A Remote Patient Monitoring System with Feedback Mechanisms using a Smartwatch: Concept, Implementation and Evaluation based on the activeDCM Randomized Controlled Trial.

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.