Wireless Assessment of Respiratory and Circulatory Distress - Europe (WARD-EU)

February 27, 2026 updated by: Eske Kvanner Aasvang
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

1240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: WARD-CSS Continuous Monitoring
Participants receive continuous monitoring using the WARD-CSS system during hospitalization and, where applicable, at home after discharge. Pre-implementation baseline data will be collected prior to WARD-CSS rollout for within-subject comparisons of usability, workflow integration, patient experience, adherence, and alert response.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of monitoring practices and WARD-CSS feasibility
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.

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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient experience and usability
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.

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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Compliance Rate
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.

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
From enrollment up to seven days from either admission in the in-hospital cohort or discharge to home in the home monitoring cohort.
Incidence of complications
Time Frame: 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)
From enrollment until 30 days post-discharge.
Healthcare Professional Response to Alerts
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.

Proportion of system alerts responded to using in-app response buttons: attend, snooze etc.

Unit of Measure: % of alerts responded per patient
From enrollment up to seven days from either admission in the in-hospital cohort or discharge to home in the home monitoring cohort.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eske Kvanner Aasvang

Collaborators

Rigshospitalet, Denmark
Jagiellonian University
Bispebjerg Hospital
NOVA Medical School
University Medical Center Groningen, Netherland

Investigators

  • Study Chair: Eske K Aasvang, DMSci, Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 16, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

February 19, 2026

First Submitted That Met QC Criteria

February 27, 2026

First Posted (Actual)

March 5, 2026

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THCS Grant 101095654

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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