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Background Digital health technologies have the potential to improve patient care sustainably. A digital capturing of patient-reported outcome measures (PROM) could facilitate patients’ surveillance and endpoint assessment within clinical trials especially in heart failure (HF) patients. However, data regarding the availability of digital infrastructure and patients’ willingness to use digital health solutions are scarce. Therefore, we conducted a survey as part of a digital-based HF registry. Methods and results The Helios Heart registry (H2-registry) has been introduced as a prospective registry being based on digitally augmented processes throughout the whole trial conduction from patients’ selection to data collection and follow-up (FU). PROMs are captured paper-based at recruitment, but patients are offered two digital solutions for FU. Overall, 125 patients (mean age 67.8 years, 34.4% female) were included in the single-center run-in phase of 16 weeks. Of them, 52.0% were not interested in any digital contact as part of the FU. If digital PROM capturing was conceivable, a web-based solution (70.0%) was preferred to an application-based approach (30.0%). Discrepancies occurred regarding the availability of email accounts and smartphones. Patients in the non-digital group were older (72.0 years vs. 63.2 years, P < 0.01) and more frequently female (female sex, non-digital vs. digital group: 47.7% vs. 20.0%, P < 0.01). Conclusions Our survey illustrated difficulties of implementing a digital FU to record PROMs in a contemporary HF cohort in particular among older patients. Further research is required to specify reasons in case of patients’ unwillingness and to better tailor digital health solutions to patients’ specific needs.
Background Mobile health (mHealth) approaches are already having a fundamental impact on clinical practice in cardiovascular medicine. A variety of different health apps and wearable devices for capturing health data such as electrocardiograms (ECGs) exist. However, most mHealth technologies focus on distinct variables without integrating patients’ quality of life, and the impact on clinical outcome measures of implementing those digital solutions into cardiovascular health care is still to be determined. Objective Within this document, we describe the TeleWear project, which was recently initiated as an approach for contemporary patient management integrating mobile-collected health data and the standardized mHealth-guided measurement of patient-reported outcomes (PROs) in patients with cardiovascular disease. Methods The specifically designed mobile app and clinical frontend form the central elements of our TeleWear infrastructure. Because of its flexible framework, the platform allows far-reaching customization with the possibility to add different mHealth data sources and respective questionnaires (patient-reported outcome measures). Results With initial focus on patients with cardiac arrhythmias, a feasibility study is currently carried out to assess wearable-recorded ECG and PRO transmission and its evaluation by physicians using the TeleWear app and clinical frontend. First experiences made during the feasibility study yielded positive results and confirmed the platform’s functionality and usability. Conclusions TeleWear represents a unique mHealth approach comprising PRO and mHealth data capturing. With the currently running TeleWear feasibility study, we aim to test and further develop the platform in a real-world setting. A randomized controlled trial including patients with atrial fibrillation that investigates PRO- and ECG-based clinical management based on the established TeleWear infrastructure will evaluate its clinical benefits. Widening the spectrum of health data collection and interpretation beyond the ECG and use of the TeleWear infrastructure in different patient subcohorts with focus on cardiovascular diseases are further milestones of the project with the ultimate goal to establish a comprehensive telemedical center entrenched by mHealth.
UNSTRUCTURED Mobile Health (mHealth) approaches are already having a fundamental impact on clinical practice in cardiovascular medicine. A variety of different health applications and wearable devices for capturing health data such as electrocardiograms (ECG) exist. However, most mHealth technologies focus on distinct variables without integrating patients’ quality of life and the impact on clinical outcome measures of implementing those digital solutions into cardiovascular health care are still to be determined. Within this document, we describe the TeleWear project, which was recently initiated as an approach for contemporary patient management integrating mobile collected health data and the standardized mHealth-guided measuring of patient-reported outcomes (PROs) in patients with cardiovascular disease. The specifically designed mobile application and clinical frontend form the central elements of our TeleWear infrastructure. The platform allows far-reaching customization with the possibility to add different mHealth data sources and respective questionnaires. With initial focus on patients with cardiac arrhythmias, a feasibility study is currently carried out to assess wearable-recorded ECG and PRO transmission and its evaluation by physicians utilizing the TeleWear application and clinical frontend. A randomized controlled trial including atrial fibrillation patients which investigates PRO- and ECG-based clinical management based on the established TeleWear infrastructure will be the next step towards the establishment of a comprehensive telemedical center entrenched by mHealth.
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