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

NCT06077851 | Completed

• 1 other identifier: 2308603
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vital Sign Monitoring; Clinical Deterioration; Hospital At Home

Outcome Measures

Primary Outcomes (3)

• (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

• Mortality

  within 30 days

Secondary Outcomes (3)

• (Re)admission

  within 7 days after discharge/assessment by paramedic personnel

• Inquiries to the Emergency Medical Service

  within 30 days

• Mortality and types of SAEs

  within 30 days

Other Outcomes (4)

• Frequency of automatically generated alerts on deviating vital signs

  72 hours

• Number of automatically generated alerts

  72 hours

• Frequency of alerts which are responded to by healthcare personnel

  72 hours

Interventions

Continuously monitoring DEVICE

Included patients are monitored with WARD equipment the first days after discharge. Monitoring will last for a maximum of three days.

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• Rigshospitalet, Denmark: collaborator
• Technical University of Denmark: collaborator
• Emergency Medical Services, Capital Region, Denmark: collaborator

Study Sites (1)

Bispebjerg Hospital

Copenhagen, NV, 2400, Denmark

Location

MeSH Terms

Conditions

Clinical Deterioration

Condition Hierarchy (Ancestors)

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

Study Officials

• Emilie Sigvardt, MD

  Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 11, 2023
• Study Start: October 3, 2023
• Primary Completion: October 30, 2025
• Study Completion: November 30, 2025
• Last Updated: March 13, 2026

Record last verified: 2025-06

Locations

DK (1)