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CoMo

???Implementation of Continuous Monitoring at the General Ward for the Right Care at the Right Place?? - ???Implementation of Continuous Monitoring at the General Ward for the Right Care at the Right Place??

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON58467
Enrollment
690
Registered
2026-03-17
Start date
2026-03-24
Completion date
Unknown
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with (risk of) sepsis or infection, after a kidney-transplant, with Obstructive Sleep Apnea Syndrome Blood-poisining or inflammation, kidney-transplantation, sleep apnea or breathing pauses during sleep

Interventions

The intervention under research is the implementation of continuous monitoring with wearable sensors by the three different patientgroups.&nbsp

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Nurses• Inclusion criteria:• Employed at one of the participating wards where continuous monitoring is implemented.• Directly involved in patient care and use of wearable monitoring technology.• Willing and able to complete questionnaires and/or participate in interviews or focus groups.• Provide informed consent for participation in the study. Patients• Inclusion criteria:• Adults (=18 years) admitted to a general ward at UMCG.• Belong to one of the three target groups:o Postoperative patients with (risk of) obstructive sleep apnea (OSAS).o Patients after kidney transplantation requiring intensive monitoring.o Patients at risk of sepsis admitted from the emergency department.• Receive continuous monitoring using wearable sensors as part of standard care (for prospectivedata collection).• Provide informed consent for participation in the study (for prospective data collection).

Exclusion criteria

Exclusion criteria: Nurses:• Exclusion criteria:• Not involved in direct patient care or not working on the participating wards.• Temporary staff or interns without sufficient exposure to the monitoring system.• Decline to participate or do not provide informed consent. Patients:• Exclusion criteria:• Patients under 18 years of age.• Patients who do not receive continuous monitoring as part of their care (for prospective datacollection).• Patients unable to provide informed consent (e.g., due to cognitive impairment or languagebarriers without available translation) (for prospective data collection).• Patients admitted to wards not participating in the implementation.

Design outcomes

Primary

MeasureTime frame
6.1.1. For primary outcomes:Process evaluation: During the first three months of implementation, nurse and patient experiences withcontinuous monitoring using wearable sensors will be evaluated using a mixed-methods approach:Month 1-3:• Semi-structured interviews with 10–12 nurses, exploring:o Introduction and experiences: How nurses were introduced to continuous monitoring withwearable sensors and their practical experiences.o Knowledge and use: Existing knowledge and experience with sensor-based monitoring andhow information was communicated.o Perception and motivation: Attitudes toward the technology and whether it motivatesuse, including reasons why.Value and impact: Perceived benefits for nurses and patients, and differences before andafter implementation.o Protocol and training: Clarity of the protocol, training needs, and suggestions forimprovement.o Effect on work: Impact on daily tasks (supportive, simplifying, hindering).o Future application: How this monitoring could improve patient care.• Semi-structured interviews with 8-10 patients, exploring:o Individual experiences: Positive and negative experiences with wearing sensors and beingcontinuously monitored.o Communication with staff: How interactions and information exchange with nurses anddoctors were perceived during monitoring.o Sense of security: Whether continuous monitoring contributed to feeling safe and caredfor, or caused concerns.o Mobility and self-management: Impact on freedom of movement, comfort, and ability tomanage daily activities independently.o Perceived benefits and drawbacks: How patients view the overall value of monitoring fortheir care and recovery.o Suggestions for improvement: Ideas or feedback on how the technology or its use couldbe optimized for patient comfort and care.• Questionnaires for nurses (n=50) to evaluate the attitude and adoption of technology of the targetpopulation, including:o Normalization Process Theory (NPT): Assessed using the validated Normalization Measure

Secondary

MeasureTime frame
Implementation Process• Activity logs during implementation• Documented work agreements• Roles and responsibilities• Infrastructure and SOPs• Educational sessions and frequency of contact• Staff deploymentQuality of Care, Care Logistics and Care CapacityElectronic Health Record (EHR) data:• Demographics: age, sex, diagnosis• Preoperative data: ASA classification, STOPBANG• Length of stay per unit (PACU, ICU, ward)• Diagnostic procedures• Bed occupancy and staffing per day• Complications (Clavien-Dindo), medication administration• MEWS and pain scores• Unplanned ICU admissions• 30-day mortality• Rapid response team (SIT) calls• Consultations by ICU liaison nurses (CIV)• Transfers and discharge destinations• Communication events between CMU and ward staf (as reported in the EHR)Prospective monitoring data:• Vital signs and waveforms measured by the sensors• Number of alarms based on sensor data• FTEs required for monitoring Healthcare costs• Cost-consequence analysis following McIntosh et al. (1999)• Budget impact analysis (1–5 year horizon) from the provider perspective, including sensitivityanalysis (Mauskopf et al., 2007)

Countries

Netherlands

Contacts

Public ContactL Wijngaarden

Universitair Medisch Centrum Groningen

l.wijngaarden@umcg.nl0625651679

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: May 22, 2026