User ExperienceNCT06289699
Alert Frequency, Nurse, and Patient Satisfaction With a wCVSM Software Across Health Care Systems and Cultures
An observational study of User Experience and Postoperative Complications, run by Christian S. Meyhoff at 5 sites in 5 countries.
Trial summary
The goal of this prospective, international multi-centre pilot study is to assess the functionality and user experience of a new vital sign monitoring system in 20 patients and 20 nurses in the general ward at each centre. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- User Experience, Postoperative Complications, Acute Medical Conditions
- How many people
- 100 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 26 Feb 2024to 31 Dec 2026
- 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: 20 Patients in the general ward (surgical or medical) will be monitored with wCVSM and answer a questionnaire afterwards. 20 nurses will answer a questionnaire after having had the responsibility for a monitored patient for a full shift (including a shift where monitoring is initiated or a shift where the patient is discharged). Therefore, multiple nurses can be interviewed per patient. Patients will in addition have vital signs monitored as per standard practice. Participants will be recruited from wards at the study sites.
Who may be able to join
- Adults (≥18 years)
- Expected stay in the hospital ≥2 days
- Admitted for surgery with expected duration of surgery >2 hours or admitted for acute medical condition with at least one of the following vital sign deviations within 24 hours of acute admission, recorded by the staff
- RR > 21 breaths pr minute
- RR < 11 breaths pr minute
- Pulse (P) > 91 beats pr minute
Show all 10Show fewer
- Pulse (P) < 50 beats pr minute
- SpO2 < 94 % without oxygen supplementation
- Systolic BP < 110 mmHg
- Systolic BP > 220 mmHg
Who cannot join
- Participant expected not to cooperate with study procedures.
- Allergy to plaster or silicone.
- Pacemaker or Implantable Cardioverter Defibrillator (ICD) device.
- Inability to give informed consent.
Trial locations and contacts
5 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
Eske Kvanner Aasvang, MD contact
5 sites in 5 countries
United States1 site, 1 recruiting
- Not yet recruiting
The Cleveland Clinic Foundation, General Anesthesiology
Cleveland, Ohio, 44195
Daniel Sessler, MD
Daniel Sessler, MD
Germany1 site
- Completed
Universitätsklinikum Hamburg-Eppendorf (UKE), Zentrum für Anästhesiologie und Intensivmedizin, Klinik und Poliklinik für Anästhesiologie
Hamburg, 20246
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen, Department of Anesthesiology
Groningen, 9700
Marjolein Haveman, TP
Marjolein Haveman, TP
Norway1 site
- Completed
St. Olavs Hospital HF, Klinikk for anestesi og intensivmedisin
Trondheim, 7006
United Kingdom1 site, 1 recruiting
- Not yet recruiting
Liverpool University Hospitals NHS Foundation Trust
Liverpool, L7 8YE
Ingeborg Welters, Dr. Med.
Ingeborg Welters, Dr. Med.
About this study
Official title: Alert Frequency, Nurse, and Patient Satisfaction With a Continuous Wireless Vital Sign Monitoring Software Across Health Care Systems and Cultures
The goal of this prospective, international multi-centre pilot study is to assess the functionality and user experience of a new vital sign monitoring system in 20 patients and 20 nurses in the general ward at each centre. The patients will be monitored with a wireless, continuous vital sign monitoring systems and answer a questionnaire afterwards. They will in addition have vital signs monitored as per standard practice. The nurses will answer a questionnaire after having had the responsibility for a monitored patient for a full shift. The main aims are: To determine the frequency of alerts activated in the app in relation to the alerts that should be activated based on measured data, to explore current practices of in-hospital monitoring by semi-structured interviews to map differences across systems and to test nurse and patient satisfaction.
Read the detailed description
The participants will be monitored for 4 days postoperatively or for 4 days after acute admission and until discharge.
Monitoring devices used in this study will be validated FDA or/and CE approved devices used within their original purpose. Centers can choose to use Sotera Visimobile or Isansys Lifeguard with accompanying sensors. These devices will be used together with the CE approved WARD web and mobile application.
Study sites include: St. Olav Hospital Trondheim, Royal Liverpool University Hospital, University Medical Centre Hamburg-Eppendorf,University Medical Centre Groningen, The Netherlands and the Cleveland Clinic.
