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Clinical Trials/NCT05223504
NCT05223504
Completed
N/A

WARD-Home - Continuous Monitoring of Vital Parameters for Early Detection of Complications in Patients Discharged After Acute Medical Hospitalization

Rigshospitalet, Denmark1 site in 1 country80 target enrollmentAugust 1, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Vital Sign
Sponsor
Rigshospitalet, Denmark
Enrollment
80
Locations
1
Primary Endpoint
Duration of data collection from the Lifetouch patch
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The current pilot study aims to investigate the feasibility of wireless, continuous monitoring of patients in the days around discharge after an acute medical hospitalization, as well as occurrence of deviating vital signs in this patient group.

Detailed Description

The healthcare system is challenged by an aging patient population with chronic diseases, and acute admissions must be housed in hospitals with fewer beds and less staff resources. This increases the need for earlier discharge and for treatment shifted to the patients' own home. Furthermore, the transition from the hospital to the home setting is one of potential hazard, due to the lack of observation and intervention possibilities. This pilot study aims to investigate the feasibility of wireless, continuous monitoring of patients in the days around discharge after an acute medical hospitalization, as well as occurrence of deviating vital signs i in the patients' own homes during the first days after discharge.

Registry
clinicaltrials.gov
Start Date
August 1, 2021
End Date
June 15, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Vibeke Eriksen

Principal Investigator

Rigshospitalet, Denmark

Eligibility Criteria

Inclusion Criteria

  • Adult patients (≥18 years) Admitted with an acute medical disease and scheduled for discharge to their own homes within five days from inclusion.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Duration of data collection from the Lifetouch patch

Time Frame: Up to 8 days of monitoring

Secondary Outcomes

  • Number of events with SpO2 < 85% in at least 5 consecutive minutes(Up to 8 days of monitoring)
  • Duration of complete peripheral saturation data(Up to 8 days of monitoring)
  • Duration of complete blood pressure data(Up to 8 days of monitoring)
  • Cummulated duration of desaturation(Up to 8 days of monitoring)
  • Number of events with SpO2 < 88% in at least 10 consecutive minutes(Up to 8 days of monitoring)
  • Number of deviating vital parameters in accordance to defined microevents(Up to 8 days of monitoring)

Study Sites (1)

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