Wireless Assessment of Respiratory and Circulatory Distress - Europe

Condition(s) studied

Investigational drug(s) / intervention(s)

WARD-CSS (Wireless Assessment of Respiratory and Circulatory Distress - Clinical Support System): Participants in Phase 2 will be monitored using the WARD-CSS system, which combines wearable wireless vital sign sensors with an application that applies clinically modeled algorithms to detect early signs of respiratory and circulatory deterioration. The system provides real-time data to healthcare professionals, reduces unnecessary alerts, and supports both in-hospital and, where feasible, post-discharge home monitoring.

Study summary

Hospital patient monitoring in Europe is often intermittent, which can delay detection of clinical deterioration during hospitalization and after discharge. The WARD-EU study aims to describe current monitoring practices and to evaluate the feasibility, acceptability, and usability of the WARD-CSS (Wireless Assessment of Respiratory and Circulatory Distress - Clinical Support System), an algorithm-based continuous monitoring system. The study seeks to assess whether WARD-CSS can be integrated into routine hospital and post-discharge care to support earlier detection of patient deterioration and improved patient monitoring.

Eligibility

Primary outcome measure(s)

• Evaluation of monitoring practices and WARD-CSS feasibility — From enrollment to up to seven days from either admission in the in-hospital cohort or discharge to home in the home monitoring cohort.
  Implementation of the WARD-CSS continuous monitoring system will be evaluated using structured surveys administered to healthcare professionals and patients. Surveys include: Self-developed questionnaires for patients and healthcare professionals administered before and after implementation to assess perceived system performance, usability, workflow integration, and implementation challenges. mHealth App Usability Questionnaire (MAUQ) administered after implementation to assess usability (total and subscale scores calculated according to scoring guidelines; higher scores indicate better usability). Normalization Measure Development Questionnaire (NoMAD) administered after implementation to assess implementation integration into routine practice (total score calculated according to scoring guidelines; higher scores indicate greater normalization/integration). For each instrument, mean total scores will be reported based on their respective validated scoring systems.

Trial sites (5)