Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07096648

Alert Burden When Monitoring Patients at Home

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Continuous Monitoring Hospital at Home Remote Monitoring Vital Signs Monitoring

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Number of vital sign alerts per patient per day

    Time frame: Up to 8 days

Secondary outcomes

  1. Number of alerts per specific vital sign parameter per patient per 24-hour period

    Time frame: Up to 8 days

  2. Frequency of any vital sign alert per hour analyzed as daytime (08.00-15.59) vs. evening and nighttime (16.00-07.59)

    Time frame: Up to 8 days

  3. The hour of day with highest frequency of alerts

    Time frame: up to 8 days

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Acronym: WARD-HOME I

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 31, 2025
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.