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Alert Burden When Monitoring Patients at Home

NCT07096648 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 110

Last updated 2025-07-31

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Bispebjerg Hospital

    lead OTHER

Principal Investigators

  • Eske K Aasvang, Professor · Rigshospitalet, Denmark

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-16
Primary Completion
2025-09-01
Completion
2025-12-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07096648 on ClinicalTrials.gov