Clinical trial NCT05536206: Continuous and Wireless Vital Sign Monitoring in Patients at Home After Acute Medical Admission
Official title: Continuous and Wireless Vital Sign Monitoring in Patients at Home After Acute Medical Admission
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vital Sign Monitoring
Clinical Deterioration
Disease Progression
Disease Attributes
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
name: Technical University of Denmark
First posted: 2022-09-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Duration of data collection from the Lifetouch patch
timeFrame: Up to 72 hours of monitoring
Secondary outcomes:
measure: Duration of complete peripheral saturation data
timeFrame: Up to 72 hours of monitoring
measure: Duration of complete blood pressure data
timeFrame: Up to 72 hours of monitoring
measure: Cummulated duration of desaturation
timeFrame: Up to 72 hours of monitoring
measure: Number of events with SpO2 < 88% in at least 10 consecutive minutes
timeFrame: Up to 72 hours of monitoring
measure: Number of events with SpO2 < 85% in at least 5 consecutive minutes
timeFrame: Up to 72 hours of monitoring
measure: Number of deviating vital parameters in accordance to defined microevents
timeFrame: Up to 72 hours of monitoring
Other outcomes:
measure: Re-admission and cause of re-admission within 30-days
timeFrame: 30-days follow up
measure: User experiences (patient and personnel)
timeFrame: Within 72 hours of monitoring
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
state: NV
Study officials:
affiliation: Bispebjerg Hospital
name: Emilie Sigvardt, MD
role: PRINCIPAL_INVESTIGATOR
References: