Continuous Monitoring on the General Ward
Continuous Monitoring of Vital Signs in Hospitalized Patients
1 other identifier
interventional
90
0 countries
N/A
Brief Summary
Rationale: Monitoring patients' vital signs is done to detect clinical deterioration. For this, the MEWS, a scoring list comprising seven vital signs measured by nursing staff, is used. Although the MEWS provides relevant data on patients' health status, the interval measurements may not capture early deterioration of vital signs, especially during the night. As a result, unsafe situations may occur such as periods of low oxygen saturation and cardiac arrhythmias, which are known to complicate postoperative course. Besides, this way of measuring vital signs may be stressful for patients and disturbs patients' sleep. New technology such as ViSi Mobile and HealthPatch allows for remote continuous monitoring of vital signs using wearable devices transmitting relevant data to nurses and clinicians. With this, the investigators think that clinical deterioration may be detected in an early phase and reduce nurse work load and patient distress. Objective: to investigate the feasibility of wearable devices on the general ward. Study design: feasibility study. Study population: adult patients hospitalized on the internal medicine ward and adult postoperative patients on the surgical ward. Intervention: patients in the intervention groups will be randomized in one of the two groups. Patients in the group 1 will wear ViSi Mobile; patients in group 2 will wear the HealthPatch. Wearable devices will be worn for at least three days. Regular MEWS measurements take place at usual time points. Main study parameters/endpoints: Evaluation with patient and care givers (primary outcome measure), MEWS calculations, time between alarm (continuous data) and next regular MEWS measurement (nurse), intervention by nurse after alarm, admission to ICU, complications, side effects of devices, STAI scores, and PCS scores will be documented. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will wear one device for at least three days. Devices can be uncomfortable by being heavy or the patches can start itching. More measurements by nurses can take place when indicated, for example after alarms. The participating patients will fill out the STAI on daily basis and the PCS on the last day of hospitalization. Both questionnaires will take a few minutes to complete. Patients could benefit from early detection of clinical deterioration and early corrective interventions or ICU admissions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 25, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedFirst Posted
Study publicly available on registry
October 14, 2016
CompletedApril 25, 2017
July 1, 2016
1.3 years
July 25, 2016
April 24, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Expectations & experiences of patients
Interviews of 15-20 minutes with patients after 2-3 days wearing a device or control group
2-3 days after informed consent
Expectations & experiences of care givers
Interviews with nurses of 15-20 minutes at the end of the study. Estimated amount of 6 nurses
1 year
Secondary Outcomes (12)
MEWS scores based on continuous data and data measured by nurses
3 times a day, up to three days.
Amount of alarms by HealthPatch or ViSi Mobile
during 2-3 days when the patient wears a device
Time between alarm (continuous data) and next regular MEWS measurement (nurse)
during 2-3 days when the patient wears a device
Amount of extra MEWS measurements by nurses due to alarms
during 2-3 days when the patient wears a device
Admission to ICU (yes/no)
during 2-3 days when the patient participates in this study
- +7 more secondary outcomes
Other Outcomes (4)
Gender
On day 1 when patients participates in the study
Age
On day 1 when patients participates in the study
Diagnosis
On day 1 when patients participates in the study
- +1 more other outcomes
Study Arms (3)
Control group
NO INTERVENTIONPatients with regular measurements by nurses only (Modified Early Warning Score (MEWS))
HealthPatch (Intervention)
EXPERIMENTALPatients with HealthPatch and regular MEWS measurements
ViSi Mobile (Intervention)
EXPERIMENTALPatients with ViSi Mobile and regular MEWS measurements
Interventions
The HealthPatch (Vital Connect) is a wireless patch and continuously measures single-lead ECG, heart rate, respiratory rate, stress, skin temperature, body posture and steps
ViSi Mobile (Sotera Wireless) is wireless device that is able to continuously measure all important vital parameters: ECG, heart rate, oxygen saturation, blood pressure, respiratory rate and skin temperature.
Eligibility Criteria
You may qualify if:
- Patient is 18 years or older on the day the informed consent will be signed.
- Patient is hospitalized on the surgical or internal medicine ward.
- MEWS measurements are required at least three times a day.
- Patient is able to speak, read and understand the local language of the investigational site, is familiar with the procedures of the study, and agrees to participate in the study program by giving oral and written informed consent prior to screening evaluations.
You may not qualify if:
- Frequency of MEWS measurements is less than three times a day.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Weenk M, Bredie SJ, Koeneman M, Hesselink G, van Goor H, van de Belt TH. Continuous Monitoring of Vital Signs in the General Ward Using Wearable Devices: Randomized Controlled Trial. J Med Internet Res. 2020 Jun 10;22(6):e15471. doi: 10.2196/15471.
PMID: 32519972DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Harry van Goor, MD, PhD, FRCS
Radboud University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2016
First Posted
October 14, 2016
Study Start
April 1, 2015
Primary Completion
August 1, 2016
Study Completion
September 1, 2016
Last Updated
April 25, 2017
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will not share