Clinical trial NCT06077851: Continuous Monitoring of Vital Signs at Home (WARD HOME II)
Official title: Continuous Monitoring With Real-time Transmission of Vital Signs to Healthcare Professionals From Patients at Home
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vital Sign Monitoring
Clinical Deterioration
Hospital At Home
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
name: Technical University of Denmark
name: Emergency Medical Services, Capital Region, Denmark
First posted: 2023-10-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: (Re)admission
timeFrame: within 30 days
measure: Serious Adverse Events
timeFrame: within 30 days
measure: Mortality
timeFrame: within 30 days
Secondary outcomes:
measure: (Re)admission
timeFrame: within 7 days after discharge/assessment by paramedic personnel
measure: Inquiries to the Emergency Medical Service
timeFrame: within 30 days
measure: Mortality and types of SAEs
timeFrame: within 30 days
Other outcomes:
measure: Frequency of automatically generated alerts on deviating vital signs
timeFrame: 72 hours
measure: Number of automatically generated alerts
timeFrame: 72 hours
measure: Frequency of alerts which are responded to by healthcare personnel
timeFrame: 72 hours
measure: Fraction of time within the study period with at least one type of data transmitted in real time from patients' homes.
timeFrame: 72 hours
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
state: NV
Study officials:
affiliation: Bispebjerg Hospital
name: Emilie Sigvardt, MD
role: PRINCIPAL_INVESTIGATOR
References: