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

Clinical Deterioration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06077851
• Other study ID #: 2308603
• Status: Recruiting
• Start date: October 3, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: October 2023
• Source: Bispebjerg Hospital
• Contact: Emilie Sigvardt, MD
• Phone: 28254123
• Email: emilie.sigvardt[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Clinical Deterioration
• Vital Sign Monitoring

Intervention

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

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen	NV

Sponsors (4)

Lead Sponsor	Collaborator
Bispebjerg Hospital	Emergency Medical Services, Capital Region, Denmark, Rigshospitalet, Denmark, Technical University of Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Frequency of automatically generated alerts on deviating vital signs	per device per patient per day	72 hours
Other	Number of automatically generated alerts	From all devices worn, per patient per day	72 hours
Other	Frequency of alerts which are responded to by healthcare personnel	Number of alerts triggered by deviating vital signs, per patient per day	72 hours
Other	Fraction of time within the study period with at least one type of data transmitted in real time from patients' homes.		72 hours
Primary	(Re)admission	Defined as acute admission to hospital for at least 12 hours with relation to prior discharge or EMS contact	within 30 days
Primary	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
Primary	Mortality		within 30 days
Secondary	(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
Secondary	Inquiries to the Emergency Medical Service	Defined as patients calls to 1813/112	within 30 days
Secondary	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