Continuous and Wireless Vital Sign Monitoring in Patients at Home After Acute Medical Admission (WARD-HOME)

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

Study Overview

• Status: Completed
• Conditions: Disease Progression; Disease Attributes; Vital Sign Monitoring; Clinical Deterioration
• Intervention / Treatment: Device: Wireless and 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 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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

• Study Contact: Name: Emilie Sigvardt, MD; Phone Number: +4528254123; Email: emilie.sigvardt@regionh.dk
• Study Contact Backup: Name: Christian S Meyhoff, MD, PhD; Phone Number: +4524910542; Email: christian.sylvest.meyhoff@regionh.dk

Study Locations

• Denmark
  • NV
    • Copenhagen, NV, Denmark, 2400
      • Bispebjerg Hospital
      • Contact: Emilie Sigvardt, MD; Phone Number: +4528254123; Email: emilie.sigvardt@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Duration of data collection from the Lifetouch patch	Up to 72 hours of monitoring

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Peripheral saturation below 88% and 85%	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
Number of deviating vital parameters in accordance to defined microevents		Up to 72 hours of monitoring

Other Outcome Measures

Outcome Measure	Time Frame
Re-admission and cause of re-admission within 30-days	30-days follow up
User experiences (patient and personnel)	Within 72 hours of monitoring

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital
• Collaborators: Rigshospitalet, Denmark; Technical University of Denmark
• Investigators: Principal Investigator: Emilie Sigvardt, MD, Bispebjerg Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): July 30, 2023
• Study Completion (Actual): July 30, 2023

Study Registration Dates

• First Submitted: September 7, 2022
• First Submitted That Met QC Criteria: September 7, 2022
• First Posted (Actual): September 10, 2022

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Progression; Clinical Deterioration; Disease Attributes
• Other Study ID Numbers: H-20009132; WARD-HOME feasibility (Other Identifier: Bispebjerg Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No