NCT07096648

Alert Burden When Monitoring Patients at Home

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 110 (actual)
• Sponsor: Bispebjerg Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Continuous Monitoring
• Vital Signs Monitoring
• Hospital at Home
• Remote Monitoring

Interventions

Type	Name	Description
DEVICE	Continuous vital sign monitoring	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.

Timeline

• Start date: 2025-06-16
• Primary completion: 2025-09-01
• Completion: 2025-12-01
• First posted: 2025-07-31
• Last updated: 2025-07-31

Locations

1 site across 1 country: Denmark