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 (Preprint)

BACKGROUND The use of digital interventions by patients for remote monitoring and management of health and disease is increasing. This observational study examined the feasibility, use, and safety of a digital smartphone app for routine monitoring of blood pressure (BP), medication, and symptoms of COVID-19 during the COVID-19 pandemic. OBJECTIVE 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. METHODS This remote, decentralized, 12-week, prospective, observational study was conducted in a community setting within the United States. Participants were approached and recruited from affiliated sites where they were enrolled in an ongoing remote decentralized study (CURE-19) of participants experiencing the COVID-19 pandemic. Potential participants were asked to complete a digital screener to determine eligibility and given informed consent forms to read and consent to using the Curebase digital platform. Following enrollment, participants downloaded the digital app to their smartphones for all data collection. Participants recorded daily BP, associated medication use, and emergent symptoms associated with SARS-CoV-2 infection. In addition, usability (adherence, acceptability, and user experience) was assessed using standard survey questions. Adverse events were collected based on participant self-report. Compliance and engagement were determined from user data entry rates. Feasibility and participant feedback were assessed upon study completion using the User Experience Questionnaire. RESULTS Of the 389 participants who enrolled in and completed the study, 380 (98%) participants downloaded and entered BP routines in week 1. App engagement remained high; 239 (62.9%) of the 380 participants remained in the study for the full 12-week observation period, and 201 (84.1%) of the 239 participants entered full BP routines into the digital app 80% or more of the time. The smartphone app scored an overall positive evaluation as assessed by the User Experience Questionnaire and was benchmarked as “excellent” for domains of perspicuity, efficiency, and dependability and “above average” for domains of attractiveness and stimulation. Highly adherent participants with hypertension demonstrated well-controlled BP, with no significant changes in average systolic or diastolic BP between week 1 and week 12 (all P>.05). Participants were able to record BP medications and symptoms of SARS-CoV-2 infection. No adverse events attributable to the use of the smartphone app were reported during the observational period. CONCLUSIONS 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.