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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06077851
Other study ID # 2308603
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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