WARD-Home - Continuous Monitoring of Vital Parameters After Discharge

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

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.

Study Overview

• Status: Completed
• Conditions: Clinical Deterioration; Vital Sign
• Intervention / Treatment: Device: Continuously monitoring

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 Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Denmark
  • Region H
    • København NV, Region H, Denmark, 2400
      • Bispebjerg and Frederiksberg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted with an acute medical disease at Bispebjerg Hospital and scheduled for discharge to their own homes within five days from inclusion.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observed patients; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Duration of data collection from the Lifetouch patch	Up to 8 days of monitoring

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Peripheral saturation below 88% and 85%	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 events with SpO2 < 85% in at least 5 consecutive minutes		Up to 8 days of monitoring
Number of deviating vital parameters in accordance to defined microevents		Up to 8 days of monitoring

Other Outcome Measures

Outcome Measure	Time Frame
Re-admission and cause of re-admission within 30-days	30-days follow up

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: University Hospital Bispebjerg and Frederiksberg; Technical University of Denmark
• Investigators: Principal Investigator: Vibeke R Eriksen, MD, PhD, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): June 15, 2022
• Study Completion (Actual): June 15, 2022

Study Registration Dates

• First Submitted: January 20, 2022
• First Submitted That Met QC Criteria: January 20, 2022
• First Posted (Actual): February 4, 2022

Study Record Updates

• Last Update Posted (Actual): June 28, 2022
• Last Update Submitted That Met QC Criteria: June 27, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Progression; Clinical Deterioration
• Other Study ID Numbers: WARD-HOME feasibility (Other Identifier: Bispebjerg Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No