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Continuous Monitoring on the General Ward

Primary Purpose

Carcinoma, Pancreatic Ductal, Colorectal Neoplasms, Arthritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HealthPatch
ViSi Mobile
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Carcinoma, Pancreatic Ductal

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Experimental

    Experimental

    Arm Label

    Control group

    HealthPatch (Intervention)

    ViSi Mobile (Intervention)

    Arm Description

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

    Patients with HealthPatch and regular MEWS measurements

    Patients with ViSi Mobile and regular MEWS measurements

    Outcomes

    Primary Outcome Measures

    Expectations & experiences of patients
    Interviews of 15-20 minutes with patients after 2-3 days wearing a device or control group
    Expectations & experiences of care givers
    Interviews with nurses of 15-20 minutes at the end of the study. Estimated amount of 6 nurses

    Secondary Outcome Measures

    MEWS scores based on continuous data and data measured by nurses
    Amount of alarms by HealthPatch or ViSi Mobile
    Time between alarm (continuous data) and next regular MEWS measurement (nurse)
    Amount of extra MEWS measurements by nurses due to alarms
    Admission to ICU (yes/no)
    Duration of ICU hospitalization in days
    Complications caused by disease or surgical procedure
    Adverse events caused by devices
    E.g. Itch or redness
    Technical failures of devices (artifacts: a period longer than 1 minute the device does not measure vital parameters)
    Outcomes of the State Trait Anxiety Inventory (STAI)
    Outcomes of the Pain Catastrophizing Scale (PCS)
    System usability Scale

    Full Information

    First Posted
    July 25, 2016
    Last Updated
    April 24, 2017
    Sponsor
    Radboud University Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02933307
    Brief Title
    Continuous Monitoring on the General Ward
    Official Title
    Continuous Monitoring of Vital Signs in Hospitalized Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2015 (Actual)
    Primary Completion Date
    August 2016 (Actual)
    Study Completion Date
    September 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Radboud University Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carcinoma, Pancreatic Ductal, Colorectal Neoplasms, Arthritis, Hypertension, Sepsis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    90 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Patients with regular measurements by nurses only (Modified Early Warning Score (MEWS))
    Arm Title
    HealthPatch (Intervention)
    Arm Type
    Experimental
    Arm Description
    Patients with HealthPatch and regular MEWS measurements
    Arm Title
    ViSi Mobile (Intervention)
    Arm Type
    Experimental
    Arm Description
    Patients with ViSi Mobile and regular MEWS measurements
    Intervention Type
    Device
    Intervention Name(s)
    HealthPatch
    Intervention Description
    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
    Intervention Type
    Device
    Intervention Name(s)
    ViSi Mobile
    Intervention Description
    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 Measure Information:
    Title
    Expectations & experiences of patients
    Description
    Interviews of 15-20 minutes with patients after 2-3 days wearing a device or control group
    Time Frame
    2-3 days after informed consent
    Title
    Expectations & experiences of care givers
    Description
    Interviews with nurses of 15-20 minutes at the end of the study. Estimated amount of 6 nurses
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    MEWS scores based on continuous data and data measured by nurses
    Time Frame
    3 times a day, up to three days.
    Title
    Amount of alarms by HealthPatch or ViSi Mobile
    Time Frame
    during 2-3 days when the patient wears a device
    Title
    Time between alarm (continuous data) and next regular MEWS measurement (nurse)
    Time Frame
    during 2-3 days when the patient wears a device
    Title
    Amount of extra MEWS measurements by nurses due to alarms
    Time Frame
    during 2-3 days when the patient wears a device
    Title
    Admission to ICU (yes/no)
    Time Frame
    during 2-3 days when the patient participates in this study
    Title
    Duration of ICU hospitalization in days
    Time Frame
    during 2-3 days when the patient participates in this study
    Title
    Complications caused by disease or surgical procedure
    Time Frame
    during 2-3 days when the patient participates in this study
    Title
    Adverse events caused by devices
    Description
    E.g. Itch or redness
    Time Frame
    during 2-3 days when the patient wears a device
    Title
    Technical failures of devices (artifacts: a period longer than 1 minute the device does not measure vital parameters)
    Time Frame
    during 2-3 days when the patient wears a device
    Title
    Outcomes of the State Trait Anxiety Inventory (STAI)
    Time Frame
    Once a day during the 2-3 days the patient participantes in this study
    Title
    Outcomes of the Pain Catastrophizing Scale (PCS)
    Time Frame
    On day 2 or 3 when patients participates in the study
    Title
    System usability Scale
    Time Frame
    1 year
    Other Pre-specified Outcome Measures:
    Title
    Gender
    Description
    Extraction from EHR
    Time Frame
    On day 1 when patients participates in the study
    Title
    Age
    Description
    Extraction from EHR
    Time Frame
    On day 1 when patients participates in the study
    Title
    Diagnosis
    Description
    Extraction from EHR
    Time Frame
    On day 1 when patients participates in the study
    Title
    Performed surgical procedure
    Description
    Extraction from EHR
    Time Frame
    On day 1 when patients participates in the study

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Harry van Goor, MD, PhD, FRCS
    Organizational Affiliation
    Radboud University Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32519972
    Citation
    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.
    Results Reference
    derived

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    Continuous Monitoring on the General Ward

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