Vital Sign MonitoringWARD-HOMENCT05536206
Continuous and Wireless Vital Sign Monitoring in Patients at Home After Acute Medical Admission
An observational study of Vital Sign Monitoring and Clinical Deterioration, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
The current study aims to investigate the feasibility of transmitting continuous and wireless vital sign data in real time from patients home to the hospital in patients discharged after an acute medical hospitalization Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vital Sign Monitoring, Clinical Deterioration, Disease Progression
- What is being tested?
- Wireless and continuously monitoring
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2022to 30 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 admitted with an acute medical disease at Bispebjerg Hospital and scheduled for discharge to their own homes within five days from inclusion.
Who may be able to join
- Adult patients (≥18 years) Admitted with an acute medical disease and scheduled for discharge to their own homes within five days from inclusion.
Who cannot join
- Allergy to plaster, plastic, or silicone.
- A pacemaker or Implantable Cardioverter Defibrillator (ICD) device.
- If the patient was deemed not able to open the front door when visited by the investigator.
- Inability to give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
The current study aims to investigate the feasibility of transmitting continuous and wireless vital sign data in real time from patients home to the hospital in patients discharged after an acute medical hospitalization
Read the detailed description
The healthcare system is challenged by an aging patient population with chronic diseases, and acute admissions must be housed in hospitals with fewer beds and less staff resources. This increases the need for earlier discharge and for treatment shifted to the patients' own home. Furthermore, the transition from the hospital to the home setting is one of potential hazard, due to the lack of observation and intervention possibilities.
This study aims to investigate the feasibility of wireless, continuous monitoring of patients in the days around discharge after an acute medical hospitalization, as well as occurrence of deviating vital signs i in the patients' own homes during the first days after discharge. Data will be transmitted continuously in real time from patient's homes to mobile applications for portable handheld devices such as healthcare personnel's smartphones.
- Being tested
- Wireless and continuously monitoring
- Medical subject headings
- Clinical Deterioration, Disease Progression, Disease Attributes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wireless and continuously monitoringDevice
Included patients are monitored with WARD equipment during the last part of hospitalization and the first days after discharge with data transmitted in real time to personnel at the hospital. Monitoring will last for a maximum of 72 hours.
| Study group | Role | What they receive |
|---|---|---|
| Observed patients | Adult patients (≥18 years) admitted with an acute medical disease and who are scheduled for discharge to their own homes within five days from inclusion. Receives: Device: Wireless and continuously monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of data collection from the Lifetouch patch
Measured: Up to 72 hours of monitoring
Secondary outcomes (6)
Duration of complete peripheral saturation data
Measured: Up to 72 hours of monitoring
Duration of complete blood pressure data
Measured: Up to 72 hours of monitoring
Cummulated duration of desaturation
Peripheral saturation below 88% and 85%
Measured: Up to 72 hours of monitoring
Number of events with SpO2 < 88% in at least 10 consecutive minutes
Measured: Up to 72 hours of monitoring
Number of events with SpO2 < 85% in at least 5 consecutive minutes
Measured: Up to 72 hours of monitoring
Number of deviating vital parameters in accordance to defined microevents
Measured: Up to 72 hours of monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start1 Dec 2022
- Primary completion30 Jul 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vital Sign 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Technical University of Denmark
- Responsible party
- Principal investigator, Emilie Sigvardt, Bispebjerg Hospital
- Investigators
- Emilie Sigvardt, MD, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05536206
- Sponsor's protocol ID
- H-20009132
- Other IDs
- WARD-HOME feasibility
- Acronym
- WARD-HOME
- Status last verified
- Sep 2023
- First submitted
- 7 Sep 2022
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous and Wireless Vital Sign Monitoring in Patients at Home After Acute Medical Admission
- ClinicalTrials.gov ID
- NCT05536206
- Acronym / sponsor ID
- WARD-HOME / H-20009132
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Technical University of Denmark
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 10 Sep 2022 (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 current study aims to investigate the feasibility of transmitting continuous and wireless vital sign data in real time from patients home to the hospital in patients discharged after an acute medical hospitalization
Detailed description
The healthcare system is challenged by an aging patient population with chronic diseases, and acute admissions must be housed in hospitals with fewer beds and less staff resources. This increases the need for earlier discharge and for treatment shifted to the patients' own home. Furthermore, the transition from the hospital to the home setting is one of potential hazard, due to the lack of observation and intervention possibilities.
This study aims to investigate the feasibility of wireless, continuous monitoring of patients in the days around discharge after an acute medical hospitalization, as well as occurrence of deviating vital signs i in the patients' own homes during the first days after discharge. Data will be transmitted continuously in real time from patient's homes to mobile applications for portable handheld devices such as healthcare personnel's smartphones.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observed patients | – | Device: Wireless and continuously monitoringAdult patients (≥18 years) admitted with an acute medical disease and who are scheduled for discharge to their own homes within five days from inclusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted with an acute medical disease at Bispebjerg Hospital and scheduled for discharge to their own homes within five days from inclusion.
Key inclusion criteria (1 listed)
- Adult patients (≥18 years) Admitted with an acute medical disease and scheduled for discharge to their own homes within five days from inclusion.
Key exclusion criteria (4 listed)
- Allergy to plaster, plastic, or silicone.
- A pacemaker or Implantable Cardioverter Defibrillator (ICD) device.
- If the patient was deemed not able to open the front door when visited by the investigator.
- Inability to give informed consent.
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 |
|---|---|---|
| Wireless and continuously monitoringIncluded patients are monitored with WARD equipment during the last part of hospitalization and the first days after discharge with data transmitted in real time to personnel at the hospital. Monitoring will last for a maximum of 72 hours. | Device | Observed patients |
Primary outcome
Duration of data collection from the Lifetouch patch
Time frame: Up to 72 hours of monitoring
6 secondary outcomes
Duration of complete peripheral saturation data
Time frame: Up to 72 hours of monitoring
Duration of complete blood pressure data
Time frame: Up to 72 hours of monitoring
Cummulated duration of desaturation
Time frame: Up to 72 hours of monitoring
Number of events with SpO2 < 88% in at least 10 consecutive minutes
Time frame: Up to 72 hours of monitoring
Number of events with SpO2 < 85% in at least 5 consecutive minutes
Time frame: Up to 72 hours of monitoring
Number of deviating vital parameters in accordance to defined microevents
Time frame: Up to 72 hours of monitoring
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Emilie Sigvardt, MD principal investigator
Bispebjerg Hospital
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 Vital Sign Monitoring and Clinical Deterioration, 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 4 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: finished, as of the sponsor's last update on 28 Sep 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Duration of data collection from the Lifetouch patch (time frame: Up to 72 hours of monitoring). 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 28 Sep 2023.