Actively Recruiting

Age: 18Years +
All Genders
ID05378139

WARD Prospective Study - Continuous Wireless Monitoring of Vital Signs and Automated Alerts in Participants at Home and During Hospitalization

Led by University Hospital Bispebjerg and Frederiksberg · Updated on 2025-04-11

3095

Participants Needed

1

Research Sites

25 weeks

Total Duration

On this page

Sponsors

U

University Hospital Bispebjerg and Frederiksberg

Lead Sponsor

R

Rigshospitalet, Denmark

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the implementation and effectiveness of continuous wireless monitoring of vital signs with real-time alerts in patients who are either at home or hospitalized. This study focuses on high-risk patients with acute conditions or those undergoing major elective surgery, aiming to improve detection of physiological changes that may indicate clinical deterioration. The study builds on the WARD project, which integrates continuous measurements of multiple physiological signals with artificial intelligence to support clinical decision-making. Participants will have their vital signs continuously monitored using a specially developed app that collects data through a wireless device. The WARD-Clinical Support System (WARD-CSS) uses machine learning algorithms to interpret the data, predict potential health issues, and alert clinical staff via a mobile device with an easy-to-use interface. The study includes patients at home, during hospitalization, and after surgery, assessing how well the system works in these settings. During the study, participants' vital signs data quality and clinical user satisfaction will be tracked over 30 days. The researchers will evaluate how often patients are monitored with sufficient data quality and how satisfied clinical users are with the system. Participants may undergo assessments and monitoring through the app without interfering with their usual care. Safety and ease of use will be important aspects of the study's observations.

CONDITIONS

Brief Title

Continuous Wireless Monitoring of Vital Signs and Automated Alerts in Participants at Home and During Hospitalization

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult participants (18 years or older)
  • Patients assessed by clinical staff as having an acute condition with risk for clinical deterioration at home (without need for hospitalization) or in hospital
  • Patients at home before, during, or after elective major surgery lasting more than one hour under general or regional anesthesia
Not Eligible

You will not qualify if you...

  • Participants expected not to cooperate with study procedures
  • Allergy to plaster or silicone
  • Having a pacemaker or Implantable Cardioverter Defibrillator (ICD) device
  • Inability to give informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote)

Monitoring

Duration - Up to 30 days

Participants are continuously monitored for vital signs using a wireless device and app to assess physiological status both at home and during hospitalization.

Continuous monitoring with device usage throughout the period

Trial Site Locations

Total: 1 location

1

Rigshospitalet

Copenhagen, Copenhagen, Denmark, 2100

Actively Recruiting

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Research Team

E

Eske Aasvang, MD

A

Aslak B Johansen, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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