Rationale design and efficacy of a smartphone application for improving self-awareness of adherence to edoxaban treatment: study protocol for a randomised controlled trial (adhere app).

INTRODUCTION: High adherence to oral anticoagulants is essential for stroke prevention in patients with atrial fibrillation (AF). We developed a smartphone application (app) that pushes alarms for taking medication and measuring blood pressure (BP) and heart rate (HR) at certain times of the day. In addition to drug alarms, the habit of measuring one's BP and HR may reinforce drug adherence by improving self-awareness of the disease. This pilot study aims to test the feasibility and efficacy of the smartphone app-based intervention for improving drug adherence in patients with AF. METHODS AND ANALYSIS: A total of 10 university hospitals in Korea will participate in this randomised control trial. Patients with AF, being treated with edoxaban for stroke prevention will be included in this study. Total of 500 patients will be included and the patients will be randomised to the conventional treatment group (250 patients) and the app conditional feedback group (250 patients). Patients in the app conditional feedback group will use the medication reminder app for medication and BP check alarms. The automatic BP machine will be linked to the smartphone via Bluetooth. The measured BP and HR will be updated automatically on the smartphone app. The primary endpoint is edoxaban adherence by pill count measurement at 3 and 6 months of follow-up. Secondary endpoints are clinical composite endpoints including stroke, systemic embolic event, major bleeding requiring hospitalisation or transfusion, or death during the 6 months. As of 24t November 2021, 80 patients were enrolled. ETHICS AND DISSEMINATION: This study was approved by the Seoul National University Bundang Hospital Institutional Review Board and will be conducted according to the principles of the Declaration of Helsinki. The study results will be published in a reputable journal. TRIAL REGISTRATION NUMBER: KCT0004754.

Effects of renin-angiotensin system blockers on the risk and outcomes of severe acute respiratory syndrome coronavirus 2 infection in patients with hypertension.

BACKGROUND/AIMS: There are concerns that the use of renin-angiotensin system (RAS) blockers may increase the risk of being infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or progressing to a severe clinical course after infection. This this study aimed to investigate the influence of RAS blockers on the risk and severity of SARS-CoV-2 infection. METHODS: We conducted a retrospective cohort study analyzing nationwide claims data of 215,184 adults who underwent SARS-CoV-2 tests in South Korea. The SARS-CoV-2 positive rates and clinical outcomes were evaluated according to the use of RAS blockers in patients with hypertension (n = 64,243). RESULTS: In total, 38,919 patients with hypertension were on RAS blockers. The SARS-CoV-2 positive rates were significantly higher in the RAS blocker group than in the control group after adjustments (adjusted odds ratio [OR], 1.22; 95% confidence interval [CI], 1.10 to 1.36; p < 0.001), and matching by propensity score (adjusted OR, 1.16; 95% CI, 1.03 to 1.32; p = 0.017). Among the 1,609 SARS-CoV-2-positive patients with hypertension, the use of RAS blockers was not associated with poor outcomes, such as mortality (adjusted OR, 0.81; 95% CI, 0.56 to 1.17; p = 0.265), and a composite of admission to the intensive care unit and mortality (adjusted OR, 0.95; 95% CI, 0.73 to 1.22; p = 0.669). Analysis in the propensity scorematched population showed consistent results. CONCLUSION: In this Korean nationwide claims dataset, the use of RAS blockers was associated with a higher risk to SARS-CoV-2 infection but not with higher mortality or other severe clinical courses.