Continuous Monitoring of Vital Signs at Home (WARD HOME II)

Continuous Monitoring With Real-time Transmission of Vital Signs to Healthcare Professionals From Patients at Home

The study aims to investigate the use of wireless, continuous monitoring in patients at home including the frequency of alarms triggered by abnormal vital parameters and their significance for (re)hospitalisation/Serious Adverse Events(SAE) and/or death within 30 days.

Study Overview

• Status: Completed
• Conditions: Vital Sign Monitoring; Clinical Deterioration; Hospital At Home
• Intervention / Treatment: Device: Continuously monitoring

Detailed Description

Acute hospital admissions challenge the capacity of the healthcare system. Readmission is common among patients with chronic medical diseases, and many patients admitted for acute conditions are often subsequently observed at the hospital for hours and often with one overnight stay for observation purposes alone. Recent medico technical research has allowed continuous and wireless monitoring of patients' vital signs in-hospital, but the practice at home remains uninvestigated. However, the technology has the potential to relieve hospital overcrowding by offering continuous and real time analytics of vital signs in high-risk patients at home.

• Study Type: Observational
• Enrollment (Actual): 83

Contacts and Locations

Study Locations

• Denmark
  • NV
    • Copenhagen, NV, Denmark, 2400
      • Bispebjerg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted with an acute medical disease at Bispebjerg Hospital or Rigshospitalet, or assessed by paramedic personnel at home after contact to the EMS.

Description

Inclusion Criteria:

Adult patients (≥18 years) admitted (with at least one night stay) with an acute medical disease and scheduled for discharge to their own homes

Adult patients (≥18 years) who have contacted the EMS and, after assessment by paramedic personnel, not deemed sick enough for immediate hospital admission.

Exclusion Criteria:

Patients placed on palliative treatment.

Acceptable chronically abnormal vital parameters of SpO2<88%, MAP<70, RR>24, or HR>110.

Allergy to plaster, plastic, or silicone.

A pacemaker or Implantable Cardioverter Defibrillator (ICD) device.

If the patient was deemed not able to open the front door when visited by the investigator.

Inability to give informed consent.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality		within 30 days
(Re)admission	Defined as acute admission to hospital for at least 12 hours with relation to prior discharge or EMS contact	within 30 days
Serious Adverse Events	Any adverse event, including acute admissions during the observational period. Criteria defined in protocol. Adverse events will be manually categorised as a 'severe adverse event' (SAE), or simple 'adverse event' (AE).	within 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(Re)admission	Defined as acute admission to hospital for at least 12 hours with relation to prior discharge or EMS contact	within 7 days after discharge/assessment by paramedic personnel
Inquiries to the Emergency Medical Service	Defined as patients calls to 1813/112	within 30 days
Mortality and types of SAEs	Any adverse event, including acute admissions during the observational period. Criteria defined in protocol. Adverse events will be manually categorised as a 'severe adverse event' (SAE), or simple 'adverse event' (AE).	within 30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of automatically generated alerts on deviating vital signs	per device per patient per day	72 hours
Number of automatically generated alerts	From all devices worn, per patient per day	72 hours
Frequency of alerts which are responded to by healthcare personnel	Number of alerts triggered by deviating vital signs, per patient per day	72 hours
Fraction of time within the study period with at least one type of data transmitted in real time from patients' homes.		72 hours

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital
• Collaborators: Rigshospitalet, Denmark; Emergency Medical Services, Capital Region, Denmark; Technical University of Denmark
• Investigators: Principal Investigator: Emilie Sigvardt, MD, Bispebjerg Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2023
• Primary Completion (Actual): October 30, 2025
• Study Completion (Actual): November 30, 2025

Study Registration Dates

• First Submitted: September 27, 2023
• First Submitted That Met QC Criteria: October 4, 2023
• First Posted (Actual): October 11, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Progression; Pathological Conditions, Signs and Symptoms; Clinical Deterioration
• Other Study ID Numbers: 2308603

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No