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Continuous Monitoring on the General Ward


2015-04


2016-08


2016-09


90

Study Overview

Continuous Monitoring on the General Ward

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.

N/A

  • Carcinoma, Pancreatic Ductal
  • Colorectal Neoplasms
  • Arthritis
  • Hypertension
  • Sepsis
  • DEVICE: HealthPatch
  • DEVICE: ViSi Mobile
  • HEEL-2015-03

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2016-07-25  

N/A  

2017-04-24  

2016-10-13  

N/A  

2017-04-25  

2016-10-14  

N/A  

2016-07  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Prevention


Allocation:
Randomized


Interventional Model:
Parallel


Masking:
None


Arms and Interventions

Participant Group/ArmIntervention/Treatment
NO_INTERVENTION: Control group

Patients with regular measurements by nurses only (Modified Early Warning Score (MEWS))

EXPERIMENTAL: HealthPatch (Intervention)

Patients with HealthPatch and regular MEWS measurements

DEVICE: HealthPatch

  • 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
EXPERIMENTAL: ViSi Mobile (Intervention)

Patients with ViSi Mobile and regular MEWS measurements

DEVICE: ViSi Mobile

  • 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.
Primary Outcome MeasuresMeasure DescriptionTime Frame
Expectations & experiences of patientsInterviews of 15-20 minutes with patients after 2-3 days wearing a device or control group2-3 days after informed consent
Expectations & experiences of care giversInterviews with nurses of 15-20 minutes at the end of the study. Estimated amount of 6 nurses1 year
Secondary Outcome MeasuresMeasure DescriptionTime Frame
MEWS scores based on continuous data and data measured by nurses3 times a day, up to three days.
Amount of alarms by HealthPatch or ViSi Mobileduring 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 alarmsduring 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
Duration of ICU hospitalization in daysduring 2-3 days when the patient participates in this study
Complications caused by disease or surgical procedureduring 2-3 days when the patient participates in this study
Adverse events caused by devicesE.g. Itch or rednessduring 2-3 days when the patient wears a device
Technical failures of devices (artifacts: a period longer than 1 minute the device does not measure vital parameters)during 2-3 days when the patient wears a device
Outcomes of the State Trait Anxiety Inventory (STAI)Once a day during the 2-3 days the patient participantes in this study
Outcomes of the Pain Catastrophizing Scale (PCS)On day 2 or 3 when patients participates in the study
System usability Scale1 year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:

  • 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.

  • Exclusion Criteria:

  • Frequency of MEWS measurements is less than three times a day.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.


    • PRINCIPAL_INVESTIGATOR: Harry van Goor, MD, PhD, FRCS, Radboud University Medical Center

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    • 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.