Alert Burden When Monitoring Patients at Home

NCT ID: NCT07096648

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 110 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-16
• Study Completion Date: 2025-12-01

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients

Patients discharged from hospital after admission due to an acute medical condition

Continuous vital sign monitoring

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bispebjerg Hospital

OTHER

Sponsor Role: lead

Responsible Party

Emilie Sigvardt

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eske K Aasvang, Professor

Role: STUDY_CHAIR

Rigshospitalet, Denmark

Locations

Bispebjerg Hospital

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

H-20009132/91724

Identifier Type: -

Identifier Source: org_study_id