Adherence to a lifestyle monitoring system in patients with heart disease: protocol for the care-on prospective observational trial.

Background: Lifestyle factors such as physical fitness, dietary habits, mental stress, and sleep quality, are strong predictors of the occurrence, clinical course, and overall treatment outcomes of common cardiovascular diseases. However, these lifestyle factors are rarely monitored, nor used in daily clinical practice and personalized cardiac care. Moreover, non-adherence to long-term self-reporting of these lifestyle factors is common. In the present study, we evaluate adherence to a continuous unobtrusive and patient-friendly lifestyle monitoring system using evidence-based assessment tools.

Methods: In a prospective observational trial (N = 100), the project investigates usability of and adherence to a monitoring system for multiple lifestyle factors relevant to cardiovascular disease, i.e., daily physical activity levels, dietary habits, mental stress, smoking, and sleep quality. Patients with coronary artery disease, valvular disease and arrhythmias undergoing an elective intervention are asked to participate. The monitoring system consists of a secured online platform with a custom-built conversational interface-a chatbot-and a wrist-worn wearable medical device. The wrist-worn device collects continuous objective data on physical activity and the chatbot is used to collect self-report data. Participants collect self-reported lifestyle data via the chatbot for a maximum of 4 days every other week; in the same week physiological data are collected for 7 days for 24 h. Data collection starts one week before the intervention and continues until 1-year after discharge. Via a dashboard, patients can observe their lifestyle measures and adherence to self-reporting, set and track personal goals, and share their lifestyle data with practitioners and relatives. The primary outcome of the trial is adherence to using the integrated platform for self-tracking data. The secondary outcomes include system usability, determinants of adherence and the relation between baseline lifestyle behaviour and long-term patient-relevant outcomes.

Discussion: Systematic monitoring during daily life is essential to gain insights into patients' lifestyle behaviour. In this context, adherence to monitoring systems is critical for cardiologists and other care providers to monitor recovery after a cardiac intervention and to detect clinical deterioration. With this project, we will evaluate patients' adherence to lifestyle monitoring technology. This work contributes to the understanding of patient-centered data collection and interpretation, to enable personalized care after cardiac interventions in order to ultimately improve patient-relevant outcomes and reduce health care costs.

Trial Registration: Netherlands Trial Registry (NTR) NL9861. Registered 6th of November 2021.