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Alert Burden When Monitoring Patients at Home

Alert Burden When Monitoring Patients at Home

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07096648
Acronym
WARD-HOME I
Enrollment
110
Registered
2025-07-31
Start date
2025-06-16
Completion date
2025-12-01
Last updated
2025-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

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

Bispebjerg Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Number of vital sign alerts per patient per dayUp to 8 days

Secondary

MeasureTime frame
Number of alerts per specific vital sign parameter per patient per 24-hour periodUp 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 alertsup to 8 days

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026