Alert Frequency, Nurse, and Patient Satisfaction With a wCVSM Software Across Health Care Systems… (NCT06289699) | Clinical Trial Compass
RecruitingNot Applicable
Alert Frequency, Nurse, and Patient Satisfaction With a wCVSM Software Across Health Care Systems and Cultures
United States, Germany, Netherlands100 participantsStarted 2024-02-26
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* Pulse (P) \< 50 beats pr minute
* SpO2 \< 94 % without oxygen supplementation
* Systolic BP \< 110 mmHg
* Systolic BP \> 220 mmHg
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency of alerts activated in the app in relation to the alerts that should be activated based on measured data
Timeframe: during monitoring period, on average 3 months