Remote blood pressure monitoring in high risk pregnancy - study protocol for a randomised controlled trial (REMOTE CONTROL trial).

BACKGROUND: Pregnant women at high risk for developing a hypertensive disorder of pregnancy require frequent antenatal assessments, especially of their blood pressure. This expends significant resources for both the patient and healthcare system. An alternative to in-clinic assessments is a remote blood pressure monitoring strategy, in which patients self-record their blood pressure at home using a validated blood pressure machine. This has the potential to be cost-effective, increase patient satisfaction, and reduce outpatient visits, and has had widespread uptake recently given the increased need for remote care during the ongoing COVID-19 pandemic. However robust evidence supporting this approach over a traditional face-to-face approach is lacking, and the impact on maternal and foetal outcomes has not yet been reported. Thus, there is an urgent need to assess the efficacy of remote monitoring in pregnant women at high risk of developing a hypertensive disorder of pregnancy. METHODS: The REMOTE CONTROL trial is a pragmatic, unblinded, randomised controlled trial, which aims to compare remote blood pressure monitoring in high-risk pregnant women with conventional face-to-face clinic monitoring, in a 1:1 allocation ratio. The study will recruit patients across 3 metropolitan Australian teaching hospitals and will evaluate the safety, cost-effectiveness, impact on healthcare utilisation and end-user satisfaction of remote blood pressure monitoring. DISCUSSION: Remote blood pressure monitoring is garnering interest worldwide and has been increasingly implemented following the COVID-19 pandemic. However, robust data regarding its safety for maternofoetal outcomes is lacking. The REMOTE CONTROL trial is amongst the first randomised controlled trials currently underway, powered to evaluate maternal and foetal outcomes. If proven to be as safe as conventional clinic monitoring, major potential benefits include reducing clinic visits, waiting times, travel costs, and improving delivery of care to vulnerable populations in rural and remote communities. TRIAL REGISTRATION: The trial has been prospectively registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12620001049965p, on October 11th, 2020).

Hypertension management before and under the COVID-19 pandemic: lessons and future directions.

Hypertension is a significant risk factor for cardiovascular diseases. The prevalence of hypertension and its complications is increasing yearly, yet it remains inadequately controlled worldwide. It has already been recognized that self-management, including self-measured blood pressure monitoring at home, is more important than office blood pressure monitoring. The practical application of telemedicine using digital technology was already underway. COVID-19 has promoted the popularization of these management systems in primary care, although the COVID-19 pandemic disrupted lifestyle and healthcare access. At the beginning of the pandemic, we were at the mercy of information on whether certain antihypertensive drugs, for example, might pose a risk of infection in the face of unknown infectious diseases. Over the past three years, however, much knowledge has been accumulated. It has been scientifically proven that there is no serious problem in managing hypertension in the same way as before the pandemic. That is to control blood pressure mainly through home blood pressure monitoring and continuing conventional drug therapy while modifying lifestyle. On the other hand, in the New Normal era, it is necessary to accelerate digital hypertension management and the establishment of new social networks and medical systems to prepare for the re-emergence of future pandemics while continuing to protect against infection. This review will summarize the lessons and future directions we learned from the impact of the COVID-19 pandemic on hypertension management. The COVID-19 pandemic has disrupted our daily life, restricted access to healthcare, and altered some of the conventional management of hypertension.

Digital redesign of hypertension management with practice and patient apps for blood pressure control (PIA study): A cluster-randomised controlled trial in general practices

Summary Background Long-term hypertension control prevents heart attacks and other cardiovascular diseases, yet implementation is insufficient worldwide. The redesign of hypertension management by information and communication technology (ICT) improved hypertension control, e.g., by transmission of blood pressure (BP) measurements to a central webspace. However, an easy-to-use secure patient app connected with a practice management centre is lacking. This study evaluates the effectiveness of the newly developed PIA (PC-supported case management of hypertensive patients to implement guideline-based hypertension therapy using a physician-defined and -supervised, patient-specific therapeutic algorithm) intervention with PIA-ICT and eLearning for general practices. Methods The effectiveness of the PIA intervention was evaluated in a cluster-randomised study. Practices were randomly allocated (1:1) to the intervention or the control group (usual care). Group allocation was unmasked for participants and researchers. The primary outcome was the BP control rate (BP < 140/90 mmHg) after 6–12 months. Secondary outcomes included BP changes and satisfaction with PIA-ICT. The trial is registered in the German Clinical Trials Register (DRKS00012680). Findings Starting from December 1, 2019, 64 general practices were recruited over 1 year during the COVID-19 pandemic. Overall, 848 patients were enrolled between April 15, 2020 and March 31, 2021. The study was completed Sept 30, 2021. At baseline, 636 patients (intervention: 331;control: 305) of 50 general practices met the inclusion criteria. The final dataset for analyses comprised 47 practices and 525 patients (intervention 265;control 260). In the adjusted hierarchical model, the PIA intervention increased the BP control rate significantly by 23.1% points (95% CI: 5.4–40.8%): intervention 59.8% (95% CI: 47.4–71.0%) compared to 36.7% (95% CI: 24.9–50.3%) in the control group. Systolic BP decreased by 21.1 mmHg in the intervention and 15.5 mmHg in the control group. Interpretation The PIA redesign of care processes improved BP in an outcome-relevant way. Prospectively, it may constitute an important model for hypertension care in Germany. Funding This study is funded by the German Innovation Fund (Grant number: 01NVF17002).

