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

Disease Progression Clinical Trial

— WARD-HOME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05536206
• Other study ID #: H-20009132
• Secondary ID: WARD-HOME feasib
• Status: Completed
• Start date: December 1, 2022
• Est. completion date: July 30, 2023

Study information

• Verified date: September 2023
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 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. Data will be transmitted continuously in real time from patient's homes to mobile applications for portable handheld devices such as healthcare personnel's smartphones.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 30, 2023
• Est. primary completion date: July 30, 2023
• 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
• Disease Attributes
• Disease Progression
• Vital Sign Monitoring

Intervention

Device:
• Wireless and continuously monitoring
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.

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen	NV

Sponsors (3)

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

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
Other	User experiences (patient and personnel)		Within 72 hours of monitoring
Primary	Duration of data collection from the Lifetouch patch		Up to 72 hours of monitoring
Secondary	Duration of complete peripheral saturation data		Up to 72 hours of monitoring
Secondary	Duration of complete blood pressure data		Up to 72 hours of monitoring
Secondary	Cummulated duration of desaturation	Peripheral saturation below 88% and 85%	Up to 72 hours of monitoring
Secondary	Number of events with SpO2 < 88% in at least 10 consecutive minutes		Up to 72 hours of monitoring
Secondary	Number of events with SpO2 < 85% in at least 5 consecutive minutes		Up to 72 hours of monitoring
Secondary	Number of deviating vital parameters in accordance to defined microevents		Up to 72 hours of monitoring