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

Recruiting

• Conditions: Clinical Deterioration; Vital Sign Monitoring; Hospital At Home

• Registration Number: NCT06077851
• Lead Sponsor: Bispebjerg Hospital

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.

Study Timeline

• Study First Submitted: 2023-09-27
• Status Verified: 2023-10
• Study Start: 2023-10-03
• Study First Submitted QC: 2023-10-04
• Last Update Submitted: 2023-10-04
• Study First Posted: 2023-10-11
• Last Update Posted: 2023-10-11
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
(Re)admission	within 30 days	Defined as acute admission to hospital for at least 12 hours with relation to prior discharge or EMS contact
Serious Adverse Events	within 30 days	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).
Mortality	within 30 days

Secondary Outcome Measures

Name	Time	Method
(Re)admission	within 7 days after discharge/assessment by paramedic personnel	Defined as acute admission to hospital for at least 12 hours with relation to prior discharge or EMS contact
Inquiries to the Emergency Medical Service	within 30 days	Defined as patients calls to 1813/112
Mortality and types of SAEs	within 30 days	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).

Trial Locations

Locations (1)

Bispebjerg Hospital; 🇩🇰 Copenhagen, NV, Denmark