Wireless Assessment of Respiratory and Circulatory Distress - Europe

The WARD-EU study is a multinational, multicentric, mixed-methods observational investigation conducted across four European countries. The study is designed to explore variation in hospital patient monitoring practices and to evaluate the implementation potential of an algorithm-based continuous monitoring system across different healthcare settings.

The study consists of two sequential phases. Phase 1 (pre-implementation) focuses on mapping existing monitoring practices for adult patients admitted for medical or surgical conditions with an expected hospital stay of at least two days. Data will be collected using structured questionnaires administered to patients and nursing staff to characterize monitoring frequency, workflows, perceived safety, and user experience within participating healthcare systems.

Phase 2 (post-implementation) evaluates the integration of the WARD-CSS (Wireless Assessment of Respiratory and Circulatory Distress - Clinical Support System) into routine clinical practice. WARD-CSS combines wearable wireless sensors for continuous vital sign monitoring with an application incorporating clinically modelled algorithms designed to detect early signs of respiratory and circulatory deterioration while reducing unnecessary alerts. During this phase, the system will be used for in-hospital monitoring and, where feasible, extended to post-discharge home monitoring.

Data collection in Phase 2 will include questionnaires from healthcare professionals and patients to assess usability, feasibility, and acceptability of the system, as well as descriptive analysis of system-generated vital sign data, monitoring adherence, and measurement frequency. Complications occurring within 30 days following hospital discharge will be recorded. Qualitative feedback will be used to identify facilitators and barriers to implementation, including technological challenges, workflow integration, and patient compliance, particularly in home-monitoring settings.

The study will enroll adult patients and healthcare professionals from participating centers. Participants may be involved during hospitalization and, for selected patients, during home monitoring following discharge, with follow-up up to 30 days. Data will be analyzed descriptively using appropriate parametric and non-parametric methods to identify patterns and variability across countries and care settings.

The study will be conducted in accordance with the Clinical Study Protocol, ICH-GCP, ISO 14155, the Declaration of Helsinki, and applicable national regulatory requirements. Ethics approval will be obtained from relevant committees in all participating countries, and data handling will comply with the General Data Protection Regulation and local data protection laws.

• WARD-CSS (Wireless Assessment of Respiratory and Circulatory Distress - Clinical Support System) (Device): 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.

Primary outcomes

• 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.

Secondary outcomes

• Patient experience and usability [From enrollment to up to seven days from either admission in the in-hospital cohort or discharge to home in the home monitoring cohort.]: Patient-reported comfort, perceived safety, and usability of monitoring will be assessed using structured self-developed questionnaires. Surveys will evaluate: * Physical comfort during monitoring * Perceived safety while being monitored * Ease of use and overall usability of the monitoring system Responses will be scored using predefined scales. Higher scores will indicate more positive patient experience (greater comfort, safety, and usability). Assessments will be conducted during standard monitoring practice (pre-implementation) and during WARD-CSS-supported monitoring (post-implementation), including home monitoring where applicable.

Other outcomes

• Patient Compliance Rate [From enrollment up to seven days from either admission in the in-hospital cohort or discharge to home in the home monitoring cohort.]: Percentage of prescribed monitoring time during which the WARD-CSS device was actively worn and transmitting valid data. Unit of Measure: % of prescribed monitoring time
• Incidence of complications [From enrollment until 30 days post-discharge.]: The incidence of severe adverse events (SAEs) will be assessed according to predefined criteria outlined in the WARD Outcome Manual (Appendix 12). SAEs include clinically significant events such as life-threatening deterioration, unplanned intensive care unit admission, or other events meeting SAE criteria as defined in the study manual. The number and proportion of participants experiencing at least one SAE will be recorded for: Patients receiving standard monitoring (pre-implementation) Patients monitored using the WARD-CSS system during hospitalization and/or home monitoring (post-implementation)
• Healthcare Professional Response to Alerts [From enrollment up to seven days from either admission in the in-hospital cohort or discharge to home in the home monitoring cohort.]: Proportion of system alerts responded to using in-app response buttons: attend, snooze etc. Unit of Measure: % of alerts responded per patient

Sex: All, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

* Adults (≥18 years) admitted to hospitals due to medical or surgical conditions with an expected hospital stay of at least two days.
* Adults discharged from the hospital who are receiving home-based monitoring using WARD-CSS (Phase 2 only).
* Willingness to participate and provide informed consent.

Exclusion Criteria:

* Patients with severe comorbidities (e.g., severe dementia) that preclude continuous monitoring.
* Patients unwilling or unable to provide informed consent.
* Patients unable to wear the monitoring equipment.

• Eske K Aasvang, DMSci, Study chair, Copenhagen University Hospital, Rigshospitalet