Vital Sign MonitoringNCT06077851
Continuous Monitoring of Vital Signs at Home (WARD HOME II)
An observational study of Vital Sign Monitoring and Clinical Deterioration, run by Bispebjerg Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vital Sign Monitoring, Clinical Deterioration, Hospital At Home
- What is being tested?
- Continuously monitoring
- Type of treatment
- Medical device
- How many people
- 83 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Oct 2023to 30 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted with an acute medical disease at Bispebjerg Hospital or Rigshospitalet, or assessed by paramedic personnel at home after contact to the EMS.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Monitoring With Real-time Transmission of Vital Signs to Healthcare Professionals From Patients at Home
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.
Read the 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.
- Being tested
- Continuously monitoring
- Medical subject headings
- Clinical Deterioration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuously monitoringDevice
Included patients are monitored with WARD equipment the first days after discharge. Monitoring will last for a maximum of three days.
What is being measured
The primary outcome is the main question the study is designed to answer.
(Re)admission
Defined as acute admission to hospital for at least 12 hours with relation to prior discharge or EMS contact
Measured: 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).
Measured: within 30 days
Mortality
Measured: within 30 days
Secondary outcomes (3)
(Re)admission
Defined as acute admission to hospital for at least 12 hours with relation to prior discharge or EMS contact
Measured: within 7 days after discharge/assessment by paramedic personnel
Inquiries to the Emergency Medical Service
Defined as patients calls to 1813/112
Measured: 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).
Measured: within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start3 Oct 2023
- Primary completion30 Oct 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vital Sign MonitoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Technical University of Denmark, Emergency Medical Services, Capital Region, Denmark
- Responsible party
- Principal investigator, Emilie Sigvardt, Bispebjerg Hospital
- Investigators
- Emilie Sigvardt, MD, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077851
- Sponsor's protocol ID
- 2308603
- Status last verified
- Jun 2025
- First submitted
- 27 Sep 2023
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Monitoring With Real-time Transmission of Vital Signs to Healthcare Professionals From Patients at Home
- ClinicalTrials.gov ID
- NCT06077851
- Acronym / sponsor ID
- 2308603
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Technical University of Denmark, Emergency Medical Services, Capital Region, Denmark
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted with an acute medical disease at Bispebjerg Hospital or Rigshospitalet, or assessed by paramedic personnel at home after contact to the EMS.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuously monitoringIncluded patients are monitored with WARD equipment the first days after discharge. Monitoring will last for a maximum of three days. | Device | – |
Primary outcome
(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
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).
Mortality
Time frame: within 30 days
3 secondary outcomes
(Re)admission
Time frame: within 7 days after discharge/assessment by paramedic personnel
Inquiries to the Emergency Medical Service
Time frame: within 30 days
Mortality and types of SAEs
Time frame: within 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilie Sigvardt, MD principal investigator
Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vital Sign Monitoring and Clinical Deterioration, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(Re)admission (time frame: within 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.