A mobile health intervention for improving the technique of inhaled medications among children with asthma: A pilot study.

Objective: BreatheSuite MDI is a Bluetooth-enabled inhaler attachment and mobile application which aims to improve asthma control. The objective was to compare pressurized metered dose inhaler (pMDI) technique and asthma control test (ACT) scores pre- and post-use of the device and mobile application. Secondary objectives were to assess user satisfaction and therapy adherence. Methods: Patients between the ages of 8 and 18 were recruited from several pediatric asthma clinics. Technique and ACT scores were assessed at baseline. Users were given no prompts on technique during the first month of device use. For the subsequent three months, users were given technique scores through the mobile application after each inhaler use and provided weekly performance summaries. At the end of the study, technique and ACT scores were analyzed and an exit survey was completed. Conditional logistic regression was used to examine the association between well-controlled asthma (ACT score > 19) and the intervention. Results: 24 patients completed the study. Technique scores improved following the use of Breathesuite (44.19 vs. 62.54; P = 0.01). Well-controlled asthma did not significantly improve (OR = 1.20 [0.4-3.9], P = 0.76). 87% of study subjects agreed or strongly agreed that their asthma control improved while using BreatheSuite; 79% were satisfied with the device and mobile application; and 91% preferred using the device compared to a standard logbook to track inhaler usage. Conclusions: In this pilot study, the use of BreatheSuite device was associated with improved technique scores. These results need to be confirmed by a randomized controlled trial. There was high user satisfaction with the BreatheSuite device.

A 12-Month Follow-Up of the Effects of a Digital Diabetes Prevention Program (VP Transform for Prediabetes) on Weight and Physical Activity Among Adults With Prediabetes: Secondary Analysis.

BACKGROUND: The prevalence of diabetes is increasing rapidly. Previous research has demonstrated the efficacy of a diabetes prevention program (DPP) in lifestyle modifications that can prevent or delay the onset of type 2 diabetes among individuals at risk. Digital DPPs have the potential to use technology, in conjunction with behavior change science, to prevent prediabetes on a national and global scale. OBJECTIVE: The aim of this study is to investigate the effects of a digital DPP (Virgin Pulse [VP] Transform for Prediabetes) on weight and physical activity among participants who had completed 12 months of the program. METHODS: This study was a secondary analysis of retrospective data of adults with prediabetes who were enrolled in VP Transform for Prediabetes for 12 months of the program. The program incorporates interactive mobile computing, remote monitoring, an evidence-based curriculum, behavior tracking tools, health coaching, and online peer support to prevent or delay the onset of type 2 diabetes. RESULTS: The sample (N=1095) was comprised of people with prediabetes who completed at least 9 months of the VP Transform for Prediabetes program. Participants were 67.7% (n=741) female, with a mean age of 53.6 (SD 9.75) years. After 12 months, participants decreased their weight by an average of 10.9 lbs (5.5%; P<.001) and increased their physical activity by 91.2 (P<.001) minutes. CONCLUSIONS: These results suggest that VP Transform for Prediabetes is effective at preventing type 2 diabetes through a significant reduction in body weight and increase of physical activity. Furthermore, these results suggest that the DPP remains effective 12 months after beginning the program. A prospective randomized controlled clinical study is warranted to validate these findings.

Usability Testing of a Digital Assessment Routing Tool: Protocol for an Iterative Convergent Mixed Methods Study.

BACKGROUND: Musculoskeletal conditions account for 16% of global disability, resulting in a negative effect on millions of patients and an increasing burden on health care utilization. Digital technologies that improve health care outcomes and efficiency are considered a priority; however, innovations are often inadequately developed and poorly adopted. Further, they are rarely tested with sufficient rigor in clinical trials-the gold standard for clinical proof of efficacy. We have developed a new musculoskeletal Digital Assessment Routing Tool (DART) that allows users to self-assess and be directed to the right care. DART requires usability testing in preparation for clinical trials. OBJECTIVE: This study will use the iterative convergent mixed methods design to assess and mitigate all serious usability issues to optimize user experience and adoption. Using this methodology, we will provide justifiable confidence to progress to full-scale randomized controlled trials when DART is integrated into clinical management pathways. This study protocol will provide a blueprint for future usability studies of mobile health solutions. METHODS: We will collect qualitative and quantitative data from 20-30 participants aged 18 years and older for 4 months. The exact number of participants recruited will be dependent on the number of iterative cycles required to reach the study end points. Building on previous internal testing and stakeholder involvement, quantitative data collection is defined by the constructs within the ISO 9241-210-2019 standard and the system usability scale, providing a usability score for DART. Guided by the participant responses to quantitative questioning, the researcher will focus the qualitative data collection on specific usability problems. These will then be graded to provide the rationale for further DART system improvements throughout the iterative cycles. RESULTS: This study received approval from the Queen Mary University of London Ethics of Research Committee (QMREC2018/48/048) on June 4, 2020. At manuscript submission, study recruitment was on-going, with data collection to be completed and results published in 2021. CONCLUSIONS: This study will provide evidence concerning mobile health DART system usability and acceptance determining system improvements required to support user adoption and minimize suboptimal system usability as a potential confounder within subsequent noninferiority clinical trials. Success should produce a safe effective system with excellent usability, facilitating quicker and easier patient access to appropriate care while reducing the burden on primary and secondary care musculoskeletal services. This deliberately rigorous approach to mobile health innovation could be used as a guide for other developers of similar apps. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/27205.

