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

NCT ID: NCT06077851

Last Updated: 2025-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-03

Study Completion Date

2025-11-01

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.

Conditions

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Vital Sign Monitoring Clinical Deterioration Hospital At Home

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Continuously monitoring

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

Intervention Type DEVICE

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

Technical University of Denmark

OTHER

Sponsor Role collaborator

Emergency Medical Services, Capital Region, Denmark

OTHER_GOV

Sponsor Role collaborator

Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Emilie Sigvardt

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emilie Sigvardt, MD

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital

Locations

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Bispebjerg Hospital

Copenhagen, NV, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Emilie Sigvardt, MD

Role: CONTACT

Christian Sylvest Meyhoff, MD, PhD

Role: CONTACT

+4524910542

Facility Contacts

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Emilie Sigvardt, MD

Role: primary

+4528254123

Other Identifiers

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2308603

Identifier Type: -

Identifier Source: org_study_id

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