmes using electronic monitoring devices (EMDs) could support self-management and increase medication adherence and asthma control. However, evidence on long-term benefits and acceptability is scarce. This study aims to investigate the effectiveness of a smart inhaler asthma self-management programme on medication adherence and clinical outcomes in adults with uncontrolled asthma, to evaluate its acceptability and to identify subgroups who would benefit most based on patient characteristics. METHODS AND ANALYSIS: This open-label cluster randomised controlled trial of 12 months will be conducted in primary care in the Netherlands. General practices will be randomly assigned to either intervention or control group. We aim to include 242 patients. The intervention consists of (1) an EMD attached to the patient's inhaler that measures medication use; (2) a smartphone application to set medication reminders, receive motivational messages and track asthma symptoms; and (3) a portal for healthcare professionals to view data on medication use. The control group is passively monitored by the EMD but cannot view their inhaler data or receive feedback. Eligible patients are adults with suboptimal controlled asthma (Asthma Control Questionnaire score ≥0.75) with evidence of non-adherence established by the EMD during a 6-week run-in period. Primary outcome is the difference in mean medication adherence between intervention and control group. Secondary outcomes include asthma control, asthma-related quality of life, exacerbations, acceptance, cost-effectiveness and whether the effect of the intervention on medication adherence and asthma control is modified by patient characteristics (eg, self-efficacy, medication beliefs and eHealth literacy).Trial registration numberNL7854.

Beliefs, Perceptions, and Behaviors Regarding Chronic Respiratory Diseases of Roma in Crete, Greece: A Qualitative FRESH AIR Study.

Background: The global burden of chronic respiratory diseases (CRDs) disproportionally affects Roma populations. Health interventions addressing CRD among Roma or other vulnerable groups often fail to be effective, as their implementation strategy misaligns with the local context. To design context-driven strategies, we studied CRD-related beliefs, perceptions, and behaviors among a Greek Roma population, focussing on asthma and COPD. Methods: For this qualitative study in Crete, Greece, we used a Rapid Assessment Process. We conducted interviews and focus groups with purposively selected Roma community members (CMs), key informants (KIs) and healthcare professionals (HPs) serving the population. Data were triangulated using observations of households and clinical consultations. Key themes were identified using Thematic Content Analysis. The Health Belief Model, the Explanatory Model of Illness, and the Theory of Planned Behavior that are complementary is some aspects, guided our methodology with the several variables from them to be integrated to better understand CRD risk preventative behavior. Results: We conducted six focus groups, seven interviews and 13 observations among 15 CMs, four KIs, and three HPs. Five themes emerged: (1) Poor CRD-awareness (smoking and household air pollution were perceived as harmful, but almost exclusively associated with acute rather than chronic symptoms); (2) Low perceived susceptibility to CRD (and CMs tended to ignore respiratory symptoms); (3) High risk exposure (smoking was common, and air pollution was perceived inevitable due to financial constraints); (4) Healthcare seeking (healthcare was sought only for persistent, severe symptoms, daily needs were a priority); (5) Perceived barriers/facilitators to care (health illiteracy, perceived discrimination and financial constraints were main barriers; established trust the main facilitator). Conclusion: These five themes highlight that strategies to tackle CRD in the studied Roma setting require a multilevel approach: bridging awareness gaps at the population level, providing resources to enhance the adoption of healthy behaviors, and fighting discrimination at the societal level, whilst establishing trusted relationships at the local level. Similar methodologies to address local context may strengthen the implementation of effective interventions for similarly vulnerable and/or low-resource populations.

Mapping low-resource contexts to prepare for lung health interventions in four countries (FRESH AIR): a mixed-method study.

BACKGROUND: Effectiveness of health programmes can be undermined when the implementation misaligns with local beliefs and behaviours. To design context-driven implementation strategies, we explored beliefs and behaviours regarding chronic respiratory disease (CRD) in diverse low-resource settings. METHODS: This observational mixed-method study was conducted in Africa (Uganda), Asia (Kyrgyzstan and Vietnam) and Europe (rural Greece and a Roma camp). We systematically mapped beliefs and behaviours using the SETTING-tool. Multiple qualitative methods among purposively selected community members, health-care professionals, and key informants were triangulated with a quantitative survey among a representative group of community members and health-care professionals. We used thematic analysis and descriptive statistics. FINDINGS: We included qualitative data from 340 informants (77 interviews, 45 focus group discussions, 83 observations of community members' households and health-care professionals' consultations) and quantitative data from 1037 community members and 204 health-care professionals. We identified three key themes across the settings; namely, (1) perceived CRD identity (community members in all settings except the rural Greek strongly attributed long-lasting respiratory symptoms to infection, predominantly tuberculosis); (2) beliefs about causes (682 [65·8%] of 1037 community members strongly agreed that tobacco smoking causes symptoms, this number was 198 [19·1%] for household air pollution; typical perceived causes ranged from witchcraft [Uganda] to a hot-cold disbalance [Vietnam]); and (3) norms and social structures (eg, real men smoke [Kyrgyzstan and Vietnam]). INTERPRETATION: When designing context-driven implementation strategies for CRD-related interventions across these global settings, three consistent themes should be addressed, each with common and context-specific beliefs and behaviours. Context-driven strategies can reduce the risk of implementation failure, thereby optimising resource use to benefit health outcomes. FUNDING: European Commission Horizon 2020. TRANSLATIONS: For the Greek, Russian and Vietnamese translations of the abstract see Supplementary Materials section.

