Alert Burden When Monitoring Patients at Home

NCT07096648 — Active not recruiting, 110 participants, Bispebjerg Hospital

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Registry	NCT07096648, acronym WARD-HOME I
Status	Active not recruiting
Study type	Observational
Enrollment	110 (Actual)
Sponsor	Bispebjerg Hospital (Other)
Conditions	Continuous Monitoring, Vital Signs Monitoring, Hospital at Home, Remote Monitoring
Interventions	Continuous vital sign monitoring (Device)
Dates	start 2025-06-16, primary completion 2025-09-01 (estimated), completion 2025-12-01 (estimated), first posted 2025-07-31, last updated 2025-07-31
Locations	1 site in Denmark

-Summary

The aim of this observational study is to evaluate the burden and clinical relevance of vital sign alerts during home monitoring in recently discharged medical patients.

The primary outcome is the total number of vital sign alerts per patient per day. Secondary outcomes include the number of alerts per specific vital sign parameter, the frequency of alerts during daytime versus evening and nighttime, and the peak alert time during the day.

We will compare alert data without filtering to data processed with AI-driven filtering methods to assess if these filters reduce the number of non-actionable alerts while maintaining clinical relevance.

Participants will be equipped with wearable devices to continuously monitor heart rate, respiratory rate, blood pressure, and oxygen saturation during the first days after hospital discharge. Vital signs will be transmitted remotely, and alerts will be generated based on predefined thresholds.

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+Arms and interventions

Arm	Type	Interventions	Description
Patients		Device: Continuous vital sign monitoring	Patients discharged from hospital after admission due to an acute medical condition

Continuous vital sign monitoring (Device): Continuous monitoring of vital signs performed using up to three CE- and FDA approved devices measuring heart rate, respiratory rate, systolic- and diastolic blood pressure, and SpO2. Data is transmitted to a CE-approved smartphone application that generates alerts in response to deviations based on predefined thresholds for duration and severity.

+Outcome measures

Primary outcomes

Number of vital sign alerts per patient per day [Up to 8 days]

Secondary outcomes

Number of alerts per specific vital sign parameter per patient per 24-hour period [Up to 8 days]
Frequency of any vital sign alert per hour analyzed as daytime (08.00-15.59) vs. evening and nighttime (16.00-07.59) [Up to 8 days]
The hour of day with highest frequency of alerts [up to 8 days]

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Adult patients (≥18 years) admitted with an acute medical disease and scheduled for discharge within five days from inclusion.

Exclusion Criteria:

* Allergy to plaster/silicone, pacemaker or ICD, inability to give informed consent or deemed not able to open the front door when visited by the investigator.

+Locations (1)

Facility	City	Country	Status
Bispebjerg Hospital	Copenhagen	Denmark

+Investigators

Eske K Aasvang, Professor, Study chair, Copenhagen University Hospital, Rigshospitalet

My Notes

Public

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