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OpenTrials
Completed

NCT Number: NCT05536206

Continuous and Wireless Vital Sign Monitoring in Patients at Home After Acute Medical Admission

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bispebjerg Hospital

Copenhagen, NV, 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 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.

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

Wireless and continuously monitoring

Device

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.

Primary outcomes

  1. Duration of data collection from the Lifetouch patch

    Time frame: Up to 72 hours of monitoring

Secondary outcomes

  1. Duration of complete peripheral saturation data

    Time frame: Up to 72 hours of monitoring

  2. Duration of complete blood pressure data

    Time frame: Up to 72 hours of monitoring

  3. Cummulated duration of desaturation

    Time frame: 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

    Time frame: Up to 72 hours of monitoring

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

    Time frame: Up to 72 hours of monitoring

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

    Time frame: Up to 72 hours of monitoring

Other outcomes

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

    Time frame: 30-days follow up

  2. User experiences (patient and personnel)

    Time frame: Within 72 hours of monitoring

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Collaborators

  • Rigshospitalet, Denmark
  • Technical University of Denmark

Registry information

Acronym: WARD-HOME

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 10, 2022
Registry last updated
Sep 28, 2023

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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