Vital SignNCT05223504
WARD-Home - Continuous Monitoring of Vital Parameters After Discharge
An observational study of Vital Sign and Clinical Deterioration, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The current pilot 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 in this patient group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vital Sign, Clinical Deterioration
- What is being tested?
- Continuously monitoring
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2021to 15 Jun 2022
- How long will I take part?
- 6 Months
- 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.
Denmark1 site
Bispebjerg and Frederiksberg hospital
København NV, Region H, 2400
About this study
Official title: WARD-Home - Continuous Monitoring of Vital Parameters for Early Detection of Complications in Patients Discharged After Acute Medical Hospitalization
The current pilot 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 in this patient group.
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 pilot 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.
- Conditions
- Vital Sign, Clinical Deterioration
- Being tested
- Continuously monitoring
- Medical subject headings
- Clinical Deterioration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuously monitoringDevice
Included patients are monitored with WARD equipment during the last part of hospitalization and the first days after discharge. Monitoring will last for a maximum of eight days.
| 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: 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 8 days of monitoring
Secondary outcomes (6)
Duration of complete peripheral saturation data
Measured: Up to 8 days of monitoring
Duration of complete blood pressure data
Measured: Up to 8 days of monitoring
Cummulated duration of desaturation
Peripheral saturation below 88% and 85%
Measured: Up to 8 days of monitoring
Number of events with SpO2 < 88% in at least 10 consecutive minutes
Measured: Up to 8 days of monitoring
Number of events with SpO2 < 85% in at least 5 consecutive minutes
Measured: Up to 8 days of monitoring
Number of deviating vital parameters in accordance to defined microevents
Measured: Up to 8 days of monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start1 Aug 2021
- Primary completion15 Jun 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vital SignStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- 80 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Denmark, University Hospital Bispebjerg and Frederiksberg
- Responsible party
- Principal investigator, Vibeke Eriksen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Vibeke R Eriksen, MD, PhD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05223504
- Sponsor's protocol ID
- WARD-Home feasibility
- Status last verified
- Jun 2022
- First submitted
- 20 Jan 2022
- Last updated
- 28 Jun 2022
- 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 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WARD-Home - Continuous Monitoring of Vital Parameters for Early Detection of Complications in Patients Discharged After Acute Medical Hospitalization
- ClinicalTrials.gov ID
- NCT05223504
- Acronym / sponsor ID
- WARD-Home feasibility
- Conditions
- Vital Sign, Clinical Deterioration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Technical University of Denmark, University Hospital Bispebjerg and Frederiksberg
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 4 Feb 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 pilot 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 in this patient group.
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 pilot 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observed patients | – | Device: 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 |
|---|---|---|
| Continuously monitoringIncluded patients are monitored with WARD equipment during the last part of hospitalization and the first days after discharge. Monitoring will last for a maximum of eight days. | Device | Observed patients |
Primary outcome
Duration of data collection from the Lifetouch patch
Time frame: Up to 8 days of monitoring
6 secondary outcomes
Duration of complete peripheral saturation data
Time frame: Up to 8 days of monitoring
Duration of complete blood pressure data
Time frame: Up to 8 days of monitoring
Cummulated duration of desaturation
Time frame: Up to 8 days of monitoring
Number of events with SpO2 < 88% in at least 10 consecutive minutes
Time frame: Up to 8 days of monitoring
Number of events with SpO2 < 85% in at least 5 consecutive minutes
Time frame: Up to 8 days of monitoring
Number of deviating vital parameters in accordance to defined microevents
Time frame: Up to 8 days 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 Jun 2022.
- 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.
Vibeke R Eriksen, MD, PhD principal investigator
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 Vital Sign and Clinical Deterioration, run by Copenhagen University Hospital, Rigshospitalet 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 Jun 2022. 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 8 days 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 Jun 2022.