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Completed

NCT Number: NCT06077851

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

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.

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Key information

Conditions

Vital Sign Monitoring Clinical Deterioration Disease Attributes Disease Progression Hospital at Home Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bispebjerg Hospital

Copenhagen, NV, 2400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Continuously monitoring

Device

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

Primary outcomes

  1. (Re)admission

    Time frame: within 30 days

    Defined as acute admission to hospital for at least 12 hours with relation to prior discharge or EMS contact

  2. Serious Adverse Events

    Time frame: 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).

  3. Mortality

    Time frame: within 30 days

Secondary outcomes

  1. (Re)admission

    Time frame: 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

  2. Inquiries to the Emergency Medical Service

    Time frame: within 30 days

    Defined as patients calls to 1813/112

  3. Mortality and types of SAEs

    Time frame: 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).

Other outcomes

  1. Frequency of automatically generated alerts on deviating vital signs

    Time frame: 72 hours

    per device per patient per day

  2. Number of automatically generated alerts

    Time frame: 72 hours

    From all devices worn, per patient per day

  3. Frequency of alerts which are responded to by healthcare personnel

    Time frame: 72 hours

    Number of alerts triggered by deviating vital signs, per patient per day

  4. Fraction of time within the study period with at least one type of data transmitted in real time from patients' homes.

    Time frame: 72 hours

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Collaborators

  • Emergency Medical Services, Capital Region, Denmark
  • Rigshospitalet, Denmark
  • Technical University of Denmark

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 11, 2023
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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