Effectiveness of the BreatheSuite Device in Assessing the Technique of Metered-Dose Inhalers: Validation Study.

BACKGROUND: The majority of medications used in treating asthma and chronic obstructive pulmonary disease (COPD) are taken through metered-dose inhalers (MDIs). Studies have reported that most patients demonstrate poor inhaler technique, which has resulted in poor disease control. Digital Health applications have the potential to improve the technique and adherence of inhaled medications. OBJECTIVE: This study aimed to validate the effectiveness of the BreatheSuite MDI device in assessing the technique of taking a dose via an MDI. METHODS: The study was a validation study. Thirty participants who self-reported a diagnosis of asthma or COPD were recruited from community pharmacies in Newfoundland and Labrador, Canada. Participants used a BreatheSuite MDI device attached to a placebo MDI and resembled taking 3 doses. Pharmacists used a scoring sheet to evaluate the technique of using the MDI. An independent researcher compared the results of the pharmacist's scoring sheet with the results of the BreatheSuite device. RESULTS: This study found that the BreatheSuite MDI can objectively detect several errors in the MDI technique. The data recorded by the BreatheSuite MDI device showed that all participants performed at least one error in using the MDI. The BreatheSuite device captured approximately 40% (143/360) more errors compared to observation alone. The distribution of participants who performed errors in MDI steps as recorded by BreatheSuite compared to errors reported by observation alone were as follows: shaking before actuation, 33.3% (30/90) versus 25.5% (23/90); upright orientation of the inhaler during actuation, 66.7% (60/90) versus 18.87% (17/90); coordination (actuating after the start of inhalation), 76.6% (69/90) versus 35.5% (32/90); and duration of inspiration, 96.7% (87/90) versus 34.4% (31/90). CONCLUSIONS: The BreatheSuite MDI can objectively detect several errors in the MDI technique, which were missed by observation alone. It has the potential to enhance treatment outcomes among patients with chronic lung diseases.

The Use of Digital Health in the Detection and Management of COVID-19.

Digital health is uniquely positioned to enhance the way we detect and manage infectious diseases. This commentary explores the potential of implementing digital technologies that can be used at different stages of the COVID-19 outbreak, including data-driven disease surveillance, screening, triage, diagnosis, and monitoring. Methods that could potentially reduce the exposure of healthcare providers to the virus are also discussed.

Features of a mobile health intervention to manage chronic obstructive pulmonary disease: a qualitative study.

BACKGROUND: The use of mobile health (mHealth) interventions has the potential to enhance chronic obstructive pulmonary disease (COPD) treatment outcomes. Further research is needed to determine which mHealth features are required to potentially enhance COPD self-management. AIM: The aim of this study was to explore the potential features of an mHealth intervention for COPD management with healthcare providers (HCPs) and patients with COPD. It could inform the development and successful implementation of mHealth interventions for COPD management. METHODS: This was a qualitative study. We conducted semi-structured individual interviews with HCPs, including nurses, pharmacists and physicians who work directly with patients with COPD. Interviews were also conducted with a diverse sample of patients with COPD. Interview topics included demographics, mHealth usage, the potential use of medical devices and recommendations for features that would enhance an mHealth intervention for COPD management. RESULTS: A total of 40 people, including nurses, physicians and pharmacists, participated. The main recommendations for the proposed mHealth intervention were categorised into two categories: patient interface and HCP interface. The prevalent features suggested for the patient interface include educating patients, collecting baseline data, collecting subjective data, collecting objective data via compatible medical devices, providing a digital action plan, allowing patients to track their progress, enabling family members to access the mHealth intervention, tailoring the features based on the patient's unique needs, reminding patients about critical management tasks and rewarding patients for their positive behaviours. The most common features of the HCP interface include allowing HCPs to track their patients' progress, allowing HCPs to communicate with their patients, educating HCPs and rewarding HCPs. CONCLUSION: This study identifies important potential features so that the most effective, efficient and feasible mHealth intervention can be developed to improve the management of COPD.The reviews of this paper are available via the supplemental material section.

