Wireless Assessment of Respiratory and Circulatory Distress - Europe
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEske Kvanner Aasvang
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
WARD-CSS (Wireless Assessment of Respiratory and Circulatory Distress - Clinical Support System)
DeviceParticipants 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.
Treatment groups
1,240 Participants
are divided into 1 treatment groupGroup A: WARD-CSS Continuous MonitoringExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Evaluation of monitoring practices and WARD-CSS feasibility
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.
Time frame
From enrollment to up to seven days from either admission in the in-hospital cohort or discharge to home in the home monitoring cohort.Secondary outcomes
1
Patient experience and usability
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.
Time frame
From enrollment to up to seven days from either admission in the in-hospital cohort or discharge to home in the home monitoring cohort.Other outcomes
1
Patient Compliance Rate
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
Time frame
From enrollment up to seven days from either admission in the in-hospital cohort or discharge to home in the home monitoring cohort.2
Incidence of complications
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)
Time frame
From enrollment until 30 days post-discharge.3
Healthcare Professional Response to Alerts
Proportion of system alerts responded to using in-app response buttons: attend, snooze etc. Unit of Measure: % of alerts responded per patient
Time frame
From enrollment up to seven days from either admission in the in-hospital cohort or discharge to home in the home monitoring cohort.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Eske Kvanner Aasvang
Lead sponsor
Rigshospitalet, Denmark
Sponsor institution
Rigshospitalet, Denmark
Collaborator
University Medical Center Groningen, Netherland
Collaborator
NOVA Medical School
Collaborator
Jagiellonian University
Collaborator
Bispebjerg Hospital
Collaborator
Source ClinicalTrials.gov
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