WARD-Home - Continuous Monitoring of Vital Parameters After Discharge

Clinical Deterioration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05223504
• Other study ID #: WARD-Home feasibility
• Status: Completed
• Start date: August 1, 2021
• Est. completion date: June 15, 2022

Study information

• Verified date: June 2022
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 15, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Clinical Deterioration
• Vital Sign

Intervention

Device:
• Continuously monitoring
Included patients are monitored with WARD equipment during the last part of hospitalization and the first days after discharge. Monitoring will last for a maximum of eight days.

Locations

Country	Name	City	State
Denmark	Bispebjerg and Frederiksberg hospital	København NV	Region H

Sponsors (3)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Technical University of Denmark, University Hospital Bispebjerg and Frederiksberg

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Re-admission and cause of re-admission within 30-days		30-days follow up
Primary	Duration of data collection from the Lifetouch patch		Up to 8 days of monitoring
Secondary	Duration of complete peripheral saturation data		Up to 8 days of monitoring
Secondary	Duration of complete blood pressure data		Up to 8 days of monitoring
Secondary	Cummulated duration of desaturation	Peripheral saturation below 88% and 85%	Up to 8 days of monitoring
Secondary	Number of events with SpO2 < 88% in at least 10 consecutive minutes		Up to 8 days of monitoring
Secondary	Number of events with SpO2 < 85% in at least 5 consecutive minutes		Up to 8 days of monitoring
Secondary	Number of deviating vital parameters in accordance to defined microevents		Up to 8 days of monitoring