WARD-Home - Continuous Monitoring of Vital Parameters After Discharge

Completed

• Conditions: Vital Sign; Clinical Deterioration
• Interventions: Device: Continuously monitoring

• Registration Number: NCT05223504
• Lead Sponsor: Rigshospitalet, Denmark

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.

Study Timeline

• Study Start: 2021-08-01
• Study First Submitted: 2022-01-20
• Study First Submitted QC: 2022-01-20
• Study First Posted: 2022-02-04
• Status Verified: 2022-06
• Primary Completion: 2022-06-15
• Study Completion: 2022-06-15
• Last Update Submitted: 2022-06-27
• Last Update Posted: 2022-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observed patients	Continuously monitoring	Adult patients (≥18 years) admitted with an acute medical disease and who are scheduled for discharge to their own homes within five days from inclusion.

Primary Outcome Measures

Name	Time	Method
Duration of data collection from the Lifetouch patch	Up to 8 days of monitoring

Secondary Outcome Measures

Name	Time	Method
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	Peripheral saturation below 88% and 85%
Number of events with SpO2 < 85% in at least 5 consecutive minutes	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

Trial Locations

Locations (1)

Bispebjerg and Frederiksberg hospital; 🇩🇰 København NV, Region H, Denmark