Alert Burden When Monitoring Patients at Home

NCT07096648 | Active Not Recruiting

• 1 other identifier: H-20009132/91724
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of vital sign alerts per patient per day

  Up to 8 days

Secondary Outcomes (3)

• 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

Study Arms (1)

Patients

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

Device: Continuous vital sign monitoring

Interventions

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.

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients are recruited from Copenhagen University Hospital - Bispebjerg and Frederikberg. Eligible patients are enrolled in the study at the time of hospital discharge following admission for an acute medical condition.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bispebjerg Hospital: lead

Study Sites (1)

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Study Officials

• Eske K Aasvang, Professor

  Rigshospitalet, Denmark

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: July 31, 2025
• Study Start: June 16, 2025
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

DK (1)