Integrated disease management interventions for patients with chronic obstructive pulmonary disease.

BACKGROUND: People with chronic obstructive pulmonary disease (COPD) show considerable variation in symptoms, limitations, and well-being; this often complicates medical care. A multi-disciplinary and multi-component programme that addresses different elements of care could improve quality of life (QoL) and exercise tolerance, while reducing the number of exacerbations. OBJECTIVES: To compare the effectiveness of integrated disease management (IDM) programmes versus usual care for people with chronic obstructive pulmonary disease (COPD) in terms of health-related quality of life (QoL), exercise tolerance, and exacerbation-related outcomes. SEARCH METHODS: We searched the Cochrane Airways Group Register of Trials, CENTRAL, MEDLINE, Embase, and CINAHL for potentially eligible studies. Searches were current as of September 2020. SELECTION CRITERIA: Randomised controlled trials (RCTs) that compared IDM programmes for COPD versus usual care were included. Interventions consisted of multi-disciplinary (two or more healthcare providers) and multi-treatment (two or more components) IDM programmes of at least three months' duration. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality and extracted data. If required, we contacted study authors to request additional data. We performed meta-analyses using random-effects modelling. We carried out sensitivity analyses for the quality of included studies and performed subgroup analyses based on setting, study design, dominant intervention components, and region. MAIN RESULTS: Along with 26 studies included in the 2013 Cochrane Review, we added 26 studies for this update, resulting in 52 studies involving 21,086 participants for inclusion in the meta-analysis. Follow-up periods ranged between 3 and 48 months and were classified as short-term (up to 6 months), medium-term (6 to 15 months), and long-term (longer than 15 months) follow-up. Studies were conducted in 19 different countries. The mean age of included participants was 67 years, and 66% were male. Participants were treated in all types of healthcare settings, including primary (n =15), secondary (n = 22), and tertiary care (n = 5), and combined primary and secondary care (n = 10). Overall, the level of certainty of evidence was moderate to high. We found that IDM probably improves health-related QoL as measured by St. George's Respiratory Questionnaire (SGRQ) total score at medium-term follow-up (mean difference (MD) -3.89, 95% confidence interval (CI) -6.16 to -1.63; 18 RCTs, 4321 participants; moderate-certainty evidence). A comparable effect was observed at short-term follow-up (MD -3.78, 95% CI -6.29 to -1.28; 16 RCTs, 1788 participants). However, the common effect did not exceed the minimum clinically important difference (MCID) of 4 points. There was no significant difference between IDM and control for long-term follow-up and for generic QoL. IDM probably also leads to a large improvement in maximum and functional exercise capacity, as measured by six-minute walking distance (6MWD), at medium-term follow-up (MD 44.69, 95% CI 24.01 to 65.37; 13 studies, 2071 participants; moderate-certainty evidence). The effect exceeded the MCID of 35 metres and was even greater at short-term (MD 52.26, 95% CI 32.39 to 72.74; 17 RCTs, 1390 participants) and long-term (MD 48.83, 95% CI 16.37 to 80.49; 6 RCTs, 7288 participants) follow-up. The number of participants with respiratory-related admissions was reduced from 324 per 1000 participants in the control group to 235 per 1000 participants in the IDM group (odds ratio (OR) 0.64, 95% CI 0.50 to 0.81; 15 RCTs, median follow-up 12 months, 4207 participants; high-certainty evidence). Likewise, IDM probably results in a reduction in emergency department (ED) visits (OR 0.69, 95%CI 0.50 to 0.93; 9 RCTs, median follow-up 12 months, 8791 participants; moderate-certainty evidence), a slight reduction in all-cause hospital admissions (OR 0.75, 95%CI 0.57 to 0.98; 10 RCTs, median follow-up 12 months, 9030 participants; moderate-certainty evidence), and fewer hospital days per person admitted (MD -2.27, 95% CI -3.98 to -0.56; 14 RCTs, median follow-up 12 months, 3563 participants; moderate-certainty evidence). Statistically significant improvement was noted on the Medical Research Council (MRC) Dyspnoea Scale at short- and medium-term follow-up but not at long-term follow-up. No differences between groups were reported for mortality, courses of antibiotics/prednisolone, dyspnoea, and depression and anxiety scores. Subgroup analysis of dominant intervention components and regions of study suggested context- and intervention-specific effects. However, some subgroup analyses were marked by considerable heterogeneity or included few studies. These results should therefore be interpreted with caution. AUTHORS' CONCLUSIONS: This review shows that IDM probably results in improvement in disease-specific QoL, exercise capacity, hospital admissions, and hospital days per person. Future research should evaluate which combination of IDM components and which intervention duration are most effective for IDM programmes, and should consider contextual determinants of implementation and treatment effect, including process-related outcomes, long-term follow-up, and cost-effectiveness analyses.

