Covid BP Trial | Clinical Trial App
The Covid BP Clinical Trial App was a smartphone application which facilitated patients to record blood pressure, medication and symptoms of COVID-19. It’s main function was to provide robust data entry to support a USA based observational study and a UK based treatment optimisation study.
My Role | Principal UX Designer
As part of my role as Principal Designer at Closed Loop Medicine I designed the front end and user interactions for the smart phone application, completed two rounds of user testing, iterated designs and provided developer support for implementation. The project was completed in conjunction with a counterpart UX Engineer, working for a partner organisation, P4P.
Routine Management | Promoting Data Entry
The App featured a simple routine manager prompting the user to complete digital biomarker data entry at the beginning and end of the day. User testing and refinement resulted in the routine interaction being usable and habit forming without the need for any patient training.
Blood Pressure Measurement | Data Accuracy
The trial used simple unconnected blood pressure cuffs requiring participants to manulally enter their blood pressure multiple times a day. Following user testing a successful interface which directly emulated the interface of the BP monitor was chosen. This mirror image aproach observably minimised patient error and incresed data entry acuracy.
Another factor influencing blood pressure measurement accuracy was device set up and cuff placement. In testing multiple misplacement errors were observed, even from seasoned hypertensive patients. As part of onboarding we therefore added quick paired down instructions explaining the key points of proper cuff placement. This significantly reduced errors. Instructions remained available from the measurement entry screen during normal use.
Symptom Tracker | Data Accuracy
One design challenge that had to be overcome was to allow users to choose from a large array of symptoms and then be able to quickly rate these symptoms against a VAS scale. Balancing these requirements against speed of entry resulted in a novel slider containing both an on/off switch and a severity scale. This allowed for rapid rating and reduced data entry fatigue.
Medication Tracker | Data Accuracy
The medication tracker was a simple but effective system comprised of a menu of medications and a confirmation screen. This allowed medication data entry task to be completed rapidly, regularly confirmed and easily edited.
Data History | Basic Trend Reporting
Although no data history function was required for the trial, we added a simple data display to allow the user to see that their data had been entered. This provided implicit positive feedback to acknowledge their efforts, keep transparency about what data had been collected and allowed the participant to monitor basic trends.
Product Efficacy | Trial Results & Impact
The smartphone application was deployed in two studies:
2) Personalized Antihypertensive Treatment Optimization With Smartphone‐Enabled Remote Precision Dosing of Amlodipine During the COVID‐19 Pandemic (PERSONAL‐CovidBP Trial)
Aim: The objective was to assess the efficacy and safety of smartphone‐enabled remote precision dosing of amlodipine to control blood pressure (BP) in participants with primary hypertension during the COVID‐19 pandemic.
Conclusion: Personalized dose titration with amlodipine was safe, well tolerated, and efficacious in treating primary hypertension. The majority of participants achieved BP control on novel doses, and with personalization of dose there were no trial discontinuations due to drug intolerance. App‐assisted remote clinician dose titration may better balance BP control and adverse effects and help optimize long‐term care. Full results of this study can be seen here.
1) Personalized Smartphone-Enabled Assessment of Blood Pressure and Its Treatment During the SARS-CoV-2 COVID-19 Pandemic in Patients From the CURE-19 Study: Longitudinal Observational Study.
Aim: The objective of this study was to deploy and test electronic data recording using a smartphone app developed for routine monitoring of BP in patients with primary hypertension. We tested the app for ease of data entry in BP management and tracking symptoms of new-onset COVID-19 to determine if participants found this app approach useful and sustainable.
Conclusion: The high retention, engagement and acceptability and positive feedback in this study demonstrates that routine monitoring of BP and medications using a smartphone app is feasible for patients with hypertension in a community setting. Remote monitoring of BP and data collection could be coupled with hypertensive medication in a combination product (drug+digital) for precision management of hypertension. Full results of this study can be seen here.
Registered Design Patents
The design for symptom tracking was significantly novel to warrant registered design patents. These can be viewed here.