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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Vital Sign Monitoring, Clinical Deterioration, Hospital At Home

Intervention / Treatment
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* Device: Continuously monitoring


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (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 | 
| Inquiries to the Emergency Medical Service | Defined as patients calls to 1813/112 | within 30 days | 
| 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 |