WARD-Home - Continuous Monitoring of Vital Parameters After Discharge

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Completed

CT.gov ID

NCT05223504

Collaborator

Technical University of Denmark (Other), University Hospital Bispebjerg and Frederiksberg (Other)

Enrollment

Location

10.4

Actual Duration (Months)

7.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vital Sign Clinical Deterioration	Device: Continuously monitoring

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 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 i in the patients' own homes during the first days after discharge.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

80 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

WARD-Home - Continuous Monitoring of Vital Parameters for Early Detection of Complications in Patients Discharged After Acute Medical Hospitalization

Actual Study Start Date :

Aug 1, 2021

Actual Primary Completion Date :

Jun 15, 2022

Actual Study Completion Date :

Jun 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
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 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.

Arm

Intervention/Treatment

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

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.

Outcome Measures

Primary Outcome Measures

Duration of data collection from the Lifetouch patch [Up to 8 days of monitoring]

Secondary Outcome Measures

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]
Peripheral saturation below 88% and 85%
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]
Number of deviating vital parameters in accordance to defined microevents [Up to 8 days of monitoring]

Other Outcome Measures

Re-admission and cause of re-admission within 30-days [30-days follow up]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bispebjerg and Frederiksberg hospital	København NV	Region H	Denmark	2400

Sponsors and Collaborators

Rigshospitalet, Denmark
Technical University of Denmark
University Hospital Bispebjerg and Frederiksberg

Investigators

Principal Investigator: Vibeke R Eriksen, MD, PhD, Rigshospitalet, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vibeke Eriksen, Principal Investigator, Rigshospitalet, Denmark

ClinicalTrials.gov Identifier:

NCT05223504

Other Study ID Numbers:

WARD-Home feasibility

First Posted:

Feb 4, 2022

Last Update Posted:

Jun 28, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Clinical Deterioration

Study Results

No Results Posted as of Jun 28, 2022