Wireless Assessment of Respiratory and Circulatory Distress - Europe

NCT07451249 | Not Yet Recruiting

• 1 other identifier: THCS Grant 101095654
• Study Type: interventional
• Target: 1,240
• Locations: 4 countries
• Sites: 5

Brief 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.

Conditions

Patient Deterioration; Patient Monitoring; Clinical Deterioration

Keywords

monitoring; Post-discharge monitoring; Clinical deterioration

Outcome Measures

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.

  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

  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 (3)

• 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.

• Incidence of complications

  From enrollment until 30 days post-discharge.

• 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.

Study Arms (1)

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.

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

Interventions

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.

WARD-CSS Continuous Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NOVA Medical School: collaborator
• Jagiellonian University: collaborator
• Eske Kvanner Aasvang: lead
• Rigshospitalet, Denmark: collaborator
• University Medical Center Groningen, Netherland: collaborator
• Bispebjerg Hospital: collaborator

Study Sites (5)

Rigshospitalet

Copenhagen, Capital Region, 2100, Denmark

Location

Bispebjerg hospital

Copenhagen, 2400, Denmark

Location

University Medical Center Groningen

Groningen, 9713, Netherlands

Location

Jagiellonian University Medical College

Krakow, 31008, Poland

Location

NOVA Medical School

Lisbon, 1169-056, Portugal

Location

MeSH Terms

Conditions

Clinical Deterioration

Condition Hierarchy (Ancestors)

Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Eske K Aasvang, DMSci

  Rigshospitalet, Denmark

  STUDY CHAIR

Central Study Contacts

Eske K Aasvang, DMSci

CONTACT

+4526232076; Eske.Kvanner.Aasvang.01@regionh.dk

Sharri S Mortensen, MD

CONTACT

+4522989761; sharri.junadi.mortensen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: March 5, 2026
• Study Start: March 16, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: March 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2); NL (1); PT (1); PL (1)