A systematic approach to context-mapping to prepare for health interventions: development and validation of the SETTING-tool in four countries.

Effectiveness of health interventions can be substantially impaired by implementation failure. Context-driven implementation strategies are critical for successful implementation. However, there is no practical, evidence-based guidance on how to map the context in order to design context-driven strategies. Therefore, this practice paper describes the development and validation of a systematic context-mapping tool. The tool was cocreated with local end-users through a multistage approach. As proof of concept, the tool was used to map beliefs and behaviour related to chronic respiratory disease within the FRESH AIR project in Uganda, Kyrgyzstan, Vietnam and Greece. Feasibility and acceptability were evaluated using the modified Conceptual Framework for Implementation Fidelity. Effectiveness was assessed by the degree to which context-driven adjustments were made to implementation strategies of FRESH AIR health interventions. The resulting Setting-Exploration-Treasure-Trail-to-Inform-implementatioN-strateGies (SETTING-tool) consisted of six steps: (1) Coset study priorities with local stakeholders, (2) Combine a qualitative rapid assessment with a quantitative survey (a mixed-method design), (3) Use context-sensitive materials, (4) Collect data involving community researchers, (5) Analyse pragmatically and/or in-depth to ensure timely communication of findings and (6) Continuously disseminate findings to relevant stakeholders. Use of the tool proved highly feasible, acceptable and effective in each setting. To conclude, the SETTING-tool is validated to systematically map local contexts for (lung) health interventions in diverse low-resource settings. It can support policy-makers, non-governmental organisations and health workers in the design of context-driven implementation strategies. This can reduce the risk of implementation failure and the waste of resource potential. Ultimately, this could improve health outcomes.

Self-Management Maintenance Inhalation Therapy With eHealth (SELFIE): Observational Study on the Use of an Electronic Monitoring Device in Respiratory Patient Care and Research.

BACKGROUND: Electronic inhalation monitoring devices (EIMDs) are available to remind patients with respiratory diseases to take their medication and register inhalations for feedback to patients and health care providers as well as for data collection in research settings. OBJECTIVE: This study aimed to assess the validity as well as the patient-reported usability and acceptability of an EIMD. METHODS: This observational study planned to include 21 community pharmacies in the Netherlands. Patient-reported inhalations were collected and compared to EIMD registrations to evaluate the positive predictive value of these registrations as actual patient inhalations. Patients received questionnaires on their experiences and acceptance. RESULTS: A convenience sample of 32 patients was included from across 18 pharmacies, and 932 medication doses were validated. Of these, 796 registrations matched with patient-reported use (true-positive, 85.4%), and 33 inhalation registrations did not match with patient-reported use (false-positive, 3.5%). The positive predictive value was 96.0%, and 103 patient-reported inhalations were not recorded in the database (false-negative, 11.1%). Overall, patients considered the EIMD to be acceptable and easy to use, but many hesitated to continue its use. Reminders and motivational messages were not appreciated by all users, and more user-tailored features in the app were desired. CONCLUSIONS: Patients' interaction with the device in real-world settings is critical for objective measurement of medication adherence. The positive predictive value of this EIMD was found to be acceptable. However, patients reported false-negative registrations and a desire to include more user-tailored features to increase the usability and acceptability of the EIMD.

From research to evidence-informed decision making: a systematic approach.

Background: Knowledge creation forms an integral part of the knowledge-to-action framework aimed at bridging the gap between research and evidence-informed decision making. Although principles of science communication, data visualisation and user-centred design largely impact the effectiveness of communication, their role in knowledge creation is still limited. Hence, this article aims to provide researchers a systematic approach on how knowledge creation can be put into practice. Methods: A systematic two-phased approach towards knowledge creation was formulated and executed. First, during a preparation phase the purpose and audience of the knowledge were defined. Subsequently, a developmental phase facilitated how the content is 'said' (language) and communicated (channel). This developmental phase proceeded via two pathways: a translational cycle and design cycle, during which core translational and design components were incorporated. The entire approach was demonstrated by a case study. Results: The case study demonstrated how the phases in this systematic approach can be operationalised. It furthermore illustrated how created knowledge can be delivered. Conclusion: The proposed approach offers researchers a systematic, practical and easy-to-implement tool to facilitate effective knowledge creation towards decision-makers in healthcare. Through the integration of core components of knowledge creation evidence-informed decision making will ultimately be optimized.