MonitoringNCT05181111
Continuous Monitoring of Patients in and After the Acute Admission Ward to Optimize Clinical Pathways
A study testing Wearable Sensor in people with Monitoring and Clinical Deterioration, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
Hospitals aim to hospitalize patients when necessary and discharge patients when possible. However, the triage process and discharge management of patients in e.g. the Acute Admission Ward, is not a trivial task. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Monitoring, Clinical Deterioration, Acute Disease
- What is being tested?
- Wearable Sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 Dec 2021to 8 Nov 2023
- Phase
- Interventional
- 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
Who may be able to join
- In order for a patient to be eligible to participate in this study, the following criteria need to be met:
- admitted to the AAW
- Age ≥ 18 years
- Able to speak and read Dutch
- Willing and able to provide written informed consent
Who cannot join
- A patient who meets any of the following criteria will be excluded from participation:
- Not able or willing to wear a wearable sensor on the chest continuously for 14 days
- Planned major surgery in the upcoming 30 days
- At the time of AAW admission already known to be discharged home or admitted to the hospital
- Any skin condition, for example prior rash, discoloration, scars, infection, injury or open wounds at the area (Left lower rib) where the sensor needs to be placed
- Known sensitivity to medical adhesives
Show all 10Show fewer
- Wearing an active implantable device (e.g. ICD, pacemaker)
- Intend to go to the sauna or go swimming in the upcoming 14 days
- Pregnant or breastfeeding
- Use of creams or lotions that are known to influence the skin at the area where sensor is placed (such as medical and non-medical creams or lotions)
Trial locations and contacts
1 site in 1 country.
About this study
Hospitals aim to hospitalize patients when necessary and discharge patients when possible. However, the triage process and discharge management of patients in e.g. the Acute Admission Ward, is not a trivial task. The upcoming technology of wearable monitoring devices, whereby patients can be continuously monitored with an unobtrusive vital signs device, might help getting more insight into patients' health condition and thus help facilitate efficient and effective triaging.
Therefore, the primary objective is to assess the effects of continuous monitoring of patients in the acute admission ward (AAW) on the percentage of patients who can be discharged home. Secondary objectives are to assess the length of stay in the acute admission ward and in the in-hospital wards, as well as the effect on admission to the intensive care unit, rapid response team calls and hospital readmission. The predictive value of algorithms applied to the monitoring data combined with other parameters to detect timely deterioration and predict discharge will be assessed. Facilitators and barriers for implementing such a system will be investigated.
- Conditions
- Monitoring, Clinical Deterioration, Acute Disease
- Being tested
- Wearable Sensor, Usual Care
- Keywords
- prediction, acute admission ward, continuous monitoring
- Medical subject headings
- Clinical Deterioration, Acute Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable SensorDevice
Also called Philips Healthdot
The sensor measures vital signs including heart rate and respiratory rate, posture and level of physical activity.
Usual CareOther
Usual Care Monitoring
| Study group | Role | What they receive |
|---|---|---|
| Monitoring Group | Experimental | wearable sensor, besides usual care monitoring Receives: Device: Wearable Sensor; Other: Usual Care |
| Usual Care group | Other | usual care monitoring Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients discharged home from acute admission ward
Percentage of patients discharged home from acute admission ward
Measured: up to 7 days
Secondary outcomes (5)
Length of stay in the acute admission ward
Length of stay in the acute admission ward
Measured: up to 7 days
Length of stay in the in-hospital wards
Length of stay in the in-hospital wards
Measured: up to 31 days
Percentage of Rapid Response Team calls
Percentage of Rapid Response Team calls
Measured: up to 31 days
Percentage of Intensive Care Unit Admissions
Percentage of Intensive Care Unit Admissions
Measured: up to 31 days
Percentage of unplanned readmissions to the hospitals
Percentage of unplanned readmissions to the hospitals
Measured: up to 31 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start6 Dec 2021
- Primary completion8 Nov 2023
- Study completion8 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Twente, Philips Research Eindhoven
- Responsible party
- Sponsor
- Investigators
- Carine JM Doggen, Prof PhD, Principal investigator, Rijnstate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05181111
- Sponsor's protocol ID
- LHC 2021-1838
- Status last verified
- Aug 2026
- First submitted
- 23 Dec 2021
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Kant N, Garssen SH, Vernooij CA, Mauritz GJ, Koning MV, Bosch FH, Doggen CJM. Enhancing discharge decision-making through continuous monitoring in an acute admission ward: a randomized controlled trial. Intern Emerg Med. 2024 Jun;19(4):1051-1061. doi: 10.1007/s11739-024-03582-y. Epub 2024 Apr 15.
