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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05536206
Other study ID # H-20009132
Secondary ID WARD-HOME feasib
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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