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
About this trial
This is an interventional prevention trial for Carcinoma, Pancreatic Ductal
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.
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
NCT ID
NCT02933307
First Posted
July 25, 2016
Last Updated
April 24, 2017
Sponsor
Radboud University Medical Center
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
Learn more about this trial
Continuous Monitoring on the General Ward
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