Continuous and Wireless Vital Sign Monitoring in Patients at Home After Acute Medical Admission

NCT05536206 | Completed

• 2 other identifiers: H-20009132WARD-HOME feasibility
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The current study aims to investigate the feasibility of transmitting continuous and wireless vital sign data in real time from patients home to the hospital in patients discharged after an acute medical hospitalization

Conditions

Vital Sign Monitoring; Clinical Deterioration; Disease Progression; Disease Attributes

Outcome Measures

Primary Outcomes (1)

• Duration of data collection from the Lifetouch patch

  Up to 72 hours of monitoring

Secondary Outcomes (6)

• Duration of complete peripheral saturation data

  Up to 72 hours of monitoring

• Duration of complete blood pressure data

  Up to 72 hours of monitoring

• Cummulated duration of desaturation

  Up to 72 hours of monitoring

• Number of events with SpO2 < 88% in at least 10 consecutive minutes

  Up to 72 hours of monitoring

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

  Up to 72 hours of monitoring

Other Outcomes (2)

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

  30-days follow up

• User experiences (patient and personnel)

  Within 72 hours of monitoring

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: Wireless and continuously monitoring

Interventions

Wireless and continuously monitoring DEVICE

Included patients are monitored with WARD equipment during the last part of hospitalization and the first days after discharge with data transmitted in real time to personnel at the hospital. Monitoring will last for a maximum of 72 hours.

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

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

Study Sites (1)

Bispebjerg Hospital

Copenhagen, NV, 2400, Denmark

Location

MeSH Terms

Conditions

Clinical Deterioration; Disease Progression; Disease Attributes

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Emilie Sigvardt, MD

  Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 10, 2022
• Study Start: December 1, 2022
• Primary Completion: July 30, 2023
• Study Completion: July 30, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)