Continuous MonitoringWARD-HOME INCT07096648
Alert Burden When Monitoring Patients at Home
An observational study of Continuous Monitoring and Vital Signs Monitoring, run by Bispebjerg Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Continuous Monitoring, Vital Signs Monitoring, Hospital at Home
- What is being tested?
- Continuous vital sign monitoring
- Type of treatment
- Medical device
- How many people
- 110 participants
- Where
- 1 siteDenmark
- Study dates
- 16 Jun 2025to 1 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adult patients (≥18 years) admitted with an acute medical disease and scheduled for discharge within five days from inclusion.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Being tested
- Continuous vital sign monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous vital sign monitoringDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients discharged from hospital after admission due to an acute medical condition Receives: Device: Continuous vital sign monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of vital sign alerts per patient per day
Measured: Up to 8 days
Secondary outcomes (3)
Number of alerts per specific vital sign parameter per patient per 24-hour period
Measured: 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)
Measured: Up to 8 days
The hour of day with highest frequency of alerts
Measured: up to 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start16 Jun 2025
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Continuous MonitoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emilie Sigvardt, Bispebjerg Hospital
- Investigators
- Eske K Aasvang, Professor, Study chair, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096648
- Sponsor's protocol ID
- H-20009132/91724
- Acronym
- WARD-HOME I
- Status last verified
- Jul 2025
- First submitted
- 17 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alert Burden When Monitoring Patients at Home
- ClinicalTrials.gov ID
- NCT07096648
- Acronym / sponsor ID
- WARD-HOME I / H-20009132/91724
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Device: Continuous vital sign monitoringPatients discharged from hospital after admission due to an acute medical condition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Adult patients (≥18 years) admitted with an acute medical disease and scheduled for discharge within five days from inclusion.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous vital sign monitoringContinuous 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. | Device | Patients |
Primary outcome
Number of vital sign alerts per patient per day
Time frame: Up to 8 days
3 secondary outcomes
Number of alerts per specific vital sign parameter per patient per 24-hour period
Time frame: 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)
Time frame: Up to 8 days
The hour of day with highest frequency of alerts
Time frame: up to 8 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eske K Aasvang, Professor study chair
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Continuous Monitoring and Vital Signs Monitoring, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of vital sign alerts per patient per day (time frame: Up to 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.