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App-tivating Experience: The Design and Deployment of a Remote Health Care Eco-System for Therapy Adherence
DescriptionCreating a diagnostic or therapeutic device that can be used in clinical trial evaluations entails a well-trodden path for medtech product development practitioners. But what happens when the intended product is a downloadable software application that exists only in the digital realm of a user’s smartphone or computer? What are the usability implications of designing a digital only experience? This presentation shares the wisdom acquired from developing a user-centered, clinical-trial-ready, software ecosystem with both patient and clinician interfaces.

Two years ago, Veranex started working with a pharmaceutical client to design a desktop application (and a patient mobile app) for sleep specialists and their clinical admin that could collate and report medication adherence results and clinical efficacy among sleep apnea patients who have been prescribed an oral-based drug to be taken at home. Sleep apnea is a condition where a patient stops breathing repeatedly during sleep. Over time, undue stress is placed on every organ of the body, increasing co-morbidity risks for diabetes, stroke, heart and kidney disease and dementia. Left unchecked, sleep apnea’s causal impact on life expectancy is significant.

To offer a more holistic approach to sleep apnea management , the client wanted its pharmacological intervention to be paired with monitoring technology; as a novel market entrant, the therapy had to demonstrate competitive efficacy compared to Continuous Positive Airway Pressure (CPAP) systems and their well-established patient adherence reporting capabilities.

Early wireframe evaluations with sleep specialists revealed that (irrespective of highly intuitive design concepts) absence of additional reimbursement funds limited data review to only during scheduled 10- minute patient appointments. As a result, the team determined that the primary end users and beneficiaries of the proposed rapid reporting, adherence-based monitoring platform had to be the patient themselves.

A hypothesis quickly emerged: giving patients the ability to track and report daily sleep-related trend data and show clear correlations between prescribed therapy and key health performance metrics would be an important motivator for better medication adherence, higher engagement of optimal sleep habits and improved overall clinical outcomes. Such a system could also reduce the clinician-side burden of patient management and poor outcomes – particularly with patients who are less adherent to their sleep apnea regimen. Through a series of iterative design and user research cycles, this theory was refined with both patients and sleep physicians. During development, the development team configured and honed an ecosystem to serve the needs of the two very different user groups.

The patient-facing experience: The patient mobile app needs were varied, occurring over a range of use environments and situations: from onboarding in the clinician’s office, prompts and instructions at home, accommodations for nocturnal habits and travel, universal access to data, and error management.

At the start, clinicians were clear that the app had to facilitate patient onboarding independently, without precious nursing resources. An intuitive tutorial experience along with a deeper-dive patient facing FAQ were put in place so that diverse patient demographics (from young adults to seniors, tech savvy and tech averse, non-native English speakers) could comfortably navigate their own set up.

The primary goal of the app was to deliver detailed post-sleep reporting and sleep health engagement. The team refined data visualization and copy writing so that technical metrics (i.e. mean SPO2, oxygen desaturation index) were curated into consumer-friendly terms. Typography, iconography and color palette visual design evolved to emphasize unique data points and spot trends. The interface design was responsive to multiple viewport dimensions so users could equitably access information in the right layout regardless of their device’s screen size.

The app prompted the patient in the home environment at key interaction moments (prior to sleep, on awakening) to correctly perform time-dependent tasks and complete patient reported outcome (PRO) surveys. Over time, the app showed the patient how their sleep habits and symptoms correlated to their actions and therapy adherence.

Differences in nocturnal habits among third shift workers, frequent travelers adjusting between time zones, and those who regularly get up intermittently throughout the night had to be accounted for. Users with different lifestyles, health expectations, and levels of engagement were supported with a customizable interface, encouraging engagement over the long term.

Through iteration, the team identified and mitigated issues including use errors, smart device logistics and connection errors. The refined design pre-empted error states and made them easy to resolve if they occurred. Error events were communicated with easily identifiable color schemes, iconography and succinct instructions with supporting illustrations.

Empowering patients also meant giving them access their data anywhere. The digital platform used multi-layered cybersecurity measures to ensure the protection of sensitive patient health information (PHI). Patients had clear communication of where and when their data was shared, who had visibility to the data, and were appropriately notified of any potential risks of data loss or errors. They were also given the ability to opt out from the experience at any time, if desired.


The clinician portal: The clinician web portal side of the digital eco-system reported sleep metrics for all enrolled patients under the clinical team’s care. A patient dashboard (a webpage with a quick overview patient list) enabled clinicians to quickly identify, prioritize, and flag patients who needed clinician review. The patient detail section (that reported in-depth patient sleep metrics and PRO responses) displayed information using very different visualization tools than that of patient mobile app: raw (and expandable) data of individual patient full sleep cycle trends such as individual oxygen desaturation events and hypoxic burden, compared to the patient app that summarized overall night performance.

Once the design team arrived at a complete ecosystem, the transition to a functional, coded and fully tested prototype began. Many significantly underestimate the complexity and importance of this stage of the development phase; executing this work carefully and thoroughly was vital for successful clinical trial implementation with real patients using actual drug doses. The Veranex team was able to dynamically navigate the feasibility limitations and hurdles in this phase because the designers and software developers shared a common advocacy for end users and worked in collaboration to find practical compromises.

At the Alpha launch of the system, the project team tested the prototype with a small group sourced from the clinical trial administrators, Veranex and client teams. By working with actual user sleep data (compared to the mock data sets from earlier phases), the team chose to simplify the patient-facing data visualization to aid clearer understanding and avoid misinterpretation and unwelcome queries to the doctor’s office. Reviewer roles of the clinical portal were also developed at this stage, enabling quality review of clinical trial data which de-identified PHI. Examples of these subtle but meaningful modifications will be shared in the presentation.

At the launch of the Beta version, the system was trialed with approximately 1,000 first-time patients across multiple clinical sites. This user set inevitably generated new outlier cases that required additional design considerations, such as: one patient upgraded to a new smartphone mid-trial which required re-onboarding to an existing account and another patient who went camping overnight without internet-access and required notifications to address cloud data uploading glitches. A Veranex-managed customer support line was also included in the solution set to gather and address ongoing feedback, offloading burden from individual clinical trial sites.

In the future (in time for HFES HCS 2026), it is expected that results from the clinical trial will be available, providing evidence for the initial project hypothesis that data engagement can lead to motivated, adherent patient action.
Event Type
Oral Presentations
TimeTuesday, April 12:30pm - 3:00pm EDT
LocationPier 2/3
Tracks
Digital Health (DH)