Patient DeteriorationWARD-EUNCT07451249
Wireless Assessment of Respiratory and Circulatory Distress - Europe
A study testing WARD-CSS (Wireless Assessment of Respiratory and Circulatory Distress - Clinical Support System) in people with Patient Deterioration and Patient Monitoring, run by Eske Kvanner Aasvang at 5 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patient Deterioration, Patient Monitoring, Clinical Deterioration
- What is being tested?
- WARD-CSS (Wireless Assessment of Respiratory and Circulatory Distress - Clinical Support System)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,240 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 16 Mar 2026to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
5 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 4 countries
Denmark2 sites
Rigshospitalet
Copenhagen, Capital Region, 2100
Eske Aasvang, MD, 26232076, eske.kvanner.aasvang.01@regionh.dk
Bispebjerg hospital
Copenhagen, 2400
Christian Meyhoff, MD, +45 24910542, christian.sylvest.meyhoff@regionh.dk
Netherlands1 site
University Medical Center Groningen
Groningen, 9713
Marjolein Havemen, 0, m.e.haveman@umcg.nl
Poland1 site
Jagiellonian University Medical College
Krakow, 31008
Wojciech Szczeklik, MD, 0, wojciech.szczeklik@uj.edu.pl
Portugal1 site
NOVA Medical School
Lisbon, 1169-056
Lúcia Domingues, 0, lucia.domingues@nms.unl.pt
About this study
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.
Read the 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.
- Being tested
- WARD-CSS (Wireless Assessment of Respiratory and Circulatory Distress - Clinical Support System)
- Keywords
- monitoring, Post-discharge monitoring, Clinical deterioration
- Medical subject headings
- Clinical Deterioration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| WARD-CSS Continuous Monitoring | Experimental | 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. Receives: Device: WARD-CSS (Wireless Assessment of Respiratory and Circulatory Distress - Clinical Support System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From enrollment to up to seven days from either admission in the in-hospital cohort or discharge to home in the home monitoring cohort.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start16 Mar 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient DeteriorationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eske Kvanner Aasvang
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, University Medical Center Groningen, Netherland, NOVA Medical School, Jagiellonian University, Bispebjerg Hospital
- Responsible party
- Sponsor-investigator, Eske Kvanner Aasvang, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Eske K Aasvang, DMSci, Study chair, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07451249
- Sponsor's protocol ID
- THCS Grant 101095654
- Acronym
- WARD-EU
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wireless Assessment of Respiratory and Circulatory Distress - Europe
- ClinicalTrials.gov ID
- NCT07451249
- Acronym / sponsor ID
- WARD-EU / THCS Grant 101095654
- Keywords
- monitoring, Post-discharge monitoring, Clinical deterioration
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,240 participants (estimated)
- Lead sponsor
- Eske Kvanner AasvangUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, University Medical Center Groningen, Netherland, NOVA Medical School, Jagiellonian University, Bispebjerg Hospital
- Study start
- 16 Mar 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WARD-CSS Continuous Monitoring | Experimental | Device: WARD-CSS (Wireless Assessment of Respiratory and Circulatory Distress - Clinical Support System)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | WARD-CSS Continuous Monitoring |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eske K Aasvang, DMSci study chair
Copenhagen University Hospital, Rigshospitalet
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WARD-CSS (Wireless Assessment of Respiratory and Circulatory Distress - Clinical Support System) in people with Patient Deterioration and Patient Monitoring, run by Eske Kvanner Aasvang at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark, Netherlands, Poland, Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eske K Aasvang, DMSci (+4526232076, Eske.Kvanner.Aasvang.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.