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

Sponsor
Bispebjerg Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05536206
Collaborator
Rigshospitalet, Denmark (Other), Technical University of Denmark (Other)
30
1
5.9
5

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Continuous and Wireless Vital Sign Monitoring in Patients at Home After Acute Medical Admission
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

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: 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.

Outcome Measures

Primary Outcome Measures

  1. Duration of data collection from the Lifetouch patch [Up to 72 hours of monitoring]

Secondary Outcome Measures

  1. Duration of complete peripheral saturation data [Up to 72 hours of monitoring]

  2. Duration of complete blood pressure data [Up to 72 hours of monitoring]

  3. Cummulated duration of desaturation [Up to 72 hours of monitoring]

    Peripheral saturation below 88% and 85%

  4. Number of events with SpO2 < 88% in at least 10 consecutive minutes [Up to 72 hours of monitoring]

  5. Number of events with SpO2 < 85% in at least 5 consecutive minutes [Up to 72 hours of monitoring]

  6. Number of deviating vital parameters in accordance to defined microevents [Up to 72 hours of monitoring]

Other Outcome Measures

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

  2. User experiences (patient and personnel) [Within 72 hours of monitoring]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 Hospital Copenhagen NV Denmark 2400

Sponsors and Collaborators

  • Bispebjerg Hospital
  • Rigshospitalet, Denmark
  • Technical University of Denmark

Investigators

  • Principal Investigator: Emilie Sigvardt, MD, Bispebjerg Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Emilie Sigvardt, MD, Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT05536206
Other Study ID Numbers:
  • H-20009132
  • WARD-HOME feasibility
First Posted:
Sep 10, 2022
Last Update Posted:
Sep 10, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 10, 2022