- Keywords
- continuous wireless vital sign monitoring, vital sign deviation, healthcare system and culture, User Experience, Postoperative Complications, Acute Medical Conditions
- Medical subject headings
- Postoperative Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of alerts activated in the app in relation to the alerts that should be activated based on measured data
Measured: during monitoring period, on average 3 months
Secondary outcomes (12)
Technical feasibility
will be assessed as data capture of vital signs as percentage of data from each of the vital sign sensors of the total monitoring period.
Measured: during monitoring period, on average 3 months
Alert relay to smartphones
will be assessed by comparing % of alerts received compared to alerts generated by the WARD24/7 App.
Measured: during monitoring period, on average 3 months
Response to alerts
will be assessed using the response buttons as % of nurses pressing attend, snooze, or refer to colleague on the WARD24/7 App.
Measured: during monitoring period, on average 3 months
Patients experiences from being monitored with wCSVM.
will be assessed by a questionnaire named "Patient experience with wireless vital sign monitorering" consisting of 8 items. Each item can be answered with: strongly agree, agree, neither agree nor disagree, disagree, and strongly disagree.
Measured: during monitoring period, on average 3 months
Relevance of alarms
by using feedback from the nurses given in the app, % of relevant alerts
Measured: during monitoring period, on average 3 months
Frequency of delivered alarms on oxygen saturation (SpO2) pr patient pr day
Measured: during monitoring period, on average 3 months
Frequency of delivered alarms on respiration rate (RR) pr patient pr day
Measured: during monitoring period, on average 3 months
Frequency of delivered alarms on heart rate (HR) pr patient pr day
Measured: during monitoring period, on average 3 months
Frequency of delivered alarms on blod pressure (BP) pr patient pr day
Measured: during monitoring period, on average 3 months
Overall score of user satisfaction from use of WARD24/7 app
assessed by the mHealth App Usability Questionnaire (MAUQ) consisting of 18 items. In this questionnaire, 1 - strongly disagree, 2 - disagree, 3 - somewhat disagree, 4 - neither agree nor disagree, 5 - somewhat agree, 6 - agree, 7 - strongly agree.To determine the usability of an app, calculate the total and determine the average of the responses to all statements. The higher the overall average, the higher the usability of the app.
Measured: during monitoring period, on average 3 months
Subscale MAUQ scores
assessed by the mHealth App Usability Questionnaire (MAUQ) consisting of 18 items. In this questionnaire, 1 - strongly disagree, 2 - disagree, 3 - somewhat disagree, 4 - neither agree nor disagree, 5 - somewhat agree, 6 - agree, 7 - strongly agree.To determine the usability of an app, calculate the total and determine the average of the responses to all statements. The higher the overall average, the higher the usability of the app.
Ease of use and satisfaction (5 items, MAUQ_E), system information arrangement (7 items, MAUQ_I), and usefulness (6 items, MAUQ_U).
Measured: during monitoring period, on average 3 months
Monitoring practices prior to the wCVSM
assessed by a semi structured interview guide including information on type of monitoring (manual/intermittent, type of vital signs collected, frequency of measurements, escalation protocols etc.).
Measured: Baseline, on average 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start26 Feb 2024
- Primary completion1 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for User ExperienceStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christian S. Meyhoff
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Sponsor-investigator, Christian S. Meyhoff, University Hospital Bispebjerg and Frederiksberg
- Investigators
- Christian S Meyhoff, MD, PhD, Principal investigator, Copenhagen University Hospital - Bispebjerg and Frederiksberg, Copenhagen, DenmarkEske K Aasvang, MD, DMSci, Principal investigator, Rigshospitalet, Copenhagen University, Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06289699
- Sponsor's protocol ID
- WARD-CSS international 1251
- Status last verified
- Aug 2025
- First submitted
- 22 Jan 2024
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alert Frequency, Nurse, and Patient Satisfaction With a Continuous Wireless Vital Sign Monitoring Software Across Health Care Systems and Cultures
- ClinicalTrials.gov ID
- NCT06289699
- Acronym / sponsor ID
- WARD-CSS international 1251
- Keywords
- continuous wireless vital sign monitoring, vital sign deviation, healthcare system and culture, User Experience, Postoperative Complications, Acute Medical Conditions
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Christian S. MeyhoffUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Mar 2024 (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 goal of this prospective, international multi-centre pilot study is to assess the functionality and user experience of a new vital sign monitoring system in 20 patients and 20 nurses in the general ward at each centre. The patients will be monitored with a wireless, continuous vital sign monitoring systems and answer a questionnaire afterwards. They will in addition have vital signs monitored as per standard practice. The nurses will answer a questionnaire after having had the responsibility for a monitored patient for a full shift. The main aims are: To determine the frequency of alerts activated in the app in relation to the alerts that should be activated based on measured data, to explore current practices of in-hospital monitoring by semi-structured interviews to map differences across systems and to test nurse and patient satisfaction.