Perceptions of Patients Regarding Mobile Health Interventions for the Management of Chronic Obstructive Pulmonary Disease: Mixed Methods Study.

BACKGROUND: Using a mobile health (mHealth) intervention consisting of a smartphone and compatible medical device has the potential to enhance chronic obstructive pulmonary disease (COPD) treatment outcomes while mitigating health care costs. OBJECTIVE: This study aims to describe the demographics, use, and access to smartphones of patients with COPD. It also aims to explore and develop an understanding of potential facilitators and barriers that might influence patients using mHealth interventions for COPD management. METHODS: This was an explanatory, sequential mixed methods study. Patients who attended respirology clinics completed a questionnaire on technology access and use. We conducted semistructured individual interviews with the patients. Interview topics included the following: demographics, mHealth use, perceptions toward challenges of mHealth adoption, factors facilitating mHealth adoption, and preferences regarding features of mHealth interventions for COPD management. RESULTS: A total of 100 adults completed the survey but 22 participants were excluded because they were not diagnosed with COPD. Of these, 10 patients with COPD participated in the interview. The quantitative component revealed that many patients with COPD owned a mobile phone, but only about one-fourth of the participants (18/77, 23%) owned a smartphone. The likelihood of owning a smartphone was not associated with age, sex, marital status, or geographical location, but patients with high educational status were more likely to own a smartphone. The qualitative component found that patients with COPD, in general, had a positive attitude toward mHealth adoption for COPD management, but several facilitators and barriers were identified. The main facilitators of mHealth adoption are possible health benefits for patients, ease of use, educating patients, and credibility. Alternatively, the barriers to adoption are technical issues, lack of awareness, potential limited uptake from older adults, privacy and confidentiality issues, finances, and lack of interest in mHealth. CONCLUSIONS: It is important to understand the perceptions of patients with COPD regarding the adoption of innovative mHealth interventions for COPD management. This study identifies some potential facilitators and barriers that may inform the successful development and implementation of mHealth interventions for COPD management.

A Digital Diabetes Prevention Program (Transform) for Adults With Prediabetes: Secondary Analysis.

BACKGROUND: The prevalence of diabetes is increasing among adults globally. Research has demonstrated that a diabetes prevention program (DPP), which focuses on developing and maintaining health-promoting lifestyle modifications, can prevent or delay the onset of type 2 diabetes among at-risk individuals. The implementation of a digitally adapted DPP has the potential to prevent prediabetes on a national and global scale by using technology and behavior change science. OBJECTIVE: This study aimed to investigate the effects of a novel digital therapeutic DPP (Transform) on weight loss, body mass index (BMI), exercise frequency, and work absenteeism. METHODS: This study was a secondary analysis of retrospective data of adults with prediabetes who were enrolled in the Transform DPP from December 2016 to December 2017. The program incorporates interactive mobile computing, remote monitoring, an evidence-based curriculum, behavior tracking tools, health coaching, and online peer support to prevent or delay the onset of type 2 diabetes. The analysis included data that were collected at baseline and after 4 months of the Transform DPP. RESULTS: The sample (N=273) comprised people with prediabetes who completed 4 months of the Transform program. Participants included 70.3% women, with a mean age of 54.0 (SD 11.2) years. On average, participants decreased their weight by 13.3 lbs (6.5%) and their BMI by 1.9 kg/m2. On average, participants increased their exercise frequency by 1.7 days per week, and absenteeism was reduced by almost half a day per month. CONCLUSIONS: These results suggest that the digital therapeutic DPP (Transform) is effective at preventing type 2 diabetes through a significant reduction in body weight and an increase of physical activity. A prospective, controlled clinical study is warranted to validate these findings.

The Iterative Convergent Design for Mobile Health Usability Testing: Mixed Methods Approach.

Although patients express an interest in using mobile health (mHealth) interventions to manage their health and chronic conditions, many current mHealth interventions are difficult to use. Usability testing is critical for the success of novel mHealth interventions. Researchers recognize the utility of using qualitative and quantitative approaches for usability testing, but many mHealth researchers lack the awareness of integration approaches from advances in mixed methods research that can add value to mHealth technology. As efficient usability testing proceeds iteratively, we introduce a novel mixed methods design developed specifically for mHealth researchers. The iterative convergent mixed methods design involves simultaneous qualitative and quantitative data collection and analysis that continues cyclically through multiple rounds of mixed methods data collection and analysis until the mHealth technology under evaluation is found to work to the satisfaction of the researcher. In cyclical iterations, early development is more qualitatively driven but progressively becomes more quantitatively driven. Using this design, mHealth researchers can leverage mixed methods integration procedures in the research question, data collection, data analysis, interpretation, and dissemination dimensions. This study demonstrates how the iterative convergent mixed methods design provides a novel framework for generating unique insights into multifaceted phenomena impacting mHealth usability. Understanding these practices can help developers and researchers leverage the strengths of an integrated mixed methods design.

