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BACKGROUND: Technological advances allow recording and sharing of health-related data in a patient-centric way using smartphones and wearables. Secure sharing of such patient-generated data with physicians would enable a dense management of individual health trajectories, monitoring of risk factors and asynchronous feedback. However, most Remote Patient Monitoring (RPM) systems currently available are not fully integrated into hospital IT systems or lack the patient-centric design. OBJECTIVE: The objective was to conceptualize and implement a user-friendly, reusable, interoperable and secure RPM system incorporating asynchronous feedback mechanisms, using a broadly available consumer wearable (Apple Watch). Additionally, the study sought to evaluate factors influencing patient acceptance of such systems. METHODS: The RPM system requirements were established through focus group sessions. Subsequently, a system concept was designed and implemented using an iterative approach, ensuring technical feasibility from the beginning. To assess clinical feasibility, the system was employed as part of the activeDCM prospective, randomized, interventional study focusing on Dilated Cardiomyopathy (DCM). Each patient used the system for at least 12 months. The System Usability Scale (SUS) was employed to measure usability from a subjective patient perspective. Additionally, an evaluation was conducted on the objective wearable interaction frequency as well as the completeness of transmitted data, classified into Sensor-based Health Data (SHD) and Patient Reported Outcome Measures (PROM). Descriptive statistics using boxplots, along bootstrapped multiple linear regression with a 95% confidence interval (CI) were utilized for evaluation, analyzing the influence of age, sex, device experience and intervention group membership. RESULTS: The RPM system consists of four interoperable components: patient-devices, data-server, data-viewer and notification-service. The evaluation of the system was conducted with 95 consecutive DCM patients (female: 28 of 95 (29%), age: 50±12 years) completing the activeDCM study protocol. The wearable/ smartphone application of the system achieved a mean SUS score of 78±17, which was most influenced by device experience. 83 of 95 patients (87%) could integrate the wearable application (very) well into their daily routine and 67 of 95 (70%) saw a benefit of the RPM system for management of their health condition. Patients interacted on average with the wearable on 61%±26% of days enrolled in the study, corresponding to 239±99 of 396±39 days. SHD was available on average for 78%±23% of days and PROM data 64%±27% of weeks enrolled in the study, corresponding to 307±87 of 396±39 days and 35±15 of 56±5 weeks, respectively. Wearable interaction frequency, SHD and PROM completeness were most influenced by intervention group membership. CONCLUSIONS: Our results mark a first step towards integrating RPM systems, based on a consumer wearable device for primary patient input, into standardized clinical workflows. They can serve as a blueprint for creating a user-friendly, reusable, interoperable and secure RPM system, that can be integrated into patients' daily routines. CLINICALTRIAL: ClinicalTrials.gov-Identifier: NCT04359238.
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BACKGROUND: Dilated cardiomyopathy (DCM) is a leading cause of heart failure, particularly in younger individuals. Low physical strength is a global risk factor for cardiovascular mortality, and physical activity and a healthy lifestyle have been shown to improve outcomes in patients with heart failure. However, inappropriate exercise may increase the risk of arrhythmias in certain individuals with DCM. The determinants for predicting individual risks in this setting are poorly understood, and clinicians are hesitant to recommend sports for cardiomyopathy patients. The activeDCM trial aims to assess the safety and efficacy of a personalized exercise and activity programme for individuals with DCM. STUDY DESIGN: The activeDCM trial is a prospective, randomized, interventional trial with a 12 month follow-up. Three hundred patients, aged 18-75 years with DCM, left ventricular ejection fraction (LVEF) ≤ 50% and New York Heart Association (NYHA) classes I-III, will be enrolled. The intervention includes a personalized exercise and activity programme. The primary outcome is the increase in peak oxygen uptake (VO2max, mL/kg/min) from baseline to 12 months. Secondary endpoints include adherence to personalized activity programmes, freedom from clinically relevant arrhythmia, unplanned hospitalization for heart failure and changes in NYHA class, quality of life scores, 6 min walk distance, muscular strength, N-terminal pro-B-type natriuretic peptide (NT-proBNP) and high-sensitivity troponin T (hsTnT) levels and cardiac function. Advanced research questions include high-density phenome and omics analysis combined with digital biomarkers derived from Apple Watch devices. DISCUSSION: The activeDCM trial will provide valuable insights into the safety and efficacy of personalized exercise training in DCM patients, inform clinical practice and contribute to the development of heart failure management programmes. The study will generate data on the impact of exercise on various aspects of cardiovascular disease, including genetic, metabolic, phenotypic and longitudinal aspects, facilitating the development of future digital tools and strategies, including the incorporation of smart wearable devices.
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Hypertrophic obstructive cardiomyopathy (HOCM) increases the risk for mother and fetus during pregnancy. Alcohol septal ablation (ASA) is an established procedure in nonpregnant patients with HOCM. In this report, we present a case of a 29-year-old woman in her 29th gestational week with decompensated HOCM undergoing a successful ASA. (Level of Difficulty: Advanced.).