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

NCT05378139 | Recruiting DMC

• 1 other identifier: 2203648
• Study Type: observational
• Target: 3,095
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study is to test and assess the implementation and effectiveness of continuous wireless vital signs monitoring with real-time alerts on: The frequency of patients monitored with adequate data quality as adequate clinical user satisfaction in the initial versus the last part of the trial (primary outcome).

Conditions

Surgical Complication; Pulmonary Disease; Hematologic Diseases; Oncology; Cardiac Disease; Infections

Outcome Measures

Primary Outcomes (2)

• Data quality

  The number (frequency) of patients having adequate data quality (defined as at least 60% of the monitoring time with simultaneous recording of SpO2, respiratory rate, heart rate)

  30 days

• user satisfaction

  Number of users with adequate clinical user satisfaction (defined as the nurse in charge of the patient at the end of monitoring answers "Agree" or "Strongly agree" to the question "WARD-monitoring was beneficial for monitoring of vital signs in this patientparticipant (response options: Strongly Disagree - Disagree - Neutral - Agree - Strongly Agree)).

  30 days

Interventions

Vital signs measurements with new app DEVICE

Patients vital signs are monitored through an app for the nurses to use

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients assessed by the clinical staff as having an acute condition with risk for clinical deterioration and being either at home (with no apparent need for hospitalization), and/or in hospital OR Patients at either at home before, in-hospital and/or after hospitalization for elective major surgery, defined as surgery lasting more than one hour under general- or regional anaesthesia

You may qualify if:

• Adult participants (≥18 years)
• Patients assessed by the clinical staff as having an acute condition with risk for clinical deterioration and being either at home (with no apparent need for hospitalization), and/or in hospital OR
• Patients at either at home before, in-hospital and/or after hospitalization for elective major surgery, defined as surgery lasting more than one hour under general- or regional anaesthesia

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg: lead
• Rigshospitalet, Denmark: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Lung Diseases; Hematologic Diseases; Neoplasms; Heart Diseases; Infections

Interventions

Vital Signs

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Hemic and Lymphatic Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Eske Aasvang, MD

CONTACT

26232076; eske.kvanner.aasvang@regionh.dk

Aslak B Johansen, MD

CONTACT

aslak.broby.johansen@regionh.dk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: May 18, 2022
• Study Start: February 1, 2021
• Primary Completion: June 27, 2025
• Study Completion: December 22, 2025
• Last Updated: April 11, 2025

Record last verified: 2024-07

Locations

DK (1)