Progress 07/01/22 to 08/03/23

Outputs
Target Audience:Loon Medical has created the MamaBear Health smartphone Application. MamaBear is intended to provide caregivers with a way to collect symptoms from children aged 0-4 suffering a respiratory exacerbation. MamaBear provides clinicians with objective, quality-controlled, and recorded symptoms for acute and longitudinal assessment. In 2018, there were 1.6M ED visits, 1.8M Urgent Care visits, and 10.2M Office visits in Rural areas for respiratory issues, and 36% of these patients were seen more than once. Approximately 8.5 million households with children under 5 in the United States Rural and Tribal areas.According to the CDC, in 2019, the prevalence of asthma in this age group was highest among black children (11.1%), followed by multiracial children (9.5%), Hispanic children (7.6%), and white children (7.2%).Tribal communities have the highest rates of respiratory disorders, but the prevalence and incidence are unavailable. A 2015 paper indicated that the severity of symptoms was associated with gender (boys) and uninsured lower-income families.Rural cliniciansinclude general practitioners (30%), nurse practitioners (31%), physician's assistants (20%), and primary care doctors (19%).These doctors encounter asymptomatic children between 40-60% of the time. Approximately 1,000 U.S. pediatric pulmonologists encounter asymptomatic patients 85% of the time. These clinicians are included in the target audience. Changes/Problems: Nothing Reported What opportunities for training and professional development has the project provided?The project provided resources for our summer intern to undergo data and survey best practices training. How have the results been disseminated to communities of interest?We were approved for both the Google and Apple app stores. We have provided information on Facebook parent groups, presented to clinicians, designed a website, and advertised via car magnets, and street signs, and provided postcards for clinicians to disseminate. What do you plan to do during the next reporting period to accomplish the goals? Nothing Reported

Impacts
What was accomplished under these goals? 1. Assess specialist access asthma guidelines knowledge and determine how the Loon Medical Smartphone APP might improve asthma care delivery. Accomplishment: Tabulated survey results in PDF format using Survey Monkey Analytics tools. 2. Define Smartphone APP design parameters. Accomplishment: Word and Excel document with APP design parameters and Cybersecurity and HIPAA assessment complete. 3. Design APP Wireframe. Accomplishment: Completed App Wireframe and feedback from the consulting clinician on the completeness and usability of the design and HIPAA and Cybersecurity requirements documentation. 4. Build an Android and iOS APP. Accomplishment: Completed Android and iOS apps.

Publications

Progress 07/01/22 to 02/28/23

Outputs
Target Audience:The target audience for this APP is caretakers and clinicians who care for infants and preschoolers in rural US areas. LoonMD has presented the APP Wireframe to 3pediatric pulmonologists who provide care in rural areas. Changes/Problems:We do not have major changes/problems in the approach. What opportunities for training and professional development has the project provided?LoonMD hired a STEM college intern for 6 weeksthis summer. She was trained and received certification in privacy requirements through the University of Minnesota to support the work she did on the survey. She was exposed to APP Development and clinical respiratory disorders. How have the results been disseminated to communities of interest? Nothing Reported What do you plan to do during the next reporting period to accomplish the goals?The LoonMD team will complete Objective 4: build the iOS and Android APP, and publish it to both the APP and Google Play store. The team will also work with LARTA Institute to develop the commercialization plan for the Phase 2 SBIR grant.

Impacts
What was accomplished under these goals? Objective1:Assesspediatric pulmonologyaccessandclinicianasthmaguidelinesknowledgeinruralareas. The PI and consulting pediatric pulmonologist developed a24-question survey. The consulting clinician sent the surveyto approximately 500 rural clinicians. These clinicians were identified on the "Rural providers from the Centers for Medicare & Medicaid Services (CMS) Quality, Certification & Oversights Report".Fourteen clinicians from 11 U.S. states have responded to date. From the results, we have uncovered that there is an unmet need to improve patient history in individuals who cannot describe signs, undergo provocation testing, and do not have signs in the medical clinic. Clinicians report that caretaker recounting of signs is very or extremely important in their therapeutic and diagnostic decision-making and that the history a caretaker provides is sometimes reliable. Caretakers are equipped with a data acquisition system, and their smartphones, almost constantly during the day. However, most caretakers rarely collect patient data and bring it to the clinic. When they do, the clinician finds the data extremely useful. In cases where it is not useful, the quality of the image and video is the primary issue, followed by the context of why/when the data was collected and the patient physical positioning. This creates a tremendous opportunity to standardize the collection of clinical information, photograph, video,and audioso that the clinician can optimize care sooner in patients in a more reliable/meaningful clinic visit where the child is no longer manifesting signs. Clinicians believe that collecting outcome data, in the form of pre and post-bronchodilator administration would make an impact on their therapeutic decision-making. Clinicians are open to and would prescribe an APP to collect signs, context, video, and audio data on a caregiver's smartphone. LoonMD's APP data review must be quick to review (~1 minute) and not add work outside of the clinic for the clinician. Furthermore, clinicians are very concerned about how the data would be incorporated into the Electronic Health Record.More than 65% of clinicians are somewhat or not at all confident in diagnosing asthma. However, when the child has in-office wheezing or multiple respiratory exacerbations they become more confident. We are hopeful to collect more survey responses as the project progresses. Objective2:DefineAPPdesignparameters. The APP developer joined the LoonMD team on August 17, 2022.The PI assessed the regulatory requirements including Health Insurance Portability and Accountability Act (HIPAA), Federal Food, Drug, and Cosmetic Act (FD&C Act), and the Federal Trade Commission Act (FTC Act). We utilized the FTC Commission Health Apps Interactive tool and guidance from the Department of Health and Human Services and the FDA. Based upon our findings, the LoonMD Application is not required to be HIPAA compliant, and will not be subject to regulatory oversight by FDA. The LoonMD App is considered a Personal Health Record (PHR) provider and is therefore required to notify affected consumers, the FTC, and perhaps the media following any breach ofinformation. From this learning, we will design an encryption module to add additional security to the server provider's pre-existing. Furthermore, we will collect email addresses in the event notification is required. The PI, APP Developer, and Pediatric Pulmonary consulting clinician determined the APP design parameters. A 33-page specification document was created to capture design considerations. This comprehensive document includes a) Product Definition, b) Rural marketconnectivity and memoryassessments, c)System function, d) Product Manufacturing, e) Labeling, and f) Design Requirements.Furthermore, smartphone quality and functionality requirements were identified. This is a living document and will continually be updated as we improve the product. Objective 3: Design APP Wireframe.A simple wireframe was created in FIGMA and is currently being optimized by the team. A JUSTINMIND prototype was created to test the User Interface and User Experience. Two additional pediatric pulmonologists have reviewed the design and provided feedback to improve the clinical utility of the APP information. The back end of the APP including SQL database development and testing modules is 75% complete. We are currently in line with the projected timelines submitted with the Grant Proposal materials.

Publications