WARD-Home - Continuous Monitoring of Vital Parameters After Discharge

NCT05223504 | Completed

• 1 other identifier: WARD-Home feasibility
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Vital Sign; Clinical Deterioration

Outcome Measures

Primary Outcomes (1)

• Duration of data collection from the Lifetouch patch

  Up to 8 days of monitoring

Secondary Outcomes (6)

• 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 events with SpO2 < 85% in at least 5 consecutive minutes

  Up to 8 days of monitoring

Other Outcomes (1)

• Re-admission and cause of re-admission within 30-days

  30-days follow up

Study Arms (1)

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

Interventions

Continuously monitoring DEVICE

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.

Observed patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Technical University of Denmark: collaborator
• University Hospital Bispebjerg and Frederiksberg: collaborator

Study Sites (1)

Bispebjerg and Frederiksberg hospital

København NV, Region H, 2400, Denmark

Location

MeSH Terms

Conditions

Clinical Deterioration

Condition Hierarchy (Ancestors)

Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vibeke R Eriksen, MD, PhD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 4, 2022
• Study Start: August 1, 2021
• Primary Completion: June 15, 2022
• Study Completion: June 15, 2022
• Last Updated: June 28, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)