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NCT Number: NCT05223504

WARD-Home - Continuous Monitoring of Vital Parameters After Discharge

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.

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Key information

Conditions

Vital Sign Clinical Deterioration Disease Attributes Disease Progression Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bispebjerg and Frederiksberg hospital

København NV, Region H, 2400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Continuously monitoring

Device

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.

Primary outcomes

  1. Duration of data collection from the Lifetouch patch

    Time frame: Up to 8 days of monitoring

Secondary outcomes

  1. Duration of complete peripheral saturation data

    Time frame: Up to 8 days of monitoring

  2. Duration of complete blood pressure data

    Time frame: Up to 8 days of monitoring

  3. Cummulated duration of desaturation

    Time frame: Up to 8 days of monitoring

    Peripheral saturation below 88% and 85%

  4. Number of events with SpO2 < 88% in at least 10 consecutive minutes

    Time frame: Up to 8 days of monitoring

  5. Number of events with SpO2 < 85% in at least 5 consecutive minutes

    Time frame: Up to 8 days of monitoring

  6. Number of deviating vital parameters in accordance to defined microevents

    Time frame: Up to 8 days of monitoring

Other outcomes

  1. Re-admission and cause of re-admission within 30-days

    Time frame: 30-days follow up

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Technical University of Denmark
  • University Hospital Bispebjerg and Frederiksberg

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 4, 2022
Registry last updated
Jun 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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