PubMed 38619713Garssen SH, Kant N, Vernooij CA, Mauritz GJ, Koning MV, Bosch FH, Doggen CJM. Continuous monitoring of patients in and after the acute admission ward to improve clinical pathways: study protocol for a randomized controlled trial (Optimal-AAW). Trials. 2023 Jun 15;24(1):405. doi: 10.1186/s13063-023-07416-8.
PubMed 37316919
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Monitoring of Patients in and After the Acute Admission Ward to Optimize Clinical Pathways
- ClinicalTrials.gov ID
- NCT05181111
- Acronym / sponsor ID
- LHC 2021-1838
- Conditions
- Monitoring, Clinical Deterioration, Acute Disease
- Keywords
- prediction, acute admission ward, continuous monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Collaborators
- University of Twente, Philips Research Eindhoven
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 8 Nov 2023 (actual)
- Study completion
- 8 Nov 2023 (actual)
- First posted
- 6 Jan 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.
Hospitals aim to hospitalize patients when necessary and discharge patients when possible. However, the triage process and discharge management of patients in e.g. the Acute Admission Ward, is not a trivial task. The upcoming technology of wearable monitoring devices, whereby patients can be continuously monitored with an unobtrusive vital signs device, might help getting more insight into patients' health condition and thus help facilitate efficient and effective triaging.
Therefore, the primary objective is to assess the effects of continuous monitoring of patients in the acute admission ward (AAW) on the percentage of patients who can be discharged home. Secondary objectives are to assess the length of stay in the acute admission ward and in the in-hospital wards, as well as the effect on admission to the intensive care unit, rapid response team calls and hospital readmission. The predictive value of algorithms applied to the monitoring data combined with other parameters to detect timely deterioration and predict discharge will be assessed. Facilitators and barriers for implementing such a system will be investigated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monitoring Group | Experimental | Device: Wearable Sensor, Other: Usual Carewearable sensor, besides usual care monitoring |
| Usual Care group | Other | Other: Usual Careusual care monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- In order for a patient to be eligible to participate in this study, the following criteria need to be met:
- admitted to the AAW
- Age ≥ 18 years
- Able to speak and read Dutch
- Willing and able to provide written informed consent
Key exclusion criteria (10 listed)
- Not able or willing to wear a wearable sensor on the chest continuously for 14 days
- Planned major surgery in the upcoming 30 days
- At the time of AAW admission already known to be discharged home or admitted to the hospital
- Any skin condition, for example prior rash, discoloration, scars, infection, injury or open wounds at the area (Left lower rib) where the sensor needs to be placed
- Known sensitivity to medical adhesives
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 |
|---|---|---|
| Wearable SensorAlso: Philips HealthdotThe sensor measures vital signs including heart rate and respiratory rate, posture and level of physical activity. | Device | Monitoring Group |
| Usual CareUsual Care Monitoring | Other | Monitoring Group, Usual Care group |
Primary outcome
Percentage of patients discharged home from acute admission ward
Time frame: up to 7 days
Percentage of patients discharged home from acute admission ward
5 secondary outcomes
Length of stay in the acute admission ward
Time frame: up to 7 days
Length of stay in the in-hospital wards
Time frame: up to 31 days
Percentage of Rapid Response Team calls
Time frame: up to 31 days
Percentage of Intensive Care Unit Admissions
Time frame: up to 31 days
Percentage of unplanned readmissions to the hospitals
Time frame: up to 31 days
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 14 Aug 2026.
- Derived from this study: PubMed 38619713Kant N, Garssen SH, Vernooij CA, Mauritz GJ, Koning MV, Bosch FH, Doggen CJM. Enhancing discharge decision-making through continuous monitoring in an acute admission ward: a randomized controlled trial. Intern Emerg Med. 2024 Jun;19(4):1051-1061. doi: 10.1007/s11739-024-03582-y. Epub 2024 Apr 15.
- Derived from this study: PubMed 37316919Garssen SH, Kant N, Vernooij CA, Mauritz GJ, Koning MV, Bosch FH, Doggen CJM. Continuous monitoring of patients in and after the acute admission ward to improve clinical pathways: study protocol for a randomized controlled trial (Optimal-AAW). Trials. 2023 Jun 15;24(1):405. doi: 10.1186/s13063-023-07416-8.
- Individual participant dataSharing planned: Yes
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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.
Carine JM Doggen, Prof PhD principal investigator
Rijnstate Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable Sensor in people with Monitoring and Clinical Deterioration, run by Rijnstate Hospital at 1 site in Netherlands.
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 5 inclusion and 10 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 14 Aug 2026. 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 Netherlands. 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?
Percentage of patients discharged home from acute admission ward (time frame: up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05181111, which also lists 2 linked publications.
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 14 Aug 2026.