Detailed description
The participants will be monitored for 4 days postoperatively or for 4 days after acute admission and until discharge.
Monitoring devices used in this study will be validated FDA or/and CE approved devices used within their original purpose. Centers can choose to use Sotera Visimobile or Isansys Lifeguard with accompanying sensors. These devices will be used together with the CE approved WARD web and mobile application.
Study sites include: St. Olav Hospital Trondheim, Royal Liverpool University Hospital, University Medical Centre Hamburg-Eppendorf,University Medical Centre Groningen, The Netherlands and the Cleveland Clinic.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 20 Patients in the general ward (surgical or medical) will be monitored with wCVSM and answer a questionnaire afterwards. 20 nurses will answer a questionnaire after having had the responsibility for a monitored patient for a full shift (including a shift where monitoring is initiated or a shift where the patient is discharged). Therefore, multiple nurses can be interviewed per patient. Patients will in addition have vital signs monitored as per standard practice. Participants will be recruited from wards at the study sites.
Key inclusion criteria (10 listed)
- Adults (≥18 years)
- Expected stay in the hospital ≥2 days
- Admitted for surgery with expected duration of surgery >2 hours or admitted for acute medical condition with at least one of the following vital sign deviations within 24 hours of acute admission, recorded by the staff
Key exclusion criteria (4 listed)
- Participant expected not to cooperate with study procedures.
- Allergy to plaster or silicone.
- Pacemaker or Implantable Cardioverter Defibrillator (ICD) device.
- 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.
Primary outcome
Frequency of alerts activated in the app in relation to the alerts that should be activated based on measured data
Time frame: during monitoring period, on average 3 months
12 secondary outcomes
Technical feasibility
Time frame: during monitoring period, on average 3 months
Alert relay to smartphones
Time frame: during monitoring period, on average 3 months
Response to alerts
Time frame: during monitoring period, on average 3 months
Patients experiences from being monitored with wCSVM.
Time frame: during monitoring period, on average 3 months
Relevance of alarms
Time frame: during monitoring period, on average 3 months
Frequency of delivered alarms on oxygen saturation (SpO2) pr patient pr day
Time frame: during monitoring period, on average 3 months
Frequency of delivered alarms on respiration rate (RR) pr patient pr day
Time frame: during monitoring period, on average 3 months
Frequency of delivered alarms on heart rate (HR) pr patient pr day
Time frame: during monitoring period, on average 3 months
Frequency of delivered alarms on blod pressure (BP) pr patient pr day
Time frame: during monitoring period, on average 3 months
Overall score of user satisfaction from use of WARD24/7 app
Time frame: during monitoring period, on average 3 months
Subscale MAUQ scores
Time frame: during monitoring period, on average 3 months
Monitoring practices prior to the wCVSM
Time frame: Baseline, on average 3 months
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 12 Aug 2025.
- 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.
Eske Kvanner Aasvang, MD contact
Christian S Meyhoff, MD, PhD principal investigator
Copenhagen University Hospital - Bispebjerg and Frederiksberg, Copenhagen, Denmark
Eske K Aasvang, MD, DMSci principal investigator
Rigshospitalet, Copenhagen University, Copenhagen, Denmark
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of User Experience and Postoperative Complications, run by Christian S. Meyhoff at 5 sites in 5 countries.
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 10 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: looking for participants now, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Germany, Netherlands, Norway, United Kingdom. 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?
Contact Katja K Head of Clinical, MD (004528781188 ext. 004528781188, katja.groenbaek@ward247.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of alerts activated in the app in relation to the alerts that should be activated based on measured data (time frame: during monitoring period, on average 3 months). 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 12 Aug 2025.