White Coat Uncontrolled Hypertension in Teleconsultation: A New and Frequent Entity.

INTRODUCTION: Cardiovascular risk seems not to be greater in patients with white coat uncontrolled hypertension (WUCH) than in patients with sustained blood pressure (BP) control. Therefore, its detection is important to avoid overtreatment. The COVID-19 pandemic determined a massive migration of hypertension consultations from the face-to-face modality to teleconsultations, and it is unknown whether WUCH exists in this context. AIM: We aimed to evaluate the prevalence of WUCH through home BP monitoring (HBPM) in treated hypertensive patients evaluated by teleconsultation. METHODS: We included treated hypertensive patients that owned a digital BP monitor. During teleconsultation, patients were asked to perform two BP measurements and then a 7-day HBPM, using the same device. Patients were classified as having WUCH if BP was ≥ 140 and/or 90 mmHg in teleconsultation and < 135/85 mmHg on HBPM. The prevalence of WUCH and its 95% confidence interval were estimated. One-way ANOVA, the Chi-square test or Fisher's exact test were used to compare the characteristics of these patients with the other groups. RESULTS: We included 341 patients (45.2% male, mean age 62.3 years). The prevalence of WUCH was 33.1% (95% CI 28.3-38.3%). Significant differences were found in terms of age, the number of antihypertensive drugs and the use of calcium channel blockers, all lower in the WUCH group as compared with the groups with elevated BP on HBPM. CONCLUSION: WUCH exists in teleconsultation and is very frequent. It can be easily detected though HBPM, thus avoiding overmedication, and its potential impact on side-effects and health costs.

Home Blood Pressure and Telemedicine: A Modern Approach for Managing Hypertension During and After COVID-19 Pandemic.

Hypertension is the most common cardiovascular risk factor for acute cardiovascular outcomes, including acute coronary disease, stroke, chronic kidney disease and congestive heart failure. Despite the fact that it represents the most prevalent risk factor in the general population, mostly in elderly individuals, its awareness is still relatively low, being about one third of patients living with undiagnosed hypertension and high risk of experiencing acute cardiovascular events. In addition, though recent improvement in pharmacological and non-pharmacological therapeutic options, hypertension is largely uncontrolled, with about 35-40% of treated hypertensive patients achieving the recommended therapeutic targets. Among different modern interventions proposed for improving blood pressure control in treated hypertensive patients, a systematic adoption of home BP monitoring has demonstrated to be one of the most effective. Indeed, it improves patients' awareness of the disease and adherence to prescribed medications and allows tailoring and personalizing BP lowering therapies. Home BP monitoring is particularly suitable for telemedicine and mobile-health solutions. Indeed, in specific conditions, when face-to-face interactions between patients and physicians are not allowed or even suspended, as in case of COVID-19 pandemic, telemedicine may ensure effective management of hypertension, as well as other cardiovascular and non-cardiovascular comorbidities. This review will summarize strengths and limitations of telemedicine in the clinical management of hypertension with a particular focus on the lessons learned during the COVID-19 pandemic.

COVID-19 and hypertension-evidence and practical management: Guidance from the HOPE Asia Network.

There are several risk factors for worse outcomes in patients with coronavirus 2019 disease (COVID-19). Patients with hypertension appear to have a poor prognosis, but there is no direct evidence that hypertension increases the risk of new infection or adverse outcomes independent of age and other risk factors. There is also concern about use of renin-angiotensin system (RAS) inhibitors due to a key role of angiotensin-converting enzyme 2 receptors in the entry of the SARS-CoV-2 virus into cells. However, there is little evidence that use of RAS inhibitors increases the risk of SARS-CoV-2 virus infection or worsens the course of COVID-19. Therefore, antihypertensive therapy with these agents should be continued. In addition to acute respiratory distress syndrome, patients with severe COVID-19 can develop myocardial injury and cytokine storm, resulting in heart failure, arteriovenous thrombosis, and kidney injury. Troponin, N-terminal pro-B-type natriuretic peptide, D-dimer, and serum creatinine are biomarkers for these complications and can be used to monitor patients with COVID-19 and for risk stratification. Other factors that need to be incorporated into patient management strategies during the pandemic include regular exercise to maintain good health status and monitoring of psychological well-being. For the ongoing management of patients with hypertension, telemedicine-based home blood pressure monitoring strategies can facilitate maintenance of good blood pressure control while social distancing is maintained. Overall, multidisciplinary management of COVID-19 based on a rapidly growing body of evidence will help ensure the best possible outcomes for patients, including those with risk factors such as hypertension.