Clinical trial NCT02933307: Continuous Monitoring on the General Ward
Official title: Continuous Monitoring of Vital Signs in Hospitalized Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carcinoma, Pancreatic Ductal
Colorectal Neoplasms
Arthritis
Hypertension
Sepsis
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2016-10-14
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Expectations & experiences of patients
timeFrame: 2-3 days after informed consent
measure: Expectations & experiences of care givers
timeFrame: 1 year
Secondary outcomes:
measure: MEWS scores based on continuous data and data measured by nurses
timeFrame: 3 times a day, up to three days.
measure: Amount of alarms by HealthPatch or ViSi Mobile
timeFrame: during 2-3 days when the patient wears a device
measure: Time between alarm (continuous data) and next regular MEWS measurement (nurse)
timeFrame: during 2-3 days when the patient wears a device
measure: Amount of extra MEWS measurements by nurses due to alarms
timeFrame: during 2-3 days when the patient wears a device
measure: Admission to ICU (yes/no)
timeFrame: during 2-3 days when the patient participates in this study
measure: Duration of ICU hospitalization in days
timeFrame: during 2-3 days when the patient participates in this study
measure: Complications caused by disease or surgical procedure
timeFrame: during 2-3 days when the patient participates in this study
measure: Adverse events caused by devices
timeFrame: during 2-3 days when the patient wears a device
measure: Technical failures of devices (artifacts: a period longer than 1 minute the device does not measure vital parameters)
timeFrame: during 2-3 days when the patient wears a device
measure: Outcomes of the State Trait Anxiety Inventory (STAI)
timeFrame: Once a day during the 2-3 days the patient participantes in this study
measure: Outcomes of the Pain Catastrophizing Scale (PCS)
timeFrame: On day 2 or 3 when patients participates in the study
measure: System usability Scale
timeFrame: 1 year
Other outcomes:
measure: Gender
timeFrame: On day 1 when patients participates in the study
measure: Age
timeFrame: On day 1 when patients participates in the study
measure: Diagnosis
timeFrame: On day 1 when patients participates in the study
measure: Performed surgical procedure
timeFrame: On day 1 when patients participates in the study
Locations:
Study officials:
affiliation: Radboud University Medical Center
name: Harry van Goor, MD, PhD, FRCS
role: PRINCIPAL_INVESTIGATOR
References:
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.