Perceptions of Health Care Providers Regarding a Mobile Health Intervention to Manage Chronic Obstructive Pulmonary Disease: Qualitative Study.

BACKGROUND: Using a mobile health (mHealth) intervention, consisting of a smartphone and compatible medical device, has the potential to enhance chronic obstructive pulmonary disease (COPD) treatment outcomes while mitigating health care costs. OBJECTIVE: The aim of this study was to explore the potential facilitators and barriers among health care providers (HCPs) regarding the use of mHealth interventions for COPD management. METHODS: This was a qualitative study. Semistructured individual interviews were conducted with HCPs, including nurses, pharmacists, and physicians who work directly with patients with COPD. A flexible prompts guide was used to facilitate discussions. Interview topics included the following: demographics, mHealth usage, perceptions toward challenges of mHealth adoption, factors facilitating mHealth adoption, and preferences regarding features of the mHealth intervention for COPD management. Interviews were conversational in nature, and items were not asked verbatim or in the order presented. The interviews were transcribed verbatim and compared against the digital recordings to ensure the accuracy of the content. After creating a codebook for analysis, 2 researchers independently coded the remaining interview data using pattern coding. They discussed commonalities and differences in coding until a consensus was reached. RESULTS: A total of 30 nurses, physicians, and pharmacists participated. The main facilitators to mHealth adoption are possible health benefits for patients, ease of use, educating patients and their HCPs, credibility, and reducing cost to the health care system. Alternatively, the barriers to adoption are technical issues, privacy and confidentiality issues, lack of awareness, potential limited uptake from the elderly, potential limited connection between patients and HCPs, and finances. CONCLUSIONS: It is important to understand the perceptions of HCPs regarding the adoption of innovative mHealth interventions for COPD management. This study identifies some potential facilitators and barriers that may inform the successful development and implementation of mHealth interventions for COPD management.

The Effect of Smartphone Interventions on Patients With Chronic Obstructive Pulmonary Disease Exacerbations: A Systematic Review and Meta-Analysis.

BACKGROUND: The prevalence and mortality rates of chronic obstructive pulmonary disease (COPD) are increasing worldwide. Therefore, COPD remains a major public health problem. There is a growing interest in the use of smartphone technology for health promotion and disease management interventions. However, the effectiveness of smartphones in reducing the number of patients having a COPD exacerbation is poorly understood. OBJECTIVE: To summarize and quantify the association between smartphone interventions and COPD exacerbations through a comprehensive systematic review and meta-analysis. METHODS: A comprehensive search strategy was conducted across relevant databases (PubMed, Embase, Cochrane, CINHA, PsycINFO, and the Cochrane Library Medline) from inception to October 2015. We included studies that assessed the use of smartphone interventions in the reduction of COPD exacerbations compared with usual care. Full-text studies were excluded if the investigators did not use a smartphone device or did not report on COPD exacerbations. Observational studies, abstracts, and reviews were also excluded. Two reviewers extracted the data and conducted a risk of bias assessment using the US Preventive Services Task Force quality rating criteria. A random effects model was used to meta-analyze the results from included studies. Pooled odds ratios were used to measure the effectiveness of smartphone interventions on COPD exacerbations. Heterogeneity was measured using the I(2)statistic. RESULTS: Of the 245 unique citations screened, 6 studies were included in the qualitative synthesis. Studies were relatively small with less than 100 participants in each study (range 30 to 99) and follow-up ranged from 4-9 months. The mean age was 70.5 years (SD 5.6) and 74% (281/380) were male. The studies varied in terms of country, type of smartphone intervention, frequency of data collection from the participants, and the feedback strategy. Three studies were included in the meta-analysis. The overall assessment of potential bias of the studies that were included in the meta-analysis was "Good" for one study and "Fair" for 2 studies. The pooled random effects odds ratio of patients having an exacerbation was 0.20 in patients using a smartphone intervention (95% CI 0.07-0.62), a reduction of 80% for smartphone interventions compared with usual care. However, there was moderate heterogeneity across the included studies (I(2)=59%). CONCLUSION: Although current literature on the role of smartphones in reducing COPD exacerbations is limited, findings from our review suggest that smartphones are useful in reducing the number of patients having a COPD exacerbation. Nevertheless, using smartphones require synergistic strategies to achieve the desired outcome. These results should be interpreted with caution due to the heterogeneity among the studies. Researchers should focus on conducting rigorous studies with adequately powered sample sizes to determine the validity and clinical utility of smartphone interventions in the management of COPD.